{"id":18070,"date":"2020-05-05T10:28:43","date_gmt":"2020-05-05T03:28:43","guid":{"rendered":"https:\/\/pharmog.com\/wp\/?p=18070"},"modified":"2025-01-08T20:58:24","modified_gmt":"2025-01-08T13:58:24","slug":"brentuximab-adcetris","status":"publish","type":"post","link":"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/","title":{"rendered":"Brentuximab &#8211; Adcetris"},"content":{"rendered":"<h1><span class=\"ez-toc-section\" id=\"thong-tin-to-huong-dan-su-dung-cua-thuoc-adcetris\"><\/span>Th\u00f4ng tin t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a thu\u1ed1c Adcetris<span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p><em>Adcetris (Brentuximab) l\u00e0 thu\u1ed1c ph\u00e1t minh do c\u00f4ng ty Takeda s\u1ea3n xu\u1ea5t, thu\u1ed1c c\u00f3 ch\u1ee9a th\u00e0nh ph\u1ea7n ch\u00ednh l\u00e0 d\u01b0\u1ee3c ch\u1ea5t Brentuximab vedotin. Brentuximab vedotin \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u1edf ng\u01b0\u1eddi l\u1edbn \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1ec7nh u lympho Hodgkin v\u00e0 u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ho\u1eb7c u lympho \u1edf da t\u1ebf b\u00e0o T. Ngo\u00e0i ra Brentuximab c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p v\u1edbi c\u00e1c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb ung th\u01b0 kh\u00e1c v\u00e0 m\u1ed9t s\u1ed1 b\u1ec7nh kh\u00e1c m\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea trong t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng n\u00e0y. D\u01b0\u1edbi \u0111\u00e2y l\u00e0 n\u1ed9i dung t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a Thu\u1ed1c Adcetris (Th\u00f4ng tin bao g\u1ed3m li\u1ec1u d\u00f9ng, c\u00e1ch d\u00f9ng, ch\u1ec9 \u0111\u1ecbnh, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, th\u1eadn tr\u1ecdng, d\u01b0\u1ee3c l\u00fd&#8230;):<\/em><\/p><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_81 ez-toc-wrap-left counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">N\u1ed9i dung ch\u00ednh<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#thong-tin-to-huong-dan-su-dung-cua-thuoc-adcetris\" >Th\u00f4ng tin t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a thu\u1ed1c Adcetris<\/a><ul class='ez-toc-list-level-2' ><li class='ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#1-ten-hoat-chat-va-biet-duoc\" >1. T\u00ean ho\u1ea1t ch\u1ea5t v\u00e0 bi\u1ec7t d\u01b0\u1ee3c:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#2-dang-bao-che-%e2%80%93-ham-luong\" >2. D\u1ea1ng b\u00e0o ch\u1ebf &#8211; H\u00e0m l\u01b0\u1ee3ng:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#3-thong-tin-danh-cho-nguoi-su-dung\" >3. Th\u00f4ng tin d\u00e0nh cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng:<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#31-adcetris-la-thuoc-gi\" >3.1. Adcetris l\u00e0 thu\u1ed1c g\u00ec?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#32-cau-hoi-thuong-gap-pho-bien\" >3.2. C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p ph\u1ed5 bi\u1ebfn:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#4-thong-tin-danh-cho-nhan-vien-y-te\" >4. Th\u00f4ng tin d\u00e0nh cho nh\u00e2n vi\u00ean y t\u1ebf:<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#41-chi-dinh\" >4.1. Ch\u1ec9 \u0111\u1ecbnh:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#42-lieu-dung-%e2%80%93-cach-dung\" >4.2. Li\u1ec1u d\u00f9ng &#8211; C\u00e1ch d\u00f9ng:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#43-chong-chi-dinh\" >4.3. Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#44-than-trong\" >4.4 Th\u1eadn tr\u1ecdng:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#45-su-dung-cho-phu-nu-co-thai-va-cho-con-bu\" >4.5 S\u1eed d\u1ee5ng cho ph\u1ee5 n\u1eef c\u00f3 thai v\u00e0 cho con b\u00fa:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#46-tac-dung-khong-mong-muon-adr\" >4.6 T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n (ADR):<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#47-huong-dan-cach-xu-tri-adr\" >4.7 H\u01b0\u1edbng d\u1eabn c\u00e1ch x\u1eed tr\u00ed ADR:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#48-tuong-tac-voi-cac-thuoc-khac\" >4.8 T\u01b0\u01a1ng t\u00e1c v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#49-qua-lieu-va-xu-tri\" >4.9 Qu\u00e1 li\u1ec1u v\u00e0 x\u1eed tr\u00ed:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#5-co-che-tac-dung-cua-thuoc\" >5. C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng c\u1ee7a thu\u1ed1c :<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#51-duoc-luc-hoc\" >5.1. D\u01b0\u1ee3c l\u1ef1c h\u1ecdc:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#52-duoc-dong-hoc\" >5.2. D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#53-hieu-qua-lam-sang\" >5.3. Hi\u1ec7u qu\u1ea3 l\u00e2m s\u00e0ng:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#54-du-lieu-tien-lam-sang\" >5.4. D\u1eef li\u1ec7u ti\u1ec1n l\u00e2m s\u00e0ng:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#6-phan-thong-tin-kem-theo-cua-thuoc\" >6. Ph\u1ea7n th\u00f4ng tin k\u00e8m theo c\u1ee7a thu\u1ed1c:<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-23\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#61-danh-muc-ta-duoc\" >6.1. Danh m\u1ee5c t\u00e1 d\u01b0\u1ee3c:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-24\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#62-tuong-ky\" >6.2. T\u01b0\u01a1ng k\u1ef5 :<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-25\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#63-bao-quan\" >6.3. B\u1ea3o qu\u1ea3n:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-26\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#64-thong-tin-khac\" >6.4. Th\u00f4ng tin kh\u00e1c :<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-27\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#65-tai-lieu-tham-khao\" >6.5 T\u00e0i li\u1ec7u tham kh\u1ea3o:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-28\" href=\"https:\/\/pharmog.com\/wp\/brentuximab-adcetris\/#7-nguoi-dang-tai-tac-gia\" >7. Ng\u01b0\u1eddi \u0111\u0103ng t\u1ea3i \/T\u00e1c gi\u1ea3:<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n<h2><span class=\"ez-toc-section\" id=\"1-ten-hoat-chat-va-biet-duoc\"><\/span><strong>1. T\u00ean ho\u1ea1t ch\u1ea5t v\u00e0 bi\u1ec7t d\u01b0\u1ee3c: <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong><em>Ho\u1ea1t ch\u1ea5t :<\/em> <a href=\"https:\/\/pharmog.com\/wp\/brentuximab\/\">Brentuximab (Brentuximab vedotin)<\/a><\/strong><\/p>\n<p><strong><em>Ph\u00e2n lo\u1ea1i: <\/em><\/strong><em>Thu\u00f4\u0301c ch\u00f4\u0301ng ung th\u01b0 &gt; Kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng.<\/em><\/p>\n<p><strong><em>Nh\u00f3m<\/em><\/strong> <strong><em>ph\u00e1p l\u00fd: <\/em><\/strong><em>Thu\u1ed1c k\u00ea \u0111\u01a1n ETC \u2013 (Ethical drugs, prescription drugs, Prescription only medicine)<\/em><\/p>\n<p><strong><em>M\u00e3 ATC<\/em><\/strong> (Anatomical Therapeutic Chemical): L01XC12.<\/p>\n<p><strong><em>Bi\u1ec7t d\u01b0\u1ee3c g\u1ed1c:<\/em><\/strong> Adcetris<\/p>\n<p><strong><em>H\u00e3ng s\u1ea3n xu\u1ea5t <\/em><\/strong>: BSP Pharmaceuticals S.p.A (C\u1edf s\u1edf \u0111\u00f3ng g\u00f3i v\u00e0 xu\u1ea5t x\u01b0\u1edfng : Takeda Austria GmbH. \u0110\/c: St.Peter Strasse 25, 4020 Linz &#8211; Austria).<\/p>\n<p><strong><em>H\u00e3ng \u0111\u0103ng k\u00ed<\/em><\/strong>: Takeda Austria GmbH.<\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h2><span class=\"ez-toc-section\" id=\"2-dang-bao-che-%e2%80%93-ham-luong\"><\/span><strong>2. D\u1ea1ng b\u00e0o ch\u1ebf &#8211; H\u00e0m l\u01b0\u1ee3ng: <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong><em>D\u1ea1ng thu\u1ed1c v\u00e0 h\u00e0m l\u01b0\u1ee3ng<\/em><\/strong><\/p>\n<p>B\u1ed9t pha dung d\u1ecbch ti\u00eam truy\u1ec1n. M\u1ed7i l\u1ecd: Brentuximab vedotin 50 mg.<\/p>\n<p>M\u1ed7i mL dung d\u1ecbch ho\u00e0n nguy\u00ean: Brentuximab vedotin 5 mg.<\/p>\n<p><strong><em>H\u00ecnh \u1ea3nh tham kh\u1ea3o:<\/em><\/strong><\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\"><strong><em>ADCETRIS<\/em><\/strong><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><em>M\u1ed7i l\u1ecd b\u1ed9t c\u00f3 ch\u1ee9a:<\/em><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Brentuximab<\/td>\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\n<td>50 mg<\/td>\n<\/tr>\n<tr>\n<td>T\u00e1 d\u01b0\u1ee3c<\/td>\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\n<td>v\u1eeba \u0111\u1ee7 (Xem m\u1ee5c 6.1)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><img loading=\"lazy\" decoding=\"async\" width=\"915\" height=\"509\" class=\"wp-image-60494\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/adcetris-bot-pha-dung-dich-tiem-truyen-moi-lo-b.png\" alt=\"Adcetris (B\u1ed9t pha dung d\u1ecbch ti\u00eam truy\u1ec1n. M\u1ed7i l\u1ecd: Brentuximab vedotin 50 mg)\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/adcetris-bot-pha-dung-dich-tiem-truyen-moi-lo-b.png 915w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/adcetris-bot-pha-dung-dich-tiem-truyen-moi-lo-b-300x167.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/adcetris-bot-pha-dung-dich-tiem-truyen-moi-lo-b-768x427.png 768w\" sizes=\"auto, (max-width: 915px) 100vw, 915px\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"3-thong-tin-danh-cho-nguoi-su-dung\"><\/span><strong>3. Th\u00f4ng tin d\u00e0nh cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"31-adcetris-la-thuoc-gi\"><\/span>3.1. Adcetris l\u00e0 thu\u1ed1c g\u00ec?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><a id=\"post-18070-_Hlk172146709\"><\/a> Adcetris (Brentuximab) l\u00e0 thu\u1ed1c ph\u00e1t minh do c\u00f4ng ty Takeda s\u1ea3n xu\u1ea5t, thu\u1ed1c c\u00f3 ch\u1ee9a th\u00e0nh ph\u1ea7n ch\u00ednh l\u00e0 d\u01b0\u1ee3c ch\u1ea5t Brentuximab vedotin. Brentuximab vedotin \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u1edf ng\u01b0\u1eddi l\u1edbn \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1ec7nh u lympho Hodgkin v\u00e0 u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ho\u1eb7c u lympho \u1edf da t\u1ebf b\u00e0o T. Ngo\u00e0i ra Brentuximab c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p v\u1edbi c\u00e1c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb ung th\u01b0 kh\u00e1c v\u00e0 m\u1ed9t s\u1ed1 b\u1ec7nh kh\u00e1c m\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea trong t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng n\u00e0y.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"32-cau-hoi-thuong-gap-pho-bien\"><\/span>3.2. C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p ph\u1ed5 bi\u1ebfn:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><a id=\"post-18070-_Hlk171339962\"><\/a><a id=\"post-18070-_Hlk172146695\"><\/a><em>Adcetris c\u00f3 ph\u1ea3i l\u00e0 thu\u1ed1c h\u00f3a tr\u1ecb kh\u00f4ng?<\/em><\/p>\n<p>Adcetris l\u00e0 m\u1ed9t lo\u1ea1i thu\u1ed1c nh\u1eafm m\u1ee5c ti\u00eau (\u0111\u00edch) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb ung th\u01b0 nh\u01b0ng kh\u00f4ng ph\u1ea3i l\u00e0 thu\u1ed1c h\u00f3a tr\u1ecb truy\u1ec1n th\u1ed1ng. Adcetris bao g\u1ed3m 3 ph\u1ea7n:<\/p>\n<p>-m\u1ed9t kh\u00e1ng th\u1ec3 t\u00ecm protein CD30 tr\u00ean t\u1ebf b\u00e0o ung th\u01b0<\/p>\n<p>-thu\u1ed1c ch\u1ed1ng ung th\u01b0 (h\u00f3a tr\u1ecb) (g\u00e2y ch\u1ebft t\u1ebf b\u00e0o)<\/p>\n<p>-\u201cch\u1ea5t li\u00ean k\u1ebft\u201d gi\u00fap g\u1eafn thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ung th\u01b0 v\u00e0o kh\u00e1ng th\u1ec3 \u0111\u1ec3 thu\u1ed1c c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c gi\u1ea3i ph\u00f3ng b\u00ean trong t\u1ebf b\u00e0o ung th\u01b0.<\/p>\n<p>Adcetris k\u1ebft h\u1ee3p kh\u00e1ng th\u1ec3 v\u00e0 thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ung th\u01b0, cho ph\u00e9p kh\u00e1ng th\u1ec3 h\u01b0\u1edbng thu\u1ed1c \u0111\u1ebfn m\u1ee5c ti\u00eau l\u00e0 t\u1ebf b\u00e0o ung th\u01b0 u lympho \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 CD30. Thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ung th\u01b0 l\u00e0 monomethyl auristatin E (MMAE), \u1ee9c ch\u1ebf qu\u00e1 tr\u00ecnh tr\u00f9ng h\u1ee3p vi \u1ed1ng v\u00e0 d\u1eabn \u0111\u1ebfn ch\u1ebft t\u1ebf b\u00e0o.<\/p>\n<p><em>Adcetris (Brentuximab) c\u00f3 n\u1eb1m trong danh m\u1ee5c b\u1ea3o hi\u1ec3m y t\u1ebf \u1edf Vi\u1ec7t Nam kh\u00f4ng?<\/em><\/p>\n<p>Adcetris c\u00f3 ch\u1ee9a ho\u1ea1t ch\u1ea5t Brentuximab, thu\u1ed1c n\u00e0y CH\u01afA n\u1eb1m trong danh m\u1ee5c b\u1ea3o hi\u1ec3m y t\u1ebf \u1edf Vi\u1ec7t Nam. Tuy nhi\u00ean v\u1edbi m\u1ed9t s\u1ed1 lo\u1ea1i b\u1ea3o hi\u1ec3m kh\u00e1c v\u1eabn c\u00f3 th\u1ec3 chi tr\u1ea3 thu\u1ed1c n\u00e0y n\u1ebfu c\u00f3 trong \u0111i\u1ec1u kho\u1ea3n.<\/p>\n<p><em>T\u00f4i kh\u00f4ng th\u1ec3 mua \u0111\u01b0\u1ee3c<\/em> <em>Adcetris, hi\u1ec7n t\u1ea1i c\u00f3 thu\u1ed1c n\u00e0o c\u00f3 th\u1ec3 mua thay th\u1ebf \u0111\u01b0\u1ee3c kh\u00f4ng?<\/em><\/p>\n<p>T\u00ednh t\u1edbi n\u0103m 2024, ch\u1ec9 c\u00f3 duy nh\u1ea5t th\u01b0\u01a1ng hi\u1ec7u Adcetris c\u00f3 ch\u1ee9a th\u00e0nh ph\u1ea7n Brentuximab vedotin. V\u00ec v\u1eady b\u1ea1n n\u00ean h\u1ecfi l\u1ea1i b\u00e1c s\u1ef9 \u0111\u1ec3 c\u00e2n nh\u1eafc thay th\u1ebf ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb kh\u00e1c trong tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng th\u1ec3 mua \u0111\u01b0\u1ee3c Adcetris.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"4-thong-tin-danh-cho-nhan-vien-y-te\"><\/span><strong>4. Th\u00f4ng tin d\u00e0nh cho nh\u00e2n vi\u00ean y t\u1ebf: <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"41-chi-dinh\"><\/span>4.1. Ch\u1ec9 \u0111\u1ecbnh:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>ADCETRIS \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi l\u1edbn b\u1ecb u lympho Hodgkin (HL) CD30+ t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb:<\/p>\n<p>(1). sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n (ASCT) ho\u1eb7c<\/p>\n<p>(2). sau \u00edt nh\u1ea5t 2 li\u1ec7u ph\u00e1p tr\u01b0\u1edbc \u0111\u00f3 khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n ho\u1eb7c h\u00f3a tr\u1ecb li\u1ec7u \u0111a thu\u1ed1c kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p>ADCETRIS \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi l\u1edbn b\u1ecb u lympho Hodgkin CD30+ c\u00f3 t\u0103ng nguy c\u01a1 t\u00e1i ph\u00e1t ho\u1eb7c ti\u1ebfn tri\u1ec3n sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc).<\/p>\n<p>ADCETRIS \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi l\u1edbn b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn (sALCL) t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb.<\/p>\n<p>ADCETRIS \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi l\u1edbn b\u1ecb u lympho \u1edf da t\u1ebf b\u00e0o T (CTCL) CD30+ sau \u00edt nh\u1ea5t m\u1ed9t li\u1ec7u ph\u00e1p to\u00e0n th\u00e2n tr\u01b0\u1edbc \u0111\u00f3 (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc).<\/p>\n<h3><span class=\"ez-toc-section\" id=\"42-lieu-dung-%e2%80%93-cach-dung\"><\/span>4.2. Li\u1ec1u d\u00f9ng &#8211; C\u00e1ch d\u00f9ng:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong><em>C\u00e1ch d\u00f9ng<\/em><\/strong> :<\/p>\n<p>Brentuximab vedotin c\u00e2\u0300n \u0111\u01b0\u01a1\u0323c s\u01b0\u0309 du\u0323ng v\u1edbi s\u01b0\u0323 gia\u0301m sa\u0301t cu\u0309a ba\u0301c si\u0303 co\u0301 kinh nghi\u00ea\u0323m trong vi\u1ec7c s\u1eed d\u1ee5ng thu\u1ed1c ch\u1ed1ng ung th\u01b0.<\/p>\n<p>Li\u1ec1u khuy\u1ebfn c\u00e1o c\u1ee7a ADCETRIS \u0111\u01b0\u01a1\u0323c d\u00f9ng truy\u00ea\u0300n ti\u0303nh ma\u0323ch trong 30 phu\u0301t.<\/p>\n<p>V\u1ec1 h\u01b0\u1edbng d\u1eabn c\u00e1ch pha v\u00e0 pha lo\u00e3ng thu\u1ed1c tr\u01b0\u1edbc khi d\u00f9ng, xem ph\u1ea7n Th\u1eadn tr\u1ecdng \u0111\u1eb7c bi\u1ec7t khi h\u1ee7y b\u1ecf v\u00e0 x\u1eed l\u00fd kh\u00e1c.<\/p>\n<p>Kh\u00f4ng \u0111\u01b0\u1ee3c d\u00f9ng brentuximab vedotin d\u01b0\u1edbi d\u1ea1ng ti\u00eam ti\u0303nh ma\u0323ch nhanh ho\u1eb7c ti\u00eam bolus t\u0129nh m\u1ea1ch. Brentuximab vedotin c\u00e2\u0300n \u0111\u01b0\u01a1\u0323c d\u00f9ng qua m\u1ed9t \u0111\u01b0\u1eddng truy\u1ec1n t\u0129nh m\u1ea1ch ri\u00eang v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c tr\u00f4\u0323n l\u00e2\u0303n v\u01a1\u0301i ca\u0301c thu\u00f4\u0301c kha\u0301c (Xem ph\u1ea7n T\u01b0\u01a1ng k\u1ef5).<\/p>\n<p><em>Th\u1eadn tr\u1ecdng \u0111\u1eb7c bi\u1ec7t khi h\u1ee7y b\u1ecf v\u00e0 x\u1eed l\u00fd kh\u00e1c<\/em><\/p>\n<p>*Th\u1eadn tr\u1ecdng chung:<\/p>\n<p>C\u1ea7n xem x\u00e9t c\u00e1c quy tr\u00ecnh x\u1eed l\u00fd v\u00e0 h\u1ee7y b\u1ecf thu\u1ed1c ch\u1ed1ng ung th\u01b0 th\u00edch h\u1ee3p. C\u1ea7n tu\u00e2n th\u1ee7 k\u1ef9 thu\u1eadt v\u00f4 khu\u1ea9n th\u00edch h\u1ee3p trong su\u1ed1t qu\u00e1 tr\u00ecnh x\u1eed l\u00fd thu\u1ed1c n\u00e0y.<\/p>\n<p>*H\u01b0\u1edbng d\u1eabn c\u00e1ch pha:<\/p>\n<p>M\u1ed7i l\u1ecd s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n ph\u1ea3i \u0111\u01b0\u1ee3c pha v\u1edbi 10,5 mL n\u01b0\u1edbc pha ti\u00eam \u0111\u1ec3 \u0111\u1ea1t n\u1ed3ng \u0111\u1ed9 cu\u1ed1i l\u00e0 5 mg\/mL. M\u1ed7i l\u1ecd thu\u1ed1c ch\u1ee9a m\u1ed9t l\u01b0\u1ee3ng th\u1eeba 10% cung c\u1ea5p 55 mg thu\u1ed1c ADCETRIS m\u1ed7i l\u1ecd v\u00e0 t\u1ed5ng th\u1ec3 t\u00edch \u0111\u00e3 pha l\u00e0 11 mL.<\/p>\n<p>(1). H\u01b0\u1edbng d\u00f2ng ch\u1ea3y v\u00e0o th\u00e0nh l\u1ecd thu\u1ed1c v\u00e0 kh\u00f4ng h\u01b0\u1edbng tr\u1ef1c ti\u1ebfp v\u00e0o b\u00e1nh thu\u1ed1c ho\u1eb7c b\u1ed9t thu\u1ed1c.<\/p>\n<p>(2). Xoay nh\u1eb9 l\u1ecd thu\u1ed1c \u0111\u1ec3 gi\u00fap h\u00f2a tan. KH\u00d4NG \u0110\u01af\u1ee2C L\u1eaeC.<\/p>\n<p>(3). Dung d\u1ecbch \u0111\u00e3 pha trong l\u1ecd l\u00e0 dung d\u1ecbch trong su\u1ed1t \u0111\u1ebfn h\u01a1i \u0111\u1ee5c v\u1edbi pH cu\u1ed1i c\u00f9ng l\u00e0 6,6.<\/p>\n<p>(4). Dung d\u1ecbch \u0111\u00e3 pha c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m tra b\u1eb1ng m\u1eaft th\u01b0\u1eddng v\u1ec1 b\u1ea5t k\u1ef3 ti\u1ec3u ph\u00e2n ngo\u1ea1i lai v\u00e0\/ho\u1eb7c \u0111\u1ed5i m\u00e0u. Trong tr\u01b0\u1eddng h\u1ee3p quan s\u00e1t th\u1ea5y c\u00f3 b\u1ea5t th\u01b0\u1eddng th\u00ec lo\u1ea1i b\u1ecf thu\u1ed1c.<\/p>\n<p>*Chu\u1ea9n b\u1ecb dung d\u1ecbch truy\u1ec1n<\/p>\n<p>Ph\u1ea3i r\u00fat m\u1ed9t l\u01b0\u1ee3ng th\u00edch h\u1ee3p ADCETRIS \u0111\u00e3 pha t\u1eeb l\u1ecd thu\u1ed1c v\u00e0 cho v\u00e0o m\u1ed9t t\u00fai truy\u1ec1n ch\u1ee9a dung d\u1ecbch ti\u00eam natri chloride 9 mg\/mL (0,9%) \u0111\u1ec3 \u0111\u1ea1t n\u1ed3ng \u0111\u1ed9 cu\u1ed1i c\u1ee7a ADCETRIS l\u00e0 0,4-1,2 mg\/mL. Th\u1ec3 t\u00edch ch\u1ea5t pha lo\u00e3ng khuy\u1ebfn c\u00e1o l\u00e0 150 mL. ADCETRIS \u0111\u00e3 pha c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c pha lo\u00e3ng trong dung d\u1ecbch ti\u00eam dextrose 5% ho\u1eb7c dung d\u1ecbch ti\u00eam Lactate Ringer.<\/p>\n<p>Nh\u1eb9 nh\u00e0ng \u0111\u1ea3o ng\u01b0\u1ee3c t\u00fai \u0111\u1ec3 tr\u1ed9n dung d\u1ecbch ch\u1ee9a ADCETRIS. KH\u00d4NG \u0110\u01af\u1ee2C L\u1eaeC.<\/p>\n<p>B\u1ea5t k\u1ef3 ph\u1ea7n thu\u1ed1c n\u00e0o c\u00f2n l\u1ea1i trong l\u1ecd sau khi \u0111\u00e3 r\u00fat th\u1ec3 t\u00edch c\u1ea7n pha lo\u00e3ng ph\u1ea3i \u0111\u01b0\u1ee3c lo\u1ea1i b\u1ecf theo \u0111\u00fang quy \u0111\u1ecbnh c\u1ee7a \u0111\u1ecba ph\u01b0\u01a1ng.<\/p>\n<p>Kh\u00f4ng \u0111\u01b0\u1ee3c pha th\u00eam thu\u1ed1c kh\u00e1c v\u00e0o dung d\u1ecbch truy\u1ec1n ADCETRIS \u0111\u00e3 \u0111\u01b0\u1ee3c chu\u1ea9n b\u1ecb ho\u1eb7c v\u00e0o b\u1ed9 truy\u1ec1n t\u0129nh m\u1ea1ch. \u0110\u01b0\u1eddng truy\u1ec1n c\u1ea7n \u0111\u01b0\u1ee3c gi\u1ed9i r\u1eeda s\u1ea1ch sau khi s\u1eed d\u1ee5ng b\u1eb1ng dung d\u1ecbch ti\u00eam natri chloride 9 mg\/mL (0,9%), dung d\u1ecbch ti\u00eam dextrose 5%, ho\u1eb7c dung d\u1ecbch ti\u00eam Lactate Ringer. Sau khi pha lo\u00e3ng, truy\u1ec1n dung d\u1ecbch ADCETRIS ngay v\u1edbi t\u1ed1c \u0111\u1ed9 truy\u1ec1n \u0111\u01b0\u1ee3c khuy\u1ebfn c\u00e1o. T\u1ed5ng th\u1eddi gian b\u1ea3o qu\u1ea3n dung d\u1ecbch t\u1eeb khi pha \u0111\u1ebfn khi truy\u1ec1n kh\u00f4ng \u0111\u01b0\u1ee3c v\u01b0\u1ee3t qu\u00e1 24 gi\u1edd.<\/p>\n<p>*X\u00e1c \u0111\u1ecbnh li\u1ec1u l\u01b0\u1ee3ng:<\/p>\n<p>T\u00ednh to\u00e1n \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh t\u1ed5ng li\u1ec1u ADCETRIS (mL) c\u1ea7n d\u00f9ng \u0111\u1ec3 pha lo\u00e3ng th\u00eam (xem ph\u1ea7n Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 c\u00e1ch d\u00f9ng):<\/p>\n<p>[Li\u1ec1u ADCETRIS (mg\/kg) x th\u1ec3 tr\u1ecdng c\u1ee7a b\u1ec7nh nh\u00e2n (kg)] \/ N\u1ed3ng \u0111\u1ed9 l\u1ecd thu\u1ed1c \u0111\u00e3 pha (5 mg\/mL) = T\u1ed5ng li\u1ec1u ADCETRIS (mL) c\u1ea7n d\u00f9ng \u0111\u1ec3 pha lo\u00e3ng<\/p>\n<p>L\u01b0u \u00fd: N\u1ebfu b\u1ec7nh nh\u00e2n c\u00e2n n\u1eb7ng h\u01a1n 100 kg, c\u1ea7n s\u1eed d\u1ee5ng 100 kg \u0111\u1ec3 t\u00ednh li\u1ec1u. Li\u1ec1u khuy\u1ebfn c\u00e1o t\u1ed1i \u0111a l\u00e0 180 mg.<\/p>\n<p>*T\u00ednh to\u00e1n \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh t\u1ed5ng s\u1ed1 l\u1ecd ADCETRIS c\u1ea7n d\u00f9ng:<\/p>\n<p>T\u1ed5ng li\u1ec1u ADCETRIS (mL) c\u1ea7n d\u00f9ng \/ T\u1ed5ng th\u1ec3 t\u00edch m\u1ed7i l\u1ecd (10 mL\/l\u1ecd) = S\u1ed1 l\u1ecd ADCETRIS c\u1ea7n d\u00f9ng.<\/p>\n<p>&#8211; xem B\u1ea3ng 13.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"4\">B\u1ea3ng 13. T\u00ednh to\u00e1n m\u1eabu cho b\u1ec7nh nh\u00e2n d\u00f9ng li\u1ec1u khuy\u1ebfn c\u00e1o ADCETRIS 1,8 mg\/kg v\u1edbi c\u00e2n n\u1eb7ng trong kho\u1ea3ng t\u1eeb 60 kg \u0111\u1ebfn 120 kg<\/td>\n<\/tr>\n<tr>\n<td><strong>C\u00e2n n\u1eb7ng c\u1ee7a b\u1ec7nh nh\u00e2n (kg)<\/strong><\/td>\n<td><strong>T\u1ed5ng li\u1ec1u = c\u00e2n n\u1eb7ng c\u1ee7a b\u1ec7nh nh\u00e2n x li\u1ec1u khuy\u1ebfn c\u00e1o (1,8 mg\/kg<sup>a<\/sup>)<\/strong><\/td>\n<td><strong>T\u1ed5ng th\u1ec3 t\u00edch c\u1ea7n d\u00f9ng \u0111\u1ec3 pha lo\u00e3ng<sup>b<\/sup> = t\u1ed5ng li\u1ec1u\/ n\u1ed3ng \u0111\u1ed9 l\u1ecd thu\u1ed1c \u0111\u00e3 pha (5 mg\/mL)<\/strong><\/td>\n<td><strong>S\u1ed1 l\u1ecd thu\u1ed1c c\u1ea7n d\u00f9ng = t\u1ed5ng th\u1ec3 t\u00edch c\u1ea7n d\u00f9ng \u0111\u1ec3 pha lo\u00e3ng\/t\u1ed5ng th\u1ec3 t\u00edch m\u1ed7i l\u1ecd thu\u1ed1c (10 ml\/l\u1ecd)<\/strong><\/td>\n<\/tr>\n<tr>\n<td>60 kg<\/td>\n<td>108 mg<\/td>\n<td>21,6 mL<\/td>\n<td>2,16 l\u1ecd<\/td>\n<\/tr>\n<tr>\n<td>80 kg<\/td>\n<td>144 mg<\/td>\n<td>28,8 mL<\/td>\n<td>2,88 l\u1ecd<\/td>\n<\/tr>\n<tr>\n<td>100 kg<\/td>\n<td>180 mg<\/td>\n<td>36 mL<\/td>\n<td>3,6 l\u1ecd<\/td>\n<\/tr>\n<tr>\n<td>120 kg<sup>c<\/sup><\/td>\n<td>180 mg<sup>d<\/sup><\/td>\n<td>36 mL<\/td>\n<td>3,6 l\u1ecd<\/td>\n<\/tr>\n<tr>\n<td colspan=\"4\">a Khi c\u1ea7n gi\u1ea3m li\u1ec1u, s\u1eed d\u1ee5ng li\u1ec1u 1,2 mg\/kg \u0111\u1ec3 t\u00ednh.<\/p>\n<p>b Pha lo\u00e3ng trong 150 mL dung d\u1ecbch pha lo\u00e3ng v\u00e0 truy\u1ec1n t\u0129nh m\u1ea1ch trong 30 ph\u00fat m\u1ed7i 3 tu\u1ea7n. c N\u1ebfu c\u00e2n n\u1eb7ng c\u1ee7a b\u1ec7nh nh\u00e2n h\u01a1n 100 kg, c\u1ea7n s\u1eed d\u1ee5ng 100 kg \u0111\u1ec3 t\u00ednh li\u1ec1u.<\/p>\n<p>d Li\u1ec1u khuy\u1ebfn c\u00e1o t\u1ed1i \u0111a l\u00e0 180 mg.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>*H\u1ee7y b\u1ecf<\/p>\n<p>ADCETRIS ch\u1ec9 s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n.<\/p>\n<p>B\u1ea5t k\u1ef3 ph\u1ea7n thu\u1ed1c n\u00e0o kh\u00f4ng d\u00f9ng ho\u1eb7c v\u1eadt li\u1ec7u th\u1ea3i \u0111i ph\u1ea3i \u0111\u01b0\u1ee3c lo\u1ea1i b\u1ecf theo \u0111\u00fang quy \u0111\u1ecbnh c\u1ee7a \u0111\u1ecba ph\u01b0\u01a1ng.<\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<p><strong><em>Li\u1ec1u d\u00f9ng:<\/em><\/strong><\/p>\n<p>Li\u00ea\u0300u khuy\u00ea\u0301n ca\u0301o la\u0300 1,8 mg\/kg d\u00f9ng d\u01b0\u1edbi d\u1ea1ng truy\u00ea\u0300n ti\u0303nh ma\u0323ch trong 30 phu\u0301t m\u1ed7i 3 tu\u00e2\u0300n.<\/p>\n<p>Li\u1ec1u kh\u1edfi \u0111\u1ea7u khuy\u1ebfn c\u00e1o \u0111\u1ed1i v\u1edbi vi\u1ec7c t\u00e1i \u0111i\u1ec1u tr\u1ecb \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin ho\u1eb7c u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb tr\u01b0\u1edbc \u0111\u00e2y \u0111\u00e3 \u0111\u00e1p \u1ee9ng v\u1edbi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ADCETRIS l\u00e0 1,8 mg\/kg d\u00f9ng d\u01b0\u1edbi d\u1ea1ng truy\u1ec1n t\u0129nh m\u1ea1ch trong 30 ph\u00fat m\u1ed7i 3 tu\u1ea7n. Ngo\u00e0i ra, c\u00f3 th\u1ec3 b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb \u1edf li\u1ec1u cu\u1ed1i c\u00f9ng \u0111\u01b0\u1ee3c dung n\u1ea1p (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc).<\/p>\n<p><em>Suy th\u1eadn<\/em><\/p>\n<p>Li\u00ea\u0300u kh\u01a1\u0309i \u0111\u00e2\u0300u khuy\u00ea\u0301n ca\u0301o cho b\u00ea\u0323nh nh\u00e2n suy th\u00e2\u0323n n\u0103\u0323ng la\u0300 1,2 mg\/kg d\u00f9ng d\u01b0\u1edbi d\u1ea1ng truy\u00ea\u0300n ti\u0303nh ma\u0323ch trong 30 phu\u0301t m\u1ed7i 3 tu\u00e2\u0300n. C\u1ea7n theo d\u00f5i ch\u1eb7t ch\u1ebd b\u1ec7nh nh\u00e2n suy th\u1eadn v\u1ec1 ca\u0301c bi\u1ebfn c\u1ed1 b\u00e2\u0301t l\u01a1\u0323i (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc).<\/p>\n<p><em>Suy gan<\/em><\/p>\n<p>Li\u00ea\u0300u kh\u01a1\u0309i \u0111\u00e2\u0300u khuy\u00ea\u0301n ca\u0301o cho b\u00ea\u0323nh nh\u00e2n suy gan la\u0300 1,2 mg\/kg d\u00f9ng d\u01b0\u1edbi d\u1ea1ng truy\u00ea\u0300n ti\u0303nh ma\u0323ch trong 30 phu\u0301t m\u1ed7i 3 tu\u00e2\u0300n. C\u1ea7n theo d\u00f5i ch\u1eb7t ch\u1ebd b\u1ec7nh nh\u00e2n suy gan v\u1ec1 ca\u0301c bi\u1ebfn c\u1ed1 b\u00e2\u0301t l\u01a1\u0323i (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc).<\/p>\n<p>N\u00ea\u0301u b\u00ea\u0323nh nh\u00e2n c\u00e2n n\u0103\u0323ng h\u01a1n 100 kg, c\u1ea7n s\u1eed d\u1ee5ng 100 kg \u0111\u1ec3 t\u00ednh li\u1ec1u (xem ph\u1ea7n Th\u1eadn tr\u1ecdng \u0111\u1eb7c bi\u1ec7t khi h\u1ee7y b\u1ecf v\u00e0 x\u1eed l\u00fd kh\u00e1c).<\/p>\n<p>C\u1ea7n theo d\u00f5i c\u00f4ng th\u01b0\u0301c ma\u0301u toa\u0300n ph\u00e2\u0300n tr\u01b0\u01a1\u0301c khi du\u0300ng m\u1ed7i li\u1ec1u c\u1ee7a thu\u1ed1c n\u00e0y (xem ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 th\u1eadn tr\u1ecdng).<\/p>\n<p>C\u1ea7n theo d\u00f5i b\u1ec7nh nh\u00e2n trong v\u00e0 sau khi truy\u1ec1n (xem ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 th\u1eadn tr\u1ecdng).<\/p>\n<p>C\u1ea7n ti\u1ebfp t\u1ee5c \u0111i\u1ec1u tr\u1ecb cho \u0111\u1ebfn khi b\u1ec7nh ti\u1ebfn tri\u1ec3n ho\u1eb7c \u0111\u1ed9c t\u00ednh kh\u00f4ng th\u1ec3 ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c (xem ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 th\u1eadn tr\u1ecdng).<\/p>\n<p>B\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin ho\u1eb7c u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb \u0111\u1ea1t \u0111\u01b0\u1ee3c b\u1ec7nh \u1ed5n \u0111\u1ecbnh ho\u1eb7c t\u1ed1t h\u01a1n n\u00ean nh\u1eadn \u0111\u01b0\u1ee3c t\u1ed1i thi\u1ec3u 8 chu k\u1ef3 v\u00e0 t\u1ed1i \u0111a 16 chu k\u1ef3 (kho\u1ea3ng 1 n\u0103m) (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc).<\/p>\n<p>\u0110\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin c\u00f3 t\u0103ng nguy c\u01a1 t\u00e1i ph\u00e1t ho\u1eb7c ti\u1ebfn tri\u1ec3n sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n, vi\u1ec7c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ADCETRIS n\u00ean b\u1eaft \u0111\u1ea7u sau khi h\u1ed3i ph\u1ee5c t\u1eeb gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n d\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 l\u00e2m s\u00e0ng. Nh\u1eefng b\u1ec7nh nh\u00e2n n\u00e0y n\u00ean nh\u1eadn \u0111\u01b0\u1ee3c \u0111\u1ebfn 16 chu k\u1ef3 (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc).<\/p>\n<p>B\u1ec7nh nh\u00e2n b\u1ecb u lympho \u1edf da t\u1ebf b\u00e0o T n\u00ean nh\u1eadn \u0111\u01b0\u1ee3c \u0111\u1ebfn 16 chu k\u1ef3 (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc).<\/p>\n<p><em>\u0110i\u1ec1u ch\u1ec9nh li\u1ec1u<\/em><\/p>\n<p>Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh<\/p>\n<p>N\u1ebfu gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh xu\u1ea5t hi\u1ec7n trong khi \u0111i\u1ec1u tr\u1ecb, n\u00ean x\u1eed tr\u00ed b\u1eb1ng c\u00e1ch tr\u00ec ho\u00e3n li\u1ec1u. Xem Ba\u0309ng 10 d\u01b0\u01a1\u0301i \u0111\u00e2y v\u1ec1 khuy\u1ebfn c\u00e1o li\u1ec1u d\u00f9ng th\u00edch h\u01a1\u0323p (xem th\u00eam ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 th\u1eadn tr\u1ecdng).<\/p>\n<p>&#8211; xem B\u1ea3ng 10.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\">B\u1ea3ng 10. Khuy\u1ebfn c\u00e1o li\u1ec1u d\u00f9ng \u0111\u1ed1i v\u1edbi gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0110\u1ed9 n\u1eb7ng c\u1ee7a gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh (d\u1ea5u hi\u1ec7u v\u00e0 tri\u1ec7u ch\u1ee9ng [M\u00f4 t\u1ea3 v\u1eafn t\u1eaft theo CTCAE3])<\/strong><\/td>\n<td><strong>\u0110i\u1ec1u ch\u1ec9nh li\u1ec1u v\u00e0 l\u1ecbch d\u00f9ng thu\u1ed1c<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u0110\u1ed9 1 (&lt; LLN &#8211; 1.500\/mm<sup>3<\/sup><\/p>\n<p>&lt; LLN -1,5 x 10<sup>9<\/sup>\/L) ho\u1eb7c<\/p>\n<p>\u0110\u1ed9 2 (&lt; 1.500 -1.000\/mm<sup>3<\/sup> &lt; 1,5 &#8211; 1,0 x 10<sup>9<\/sup>\/L)<\/td>\n<td>Ti\u1ebfp t\u1ee5c v\u1edbi c\u00f9ng m\u1ee9c li\u1ec1u v\u00e0 l\u1ecbch d\u00f9ng thu\u1ed1c<\/td>\n<\/tr>\n<tr>\n<td>\u0110\u1ed9 3 (&lt; 1.000 -500\/mm<sup>3<\/sup><\/p>\n<p>&lt; 1,0 &#8211; 0,5 X 10<sup>9<\/sup>\/L) ho\u1eb7c<\/p>\n<p>\u0110\u1ed9 4 (&lt; 500\/mm<sup>3<\/sup><\/p>\n<p>&lt; 0,5 x 10<sup>9<\/sup>\/L)<\/td>\n<td>Ng\u01b0ng li\u1ec1u cho \u0111\u1ebfn khi \u0111\u1ed9c t\u00ednh tr\u1edf v\u1ec1 &lt; \u0111\u1ed9 2 ho\u1eb7c tr\u1edf v\u1ec1 \u0111\u1ed9 ban \u0111\u1ea7u, sau \u0111\u00f3 b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb l\u1ea1i v\u1edbi c\u00f9ng m\u1ee9c li\u1ec1u v\u00e0 l\u1ecbch d\u00f9ng thu\u1ed1cb. Xem x\u00e9t s\u1ef1 h\u1ed7 tr\u1ee3 c\u1ee7a y\u1ebfu t\u1ed1 t\u0103ng tr\u01b0\u1edfng (G-CSF ho\u1eb7c GM-CSF) trong c\u00e1c chu k\u1ef3 ti\u1ebfp theo \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n xu\u1ea5t hi\u1ec7n gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u1ed9 3 ho\u1eb7c \u0111\u1ed9 4.<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">a Ph\u00e2n \u0111\u1ed9 d\u1ef1a tr\u00ean Ti\u00eau chu\u1ea9n Thu\u1eadt ng\u1eef chung v\u1ec1 bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i (CTCAE) c\u1ee7a Vi\u1ec7n Ung th\u01b0 qu\u1ed1c gia M\u1ef9 (NCI) phi\u00ean b\u1ea3n 3.0; xem B\u1ea1ch c\u1ea7u trung t\u00ednh\/B\u1ea1ch c\u1ea7u h\u1ea1t; LLN= gi\u1edbi h\u1ea1n d\u01b0\u1edbi c\u1ee7a m\u1ee9c b\u00ecnh th\u01b0\u1eddng<\/p>\n<p>b Nh\u1eefng b\u1ec7nh nh\u00e2n xu\u1ea5t hi\u1ec7n gi\u1ea3m b\u1ea1ch c\u1ea7u lympho \u0111\u1ed9 3 ho\u1eb7c \u0111\u1ed9 4 c\u00f3 th\u1ec3 ti\u1ebfp t\u1ee5c \u0111i\u1ec1u tr\u1ecb m\u00e0 kh\u00f4ng c\u1ea7n t\u1ea1m ng\u01b0ng li\u1ec1u.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>B\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean<\/em><\/p>\n<p>N\u1ebfu b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean c\u1ea3m gi\u00e1c ho\u1eb7c v\u1eadn \u0111\u1ed9ng m\u1edbi xu\u1ea5t hi\u1ec7n ho\u1eb7c n\u1eb7ng l\u00ean trong khi \u0111i\u1ec1u tr\u1ecb, xem B\u1ea3ng 11 d\u01b0\u1edbi \u0111\u00e2y v\u1ec1 khuy\u1ebfn c\u00e1o li\u1ec1u d\u00f9ng th\u00edch h\u1ee3p (xem ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 th\u1eadn tr\u1ecdng).<\/p>\n<p>&#8211; xem B\u1ea3ng 11.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\">B\u1ea3ng 11. Khuy\u1ebfn c\u00e1o li\u1ec1u d\u00f9ng \u0111\u1ed1i v\u1edbi b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean c\u1ea3m gi\u00e1c ho\u1eb7c v\u1eadn \u0111\u1ed9ng m\u1edbi xu\u1ea5t hi\u1ec7n ho\u1eb7c n\u1eb7ng l\u00ean<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0110\u1ed9 n\u1eb7ng c\u1ee7a b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean c\u1ea3m gi\u00e1c ho\u1eb7c v\u1eadn \u0111\u1ed9ng (d\u1ea5u hi\u1ec7u v\u00e0 tri\u1ec7u ch\u1ee9ng [M\u00f4 t\u1ea3 v\u1eafn t\u1eaft theo CTCAE3])<\/strong><\/td>\n<td><strong>\u0110i\u1ec1u ch\u1ec9nh li\u1ec1u v\u00e0 l\u1ecbch d\u00f9ng thu\u1ed1c<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u0110\u1ed9 1 (d\u1ecb c\u1ea3m v\u00e0\/ho\u1eb7c m\u1ea5t ph\u1ea3n x\u1ea1, kh\u00f4ng m\u1ea5t ch\u1ee9c n\u0103ng)<\/td>\n<td>Ti\u1ebfp t\u1ee5c v\u1edbi c\u00f9ng m\u1ee9c li\u1ec1u v\u00e0 l\u1ecbch d\u00f9ng thu\u1ed1c<\/td>\n<\/tr>\n<tr>\n<td>\u0110\u1ed9 2 (\u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ch\u1ee9c n\u0103ng nh\u01b0ng kh\u00f4ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ho\u1ea1t \u0111\u1ed9ng s\u1ed1ng h\u00e0ng ng\u00e0y) ho\u1eb7c<\/p>\n<p>\u0110\u1ed9 3 (\u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ho\u1ea1t \u0111\u1ed9ng s\u1ed1ng h\u00e0ng ng\u00e0y)<\/td>\n<td>Ng\u01b0ng li\u1ec1u cho \u0111\u1ebfn khi \u0111\u1ed9c t\u00ednh tr\u1edf v\u1ec1 &lt; \u0111\u1ed9 1 ho\u1eb7c tr\u1edf v\u1ec1 \u0111\u1ed9 ban \u0111\u1ea7u, sau \u0111\u00f3 b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb l\u1ea1i \u1edf m\u1ee9c li\u1ec1u gi\u1ea3m xu\u1ed1ng c\u00f2n 1,2 mg\/kg m\u1ed7i 3 tu\u1ea7n<\/td>\n<\/tr>\n<tr>\n<td>\u0110\u1ed9 4 (b\u1ec7nh th\u1ea7n kinh c\u1ea3m gi\u00e1c g\u00e2y m\u1ea5t kh\u1ea3 n\u0103ng l\u00e0m vi\u1ec7c ho\u1eb7c b\u1ec7nh th\u1ea7n kinh v\u1eadn \u0111\u1ed9ng \u0111e d\u1ecda t\u00ednh m\u1ea1ng ho\u1eb7c d\u1eabn \u0111\u1ebfn li\u1ec7t)<\/td>\n<td>Ng\u1eebng \u0111i\u1ec1u tr\u1ecb<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">a Ph\u00e2n \u0111\u1ed9 d\u1ef1a tr\u00ean Ti\u00eau chu\u1ea9n Thu\u1eadt ng\u1eef chung v\u1ec1 bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i (CTCAE) c\u1ee7a Vi\u1ec7n Ung th\u01b0 qu\u1ed1c gia M\u1ef9 (NCI) phi\u00ean b\u1ea3n 3.0; xem b\u1ec7nh th\u1ea7n kinh: v\u1eadn \u0111\u1ed9ng; b\u1ec7nh th\u1ea7n kinh: c\u1ea3m gi\u00e1c; v\u00e0 \u0111au do b\u1ec7nh th\u1ea7n kinh.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>Ng\u01b0\u1eddi cao tu\u1ed5i<\/em><\/p>\n<p>D\u1ef1a tr\u00ean ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc qu\u1ea7n th\u1ec3 (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc) v\u00e0 h\u1ed3 s\u01a1 v\u1ec1 an to\u00e0n \u1edf b\u1ec7nh nh\u00e2n cao tu\u1ed5i, \u0111\u1ed3ng nh\u1ea5t v\u1edbi h\u1ed3 s\u01a1 v\u1ec1 an to\u00e0n \u1edf b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi l\u1edbn, khuy\u1ebfn c\u00e1o li\u1ec1u d\u00f9ng \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n t\u1eeb 65 tu\u1ed5i tr\u1edf l\u00ean c\u0169ng gi\u1ed1ng nh\u01b0 \u0111\u1ed1i v\u1edbi ng\u01b0\u1eddi l\u1edbn.<\/p>\n<p><em>Nh\u00f3m b\u1ec7nh nhi<\/em><\/p>\n<p>\u0110\u1ed9 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 \u1edf b\u1ec7nh nhi d\u01b0\u1edbi 18 tu\u1ed5i ch\u01b0a \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh. D\u1eef li\u1ec7u hi\u1ec7n c\u00f3 \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong c\u00e1c ph\u1ea7n T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n, \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc v\u00e0 \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc nh\u01b0ng kh\u00f4ng c\u00f3 khuy\u1ebfn c\u00e1o n\u00e0o v\u1ec1 li\u1ec1u l\u01b0\u1ee3ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c \u0111\u01b0a ra.<\/p>\n<p>Trong c\u00e1c nghi\u00ean c\u1ee9u phi l\u00e2m s\u00e0ng, suy tuy\u1ebfn \u1ee9c \u0111\u00e3 \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y (xem ph\u1ea7n D\u1eef li\u1ec7u an to\u00e0n ti\u1ec1n l\u00e2m s\u00e0ng).<\/p>\n<h3><span class=\"ez-toc-section\" id=\"43-chong-chi-dinh\"><\/span>4.3. Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Qua\u0301 m\u00e2\u0303n v\u01a1\u0301i hoa\u0323t ch\u00e2\u0301t ho\u0103\u0323c v\u1edbi b\u1ea5t k\u1ef3 t\u00e1 d\u01b0\u1ee3c n\u00e0o \u0111\u01b0\u1ee3c li\u00ea\u0323t k\u00ea trong ph\u1ea7n Th\u00e0nh ph\u1ea7n.<\/p>\n<p>S\u01b0\u0309 du\u0323ng k\u1ebft h\u1ee3p bleomycin v\u00e0 brentuximab vedotin g\u00e2y \u0111\u00f4\u0323c ti\u0301nh tr\u00ean ph\u00f4\u0309i.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"44-than-trong\"><\/span>4.4 Th\u1eadn tr\u1ecdng:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><em>B\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n<\/em><\/p>\n<p>S\u1ef1 t\u00e1i ho\u1ea1t virus John Cunningham (JCV) d\u1eabn \u0111\u1ebfn b\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n (PML) v\u00e0 t\u1eed vong c\u00f3 th\u1ec3 x\u1ea3y ra \u1edf b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin. B\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c n\u00e0y sau khi nh\u1eadn \u0111\u01b0\u1ee3c nhi\u1ec1u ph\u00e1c \u0111\u1ed3 h\u00f3a tr\u1ecb li\u1ec7u tr\u01b0\u1edbc \u0111\u00f3. B\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n l\u00e0 m\u1ed9t b\u1ec7nh h\u1ee7y myelin hi\u1ebfm g\u1eb7p c\u1ee7a h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng do s\u1ef1 t\u00e1i ho\u1ea1t virus John Cunningham ti\u1ec1m t\u00e0ng v\u00e0 th\u01b0\u1eddng g\u00e2y t\u1eed vong.<\/p>\n<p>C\u1ea7n theo d\u00f5i ch\u1eb7t ch\u1ebd b\u1ec7nh nh\u00e2n \u0111\u1ed1i v\u1edbi c\u00e1c d\u1ea5u hi\u1ec7u ho\u1eb7c tri\u1ec7u ch\u1ee9ng v\u1ec1 th\u1ea7n kinh, nh\u1eadn th\u1ee9c ho\u1eb7c h\u00e0nh vi m\u1edbi xu\u1ea5t hi\u1ec7n ho\u1eb7c n\u1eb7ng th\u00eam c\u00f3 th\u1ec3 g\u1ee3i \u00fd b\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n. T\u1ea1m ng\u01b0ng li\u1ec1u brentuximab vedotin \u0111\u1ed1i v\u1edbi b\u1ea5t k\u1ef3 tr\u01b0\u1eddng h\u1ee3p n\u00e0o nghi ng\u1edd b\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n. \u0110\u00e1nh gi\u00e1 b\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n \u0111\u01b0\u1ee3c \u0111\u1ec1 ngh\u1ecb bao g\u1ed3m kh\u00e1m th\u1ea7n kinh, ch\u1ee5p c\u1ed9ng h\u01b0\u1edfng t\u1eeb n\u00e3o t\u0103ng c\u01b0\u1eddng thu\u1ed1c c\u1ea3n quang gadolinium v\u00e0 ph\u00e2n t\u00edch d\u1ecbch n\u00e3o t\u1ee7y t\u00ecm DNA c\u1ee7a virus John Cunningham (JCV) b\u1eb1ng ph\u1ea3n \u1ee9ng chu\u1ed7i polymerase (PCR) ho\u1eb7c sinh thi\u1ebft n\u00e3o v\u1edbi b\u1eb1ng ch\u1ee9ng v\u1ec1 JCV. K\u1ebft qu\u1ea3 JVC PCR \u00e2m t\u00ednh kh\u00f4ng lo\u1ea1i tr\u1eeb \u0111\u01b0\u1ee3c b\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n. Ti\u1ebfp t\u1ee5c theo d\u00f5i v\u00e0 \u0111\u00e1nh gi\u00e1 b\u1ed5 sung n\u1ebfu kh\u00f4ng c\u00f3 ch\u1ea9n \u0111o\u00e1n n\u00e0o kh\u00e1c c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp. N\u00ean ng\u1eebng s\u1eed d\u1ee5ng brentuximab vedotin v\u0129nh vi\u1ec5n n\u1ebfu \u0111\u00e3 ch\u1ea9n \u0111o\u00e1n x\u00e1c \u0111\u1ecbnh b\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n.<\/p>\n<p>B\u00e1c s\u0129 c\u1ea7n \u0111\u1eb7c bi\u1ec7t c\u1ea3nh gi\u00e1c v\u1edbi c\u00e1c tri\u1ec7u ch\u1ee9ng g\u1ee3i \u00fd b\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n m\u00e0 b\u1ec7nh nh\u00e2n c\u00f3 th\u1ec3 kh\u00f4ng nh\u1eadn th\u1ea5y (v\u00ed d\u1ee5 c\u00e1c tri\u1ec7u ch\u1ee9ng v\u1ec1 nh\u1eadn th\u1ee9c, th\u1ea7n kinh ho\u1eb7c t\u00e2m th\u1ea7n).<\/p>\n<p><em>Vi\u00eam t\u1ee5y<\/em><\/p>\n<p>Vi\u00eam t\u1ee5y c\u1ea5p \u0111\u00e3 \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin. M\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p c\u00f3 k\u1ebft cu\u1ed9c t\u1eed vong \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o.<\/p>\n<p>C\u1ea7n theo d\u00f5i b\u1ec7nh nh\u00e2n ch\u1eb7t ch\u1ebd v\u1ec1 tri\u1ec7u ch\u1ee9ng \u0111au b\u1ee5ng m\u1edbi xu\u1ea5t hi\u1ec7n ho\u1eb7c n\u1eb7ng h\u01a1n, g\u1ee3i \u00fd vi\u00eam t\u1ee5y c\u1ea5p. Vi\u1ec7c \u0111\u00e1nh gi\u00e1 b\u1ec7nh nh\u00e2n c\u00f3 th\u1ec3 bao g\u1ed3m kh\u00e1m th\u1ef1c th\u1ec3, \u0111\u00e1nh gi\u00e1 x\u00e9t nghi\u1ec7m amylase v\u00e0 lipase huy\u1ebft thanh, ch\u1ee5p h\u00ecnh \u1ea3nh \u1ed5 b\u1ee5ng nh\u01b0 si\u00eau \u00e2m v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p ch\u1ea9n \u0111o\u00e1n th\u00edch h\u1ee3p kh\u00e1c. N\u00ean t\u1ea1m ng\u01b0ng brentuximab vedotin \u0111\u1ed1i v\u1edbi b\u1ea5t k\u1ef3 tr\u01b0\u1eddng h\u1ee3p n\u00e0o nghi ng\u1edd vi\u00eam t\u1ee5y c\u1ea5p. N\u00ean ng\u1eebng s\u1eed d\u1ee5ng brentuximab vedotin n\u1ebfu \u0111\u00e3 ch\u1ea9n \u0111o\u00e1n x\u00e1c \u0111\u1ecbnh vi\u00eam t\u1ee5y c\u1ea5p.<\/p>\n<p><em>\u0110\u00f4\u0323c ti\u0301nh tr\u00ean ph\u00f4\u0309i<\/em><\/p>\n<p>Ca\u0301c tr\u01b0\u01a1\u0300ng h\u01a1\u0323p \u0111\u00f4\u0323c ti\u0301nh tr\u00ean ph\u00f4\u0309i, bao g\u1ed3m vi\u00eam ph\u1ed5i, b\u1ec7nh ph\u1ed5i k\u1ebd v\u00e0 h\u1ed9i ch\u1ee9ng suy h\u00f4 h\u1ea5p c\u1ea5p (ARDS), m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p c\u00f3 k\u1ebft cu\u1ed9c t\u1eed vong, \u0111a\u0303 \u0111\u01b0\u01a1\u0323c ba\u0301o ca\u0301o \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n d\u00f9ng brentuximab vedotin. M\u0103\u0323c du\u0300 m\u00f4\u0301i quan h\u00ea\u0323 nh\u00e2n qua\u0309 v\u1edbi brentuximab vedotin ch\u01b0a \u0111\u01b0\u01a1\u0323c x\u00e1c \u0111\u1ecbnh, kh\u00f4ng th\u00ea\u0309 loa\u0323i tr\u01b0\u0300 nguy c\u01a1 \u0111\u00f4\u0323c ti\u0301nh tr\u00ean ph\u00f4\u0309i. Trong tr\u01b0\u01a1\u0300ng h\u01a1\u0323p ca\u0301c tri\u00ea\u0323u ch\u01b0\u0301ng m\u1edbi tr\u00ean ph\u00f4\u0309i xu\u1ea5t hi\u1ec7n ho\u0103\u0323c n\u0103\u0323ng th\u00eam (v\u00ed d\u1ee5 ho, kho\u0301 th\u01a1\u0309), c\u1ea7n ti\u1ebfn h\u00e0nh \u0111a\u0301nh gia\u0301 ch\u00e2\u0309n \u0111oa\u0301n ngay l\u1eadp t\u1ee9c va\u0300 n\u00ean \u0111i\u00ea\u0300u tri\u0323 thi\u0301ch h\u01a1\u0323p cho b\u1ec7nh nh\u00e2n. Xem x\u00e9t t\u1ea1m ng\u01b0ng li\u1ec1u brentuximab vedotin trong khi \u0111\u00e1nh gi\u00e1 v\u00e0 cho \u0111\u1ebfn khi c\u1ea3i thi\u1ec7n tri\u1ec7u ch\u1ee9ng.<\/p>\n<p><em>Nhi\u00ea\u0303m tru\u0300ng n\u0103\u0323ng va\u0300 nhi\u00ea\u0303m tru\u0300ng c\u01a1 h\u00f4\u0323i<\/em><\/p>\n<p>Ca\u0301c nhi\u00ea\u0303m tru\u0300ng nghi\u00eam tr\u1ecdng nh\u01b0 vi\u00eam ph\u00f4\u0309i, nhi\u00ea\u0303m khu\u00e2\u0309n huy\u00ea\u0301t do t\u1ee5 c\u1ea7u (staphylococcus), nhi\u1ec5m khu\u1ea9n huy\u1ebft\/s\u1ed1c nhi\u1ec5m khu\u1ea9n (bao g\u00f4\u0300m k\u1ebft cu\u1ed9c t\u1eed vong), nhi\u00ea\u0303m herpes zoster, cytomegalovirus (CMV) (t\u00e1i ho\u1ea1t) va\u0300 ca\u0301c nhi\u00ea\u0303m tr\u00f9ng c\u01a1 h\u00f4\u0323i nh\u01b0 vi\u00eam ph\u1ed5i do Pneumocystis jiroveci v\u00e0 b\u1ec7nh n\u1ea5m Candida mi\u1ec7ng \u0111a\u0303 \u0111\u01b0\u01a1\u0323c ba\u0301o ca\u0301o \u1edf nh\u1eefng b\u00ea\u0323nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin. C\u00e2\u0300n theo do\u0303i b\u00ea\u0323nh nh\u00e2n c\u1ea9n th\u1eadn trong khi \u0111i\u00ea\u0300u tri\u0323 trong tr\u01b0\u1eddng h\u1ee3p xu\u1ea5t hi\u1ec7n c\u00e1c nhi\u00ea\u0303m tru\u0300ng nghi\u00eam tr\u1ecdng va\u0300 nhi\u00ea\u0303m tru\u0300ng c\u01a1 h\u00f4\u0323i co\u0301 th\u00ea\u0309 x\u1ea3y ra.<\/p>\n<p><em>Ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n<\/em><\/p>\n<p>Ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n (IRR) t\u1ee9c th\u00ec ho\u1eb7c ch\u1eadm, cu\u0303ng nh\u01b0 pha\u0309n \u01b0\u0301ng pha\u0309n v\u00ea\u0323 \u0111a\u0303 \u0111\u01b0\u01a1\u0323c ba\u0301o ca\u0301o.<\/p>\n<p>C\u00e2\u0300n theo do\u0303i b\u00ea\u0323nh nh\u00e2n c\u1ea9n th\u1eadn trong va\u0300 sau khi ti\u00eam truy\u00ea\u0300n. N\u1ebfu x\u1ea3y ra ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7, ph\u1ea3i ng\u1eebng s\u1eed d\u1ee5ng brentuximab vedotin ngay l\u1eadp t\u1ee9c v\u00e0 v\u0129nh vi\u1ec5n v\u00e0 c\u1ea7n s\u1eed d\u1ee5ng \u0111i\u1ec1u tr\u1ecb n\u1ed9i khoa th\u00edch h\u1ee3p.<\/p>\n<p>N\u1ebfu x\u1ea3y ra m\u1ed9t ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n, n\u00ean t\u1ea1m ng\u1eebng truy\u1ec1n v\u00e0 ti\u1ebfn h\u00e0nh x\u1eed tr\u00ed n\u1ed9i khoa th\u00edch h\u1ee3p. Sau khi thuy\u00ean gi\u1ea3m tri\u1ec7u ch\u1ee9ng, c\u00f3 th\u1ec3 b\u1eaft \u0111\u1ea7u truy\u1ec1n l\u1ea1i \u1edf t\u1ed1c \u0111\u1ed9 ch\u1eadm h\u01a1n. Nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 t\u1eebng c\u00f3 ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n n\u00ean \u0111\u01b0\u1ee3c d\u00f9ng thu\u1ed1c d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc c\u00e1c l\u1ea7n truy\u1ec1n ti\u1ebfp theo. Thu\u1ed1c d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc c\u00f3 th\u1ec3 bao g\u1ed3m paracetamol, thu\u1ed1c kh\u00e1ng histamin v\u00e0 corticosteroid.<\/p>\n<p>Ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n th\u01b0\u1eddng g\u1eb7p h\u01a1n v\u00e0 n\u1eb7ng h\u01a1n \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 kh\u00e1ng th\u1ec3 kh\u00e1ng brentuximab vedotin (xem ph\u1ea7n T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n).<\/p>\n<p><em>H\u1ed9i ch\u1ee9ng ly gi\u1ea3i kh\u1ed1i u<\/em><\/p>\n<p>H\u1ed9i ch\u1ee9ng ly gi\u1ea3i kh\u1ed1i u (TLS) \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o khi s\u1eed d\u1ee5ng brentuximab vedotin. Nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 kh\u1ed1i u t\u0103ng sinh nhanh ho\u1eb7c g\u00e1nh n\u1eb7ng kh\u1ed1i u l\u1edbn c\u00f3 nguy c\u01a1 b\u1ecb h\u1ed9i ch\u1ee9ng ly gi\u1ea3i kh\u1ed1i u. C\u1ea7n theo d\u00f5i ch\u1eb7t ch\u1ebd nh\u1eefng b\u1ec7nh nh\u00e2n n\u00e0y v\u00e0 x\u1eed tr\u00ed theo th\u1ef1c h\u00e0nh y khoa t\u1ed1t nh\u1ea5t. Vi\u1ec7c x\u1eed tr\u00ed h\u1ed9i ch\u1ee9ng ly gi\u1ea3i kh\u1ed1i u c\u00f3 th\u1ec3 bao g\u1ed3m b\u00f9 n\u01b0\u1edbc t\u00edch c\u1ef1c, theo d\u00f5i ch\u1ee9c n\u0103ng th\u1eadn, hi\u1ec7u ch\u1ec9nh c\u00e1c b\u1ea5t th\u01b0\u1eddng v\u1ec1 \u0111i\u1ec7n gi\u1ea3i, \u0111i\u1ec1u tr\u1ecb ch\u1ed1ng t\u0103ng acid uric m\u00e1u v\u00e0 \u0111i\u1ec1u tr\u1ecb h\u1ed7 tr\u1ee3.<\/p>\n<p><em>B\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean<\/em><\/p>\n<p>\u0110i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin c\u00f3 th\u1ec3 g\u00e2y ra b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean, c\u1ea3 c\u1ea3m gi\u00e1c v\u00e0 v\u1eadn \u0111\u1ed9ng. B\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean do brentuximab vedotin th\u01b0\u1eddng l\u00e0 \u1ea3nh h\u01b0\u1edfng c\u1ee7a s\u1ef1 s\u1eed d\u1ee5ng t\u00edch l\u0169y thu\u1ed1c n\u00e0y v\u00e0 c\u00f3 th\u1ec3 h\u1ed3i ph\u1ee5c trong h\u1ea7u h\u1ebft c\u00e1c tr\u01b0\u1eddng h\u1ee3p. Trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, \u0111a s\u1ed1 c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u00e3 c\u1ea3i thi\u1ec7n ho\u1eb7c thuy\u00ean gi\u1ea3m c\u00e1c tri\u1ec7u ch\u1ee9ng (xem ph\u1ea7n T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n). C\u1ea7n theo d\u00f5i b\u1ec7nh nh\u00e2n v\u1ec1 c\u00e1c tri\u1ec7u ch\u1ee9ng c\u1ee7a b\u1ec7nh th\u1ea7n kinh, nh\u01b0 gi\u1ea3m c\u1ea3m gi\u00e1c, t\u0103ng c\u1ea3m gi\u00e1c, d\u1ecb c\u1ea3m, kh\u00f3 ch\u1ecbu, c\u1ea3m gi\u00e1c b\u1ecfng r\u00e1t, \u0111au do b\u1ec7nh th\u1ea7n kinh ho\u1eb7c y\u1ebfu. Nh\u1eefng b\u1ec7nh nh\u00e2n m\u1edbi b\u1ecb b\u1ec7nh th\u1ea7n kinh ho\u1eb7c b\u1ec7nh n\u1eb7ng th\u00eam c\u1ea7n tr\u00ec ho\u00e3n li\u1ec1u, gi\u1ea3m li\u1ec1u brentuximab vedotin ho\u1eb7c ng\u1eebng \u0111i\u1ec1u tr\u1ecb (xem ph\u1ea7n Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 c\u00e1ch d\u00f9ng).<\/p>\n<p><em>\u0110\u1ed9c t\u00ednh tr\u00ean huy\u1ebft h\u1ecdc<\/em><\/p>\n<p>Thi\u1ebfu m\u00e1u \u0111\u1ed9 3 ho\u1eb7c \u0111\u1ed9 4, gi\u1ea3m ti\u1ec3u c\u1ea7u v\u00e0 gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u1ed9 3 ho\u1eb7c \u0111\u1ed9 4 k\u00e9o d\u00e0i (\u2265 1 tu\u1ea7n) c\u00f3 th\u1ec3 x\u1ea3y ra khi s\u1eed d\u1ee5ng brentuximab vedotin. C\u00e2\u0300n theo d\u00f5i c\u00f4ng th\u01b0\u0301c ma\u0301u toa\u0300n ph\u00e2\u0300n tr\u01b0\u01a1\u0301c khi du\u0300ng m\u1ed7i li\u1ec1u. N\u1ebfu xu\u1ea5t hi\u1ec7n gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u1ed9 3 ho\u1eb7c \u0111\u1ed9 4, tham kh\u1ea3o ph\u1ea7n Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 c\u00e1ch d\u00f9ng.<\/p>\n<p><em>Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh c\u00f3 s\u1ed1t<\/em><\/p>\n<p>Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh c\u00f3 s\u1ed1t (s\u1ed1t kh\u00f4ng r\u00f5 nguy\u00ean nh\u00e2n v\u00e0 kh\u00f4ng c\u00f3 nhi\u1ec5m tr\u00f9ng \u0111\u01b0\u1ee3c ghi nh\u1eadn tr\u00ean l\u00e2m s\u00e0ng ho\u1eb7c v\u1ec1 m\u1eb7t vi sinh v\u1eadt h\u1ecdc, v\u1edbi s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u trung t\u00ednh tuy\u1ec7t \u0111\u1ed1i &lt; 1,0 x 109\/l\u00edt, s\u1ed1t \u2265 38,5oC; tham kh\u1ea3o CTCAE phi\u00ean b\u1ea3n 3) \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o v\u1edbi vi\u1ec7c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin. C\u1ea7n theo d\u00f5i c\u00f4ng th\u1ee9c m\u00e1u to\u00e0n ph\u1ea7n tr\u01b0\u1edbc khi d\u00f9ng m\u1ed7i li\u1ec1u c\u1ee7a \u0111i\u1ec1u tr\u1ecb n\u00e0y. C\u1ea7n theo d\u00f5i b\u1ec7nh nh\u00e2n ch\u1eb7t ch\u1ebd v\u1ec1 s\u1ed1t v\u00e0 x\u1eed tr\u00ed theo th\u1ef1c h\u00e0nh y khoa t\u1ed1t nh\u1ea5t n\u1ebfu xu\u1ea5t hi\u1ec7n gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh c\u00f3 s\u1ed1t.<\/p>\n<p><em>H\u1ed9i ch\u1ee9ng Stevens-Johnson v\u00e0 ho\u1ea1i t\u1eed bi\u1ec3u b\u00ec nhi\u1ec5m \u0111\u1ed9c<\/em><\/p>\n<p>H\u1ed9i ch\u1ee9ng Stevens-Johnson (SJS) v\u00e0 ho\u1ea1i t\u1eed bi\u1ec3u b\u00ec nhi\u1ec5m \u0111\u1ed9c (TEN) \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o khi s\u1eed d\u1ee5ng brentuximab vedotin. C\u00e1c tr\u01b0\u1eddng h\u1ee3p c\u00f3 k\u1ebft cu\u1ed9c t\u1eed vong c\u0169ng \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o. N\u1ebfu h\u1ed9i ch\u1ee9ng Stevens-Johnson v\u00e0 ho\u1ea1i t\u1eed bi\u1ec3u b\u00ec nhi\u1ec5m \u0111\u1ed9c x\u1ea3y ra, ph\u1ea3i ng\u1eebng \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin v\u00e0 c\u1ea7n s\u1eed d\u1ee5ng \u0111i\u1ec1u tr\u1ecb n\u1ed9i khoa th\u00edch h\u1ee3p.<\/p>\n<p><em>C\u00e1c bi\u1ebfn ch\u1ee9ng \u1edf d\u1ea1 d\u00e0y ru\u1ed9t<\/em><\/p>\n<p>C\u00e1c bi\u1ebfn ch\u1ee9ng \u1edf d\u1ea1 d\u00e0y ru\u1ed9t (GI) bao g\u1ed3m t\u1eafc ru\u1ed9t, vi\u00eam ti\u1ec3u-\u0111\u1ea1i tr\u00e0ng, vi\u00eam \u0111\u1ea1i tr\u00e0ng gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh, \u0103n m\u00f2n, lo\u00e9t, th\u1ee7ng v\u00e0 xu\u1ea5t huy\u1ebft, m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p c\u00f3 k\u1ebft cu\u1ed9c t\u1eed vong, \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin. Trong tr\u01b0\u1eddng h\u1ee3p c\u00f3 c\u00e1c tri\u1ec7u ch\u1ee9ng \u1edf d\u1ea1 d\u00e0y ru\u1ed9t m\u1edbi ho\u1eb7c x\u1ea5u \u0111i, c\u1ea7n th\u1ef1c hi\u1ec7n \u0111\u00e1nh gi\u00e1 ch\u1ea9n \u0111o\u00e1n ngay l\u1eadp t\u1ee9c v\u00e0 \u0111i\u1ec1u tr\u1ecb th\u00edch h\u1ee3p.<\/p>\n<p><em>\u0110\u1ed9c t\u00ednh tr\u00ean gan<\/em><\/p>\n<p>\u0110\u1ed9c t\u00ednh tr\u00ean gan d\u01b0\u1edbi d\u1ea1ng t\u0103ng alanine aminotransferase (ALT) v\u00e0 aspartate aminotransferase (AST) \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o v\u1edbi brentuximab vedotin. C\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u1ed9c t\u00ednh tr\u00ean gan nghi\u00eam tr\u1ecdng, bao g\u1ed3m k\u1ebft cu\u1ed9c t\u1eed vong, c\u0169ng \u0111\u00e3 x\u1ea3y ra. B\u1ec7nh gan c\u00f3 t\u1eeb tr\u01b0\u1edbc, b\u1ec7nh \u0111i k\u00e8m v\u00e0 thu\u1ed1c d\u00f9ng \u0111\u1ed3ng th\u1eddi c\u0169ng c\u00f3 th\u1ec3 l\u00e0m t\u0103ng nguy c\u01a1. N\u00ean x\u00e9t nghi\u1ec7m ch\u1ee9c n\u0103ng gan tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb v\u00e0 theo d\u00f5i th\u01b0\u1eddng xuy\u00ean \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n d\u00f9ng brentuximab vedotin. Nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb \u0111\u1ed9c t\u00ednh tr\u00ean gan c\u00f3 th\u1ec3 c\u1ea7n tr\u00ec ho\u00e3n li\u1ec1u, thay \u0111\u1ed5i li\u1ec1u ho\u1eb7c ng\u1eebng d\u00f9ng brentuximab vedotin.<\/p>\n<p><em>T\u0103ng \u0111\u01b0\u1eddng huy\u1ebft<\/em><\/p>\n<p>T\u0103ng \u0111\u01b0\u1eddng huy\u1ebft \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ec9 s\u1ed1 kh\u1ed1i c\u01a1 th\u1ec3 (BMI) cao c\u00f3 ho\u1eb7c kh\u00f4ng c\u00f3 ti\u1ec1n s\u1eed b\u1ec7nh \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng. Tuy nhi\u00ean, c\u1ea7n theo d\u00f5i ch\u1eb7t ch\u1ebd n\u1ed3ng \u0111\u1ed9 glucse huy\u1ebft thanh \u1edf b\u1ea5t k\u1ef3 b\u1ec7nh nh\u00e2n n\u00e0o \u0111\u00e3 t\u1eebng c\u00f3 m\u1ed9t bi\u1ebfn c\u1ed1 t\u0103ng \u0111\u01b0\u1eddng huy\u1ebft. N\u00ean s\u1eed d\u1ee5ng \u0111i\u1ec1u tr\u1ecb ch\u1ed1ng \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng khi th\u00edch h\u1ee3p.<\/p>\n<p><em>Suy th\u1eadn v\u00e0 suy gan<\/em><\/p>\n<p>Kinh nghi\u1ec7m c\u00f2n h\u1ea1n ch\u1ebf \u1edf b\u1ec7nh nh\u00e2n suy th\u1eadn v\u00e0 suy gan. D\u1eef li\u1ec7u hi\u1ec7n c\u00f3 cho th\u1ea5y \u0111\u1ed9 thanh th\u1ea3i MMAE c\u00f3 th\u1ec3 b\u1ecb \u1ea3nh h\u01b0\u1edfng b\u1edfi suy th\u1eadn n\u1eb7ng, suy gan v\u00e0 b\u1edfi n\u1ed3ng \u0111\u1ed9 albumin huy\u1ebft thanh th\u1ea5p (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc).<\/p>\n<p><em>U lympho \u1edf da t\u1ebf b\u00e0o T CD30+<\/em><\/p>\n<p>M\u1ee9c \u0111\u1ed9 hi\u1ec7u qu\u1ea3 \u0111i\u1ec1u tr\u1ecb \u1edf c\u00e1c subtype u lympho \u1edf da t\u1ebf b\u00e0o T CD30+ kh\u00e1c ngo\u00e0i u s\u00f9i d\u1ea1ng n\u1ea5m (MF) v\u00e0 u lympho \u1edf da t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u00ean ph\u00e1t (pcALCL) kh\u00f4ng r\u00f5 r\u00e0ng do thi\u1ebfu b\u1eb1ng ch\u1ee9ng c\u1ea5p \u0111\u1ed9 cao. Trong 2 nghi\u00ean c\u1ee9u pha II \u1edf 1 nh\u00f3m v\u1ec1 brentuximab vedotin, ho\u1ea1t \u0111\u1ed9ng c\u1ee7a b\u1ec7nh \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n \u1edf c\u00e1c subtype m\u00f4 h\u1ecdc c\u1ee7a h\u1ed9i ch\u1ee9ng S\u00e9zary (SS), b\u1ec7nh s\u1ea7n d\u1ea1ng u lympho (LyP) v\u00e0 u lympho \u1edf da t\u1ebf b\u00e0o T h\u1ed7n h\u1ee3p. Nh\u1eefng d\u1eef li\u1ec7u n\u00e0y cho th\u1ea5y r\u1eb1ng hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ed9 an to\u00e0n c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ngo\u1ea1i suy cho c\u00e1c subtype c\u1ee7a u lympho \u1edf da t\u1ebf b\u00e0o T CD30+ kh\u00e1c.<\/p>\n<p>Tuy nhi\u00ean, c\u1ea7n th\u1eadn tr\u1ecdng khi s\u1eed d\u1ee5ng ADCETRIS \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb u lympho \u1edf da t\u1ebf b\u00e0o T CD30+ kh\u00e1c sau khi xem x\u00e9t c\u1ea9n th\u1eadn v\u1ec1 l\u1ee3i \u00edch-nguy c\u01a1 ti\u1ec1m \u1ea9n tr\u00ean c\u01a1 s\u1edf t\u1eebng b\u1ec7nh nh\u00e2n (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc).<\/p>\n<p><em>H\u00e0m l\u01b0\u1ee3ng natri trong t\u00e1 d\u01b0\u1ee3c<\/em><\/p>\n<p>Thu\u1ed1c n\u00e0y ch\u1ee9a t\u1ed1i \u0111a 2,1 mmol (ho\u1eb7c 47 mg) natri m\u1ed7i li\u1ec1u. \u0110i\u1ec1u n\u00e0y c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111ang theo ch\u1ebf \u0111\u1ed9 \u0103n ki\u1ec3m so\u00e1t natri.<\/p>\n<p><strong>T\u00e1c \u0111\u1ed9ng c\u1ee7a thu\u1ed1c tr\u00ean ng\u01b0\u1eddi l\u00e1i xe v\u00e0 v\u1eadn h\u00e0nh m\u00e1y m\u00f3c.<\/strong><\/p>\n<p>Brentuximab vedotin c\u00f3 th\u1ec3 c\u00f3 \u1ea3nh h\u01b0\u1edfng nh\u1eb9 \u0111\u1ebfn kh\u1ea3 n\u0103ng l\u00e1i xe v\u00e0 v\u1eadn h\u00e0nh m\u00e1y m\u00f3c.<\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h3><span class=\"ez-toc-section\" id=\"45-su-dung-cho-phu-nu-co-thai-va-cho-con-bu\"><\/span>4.5 S\u1eed d\u1ee5ng cho ph\u1ee5 n\u1eef c\u00f3 thai v\u00e0 cho con b\u00fa:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><em>X\u1ebfp h\u1ea1ng c\u1ea3nh b\u00e1o<\/em><\/p>\n<p>AU TGA pregnancy category: B3<\/p>\n<p>US FDA pregnancy category: NA<\/p>\n<p><em>Th\u1eddi k\u1ef3 mang thai:<\/em><\/p>\n<p>Kh\u00f4ng c\u00f3 d\u1eef li\u1ec7u v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng brentuximab vedotin \u1edf ph\u1ee5 n\u1eef c\u00f3 thai. C\u00e1c nghi\u00ean c\u1ee9u tr\u00ean \u0111\u1ed9ng v\u1eadt \u0111\u00e3 cho th\u1ea5y \u0111\u1ed9c t\u00ednh \u0111\u1ed1i v\u1edbi sinh s\u1ea3n (xem ph\u1ea7n D\u1eef li\u1ec7u an to\u00e0n ti\u1ec1n l\u00e2m s\u00e0ng).<\/p>\n<p>Kh\u00f4ng n\u00ean s\u1eed d\u1ee5ng brentuximab vedotin trong thai k\u1ef3 tr\u1eeb khi l\u1ee3i \u00edch \u0111\u1ed1i v\u1edbi ng\u01b0\u1eddi m\u1eb9 l\u1edbn h\u01a1n nguy c\u01a1 ti\u1ec1m t\u00e0ng \u0111\u1ed1i v\u1edbi thai nhi. N\u1ebfu m\u1ed9t ph\u1ee5 n\u1eef mang thai c\u1ea7n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb, c\u1ea7n t\u01b0 v\u1ea5n r\u00f5 r\u00e0ng cho b\u1ec7nh nh\u00e2n v\u1ec1 nguy c\u01a1 ti\u1ec1m t\u00e0ng \u0111\u1ed1i v\u1edbi thai nhi.<\/p>\n<p>Xem ph\u1ea7n kh\u1ea3 n\u0103ng sinh s\u1ea3n d\u01b0\u1edbi \u0111\u00e2y \u0111\u1ec3 t\u01b0 v\u1ea5n cho ph\u1ee5 n\u1eef c\u00f3 ch\u1ed3ng \u0111ang \u0111i\u1ec1u tr\u1ecb b\u1eb1ng bentuximab vedotin.<\/p>\n<p><em>Ph\u1ee5 n\u1eef c\u00f3 kh\u1ea3 n\u0103ng mang thai:<\/em><\/p>\n<p>Ph\u1ee5 n\u1eef c\u00f3 kh\u1ea3 n\u0103ng mang thai n\u00ean s\u1eed d\u1ee5ng 2 bi\u1ec7n ph\u00e1p tr\u00e1nh thai c\u00f3 hi\u1ec7u qu\u1ea3 trong khi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin v\u00e0 cho \u0111\u1ebfn 6 th\u00e1ng sau khi \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p><em>Th\u1eddi k\u1ef3 cho con b\u00fa:<\/em><\/p>\n<p>Kh\u00f4ng c\u00f3 d\u1eef li\u1ec7u v\u1ec1 vi\u1ec7c li\u1ec7u breduximab vedotin ho\u1eb7c c\u00e1c ch\u1ea5t chuy\u1ec3n h\u00f3a c\u1ee7a n\u00f3 \u0111\u01b0\u1ee3c b\u00e0i ti\u1ebft v\u00e0o s\u1eefa m\u1eb9 hay kh\u00f4ng.<\/p>\n<p>Kh\u00f4ng th\u1ec3 lo\u1ea1i tr\u1eeb nguy c\u01a1 \u0111\u1ed1i v\u1edbi tr\u1ebb s\u01a1 sinh\/tr\u1ebb nh\u1ecf.<\/p>\n<p>C\u1ea7n quy\u1ebft \u0111\u1ecbnh li\u1ec7u n\u00ean ng\u1eebng cho con b\u00fa ho\u1eb7c ng\u1eebng\/tr\u00e1nh d\u00f9ng li\u1ec7u ph\u00e1p n\u00e0y, c\u00f3 t\u00ednh \u0111\u1ebfn nguy c\u01a1 ti\u1ec1m t\u00e0ng c\u1ee7a vi\u1ec7c cho con b\u00fa \u0111\u1ed1i v\u1edbi tr\u1ebb b\u00fa m\u1eb9 v\u00e0 l\u1ee3i \u00edch \u0111i\u1ec1u tr\u1ecb \u0111\u1ed1i v\u1edbi ng\u01b0\u1eddi m\u1eb9.<\/p>\n<p><em>Kh\u1ea3 n\u0103ng sinh s\u1ea3n<\/em><\/p>\n<p>Trong c\u00e1c nghi\u00ean c\u1ee9u phi l\u00e2m s\u00e0ng, \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin \u0111\u00e3 d\u1eabn \u0111\u1ebfn \u0111\u1ed9c t\u00ednh \u0111\u1ed1i v\u1edbi tinh ho\u00e0n v\u00e0 c\u00f3 th\u1ec3 l\u00e0m thay \u0111\u1ed5i kh\u1ea3 n\u0103ng sinh s\u1ea3n c\u1ee7a gi\u1ed1ng \u0111\u1ef1c. MMAE \u0111\u00e3 cho th\u1ea5y c\u00f3 \u0111\u1eb7c t\u00ednh g\u00e2y l\u1ec7ch b\u1ed9i (xem ph\u1ea7n D\u1eef li\u1ec7u an to\u00e0n ti\u1ec1n l\u00e2m s\u00e0ng). Do \u0111\u00f3, n\u00ean khuy\u00ean nam gi\u1edbi \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c n\u00e0y n\u00ean c\u00f3 c\u00e1c m\u1eabu tinh tr\u00f9ng \u0111\u01b0\u1ee3c \u0111\u00f4ng l\u1ea1nh v\u00e0 l\u01b0u tr\u1eef tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb. C\u1ea7n khuy\u00ean nam gi\u1edbi \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c n\u00e0y kh\u00f4ng n\u00ean c\u00f3 con trong khi \u0111i\u1ec1u tr\u1ecb v\u00e0 \u0111\u1ebfn 6 th\u00e1ng sau li\u1ec1u cu\u1ed1i c\u00f9ng.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"46-tac-dung-khong-mong-muon-adr\"><\/span>4.6 T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n (ADR):<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong><em>T\u00f3m t\u1eaft h\u1ed3 s\u01a1 v\u1ec1 an to\u00e0n<\/em><\/strong><\/p>\n<p>H\u1ed3 s\u01a1 v\u1ec1 an to\u00e0n c\u1ee7a ADCETRIS d\u1ef1a tr\u00ean d\u1eef li\u1ec7u th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng hi\u1ec7n c\u00f3, ch\u01b0\u01a1ng tr\u00ecnh NPP (Named-Patient Program) v\u00e0 kinh nghi\u1ec7m h\u1eadu m\u00e3i cho \u0111\u1ebfn nay. T\u1ea7n su\u1ea5t c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 d\u01b0\u1edbi \u0111\u00e2y v\u00e0 trong B\u1ea3ng 12 \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh d\u1ef1a tr\u00ean d\u1eef li\u1ec7u \u0111\u01b0\u1ee3c t\u1ea1o ra t\u1eeb c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng.<\/p>\n<p>Trong b\u1ed9 d\u1eef li\u1ec7u g\u1ed9p c\u1ee7a ADCETRIS d\u01b0\u1edbi d\u1ea1ng \u0111\u01a1n tr\u1ecb li\u1ec7u c\u1ee7a c\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 u lympho Hodgkin, u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn v\u00e0 u lympho \u1edf da t\u1ebf b\u00e0o T (SG035- 0003, SG035-0004, SGN35-005, SGN35-006, C25001 v\u00e0 C25007, xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc), c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i th\u01b0\u1eddng g\u1eb7p nh\u1ea5t (\u2265 10%) l\u00e0 nhi\u1ec5m tr\u00f9ng, b\u1ec7nh th\u1ea7n kinh c\u1ea3m gi\u00e1c ngo\u1ea1i bi\u00ean, bu\u1ed3n n\u00f4n, m\u1ec7t m\u1ecfi, ti\u00eau ch\u1ea3y, s\u1ed1t, nhi\u1ec5m tr\u00f9ng \u0111\u01b0\u1eddng h\u00f4 h\u1ea5p tr\u00ean, gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh, ph\u00e1t ban, ho, n\u00f4n, \u0111au kh\u1edbp, b\u1ec7nh th\u1ea7n kinh v\u1eadn \u0111\u1ed9ng ngo\u1ea1i bi\u00ean, ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n, ng\u1ee9a, t\u00e1o b\u00f3n, kh\u00f3 th\u1edf, gi\u1ea3m c\u00e2n, \u0111au c\u01a1 v\u00e0 \u0111au b\u1ee5ng.<\/p>\n<p>C\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i nghi\u00eam tr\u1ecdng c\u1ee7a thu\u1ed1c \u0111\u00e3 x\u1ea3y ra \u1edf 12% b\u1ec7nh nh\u00e2n. T\u1ea7n su\u1ea5t c\u1ee7a c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i nghi\u00eam tr\u1ecdng \u0111\u1eb7c bi\u1ec7t \u2264 1%.<\/p>\n<p>C\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i \u0111\u00e3 d\u1eabn \u0111\u1ebfn ng\u1eebng \u0111i\u1ec1u tr\u1ecb \u1edf 24% b\u1ec7nh nh\u00e2n d\u00f9ng brentuximab vedotin.<\/p>\n<p>D\u1eef li\u1ec7u v\u1ec1 \u0111\u1ed9 an to\u00e0n \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c t\u00e1i \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ADCETRIS (SGN35-006, xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc) ph\u00f9 h\u1ee3p v\u1edbi nh\u1eefng d\u1eef li\u1ec7u \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y trong c\u00e1c nghi\u00ean c\u1ee9u pha 2 then ch\u1ed1t k\u1ebft h\u1ee3p, ngo\u1ea1i tr\u1eeb b\u1ec7nh th\u1ea7n kinh v\u1eadn \u0111\u1ed9ng ngo\u1ea1i bi\u00ean c\u00f3 t\u1ef7 l\u1ec7 m\u1eafc cao h\u01a1n (28% so v\u1edbi 9% trong c\u00e1c nghi\u00ean c\u1ee9u pha 2 then ch\u1ed1t) v\u00e0 ch\u1ee7 y\u1ebfu l\u00e0 \u0111\u1ed9 2. C\u00e1c b\u1ec7nh nh\u00e2n c\u0169ng c\u00f3 t\u1ef7 l\u1ec7 \u0111au kh\u1edbp cao h\u01a1n, thi\u1ebfu m\u00e1u \u0111\u1ed9 3 v\u00e0 \u0111au l\u01b0ng so v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y trong c\u00e1c nghi\u00ean c\u1ee9u pha 2 then ch\u1ed1t k\u1ebft h\u1ee3p.<\/p>\n<p>D\u1eef li\u1ec7u v\u1ec1 \u0111\u1ed9 an to\u00e0n \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb ch\u01b0a \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n v\u00e0 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng li\u1ec1u khuy\u1ebfn c\u00e1o l\u00e0 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n trong m\u1ed9t nghi\u00ean c\u1ee9u pha 4 \u1edf m\u1ed9t nh\u00f3m (n = 60), trong c\u00e1c nghi\u00ean c\u1ee9u pha 1 t\u0103ng li\u1ec1u, c\u00e1c nghi\u00ean c\u1ee9u d\u01b0\u1ee3c l\u00fd l\u00e2m s\u00e0ng (n=15 b\u1ec7nh nh\u00e2n) v\u00e0 trong ch\u01b0\u01a1ng tr\u00ecnh NPP (n=26 b\u1ec7nh nh\u00e2n) (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc) \u0111\u1ed3ng nh\u1ea5t v\u1edbi h\u1ed3 s\u01a1 v\u1ec1 an to\u00e0n c\u1ee7a c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng then ch\u1ed1t.<\/p>\n<p><strong><em>B\u1ea3ng danh s\u00e1ch c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i<\/em><\/strong><\/p>\n<p>C\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i c\u1ee7a ADCETRIS \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea theo nh\u00f3m h\u1ec7 c\u01a1 quan c\u1ee7a MedDRA v\u00e0 thu\u1eadt ng\u1eef \u01b0u ti\u00ean (xem B\u1ea3ng 12). Trong m\u1ed7i nh\u00f3m h\u1ec7 c\u01a1 quan, c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea theo lo\u1ea1i t\u1ea7n su\u1ea5t: R\u1ea5t th\u01b0\u1eddng g\u1eb7p (\u2265 1\/10); Th\u01b0\u1eddng g\u1eb7p (\u2265 1\/100 \u0111\u1ebfn &lt; 1\/10); \u00cdt g\u1eb7p (\u2265 1\/1.000 \u0111\u1ebfn &lt; 1\/100); Hi\u1ebfm g\u1eb7p (\u2265 1\/10.000 \u0111\u1ebfn &lt; 1\/1.000); R\u1ea5t hi\u1ebfm g\u1eb7p (&lt;1\/10.000); kh\u00f4ng r\u00f5 (kh\u00f4ng th\u1ec3 \u01b0\u1edbc t\u00ednh t\u1eeb c\u00e1c d\u1eef li\u1ec7u hi\u1ec7n c\u00f3).<\/p>\n<p>&#8211; xem B\u1ea3ng 12.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\">B\u1ea3ng 12. Ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i c\u1ee7a ADCETRIS<\/td>\n<\/tr>\n<tr>\n<td><a id=\"post-18070-_Hlk172147066\"><\/a><strong>Nh\u00f3m h\u1ec7 c\u01a1 quan<\/strong><\/td>\n<td><strong>Ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i<\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>Nhi\u1ec5m tr\u00f9ng v\u00e0 nhi\u1ec5m k\u00fd sinh tr\u00f9ng<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Nhi\u1ec5m tr\u00f9ng<sup>a<\/sup>, nhi\u1ec5m tr\u00f9ng \u0111\u01b0\u1eddng h\u00f4 h\u1ea5p tr\u00ean<\/td>\n<\/tr>\n<tr>\n<td>Th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Nhi\u1ec5m herpes zoster, vi\u00eam ph\u1ed5i, nhi\u1ec5m herpes simplex, b\u1ec7nh n\u1ea5m Candida mi\u1ec7ng<\/td>\n<\/tr>\n<tr>\n<td>\u00edt g\u1eb7p:<\/td>\n<td>Vi\u00eam ph\u1ed5i do Pneumocystis jiroveci, nhi\u1ec5m t\u1ee5 c\u1ea7u khu\u1ea9n huy\u1ebft, nhi\u1ec5m cytomegalovirus ho\u1eb7c t\u00e1i ho\u1ea1t cytomegalovirus, nhi\u1ec5m khu\u1ea9n huy\u1ebft\/s\u1ed1c nhi\u1ec5m khu\u1ea9n<\/td>\n<\/tr>\n<tr>\n<td>T\u1ea7n su\u1ea5t kh\u00f4ng r\u00f5:<\/td>\n<td>B\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n m\u00e1u v\u00e0 h\u1ec7 b\u1ea1ch huy\u1ebft<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh<\/td>\n<\/tr>\n<tr>\n<td>Th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Thi\u1ebfu m\u00e1u, gi\u1ea3m ti\u1ec3u c\u1ea7u<\/td>\n<\/tr>\n<tr>\n<td>\u00edt g\u1eb7p:<\/td>\n<td>Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh c\u00f3 s\u1ed1t<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n h\u1ec7 mi\u1ec5n d\u1ecbch<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u00edt g\u1eb7p:<\/td>\n<td>Ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n chuy\u1ec3n h\u00f3a v\u00e0 dinh d\u01b0\u1ee1ng<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Th\u01b0\u1eddng g\u1eb7p<\/td>\n<td>T\u0103ng \u0111\u01b0\u1eddng huy\u1ebft<\/td>\n<\/tr>\n<tr>\n<td>\u00edt g\u1eb7p:<\/td>\n<td>H\u1ed9i ch\u1ee9ng ly gi\u1ea3i kh\u1ed1i u<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n h\u1ec7 th\u1ea7n kinh<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>B\u1ec7nh th\u1ea7n kinh c\u1ea3m gi\u00e1c ngo\u1ea1i bi\u00ean, b\u1ec7nh th\u1ea7n kinh v\u1eadn \u0111\u1ed9ng ngo\u1ea1i bi\u00ean<\/td>\n<\/tr>\n<tr>\n<td>Th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Ch\u00f3ng m\u1eb7t<\/td>\n<\/tr>\n<tr>\n<td>\u00edt g\u1eb7p:<\/td>\n<td>B\u1ec7nh \u0111a d\u00e2y th\u1ea7n kinh h\u1ee7y myelin<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n h\u00f4 h\u1ea5p, ng\u1ef1c v\u00e0 trung th\u1ea5t<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Ho, kh\u00f3 th\u1edf<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n ti\u00eau h\u00f3a<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Bu\u1ed3n n\u00f4n, ti\u00eau ch\u1ea3y, n\u00f4n, t\u00e1o b\u00f3n, \u0111au b\u1ee5ng<\/td>\n<\/tr>\n<tr>\n<td>\u00edt g\u1eb7p:<\/td>\n<td>Vi\u00eam t\u1ee5y c\u1ea5p<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n gan m\u1eadt<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>Th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>T\u0103ng alanine aminotransferase\/aspartate aminotransterase (ALT\/AST)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n da v\u00e0 m\u00f4 d\u01b0\u1edbi da<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Ph\u00e1t ban, ng\u1ee9a<\/td>\n<\/tr>\n<tr>\n<td>Th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>R\u1ee5ng t\u00f3c<\/td>\n<\/tr>\n<tr>\n<td>\u00edt g\u1eb7p:<\/td>\n<td>H\u1ed9i ch\u1ee9ng Stevens-Johnson \/h\u1ed9i ch\u1ee9ng ho\u1ea1i t\u1eed bi\u1ec3u b\u00ec nhi\u1ec5m \u0111\u1ed9c<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n h\u1ec7 c\u01a1 x\u01b0\u01a1ng v\u00e0 m\u00f4 li\u00ean k\u1ebft<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>\u0110au kh\u1edbp, \u0111au c\u01a1<\/td>\n<\/tr>\n<tr>\n<td>Th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>\u0110au l\u01b0ng<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>R\u1ed1i lo\u1ea1n to\u00e0n th\u00e2n v\u00e0 t\u00ecnh tr\u1ea1ng t\u1ea1i ch\u1ed7 ti\u00eam truy\u1ec1n<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>M\u1ec7t m\u1ecfi, s\u1ed1t, ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n<sup>a<\/sup><\/td>\n<\/tr>\n<tr>\n<td>Th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>\u1edbn l\u1ea1nh<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong><em>C\u1eadn l\u00e2m s\u00e0ng<\/em><\/strong><\/td>\n<\/tr>\n<tr>\n<td>R\u1ea5t th\u01b0\u1eddng g\u1eb7p:<\/td>\n<td>Gi\u1ea3m c\u00e2n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><sup>a<\/sup>\u0110\u1ea1i di\u1ec7n cho vi\u1ec7c g\u1ed9p c\u00e1c thu\u1eadt ng\u1eef \u01b0u ti\u00ean.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong><em>M\u00f4 t\u1ea3 c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i ch\u1ecdn l\u1ecdc<\/em><\/strong><\/p>\n<p><em>Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh<\/em><\/p>\n<p>Trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u00e3 d\u1eabn \u0111\u1ebfn tr\u00ec ho\u00e3n li\u1ec1u \u1edf 14% b\u1ec7nh nh\u00e2n. Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u1ed9 3 \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 13% b\u1ec7nh nh\u00e2n v\u00e0 gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u1ed9 4 \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 5% b\u1ec7nh nh\u00e2n. Kh\u00f4ng c\u00f3 b\u1ec7nh nh\u00e2n n\u00e0o c\u1ea7n gi\u1ea3m li\u1ec1u ho\u1eb7c ng\u1eebng \u0111i\u1ec1u tr\u1ecb do gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh.<\/p>\n<p>Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh n\u1eb7ng v\u00e0 k\u00e9o d\u00e0i (\u2265 1 tu\u1ea7n) c\u00f3 th\u1ec3 x\u1ea3y ra v\u1edbi \u0111i\u1ec1u tr\u1ecb n\u00e0y, c\u00f3 th\u1ec3 l\u00e0m t\u0103ng nguy c\u01a1 b\u1ec7nh nh\u00e2n xu\u1ea5t hi\u1ec7n c\u00e1c nhi\u1ec5m tr\u00f9ng nghi\u00eam tr\u1ecdng. Gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh c\u00f3 s\u1ed1t \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf &lt;1% b\u1ec7nh nh\u00e2n (xem ph\u1ea7n Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 c\u00e1ch d\u00f9ng).<\/p>\n<p>\u1ede nh\u00f3m b\u1ec7nh nh\u00e2n c\u1ee7a nghi\u00ean c\u1ee9u pha 2 then ch\u1ed1t (SG035-0003 v\u00e0 SG035-0004), th\u1eddi gian trung v\u1ecb gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u1ed9 3 ho\u1eb7c \u0111\u1ed9 4 l\u00e0 c\u00f3 gi\u1edbi h\u1ea1n (1 tu\u1ea7n); 2% s\u1ed1 b\u1ec7nh nh\u00e2n c\u00f3 gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u1ed9 4 k\u00e9o d\u00e0i \u2265 7 ng\u00e0y. D\u01b0\u1edbi m\u1ed9t n\u1eeda s\u1ed1 b\u1ec7nh nh\u00e2n \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n b\u1ecb gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh \u0111\u1ed9 3 ho\u1eb7c \u0111\u1ed9 4 c\u1ee7a nghi\u00ean c\u1ee9u then ch\u1ed1t pha 2 c\u00f3 c\u00e1c nhi\u1ec5m tr\u00f9ng li\u00ean quan \u0111\u1ebfn th\u1eddi gian v\u00e0 \u0111a s\u1ed1 c\u00e1c nhi\u1ec5m tr\u00f9ng li\u00ean quan \u0111\u1ebfn th\u1eddi gian l\u00e0 \u0111\u1ed9 1 ho\u1eb7c \u0111\u1ed9 2.<\/p>\n<p><em>Nhi\u1ec5m tr\u00f9ng v\u00e0 nhi\u1ec5m tr\u00f9ng c\u01a1 h\u1ed9i nghi\u00eam tr\u1ecdng<\/em><\/p>\n<p>Trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, nhi\u1ec5m tr\u00f9ng v\u00e0 nhi\u1ec5m tr\u00f9ng c\u01a1 h\u1ed9i nghi\u00eam tr\u1ecdng x\u1ea3y ra \u1edf 10% b\u1ec7nh nh\u00e2n, nhi\u1ec5m khu\u1ea9n huy\u1ebft ho\u1eb7c s\u1ed1c nhi\u1ec5m khu\u1ea9n x\u1ea3y ra \u1edf &lt;1% b\u1ec7nh nh\u00e2n. Nhi\u1ec5m tr\u00f9ng c\u01a1 h\u1ed9i \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o th\u01b0\u1eddng g\u1eb7p nh\u1ea5t l\u00e0 nhi\u1ec5m herpes zoster v\u00e0 herpes simplex.<\/p>\n<p><em>B\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean<\/em><\/p>\n<p>Trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, b\u1ec7nh th\u1ea7n kinh xu\u1ea5t hi\u1ec7n trong \u0111i\u1ec1u tr\u1ecb x\u1ea3y ra \u1edf 59% nh\u00f3m b\u1ec7nh nh\u00e2n nghi\u00ean c\u1ee9u, b\u1ec7nh th\u1ea7n kinh v\u1eadn \u0111\u1ed9ng ngo\u1ea1i bi\u00ean x\u1ea3y ra \u1edf 14% b\u1ec7nh nh\u00e2n. B\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean d\u1eabn \u0111\u1ebfn ng\u1eebng \u0111i\u1ec1u tr\u1ecb \u1edf 15% b\u1ec7nh nh\u00e2n, gi\u1ea3m li\u1ec1u \u1edf 15% b\u1ec7nh nh\u00e2n v\u00e0 tr\u00ec ho\u00e3n li\u1ec1u \u1edf 17% b\u1ec7nh nh\u00e2n. \u0110\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean, th\u1eddi gian trung v\u1ecb kh\u1edfi ph\u00e1t b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean l\u00e0 12 tu\u1ea7n. Th\u1eddi gian \u0111i\u1ec1u tr\u1ecb trung v\u1ecb \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n ng\u1eebng thu\u1ed1c do b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean l\u00e0 12 chu k\u1ef3.<\/p>\n<p>\u1ede nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean trong c\u00e1c nghi\u00ean c\u1ee9u pha 2 then ch\u1ed1t (SG035-0003 v\u00e0 SG035-0004) v\u00e0 c\u00e1c nghi\u00ean c\u1ee9u pha 3 ng\u1eabu nhi\u00ean (SGN35-005 v\u00e0 C25001), th\u1eddi gian theo d\u00f5i trung v\u1ecb t\u1eeb khi k\u1ebft th\u00fac \u0111i\u1ec1u tr\u1ecb cho \u0111\u1ebfn l\u1ea7n \u0111\u00e1nh gi\u00e1 cu\u1ed1i c\u00f9ng trong kho\u1ea3ng t\u1eeb 48,9 \u0111\u1ebfn 98 tu\u1ea7n. T\u1ea1i th\u1eddi \u0111i\u1ec3m \u0111\u00e1nh gi\u00e1 cu\u1ed1i c\u00f9ng, h\u1ea7u h\u1ebft c\u00e1c b\u1ec7nh nh\u00e2n (82-85%) b\u1ecb b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean \u0111\u00e3 thuy\u00ean gi\u1ea3m ho\u1eb7c c\u1ea3i thi\u1ec7n c\u00e1c tri\u1ec7u ch\u1ee9ng b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean. Th\u1eddi gian trung v\u1ecb t\u1eeb l\u00fac kh\u1edfi ph\u00e1t \u0111\u1ebfn khi thuy\u00ean gi\u1ea3m ho\u1eb7c c\u1ea3i thi\u1ec7n \u0111\u1ed1i v\u1edbi t\u1ea5t c\u1ea3 c\u00e1c bi\u1ebfn c\u1ed1 trong kho\u1ea3ng t\u1eeb 16 \u0111\u1ebfn 23,4 tu\u1ea7n.<\/p>\n<p>\u1ede nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin ho\u1eb7c u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin (SGN35-006) t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb, \u0111a s\u1ed1 b\u1ec7nh nh\u00e2n (80%) c\u0169ng \u0111\u00e3 c\u1ea3i thi\u1ec7n ho\u1eb7c thuy\u00ean gi\u1ea3m c\u00e1c tri\u1ec7u ch\u1ee9ng b\u1ec7nh th\u1ea7n kinh ngo\u1ea1i bi\u00ean t\u1ea1i th\u1eddi \u0111i\u1ec3m \u0111\u00e1nh gi\u00e1 cu\u1ed1i c\u00f9ng.<\/p>\n<p><em>Ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n<\/em><\/p>\n<p>Ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n (IRR), nh\u01b0 nh\u1ee9c \u0111\u1ea7u, ph\u00e1t ban, \u0111au l\u01b0ng, n\u00f4n, \u1edbn l\u1ea1nh, bu\u1ed3n n\u00f4n, kh\u00f3 th\u1edf, ng\u1ee9a v\u00e0 ho \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 13% b\u1ec7nh nh\u00e2n. Ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7 \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o (xem ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 th\u1eadn tr\u1ecdng). C\u00e1c tri\u1ec7u ch\u1ee9ng c\u1ee7a ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7 c\u00f3 th\u1ec3 bao g\u1ed3m nh\u01b0ng kh\u00f4ng gi\u1edbi h\u1ea1n v\u1edbi n\u1ed5i m\u1ec1 \u0111ay, ph\u00f9 m\u1ea1ch, h\u1ea1 huy\u1ebft \u00e1p v\u00e0 co th\u1eaft ph\u1ebf qu\u1ea3n.<\/p>\n<p><em>T\u00ednh sinh mi\u1ec5n d\u1ecbch<\/em><\/p>\n<p>Trong c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c x\u00e9t nghi\u1ec7m \u0111\u1ecbnh k\u1ef3 v\u1ec1 kh\u00e1ng th\u1ec3 kh\u00e1ng brentuximab vedotin b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng x\u00e9t nghi\u1ec7m mi\u1ec5n d\u1ecbch \u0111i\u1ec7n h\u00f3a ph\u00e1t quang nh\u1ea1y. T\u1ef7 l\u1ec7 ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n cao h\u01a1n \u0111\u00e3 \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 kh\u00e1ng th\u1ec3 kh\u00e1ng brentuximab vedotin so v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c x\u00e9t nghi\u1ec7m d\u01b0\u01a1ng t\u00ednh ho\u1eb7c \u00e2m t\u00ednh tho\u00e1ng qua.<\/p>\n<p>S\u1ef1 hi\u1ec7n di\u1ec7n c\u1ee7a kh\u00e1ng th\u1ec3 kh\u00e1ng brentuximab vedotin kh\u00f4ng t\u01b0\u01a1ng quan v\u1edbi s\u1ef1 gi\u1ea3m n\u1ed3ng \u0111\u1ed9 brentuximab vedotin trong huy\u1ebft thanh c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng v\u00e0 kh\u00f4ng d\u1eabn \u0111\u1ebfn gi\u1ea3m hi\u1ec7u qu\u1ea3 c\u1ee7a brentuximab vedotin. Trong khi s\u1ef1 hi\u1ec7n di\u1ec7n c\u1ee7a kh\u00e1ng th\u1ec3 kh\u00e1ng brentuximab vedotin kh\u00f4ng nh\u1ea5t thi\u1ebft d\u1ef1 \u0111o\u00e1n s\u1ef1 ph\u00e1t tri\u1ec3n ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n, t\u1ef7 l\u1ec7 c\u00e1c ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n cao h\u01a1n \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 kh\u00e1ng th\u1ec3 kh\u00e1ng thu\u1ed1c (ADA) d\u01b0\u01a1ng t\u00ednh k\u00e9o d\u00e0i so v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 kh\u00e1ng th\u1ec3 kh\u00e1ng thu\u1ed1c d\u01b0\u01a1ng t\u00ednh tho\u00e1ng qua v\u00e0 nh\u1eefng b\u1ec7nh nh\u00e2n kh\u00f4ng bao gi\u1edd c\u00f3 kh\u00e1ng th\u1ec3 kh\u00e1ng thu\u1ed1c d\u01b0\u01a1ng t\u00ednh. C\u00f3 m\u1ed9t xu h\u01b0\u1edbng t\u0103ng \u0111\u1ed9 thanh th\u1ea3i c\u1ee7a brentuximab vedotin \u1edf nh\u1eefng b\u1ec7nh nhi \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh d\u01b0\u01a1ng t\u00ednh v\u1edbi kh\u00e1ng th\u1ec3 kh\u00e1ng thu\u1ed1c. Kh\u00f4ng c\u00f3 b\u1ec7nh nh\u00e2n n\u00e0o &lt; 12 tu\u1ed5i (0\/11) v\u00e0 2 b\u1ec7nh nh\u00e2n \u2265 12 tu\u1ed5i (2\/23) tr\u1edf n\u00ean c\u00f3 kh\u00e1ng th\u1ec3 kh\u00e1ng thu\u1ed1c d\u01b0\u01a1ng t\u00ednh k\u00e9o d\u00e0i.<\/p>\n<p><em>Nh\u00f3m b\u1ec7nh nhi<\/em><\/p>\n<p>\u0110\u1ed9 an to\u00e0n \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t nghi\u00ean c\u1ee9u pha 1\/2 \u1edf nh\u1eefng b\u1ec7nh nhi t\u1eeb 7-17 tu\u1ed5i (n = 36) b\u1ecb u lympho Hodgkin v\u00e0 u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb (r\/r) (xem ph\u1ea7n Ch\u1ec9 \u0111\u1ecbnh). Trong nghi\u00ean c\u1ee9u n\u00e0y \u1edf 36 b\u1ec7nh nh\u00e2n, kh\u00f4ng c\u00f3 m\u1ed1i quan t\u00e2m v\u1ec1 an to\u00e0n m\u1edbi n\u00e0o \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o.<\/p>\n<p><em>B\u00e1o c\u00e1o ca\u0301c ph\u1ea3n \u1ee9ng b\u00e2\u0301t l\u01a1\u0323i nghi ng\u1edd<\/em><\/p>\n<p>B\u00e1o c\u00e1o ca\u0301c ph\u1ea3n \u1ee9ng b\u00e2\u0301t l\u01a1\u0323i nghi ng\u1edd sau khi co\u0301 gi\u00e2\u0301y phe\u0301p l\u01b0u ha\u0300nh thu\u00f4\u0301c la\u0300 \u0111i\u00ea\u0300u quan tro\u0323ng. \u0110i\u00ea\u0300u na\u0300y cho ph\u00e9p theo do\u0303i li\u00ean t\u1ee5c c\u00e2n b\u0103\u0300ng l\u01a1\u0323i i\u0301ch\/nguy c\u01a1 c\u1ee7a thu\u00f4\u0301c. C\u00e1c chuy\u00ean vi\u00ean y t\u00ea\u0301 \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u b\u00e1o c\u00e1o b\u1ea5t k\u1ef3 ph\u1ea3n \u1ee9ng b\u00e2\u0301t l\u01a1\u0323i nghi ng\u1edd na\u0300o qua h\u1ec7 th\u1ed1ng b\u00e1o c\u00e1o qu\u1ed1c gia.<\/p>\n<p><em>Th\u00f4ng b\u00e1o cho B\u00e1c s\u0129 nh\u1eefng t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n g\u1eb7p ph\u1ea3i khi s\u1eed d\u1ee5ng thu\u1ed1c.<\/em><\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h3><span class=\"ez-toc-section\" id=\"47-huong-dan-cach-xu-tri-adr\"><\/span>4.7 H\u01b0\u1edbng d\u1eabn c\u00e1ch x\u1eed tr\u00ed ADR:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Ng\u1eebng s\u1eed d\u1ee5ng thu\u1ed1c. V\u1edbi c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i nh\u1eb9, th\u01b0\u1eddng ch\u1ec9 c\u1ea7n ng\u1eebng thu\u1ed1c. Tr\u01b0\u1eddng h\u1ee3p m\u1eabn c\u1ea3m n\u1eb7ng ho\u1eb7c ph\u1ea3n \u1ee9ng d\u1ecb \u1ee9ng, c\u1ea7n ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tr\u1ecb h\u1ed7 tr\u1ee3 (gi\u1eef tho\u00e1ng kh\u00ed v\u00e0 d\u00f9ng epinephrin, th\u1edf oxygen, d\u00f9ng kh\u00e1ng histamin, corticoid&#8230;).<\/p>\n<h3><span class=\"ez-toc-section\" id=\"48-tuong-tac-voi-cac-thuoc-khac\"><\/span>4.8 T\u01b0\u01a1ng t\u00e1c v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>T\u01b0\u01a1ng t\u00e1c v\u1edbi c\u00e1c thu\u1ed1c chuy\u1ec3n h\u00f3a qua con \u0111\u01b0\u1eddng CYP3A4 (thu\u1ed1c \u1ee9c ch\u1ebf\/thu\u1ed1c g\u00e2y c\u1ea3m \u1ee9ng CYP3A4)<\/p>\n<p>S\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi brentuximab vedotin v\u1edbi ketoconazole, m\u1ed9t thu\u1ed1c \u1ee9c ch\u1ebf m\u1ea1nh CYP3A4 v\u00e0 P-gp, l\u00e0m t\u0103ng n\u1ed3ng \u0111\u1ed9 c\u1ee7a MMAE l\u00e0 ch\u1ea5t kh\u00e1ng vi c\u1ea5u tr\u00fac h\u00ecnh \u1ed1ng kho\u1ea3ng 73%, v\u00e0 kh\u00f4ng l\u00e0m thay \u0111\u1ed5i n\u1ed3ng \u0111\u1ed9 trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a brentuximab vedotin. Do \u0111\u00f3, s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi brentuximab vedotin v\u1edbi thu\u1ed1c \u1ee9c ch\u1ebf m\u1ea1nh CYP3A4 v\u00e0 P-gp c\u00f3 th\u1ec3 l\u00e0m t\u0103ng t\u1ef7 l\u1ec7 gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh. N\u1ebfu xu\u1ea5t hi\u1ec7n gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh, tham kh\u1ea3o B\u1ea3ng 10: Khuy\u1ebfn c\u00e1o li\u1ec1u d\u00f9ng \u0111\u1ed1i v\u1edbi gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh (xem ph\u1ea7n Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 c\u00e1ch d\u00f9ng).<\/p>\n<p>S\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi brentuximab vedotin v\u1edbi rifampicin, m\u1ed9t thu\u1ed1c g\u00e2y c\u1ea3m \u1ee9ng m\u1ea1nh CYP3A4, kh\u00f4ng l\u00e0m thay \u0111\u1ed5i n\u1ed3ng \u0111\u1ed9 trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a brentuximab vedotin. M\u1eb7c d\u00f9 d\u1eef li\u1ec7u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u00f2n h\u1ea1n ch\u1ebf, nh\u01b0ng vi\u1ec7c s\u1eed d\u1ee5ng rifampicin \u0111\u1ed3ng th\u1eddi d\u01b0\u1eddng nh\u01b0 l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a c\u00e1c ch\u1ea5t chuy\u1ec3n h\u00f3a MMAE c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c x\u00e9t nghi\u1ec7m.<\/p>\n<p>S\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi midazolam, m\u1ed9t c\u01a1 ch\u1ea5t c\u1ee7a CYP3A4 v\u1edbi brentuximab vedotin kh\u00f4ng l\u00e0m thay \u0111\u1ed5i chuy\u1ec3n h\u00f3a c\u1ee7a midazolam; do \u0111\u00f3 brentuximab vedotin kh\u00f4ng \u0111\u01b0\u1ee3c d\u1ef1 ki\u1ebfn l\u00e0 l\u00e0m thay \u0111\u1ed5i n\u1ed3ng \u0111\u1ed9 c\u1ee7a c\u00e1c thu\u1ed1c \u0111\u01b0\u1ee3c chuy\u1ec3n h\u00f3a b\u1edfi c\u00e1c enzyme CYP3A4.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"49-qua-lieu-va-xu-tri\"><\/span>4.9 Qu\u00e1 li\u1ec1u v\u00e0 x\u1eed tr\u00ed:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Kh\u00f4ng c\u00f3 thu\u1ed1c gi\u1ea3i \u0111\u1ed9c n\u00e0o \u0111\u01b0\u1ee3c bi\u1ebft \u0111\u1ed1i v\u1edbi qu\u00e1 li\u1ec1u breduximab vedotin. Trong tr\u01b0\u1eddng h\u1ee3p qu\u00e1 li\u1ec1u, c\u1ea7n theo d\u00f5i b\u1ec7nh nh\u00e2n ch\u1eb7t ch\u1ebd v\u1ec1 c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i, \u0111\u1eb7c bi\u1ec7t l\u00e0 gi\u1ea3m b\u1ea1ch c\u1ea7u trung t\u00ednh v\u00e0 n\u00ean s\u1eed d\u1ee5ng \u0111i\u1ec1u tr\u1ecb h\u1ed7 tr\u1ee3 (xem ph\u1ea7n C\u1ea3nh b\u00e1o v\u00e0 th\u1eadn tr\u1ecdng).<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5-co-che-tac-dung-cua-thuoc\"><\/span><strong>5. C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng c\u1ee7a thu\u1ed1c :<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"51-duoc-luc-hoc\"><\/span>5.1. D\u01b0\u1ee3c l\u1ef1c h\u1ecdc:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Nh\u00f3m d\u01b0\u1ee3c l\u00fd tr\u1ecb li\u1ec7u: Thu\u1ed1c ch\u1ed1ng ung th\u01b0; c\u00e1c thu\u1ed1c ch\u1ed1ng ung th\u01b0 kh\u00e1c; kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng, m\u00e3 ATC: L01XC12.<\/p>\n<p>ADCETRIS l\u00e0 m\u1ed9t li\u00ean h\u1ee3p kh\u00e1ng th\u1ec3-thu\u1ed1c, c\u00e2\u0301u ta\u0323o b\u01a1\u0309i kha\u0301ng th\u00ea\u0309 \u0111\u01a1n do\u0300ng ta\u0301c \u0111\u00f4\u0323ng tr\u01b0\u0323c ti\u00ea\u0301p l\u00ean CD30 (globulin mi\u1ec5n d\u1ecbch G1 [IgG1] d\u1ea1ng kh\u1ea3m (chimeric) t\u00e1i t\u1ed5 h\u1ee3p, \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t b\u1eb1ng c\u00f4ng ngh\u1ec7 t\u00e1i t\u1ed5 h\u1ee3p DNA tr\u00ean t\u1ebf b\u00e0o bu\u1ed3ng tr\u1ee9ng c\u1ee7a chu\u1ed9t Hamster Trung Qu\u1ed1c) li\u00ean k\u1ebft \u0111\u1ed3ng h\u00f3a tr\u1ecb v\u1edbi monomethylauristatin E (MMAE) l\u00e0 ch\u1ea5t kh\u00e1ng vi c\u1ea5u tr\u00fac h\u00ecnh \u1ed1ng.<\/p>\n<p><em>\u0110i\u1ec7n sinh l\u00fd tim<\/em><\/p>\n<p>B\u1ed1n m\u01b0\u01a1i s\u00e1u (46) b\u1ec7nh nh\u00e2n c\u00f3 c\u00e1c b\u1ec7nh \u00e1c t\u00ednh v\u1ec1 huy\u1ebft h\u1ecdc bi\u1ec3u hi\u1ec7n CD30 \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong s\u1ed1 52 b\u1ec7nh nh\u00e2n d\u00f9ng brentuximab vedotin 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n nh\u01b0 l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a nghi\u00ean c\u1ee9u pha 1, m\u1ed9t nh\u00f3m, nh\u00e3n m\u1edf, \u0111a trung t\u00e2m v\u1ec1 \u0111\u1ed9 an to\u00e0n tr\u00ean tim. M\u1ee5c ti\u00eau ch\u00ednh l\u00e0 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 c\u1ee7a brentuximab vedotin \u0111\u1ed1i v\u1edbi s\u1ef1 t\u00e1i c\u1ef1c t\u00e2m th\u1ea5t c\u1ee7a tim v\u00e0 ph\u00e2n t\u00edch ch\u00ednh \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc l\u00e0 s\u1ef1 thay \u0111\u1ed5i kho\u1ea3ng QT hi\u1ec7u ch\u1ec9nh (QTc) so v\u1edbi ban \u0111\u1ea7u t\u1ea1i nhi\u1ec1u th\u1eddi \u0111i\u1ec3m c\u1ee7a chu k\u1ef3 1.<\/p>\n<p>Gi\u1edbi h\u1ea1n tr\u00ean c\u1ee7a kho\u1ea3ng tin c\u1eady (CI) 90% \u0111\u1ed1i v\u1edbi \u1ea3nh h\u01b0\u1edfng trung b\u00ecnh \u0111\u1ebfn QTc l\u00e0 &lt; 10 mili gi\u00e2y t\u1ea1i m\u1ed7i th\u1eddi \u0111i\u1ec3m c\u1ee7a chu k\u1ef3 1 v\u00e0 chu k\u1ef3 3 sau l\u00fac ban \u0111\u1ea7u. C\u00e1c d\u1eef li\u1ec7u n\u00e0y cho th\u1ea5y kh\u00f4ng c\u00f3 k\u00e9o d\u00e0i kho\u1ea3ng QT c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng do vi\u1ec7c s\u1eed d\u1ee5ng brentuximab vedotin \u1edf li\u1ec1u 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n tr\u00ean b\u1ec7nh nh\u00e2n b\u1ecb c\u00e1c b\u1ec7nh \u00e1c t\u00ednh bi\u1ec3u hi\u1ec7n CD30.<\/p>\n<p><strong><em>C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng: <\/em><\/strong><\/p>\n<p>Brentuximab vedotin l\u00e0 m\u1ed9t li\u00ean h\u1ee3p kh\u00e1ng th\u1ec3-thu\u1ed1c (ADC) cung c\u1ea5p m\u1ed9t thu\u1ed1c ch\u1ed1ng ung th\u01b0 d\u1eabn \u0111\u1ebfn s\u1ef1 ch\u1ebft t\u1ebf b\u00e0o theo ch\u01b0\u01a1ng tr\u00ecnh, ch\u1ecdn l\u1ecdc tr\u00ean c\u00e1c t\u1ebf b\u00e0o kh\u1ed1i u bi\u1ec3u hi\u1ec7n CD30. D\u1eef li\u1ec7u phi l\u00e2m s\u00e0ng cho th\u1ea5y ho\u1ea1t t\u00ednh sinh h\u1ecdc c\u1ee7a brentuximab vedotin l\u00e0 do m\u1ed9t qu\u00e1 tr\u00ecnh nhi\u1ec1u b\u01b0\u1edbc. Vi\u1ec7c g\u1eafn k\u1ebft c\u1ee7a ADC v\u00e0o CD30 tr\u00ean b\u1ec1 m\u1eb7t t\u1ebf b\u00e0o l\u00e0m kh\u1edfi ph\u00e1t s\u1ef1 \u0111i v\u00e0o trong c\u1ee7a ph\u1ee9c h\u1ee3p ADC-CD30, ph\u1ee9c h\u1ee3p n\u00e0y sau \u0111\u00f3 di chuy\u1ec3n v\u00e0o khoang lysosom. Trong t\u1ebf b\u00e0o, MMAE &#8211; m\u1ed9t lo\u1ea1i c\u00f3 ho\u1ea1t t\u00ednh \u0111\u00e3 x\u00e1c \u0111\u1ecbnh, \u0111\u01b0\u1ee3c ph\u00f3ng th\u00edch th\u00f4ng qua ph\u00e2n c\u1eaft b\u1eb1ng th\u1ee7y ph\u00e2n protein. MMAE g\u1eafn v\u00e0o tubulin l\u00e0m ph\u00e1 v\u1ee1 m\u1ea1ng vi c\u1ea5u tr\u00fac h\u00ecnh \u1ed1ng trong t\u1ebf b\u00e0o, l\u00e0m ng\u1eebng chu k\u1ef3 t\u1ebf b\u00e0o v\u00e0 d\u1eabn \u0111\u1ebfn s\u1ef1 ch\u1ebft t\u1ebf b\u00e0o theo ch\u01b0\u01a1ng tr\u00ecnh c\u1ee7a t\u1ebf b\u00e0o kh\u1ed1i u bi\u1ec3u hi\u1ec7n CD30.<\/p>\n<p>U lympho Hodgkin kinh \u0111i\u1ec3n, u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn v\u00e0 c\u00e1c subtype c\u1ee7a u lympho \u1edf da t\u1ebf b\u00e0o T (bao g\u1ed3m u s\u00f9i d\u1ea1ng n\u1ea5m v\u00e0 u lympho \u1edf da t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u00ean ph\u00e1t) bi\u1ec3u hi\u1ec7n CD30 nh\u01b0 m\u1ed9t kh\u00e1ng nguy\u00ean tr\u00ean b\u1ec1 m\u1eb7t c\u1ee7a c\u00e1c t\u1ebf b\u00e0o \u00e1c t\u00ednh. S\u1ef1 bi\u1ec3u hi\u1ec7n n\u00e0y kh\u00f4ng ph\u1ee5 thu\u1ed9c v\u00e0o giai \u0111o\u1ea1n b\u1ec7nh, d\u00f2ng \u0111i\u1ec1u tr\u1ecb ho\u1eb7c t\u00ecnh tr\u1ea1ng gh\u00e9p. Nh\u1eefng \u0111\u1eb7c \u0111i\u1ec3m n\u00e0y l\u00e0m cho CD30 tr\u1edf th\u00e0nh \u0111\u00edch cho can thi\u1ec7p \u0111i\u1ec1u tr\u1ecb. Do c\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng nh\u1eafm \u0111\u00edch CD30, brentuximab vedotin c\u00f3 kh\u1ea3 n\u0103ng v\u01b0\u1ee3t qua s\u1ef1 kh\u00e1ng h\u00f3a tr\u1ecb li\u1ec7u v\u00ec CD30 \u0111\u01b0\u1ee3c bi\u1ec3u hi\u1ec7n nh\u1ea5t qu\u00e1n \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n kh\u00e1ng tr\u1ecb v\u1edbi h\u00f3a tr\u1ecb li\u1ec7u \u0111a thu\u1ed1c, b\u1ea5t k\u1ec3 t\u00ecnh tr\u1ea1ng gh\u00e9p tr\u01b0\u1edbc \u0111\u00f3. C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng nh\u1eafm \u0111\u00edch CD30 c\u1ee7a brentuximab vedotin, bi\u1ec3u hi\u1ec7n nh\u1ea5t qu\u00e1n c\u1ee7a CD30 trong su\u1ed1t c\u00e1c b\u1ec7nh u lympho Hodgkin kinh \u0111i\u1ec3n, u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn, u lympho \u1edf da t\u1ebf b\u00e0o T CD30+, ph\u1ed5 tr\u1ecb li\u1ec7u ph\u1ed5 tr\u1ecb li\u1ec7u v\u00e0 b\u1eb1ng ch\u1ee9ng l\u00e2m s\u00e0ng trong c\u00e1c b\u1ec7nh \u00e1c t\u00ednh CD30 d\u01b0\u01a1ng t\u00ednh sau khi \u0111\u00e3 s\u1eed d\u1ee5ng nhi\u1ec1u d\u00f2ng \u0111i\u1ec1u tr\u1ecb cung c\u1ea5p m\u1ed9t l\u00fd do sinh h\u1ecdc \u0111\u1ec3 s\u1eed d\u1ee5ng brentuximab vedotin \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin kinh \u0111i\u1ec3n, u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb c\u00f3 ho\u1eb7c kh\u00f4ng c\u00f3 gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n tr\u01b0\u1edbc \u0111\u00f3 v\u00e0 u lympho \u1edf da t\u1ebf b\u00e0o T CD30+ sau \u00edt nh\u1ea5t m\u1ed9t li\u1ec7u ph\u00e1p to\u00e0n th\u00e2n tr\u01b0\u1edbc \u0111\u00f3.<\/p>\n<p>Kh\u00f4ng lo\u1ea1i tr\u1eeb s\u1ef1 g\u00f3p ph\u1ea7n c\u1ee7a c\u00e1c ch\u1ee9c n\u0103ng li\u00ean quan \u0111\u1ebfn kh\u00e1ng th\u1ec3 kh\u00e1c v\u00e0o c\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng.<\/p>\n<p><strong>[XEM T\u1ea0I \u0110\u00c2Y]<\/strong><\/p>\n<h3><span class=\"ez-toc-section\" id=\"52-duoc-dong-hoc\"><\/span>5.2. D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a brentuximab vedotin \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong c\u00e1c nghi\u00ean c\u1ee9u pha 1 v\u00e0 trong ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc qu\u1ea7n th\u1ec3 d\u1eef li\u1ec7u t\u1eeb 314 b\u1ec7nh nh\u00e2n. Trong t\u1ea5t c\u1ea3 c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, brentuximab vedotin \u0111\u01b0\u1ee3c d\u00f9ng d\u01b0\u1edbi d\u1ea1ng truy\u1ec1n t\u0129nh m\u1ea1ch.<\/p>\n<p>N\u1ed3ng \u0111\u1ed9 t\u1ed1i \u0111a c\u1ee7a brentuximab vedotin ADC th\u01b0\u1eddng \u0111\u01b0\u1ee3c quan s\u00e1t v\u00e0o l\u00fac k\u1ebft th\u00fac vi\u1ec7c truy\u1ec1n ho\u1eb7c l\u1ea5y m\u1eabu g\u1ea7n nh\u1ea5t v\u1edbi l\u00fac k\u1ebft th\u00fac vi\u1ec7c truy\u1ec1n. S\u1ef1 gi\u1ea3m theo d\u1ea1ng \u0111a h\u00e0m m\u0169 v\u1ec1 n\u1ed3ng \u0111\u1ed9 ADC trong huy\u1ebft thanh \u0111\u00e3 \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y v\u1edbi th\u1eddi gian b\u00e1n h\u1ee7y pha cu\u1ed1i kho\u1ea3ng t\u1eeb 4 \u0111\u1ebfn 6 ng\u00e0y. N\u1ed3ng \u0111\u1ed9 x\u1ea5p x\u1ec9 t\u1ef7 l\u1ec7 v\u1edbi li\u1ec1u. S\u1ef1 t\u00edch l\u0169y t\u1ed1i thi\u1ec3u ho\u1eb7c t\u00edch l\u0169y ADC \u0111\u00e3 \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y v\u1edbi nhi\u1ec1u li\u1ec1u \u1edf l\u1ecbch d\u00f9ng thu\u1ed1c m\u1ed7i 3 tu\u1ea7n, ph\u00f9 h\u1ee3p v\u1edbi \u01b0\u1edbc t\u00ednh th\u1eddi gian b\u00e1n h\u1ee7y pha cu\u1ed1i. Cmax v\u00e0 AUC \u0111i\u1ec3n h\u00ecnh c\u1ee7a ADC sau khi d\u00f9ng m\u1ed9t li\u1ec1u \u0111\u01a1n 1,8 mg\/kg trong m\u1ed9t nghi\u00ean c\u1ee9u pha 1 theo th\u1ee9 t\u1ef1 kho\u1ea3ng 31,98 \u03bcg\/mL v\u00e0 79,41 \u03bcg\/mL x ng\u00e0y.<\/p>\n<p>MMAE l\u00e0 ch\u1ea5t chuy\u1ec3n h\u00f3a ch\u00ednh c\u1ee7a brentuximab vedotin. Cmax, AUC v\u00e0 Tmax trung v\u1ecb c\u1ee7a MMAE sau khi d\u00f9ng m\u1ed9t li\u1ec1u \u0111\u01a1n ADC 1,8 mg\/kg trong m\u1ed9t nghi\u00ean c\u1ee9u pha 1 theo th\u1ee9 t\u1ef1 kho\u1ea3ng 4,97 ng\/mL, 37,03 ng\/mL x ng\u00e0y v\u00e0 2,09 ng\u00e0y. N\u1ed3ng \u0111\u1ed9 MMAE gi\u1ea3m sau khi d\u00f9ng nhi\u1ec1u li\u1ec1u brentuximab vedotin v\u1edbi kho\u1ea3ng 50% \u0111\u1ebfn 80% n\u1ed3ng \u0111\u1ed9 c\u1ee7a li\u1ec1u \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y \u1edf li\u1ec1u ti\u1ebfp theo. MMAE \u0111\u01b0\u1ee3c chuy\u1ec3n h\u00f3a ch\u1ee7 y\u1ebfu th\u00e0nh m\u1ed9t ch\u1ea5t chuy\u1ec3n h\u00f3a m\u1ea1nh t\u01b0\u01a1ng \u0111\u01b0\u01a1ng; tuy nhi\u00ean, n\u1ed3ng \u0111\u1ed9 c\u1ee7a ch\u1ea5t chuy\u1ec3n h\u00f3a \u1edf m\u1ee9c th\u1ea5p h\u01a1n so v\u1edbi MMAE. V\u00ec v\u1eady, n\u00f3 kh\u00f4ng c\u00f3 kh\u1ea3 n\u0103ng c\u00f3 b\u1ea5t k\u1ef3 s\u1ef1 g\u00f3p ph\u1ea7n \u0111\u00e1ng k\u1ec3 n\u00e0o v\u00e0o t\u00e1c d\u1ee5ng to\u00e0n th\u00e2n c\u1ee7a MMAE.<\/p>\n<p>Trong chu k\u1ef3 \u0111\u1ea7u ti\u00ean, n\u1ed3ng \u0111\u1ed9 MMAE cao h\u01a1n c\u00f3 li\u00ean quan \u0111\u1ebfn s\u1ef1 gi\u1ea3m s\u1ed1 l\u01b0\u1ee3ng b\u1ea1ch c\u1ea7u trung t\u00ednh tuy\u1ec7t \u0111\u1ed1i.<\/p>\n<p><em>Ph\u00e2n b\u1ed1<\/em><\/p>\n<p>In vitro, s\u1ef1 g\u1eafn k\u1ebft c\u1ee7a MMAE v\u1edbi protein huy\u1ebft t\u01b0\u01a1ng huy\u1ebft thanh ng\u01b0\u1eddi trong kho\u1ea3ng t\u1eeb 68-82%. MMAE kh\u00f4ng ch\u1eafc thay th\u1ebf ho\u1eb7c b\u1ecb thay th\u1ebf b\u1edfi c\u00e1c thu\u1ed1c g\u1eafn k\u1ebft m\u1ea1nh v\u1edbi protein. In vitro, MMAE l\u00e0 c\u01a1 ch\u1ea5t c\u1ee7a P-gp v\u00e0 kh\u00f4ng ph\u1ea3i l\u00e0 ch\u1ea5t \u1ee9c ch\u1ebf P-gp \u1edf n\u1ed3ng \u0111\u1ed9 l\u00e2m s\u00e0ng.<\/p>\n<p>\u1ede ng\u01b0\u1eddi, th\u1ec3 t\u00edch ph\u00e2n b\u1ed1 trung b\u00ecnh c\u1ee7a ADC \u1edf tr\u1ea1ng th\u00e1i \u1ed5n \u0111\u1ecbnh l\u00e0 kho\u1ea3ng 6-10 l\u00edt. D\u1ef1a tr\u00ean \u01b0\u1edbc t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc qu\u1ea7n th\u1ec3, th\u1ec3 t\u00edch ph\u00e2n b\u1ed1 bi\u1ec3u ki\u1ebfn \u0111i\u1ec3n h\u00ecnh (VM v\u00e0 VMP) c\u1ee7a MMAE theo th\u1ee9 t\u1ef1 l\u00e0 7,37 l\u00edt v\u00e0 36,4 l\u00edt.<\/p>\n<p><em>Chuy\u1ec3n h\u00f3a<\/em><\/p>\n<p>ADC \u0111\u01b0\u1ee3c d\u1ef1 ki\u1ebfn l\u00e0 s\u1ebd \u0111\u01b0\u1ee3c d\u1ecb h\u00f3a d\u01b0\u1edbi d\u1ea1ng protein v\u1edbi c\u00e1c acid amin c\u1ea5u th\u00e0nh \u0111\u01b0\u1ee3c t\u00e1i s\u1eed d\u1ee5ng ho\u1eb7c th\u1ea3i tr\u1eeb.<\/p>\n<p>D\u1eef li\u1ec7u in vivo \u1edf \u0111\u1ed9ng v\u1eadt v\u00e0 ng\u01b0\u1eddi cho th\u1ea5y r\u1eb1ng ch\u1ec9 c\u00f3 m\u1ed9t ph\u1ea7n nh\u1ecf MMAE ph\u00f3ng th\u00edch t\u1eeb brentuximab vedotin \u0111\u01b0\u1ee3c chuy\u1ec3n h\u00f3a. N\u1ed3ng \u0111\u1ed9 c\u1ee7a ch\u1ea5t chuy\u1ec3n h\u00f3a MMAE ch\u01b0a \u0111\u01b0\u1ee3c \u0111o trong huy\u1ebft t\u01b0\u01a1ng ng\u01b0\u1eddi. \u00cdt nh\u1ea5t c\u00f3 m\u1ed9t ch\u1ea5t chuy\u1ec3n h\u00f3a c\u1ee7a MMAE \u0111\u00e3 cho th\u1ea5y l\u00e0 c\u00f3 ho\u1ea1t t\u00ednh in vitro.<\/p>\n<p>MMAE l\u00e0 c\u01a1 ch\u1ea5t c\u1ee7a CYP3A4 v\u00e0 c\u00f3 th\u1ec3 c\u1ee7a CYP2D6. D\u1eef li\u1ec7u in vitro cho th\u1ea5y s\u1ef1 chuy\u1ec3n h\u00f3a c\u1ee7a MMAE x\u1ea3y ra ch\u1ee7 y\u1ebfu qua qu\u00e1 tr\u00ecnh oxy h\u00f3a b\u1edfi CYP3A4\/5. C\u00e1c nghi\u00ean c\u1ee9u in vitro s\u1eed d\u1ee5ng microsom gan ng\u01b0\u1eddi cho th\u1ea5y MMAE ch\u1ec9 \u1ee9c ch\u1ebf CYP3A4\/5 \u1edf m\u1ee9c n\u1ed3ng \u0111\u1ed9 cao h\u01a1n r\u1ea5t nhi\u1ec1u so v\u1edbi m\u1ee9c n\u1ed3ng \u0111\u1ed9 \u0111\u1ea1t \u0111\u01b0\u1ee3c trong s\u1eed d\u1ee5ng l\u00e2m s\u00e0ng. MMAE kh\u00f4ng \u1ee9c ch\u1ebf c\u00e1c isoform kh\u00e1c.<\/p>\n<p>MMAE kh\u00f4ng g\u00e2y c\u1ea3m \u1ee9ng b\u1ea5t k\u1ef3 enzym CYP450 ch\u00ednh n\u00e0o trong nu\u00f4i c\u1ea5y s\u01a1 c\u1ea5p t\u1ebf b\u00e0o gan ng\u01b0\u1eddi.<\/p>\n<p><em>Th\u1ea3i tr\u1eeb<\/em><\/p>\n<p>ADC \u0111\u01b0\u1ee3c th\u1ea3i tr\u1eeb qua s\u1ef1 d\u1ecb h\u00f3a v\u1edbi \u0111\u1ed9 thanh th\u1ea3i v\u00e0 th\u1eddi gian b\u00e1n h\u1ee7y \u01b0\u1edbc t\u00ednh \u0111i\u1ec3n h\u00ecnh theo th\u1ee9 t\u1ef1 l\u00e0 1,457 l\u00edt\/ng\u00e0y v\u00e0 4-6 ng\u00e0y.<\/p>\n<p>S\u1ef1 th\u1ea3i tr\u1eeb MMAE b\u1ecb gi\u1edbi h\u1ea1n b\u1edfi t\u1ed1c \u0111\u1ed9 ph\u00f3ng th\u00edch t\u1eeb ADC, \u0111\u1ed9 thanh th\u1ea3i v\u00e0 th\u1eddi gian b\u00e1n h\u1ee7y bi\u1ec3u ki\u1ebfn \u0111i\u1ec3n h\u00ecnh c\u1ee7a MMAE theo th\u1ee9 t\u1ef1 l\u00e0 19,99 l\u00edt\/ng\u00e0y v\u00e0 3-4 ng\u00e0y.<\/p>\n<p>M\u1ed9t nghi\u00ean c\u1ee9u v\u1ec1 s\u1ef1 th\u1ea3i tr\u1eeb \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n d\u00f9ng brentuximab vedotin v\u1edbi li\u1ec1u 1,8 mg\/kg. Kho\u1ea3ng 24% c\u1ee7a t\u1ed5ng l\u01b0\u1ee3ng MMAE \u0111\u00e3 d\u00f9ng nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a ADC trong khi truy\u1ec1n brentuximab vedotin \u0111\u00e3 \u0111\u01b0\u1ee3c thu h\u1ed3i trong c\u1ea3 n\u01b0\u1edbc ti\u1ec3u v\u00e0 ph\u00e2n trong th\u1eddi gian 1 tu\u1ea7n. Trong s\u1ed1 l\u01b0\u1ee3ng MMAE \u0111\u01b0\u1ee3c thu h\u1ed3i, kho\u1ea3ng 72% \u0111\u01b0\u1ee3c thu h\u1ed3i trong ph\u00e2n. M\u1ed9t l\u01b0\u1ee3ng MMAE nh\u1ecf h\u01a1n (28%) \u0111\u01b0\u1ee3c th\u1ea3i tr\u1eeb trong n\u01b0\u1edbc ti\u1ec3u.<\/p>\n<p><strong><em>D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc \u1edf c\u00e1c nh\u00f3m b\u1ec7nh nh\u00e2n \u0111\u1eb7c bi\u1ec7t<\/em><\/strong><\/p>\n<p>Ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc qu\u1ea7n th\u1ec3 cho th\u1ea5y n\u1ed3ng \u0111\u1ed9 albumin huy\u1ebft thanh ban \u0111\u1ea7u l\u00e0 \u0111\u1ed3ng bi\u1ebfn s\u1ed1 c\u00f3 \u00fd ngh\u0129a \u0111\u1ed1i v\u1edbi \u0111\u1ed9 thanh th\u1ea3i MMAE. Ph\u00e2n t\u00edch cho th\u1ea5y \u0111\u1ed9 thanh th\u1ea3i MMAE th\u1ea5p h\u01a1n 2 l\u1ea7n \u1edf b\u1ec7nh nh\u00e2n c\u00f3 n\u1ed3ng \u0111\u1ed9 albumin huy\u1ebft thanh th\u1ea5p &lt; 3,0 g\/l\u00edt so v\u1edbi b\u1ec7nh nh\u00e2n c\u00f3 n\u1ed3ng \u0111\u1ed9 albumin huy\u1ebft thanh trong ph\u1ea1m vi b\u00ecnh th\u01b0\u1eddng.<\/p>\n<p><em>Suy gan<\/em><\/p>\n<p>M\u1ed9t nghi\u00ean c\u1ee9u \u0111\u00e3 \u0111\u00e1nh gi\u00e1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a brentuximab vedotin v\u00e0 MMAE sau khi d\u00f9ng ADCETRIS 1,2 mg\/kg tr\u00ean b\u1ec7nh nh\u00e2n suy gan nh\u1eb9 (Child-Pugh A; n = 1), trung b\u00ecnh (Child-Pugh B; n = 5) v\u00e0 n\u1eb7ng (Child-Pugh C; n = 1). So v\u1edbi b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ee9c n\u0103ng gan b\u00ecnh th\u01b0\u1eddng, n\u1ed3ng \u0111\u1ed9 MMAE t\u0103ng kho\u1ea3ng 2,3 l\u1ea7n (kho\u1ea3ng tin c\u1eady 90% 1,27-4,12 l\u1ea7n) \u1edf b\u1ec7nh nh\u00e2n suy gan.<\/p>\n<p><em>Suy th\u1eadn<\/em><\/p>\n<p>M\u1ed9t nghi\u00ean c\u1ee9u \u0111\u00e3 \u0111\u00e1nh gi\u00e1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a brentuximab vedotin v\u00e0 MMAE sau khi d\u00f9ng ADCETRIS 1,2 mg\/kg tr\u00ean b\u1ec7nh nh\u00e2n suy th\u1eadn nh\u1eb9 (n=4), trung b\u00ecnh (n=3) v\u00e0 n\u1eb7ng (n=3).<\/p>\n<p>So v\u1edbi b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ee9c n\u0103ng th\u1eadn b\u00ecnh th\u01b0\u1eddng, n\u1ed3ng \u0111\u1ed9 MMAE t\u0103ng kho\u1ea3ng 1,9 l\u1ea7n (kho\u1ea3ng tin c\u1eady 90% 0,85-4,21 l\u1ea7n) tr\u00ean b\u1ec7nh nh\u00e2n suy th\u1eadn n\u1eb7ng (\u0111\u1ed9 thanh th\u1ea3i creatinin &lt; 30 mL\/ph\u00fat). Kh\u00f4ng quan s\u00e1t th\u1ea5y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn b\u1ec7nh nh\u00e2n suy th\u1eadn nh\u1eb9 ho\u1eb7c trung b\u00ecnh.<\/p>\n<p><em>Ng\u01b0\u1eddi cao tu\u1ed5i<\/em><\/p>\n<p>D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc qu\u1ea7n th\u1ec3 c\u1ee7a brentuximab vedotin \u0111\u00e3 \u0111\u01b0\u1ee3c kh\u1ea3o s\u00e1t t\u1eeb m\u1ed9t s\u1ed1 nghi\u00ean c\u1ee9u, bao g\u1ed3m d\u1eef li\u1ec7u t\u1eeb 380 b\u1ec7nh nh\u00e2n l\u00ean \u0111\u1ebfn 87 tu\u1ed5i (34 b\u1ec7nh nh\u00e2n \u2265 65- &lt; 75 tu\u1ed5i v\u00e0 17 b\u1ec7nh nh\u00e2n \u2265 75 tu\u1ed5i). \u1ea2nh h\u01b0\u1edfng c\u1ee7a tu\u1ed5i \u0111\u1ebfn d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc \u0111\u00e3 \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u v\u00e0 n\u00f3 kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t \u0111\u1ed3ng bi\u1ebfn s\u1ed1 c\u00f3 \u00fd ngh\u0129a (xem ph\u1ea7n Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 c\u00e1ch d\u00f9ng).<\/p>\n<p><em>Nh\u00f3m b\u1ec7nh nhi<\/em><\/p>\n<p>D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a brentuximab vedotin ADC v\u00e0 MMAE sau khi truy\u1ec1n t\u0129nh m\u1ea1ch BV trong 30 ph\u00fat v\u1edbi li\u1ec1u 1,4 mg\/kg ho\u1eb7c 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng pha 1\/2 \u1edf 36 b\u1ec7nh nhi (7-17 tu\u1ed5i) b\u1ecb u lympho Hodgkin v\u00e0 u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb (tr\u1ebb em t\u1eeb 7-11 tu\u1ed5i, n = 12 v\u00e0 thi\u1ebfu ni\u00ean t\u1eeb 12-17 tu\u1ed5i, n = 24) (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c h\u1ecdc). Cmax c\u1ee7a ADC th\u01b0\u1eddng \u0111\u01b0\u1ee3c quan s\u00e1t v\u00e0o l\u00fac k\u1ebft th\u00fac vi\u1ec7c truy\u1ec1n ho\u1eb7c l\u1ea5y m\u1eabu g\u1ea7n nh\u1ea5t v\u1edbi l\u00fac k\u1ebft th\u00fac vi\u1ec7c truy\u1ec1n. S\u1ef1 gi\u1ea3m theo d\u1ea1ng \u0111a h\u00e0m m\u0169 v\u1ec1 n\u1ed3ng \u0111\u1ed9 ADC trong huy\u1ebft thanh \u0111\u00e3 \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y v\u1edbi th\u1eddi gian b\u00e1n h\u1ee7y pha cu\u1ed1i kho\u1ea3ng t\u1eeb 4 \u0111\u1ebfn 5 ng\u00e0y. N\u1ed3ng \u0111\u1ed9 x\u1ea5p x\u1ec9 t\u1ef7 l\u1ec7 v\u1edbi li\u1ec1u v\u1edbi m\u1ed9t xu h\u01b0\u1edbng \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y v\u1ec1 n\u1ed3ng \u0111\u1ed9 ADC th\u1ea5p h\u01a1n \u1edf tu\u1ed5i\/th\u1ec3 tr\u1ecdng th\u1ea5p h\u01a1n trong nh\u00f3m b\u1ec7nh nh\u00e2n nghi\u00ean c\u1ee9u. AUC trung v\u1ecb c\u1ee7a ADC \u1edf tr\u1ebb em v\u00e0 thi\u1ebfu ni\u00ean t\u1eeb nghi\u00ean c\u1ee9u n\u00e0y th\u1ea5p h\u01a1n theo th\u1ee9 t\u1ef1 kho\u1ea3ng 14% v\u00e0 3% \u1edf b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi l\u1edbn, trong khi n\u1ed3ng \u0111\u1ed9 MMAE cao h\u01a1n theo th\u1ee9 t\u1ef1 l\u00e0 53% v\u00e0 13% \u1edf b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi l\u1edbn. Cmax v\u00e0 AUC trung v\u1ecb c\u1ee7a ADC sau khi d\u00f9ng m\u1ed9t li\u1ec1u \u0111\u01a1n 1,8 mg\/kg theo th\u1ee9 t\u1ef1 l\u00e0 29,8 \u00b5g\/mL v\u00e0 67,9 \u00b5g*ng\u00e0y\/mL \u1edf b\u1ec7nh nh\u00e2n &lt; 12 tu\u1ed5i v\u00e0 34,4 \u00b5g\/mL v\u00e0 77,8 \u00b5g*ng\u00e0y\/mL \u1edf b\u1ec7nh nh\u00e2n \u2265 12 tu\u1ed5i. Cmax, AUC v\u00e0 Tmax trung v\u1ecb c\u1ee7a MMAE sau khi d\u00f9ng m\u1ed9t li\u1ec1u \u0111\u01a1n 1,8 mg\/kg theo th\u1ee9 t\u1ef1 l\u00e0 3,73 ng\/mL, 17,3 ng*ng\u00e0y\/mL v\u00e0 1,92 ng\u00e0y \u1edf b\u1ec7nh nh\u00e2n &lt; 12 tu\u1ed5i v\u00e0 theo th\u1ee9 t\u1ef1 l\u00e0 6,33 ng\/mL, 42,3 ng*ng\u00e0y\/mL v\u00e0 1,82 ng\u00e0y \u1edf b\u1ec7nh nh\u00e2n \u2265 12 tu\u1ed5i. C\u00f3 m\u1ed9t xu h\u01b0\u1edbng t\u0103ng \u0111\u1ed9 thanh th\u1ea3i c\u1ee7a brentuximab vedotin \u1edf b\u1ec7nh nhi \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh d\u01b0\u01a1ng t\u00ednh v\u1edbi kh\u00e1ng th\u1ec3 kh\u00e1ng thu\u1ed1c. Kh\u00f4ng c\u00f3 b\u1ec7nh nh\u00e2n n\u00e0o &lt; 12 tu\u1ed5i (0\/11) v\u00e0 2 b\u1ec7nh nh\u00e2n \u2265 12 tu\u1ed5i (2\/23) tr\u1edf n\u00ean d\u01b0\u01a1ng t\u00ednh v\u1edbi kh\u00e1ng th\u1ec3 kh\u00e1ng thu\u1ed1c.<\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h3><span class=\"ez-toc-section\" id=\"53-hieu-qua-lam-sang\"><\/span>5.3. Hi\u1ec7u qu\u1ea3 l\u00e2m s\u00e0ng:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong><em>U lympho Hodgkin<\/em><\/strong><\/p>\n<p>* Nghi\u00ean c\u1ee9u SG035-0003<\/p>\n<p>Hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ed9 an to\u00e0n c\u1ee7a brentuximab vedotin d\u01b0\u1edbi d\u1ea1ng m\u1ed9t thu\u1ed1c \u0111\u01a1n \u0111\u1ed9c \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t nghi\u00ean c\u1ee9u then ch\u1ed1t nh\u00e3n m\u1edf, m\u1ed9t nh\u00f3m, \u0111a trung t\u00e2m \u1edf 102 b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb. Xem B\u1ea3ng 1 v\u1ec1 t\u00f3m t\u1eaft c\u00e1c \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n v\u00e0 \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh ban \u0111\u1ea7u.<\/p>\n<p>&#8211; xem B\u1ea3ng 1.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\">B\u1ea3ng 1. T\u00f3m t\u1eaft c\u00e1c \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n v\u00e0 \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh ban \u0111\u1ea7u trong nghi\u00ean c\u1ee9u pha 2 v\u1ec1 u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n<\/strong><\/td>\n<td><strong>N = 102<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Tu\u1ed5i trung v\u1ecb, n\u0103m (kho\u1ea3ng)<\/td>\n<td>31 tu\u1ed5i (15-77)<\/td>\n<\/tr>\n<tr>\n<td>Gi\u1edbi t\u00ednh<\/td>\n<td>48 nam (47%)\/ 54 n\u1eef (53%)<\/td>\n<\/tr>\n<tr>\n<td>T\u00ecnh tr\u1ea1ng ho\u1ea1t \u0111\u1ed9ng c\u01a1 th\u1ec3 theo thang \u0111i\u1ec3m c\u1ee7a ECOG (Nh\u00f3m h\u1ee3p t\u00e1c ung th\u01b0 \u0110\u00f4ng \u00c2u)<\/p>\n<p>0<\/p>\n<p>1<\/td>\n<td>42 (41%)<\/p>\n<p>60 (59%)<\/td>\n<\/tr>\n<tr>\n<td>Gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n tr\u01b0\u1edbc \u0111\u00f3<\/td>\n<td>102 (100%)<\/td>\n<\/tr>\n<tr>\n<td>Ph\u00e1c \u0111\u1ed3 h\u00f3a tr\u1ecb li\u1ec7u tr\u01b0\u1edbc \u0111\u00f3<\/td>\n<td>3,5 (1-13)<\/td>\n<\/tr>\n<tr>\n<td>Th\u1eddi gian t\u1eeb khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n \u0111\u1ebfn khi t\u00e1i ph\u00e1t l\u1ea7n \u0111\u1ea7u ti\u00ean sau gh\u00e9p<\/td>\n<td>6,7 th\u00e1ng (0-131)<\/td>\n<\/tr>\n<tr>\n<td>B\u1ec7nh c\u00f3 bi\u1ec3u hi\u1ec7n CD30 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng m\u00f4 h\u1ecdc<\/td>\n<td>102 (100%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Kh\u00e1ng tr\u1ecb ti\u00ean ph\u00e1t v\u1edbi li\u1ec7u ph\u00e1p \u0111\u1ea7u tay<sup>a<\/sup><\/td>\n<td>72 (71%)<\/td>\n<\/tr>\n<tr>\n<td>Kh\u00e1ng tr\u1ecb v\u1edbi li\u1ec7u ph\u00e1p g\u1ea7n nh\u1ea5t<\/td>\n<td>43 (42%)<\/td>\n<\/tr>\n<tr>\n<td>Tri\u1ec7u ch\u1ee9ng B ban \u0111\u1ea7u<\/td>\n<td>35 (33%)<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n III t\u1ea1i l\u1ea7n ch\u1ea9n \u0111o\u00e1n \u0111\u1ea7u ti\u00ean<\/td>\n<td>27 (26%)<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n IV t\u1ea1i l\u1ea7n ch\u1ea9n \u0111o\u00e1n \u0111\u1ea7u ti\u00ean<\/td>\n<td>20 (20%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><sup>a<\/sup> u lympho Hodgkin kh\u00e1ng tr\u1ecb ti\u00ean ph\u00e1t \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a l\u00e0 th\u1ea5t b\u1ea1i trong vi\u1ec7c \u0111\u1ea1t \u0111\u01b0\u1ee3c lui b\u1ec7nh ho\u00e0n to\u00e0n, ho\u1eb7c ti\u1ebfn tri\u1ec3n trong v\u00f2ng 3 th\u00e1ng sau khi ho\u00e0n th\u00e0nh li\u1ec7u ph\u00e1p \u0111\u1ea7u tay.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>M\u01b0\u1eddi t\u00e1m (18) b\u1ec7nh nh\u00e2n (18%) nh\u1eadn \u0111\u01b0\u1ee3c 16 chu k\u1ef3 brentuximab vedotin; v\u00e0 s\u1ed1 chu k\u1ef3 trung v\u1ecb nh\u1eadn \u0111\u01b0\u1ee3c l\u00e0 9 (trong kho\u1ea3ng t\u1eeb 1 \u0111\u1ebfn 16).<\/p>\n<p>\u0110\u00e1p \u1ee9ng v\u1edbi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1edfi C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) s\u1eed d\u1ee5ng Ti\u00eau chu\u1ea9n \u0111\u00e1p \u1ee9ng s\u1eeda \u0111\u1ed5i \u0111\u1ed1i v\u1edbi u lympho \u00e1c t\u00ednh (Cheson, 2007). \u0110\u00e1p \u1ee9ng \u0111i\u1ec1u tr\u1ecb \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1eb1ng ch\u1ee5p c\u1eaft l\u1edbp vi t\u00ednh (CT) xo\u1eafn \u1ed1c ng\u1ef1c, c\u1ed5, b\u1ee5ng v\u00e0 x\u01b0\u01a1ng ch\u1eadu; ch\u1ee5p c\u1eaft l\u1edbp ph\u00e1t x\u1ea1 positron (PET) v\u00e0 d\u1eef li\u1ec7u l\u00e2m s\u00e0ng. \u0110\u00e1nh gi\u00e1 v\u1ec1 \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n t\u1ea1i c\u00e1c chu k\u1ef3 2, 4, 7, 10, 13 v\u00e0 16 v\u1edbi PET \u1edf chu k\u1ef3 4 v\u00e0 7.<\/p>\n<p>T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau theo \u0111\u00e1nh gi\u00e1 c\u1ee7a C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) l\u00e0 75% (76 trong s\u1ed1 102 b\u1ec7nh nh\u00e2n \u1edf nh\u00f3m theo \u00fd \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb [ITT]) v\u00e0 gi\u1ea3m kh\u1ed1i u \u0111\u00e3 \u0111\u1ea1t \u0111\u01b0\u1ee3c \u1edf 94% b\u1ec7nh nh\u00e2n. Lui b\u1ec7nh ho\u00e0n to\u00e0n (CR) l\u00e0 33% (34 trong s\u1ed1 102 b\u1ec7nh nh\u00e2n \u1edf nh\u00f3m ITT). Th\u1eddi gian s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9 (OS) trung v\u1ecb l\u00e0 40,5 th\u00e1ng (th\u1eddi gian quan s\u00e1t trung v\u1ecb (th\u1eddi gian cho \u0111\u1ebfn khi t\u1eed vong ho\u1eb7c l\u1ea7n ti\u1ebfp x\u00fac cu\u1ed1i c\u00f9ng) t\u1eeb li\u1ec1u \u0111\u1ea7u ti\u00ean l\u00e0 35,1 th\u00e1ng (trong kho\u1ea3ng t\u1eeb 1,8 \u0111\u1ebfn 72,9 th\u00e1ng tr\u1edf l\u00ean). T\u1ef7 l\u1ec7 s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9 \u01b0\u1edbc t\u00ednh l\u00fac 5 n\u0103m l\u00e0 41% (Kho\u1ea3ng tin c\u1eady 95% [31%, 51%]). \u0110\u00e1nh gi\u00e1 c\u1ee7a nh\u00e0 nghi\u00ean c\u1ee9u n\u00f3i chung ph\u00f9 h\u1ee3p v\u1edbi \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp v\u1ec1 c\u00e1c h\u00ecnh \u1ea3nh ch\u1ee5p. Trong s\u1ed1 nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb, 8 b\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng \u0111\u00e3 ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c c\u00f9ng lo\u00e0i. \u0110\u1ec3 bi\u1ebft k\u1ebft qu\u1ea3 v\u1ec1 hi\u1ec7u qu\u1ea3 th\u00eam, xem B\u1ea3ng 2.<\/p>\n<p>&#8211; xem B\u1ea3ng 2.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"3\">B\u1ea3ng 2. K\u1ebft qu\u1ea3 v\u1ec1 hi\u1ec7u qu\u1ea3 \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0110\u00e1p \u1ee9ng l\u00e2m s\u00e0ng t\u1ed1t nh\u1ea5t<\/strong><\/p>\n<p><strong>(N =102)<\/strong><\/td>\n<td><strong>C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF)<\/strong><\/p>\n<p><strong>N (%)<\/strong><\/td>\n<td><strong>Kho\u1ea3ng tin c\u1eady<\/strong><\/p>\n<p><strong>CI 95%<\/strong><\/td>\n<\/tr>\n<tr>\n<td>T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (CR + PR)<\/td>\n<td>76 (75)<\/td>\n<td>64,9, 82,6<\/td>\n<\/tr>\n<tr>\n<td>Lui b\u1ec7nh ho\u00e0n to\u00e0n (CR)<\/td>\n<td>34 (33)<\/td>\n<td>24,3, 43,4<\/td>\n<\/tr>\n<tr>\n<td>Lui b\u1ec7nh m\u1ed9t ph\u1ea7n (PR)<\/td>\n<td>42 (41)<\/td>\n<td>NA (kh\u00f4ng \u00e1p d\u1ee5ng)<\/td>\n<\/tr>\n<tr>\n<td>T\u1ef7 l\u1ec7 ki\u1ec3m soat b\u1ec7nh (CR + PR + SD)<\/td>\n<td>98 (96)<\/td>\n<td>90,3, 98,9<\/td>\n<\/tr>\n<tr>\n<td><strong>Th\u1eddi gian \u0111\u00e1p \u1ee9ng<\/strong><\/td>\n<td><strong>Gi\u00e1 tr\u1ecb trung v\u1ecb theo c\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp<\/strong><\/td>\n<td><strong>Kho\u1ea3ng tin c\u1eady CI 95%<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u0110\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (CR + PR)<sup>a<\/sup><\/td>\n<td>6,7 th\u00e1ng<\/td>\n<td>3,6, 14,8<\/td>\n<\/tr>\n<tr>\n<td>Lui b\u1ec7nh ho\u00e0n to\u00e0n (CR)<\/td>\n<td>27,9 th\u00e1ng<\/td>\n<td>10,8, NE<sup>b<\/sup><\/td>\n<\/tr>\n<tr>\n<td><strong>Th\u1eddi gian s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9<\/strong><\/td>\n<td><\/td>\n<td><strong>Kho\u1ea3ng tin c\u1eady 95%<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Trung v\u1ecb<\/td>\n<td>40,5 th\u00e1ng<\/td>\n<td>28,7, 61,9<\/td>\n<\/tr>\n<tr>\n<td>T\u1ef7 l\u1ec7 s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9 5 n\u0103m \u01b0\u1edbc t\u00ednh<\/td>\n<td>41%<\/td>\n<td>31%, 51%<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">a Kho\u1ea3ng th\u1eddi gian \u0111\u00e1p \u1ee9ng (DOR) l\u00e0 t\u1eeb 1,2 th\u00e1ng tr\u1edf l\u00ean \u0111\u1ebfn 43 th\u00e1ng tr\u1edf l\u00ean v\u00e0 th\u1eddi gian theo d\u00f5i trung v\u1ecb t\u1eeb li\u1ec1u \u0111\u1ea7u ti\u00ean \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u1ea1t \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (OR) theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) l\u00e0 9 th\u00e1ng.<\/p>\n<p>b Kh\u00f4ng th\u1ec3 \u01b0\u1edbc t\u00ednh \u0111\u01b0\u1ee3c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>M\u1ed9t ph\u00e2n t\u00edch th\u0103m d\u00f2 tr\u00ean c\u00f9ng m\u1ed9t b\u1ec7nh nh\u00e2n cho th\u1ea5y kho\u1ea3ng 64% b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin nh\u01b0 l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng SG035-0003 \u0111\u00e3 c\u00f3 c\u1ea3i thi\u1ec7n v\u1ec1 l\u1ee3i \u00edch l\u00e2m s\u00e0ng nh\u01b0 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1eb1ng th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n (PFS) d\u00e0i h\u01a1n so v\u1edbi h\u1ea7u h\u1ebft d\u00f2ng \u0111i\u1ec1u tr\u1ecb g\u1ea7n nh\u1ea5t tr\u01b0\u1edbc \u0111\u00f3 c\u1ee7a h\u1ecd.<\/p>\n<p>Trong s\u1ed1 35 b\u1ec7nh nh\u00e2n (33%) c\u00f3 tri\u1ec7u ch\u1ee9ng B l\u00fac ban \u0111\u1ea7u, 27 b\u1ec7nh nh\u00e2n (77%) \u0111\u00e3 c\u00f3 thuy\u00ean gi\u1ea3m t\u1ea5t c\u1ea3 tri\u1ec7u ch\u1ee9ng B trong th\u1eddi gian trung v\u1ecb t\u1eeb khi b\u1eaft \u0111\u1ea7u d\u00f9ng brentuximab vedotin l\u00e0 0,7 th\u00e1ng.<\/p>\n<p>D\u1eef li\u1ec7u \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin kh\u00f4ng ph\u1ea3i l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng cho vi\u1ec7c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c (SCT)<\/p>\n<p>* Nghi\u00ean c\u1ee9u C25007<\/p>\n<p>M\u1ed9t nghi\u00ean c\u1ee9u pha 4 \u1edf m\u1ed9t nh\u00f3m \u0111\u00e3 \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb (n = 60) \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c \u00edt nh\u1ea5t m\u1ed9t ph\u00e1c \u0111\u1ed3 h\u00f3a tr\u1ecb li\u1ec7u tr\u01b0\u1edbc \u0111\u00f3 v\u00e0 t\u1ea1i th\u1eddi \u0111i\u1ec3m b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin \u0111\u00e3 kh\u00f4ng \u0111\u01b0\u1ee3c xem l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng cho vi\u1ec7c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c ho\u1eb7c h\u00f3a tr\u1ecb li\u1ec7u \u0111a thu\u1ed1c. S\u1ed1 chu k\u1ef3 trung v\u1ecb l\u00e0 7 (trong kho\u1ea3ng t\u1eeb 1 \u0111\u1ebfn 16 chu k\u1ef3). C\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n. Theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF), t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (ORR) \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n theo \u00fd \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb (ITT) l\u00e0 50% (kho\u1ea3ng tin c\u1eady 95%, 37; 63%). T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng to\u00e0n b\u1ed9 t\u1ed1t nh\u1ea5t v\u1ec1 lui b\u1ec7nh ho\u00e0n to\u00e0n (CR) \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 7 b\u1ec7nh nh\u00e2n (12%); lui b\u1ec7nh m\u1ed9t ph\u1ea7n (PR) \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 23 b\u1ec7nh nh\u00e2n (38%). \u1ede 30 b\u1ec7nh nh\u00e2n n\u00e0y, th\u1eddi gian trung v\u1ecb \u0111\u1ebfn khi \u0111\u00e1p \u1ee9ng, \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a l\u00e0 th\u1eddi gian t\u1eeb li\u1ec1u \u0111\u1ea7u ti\u00ean \u0111\u1ebfn khi lui b\u1ec7nh ho\u00e0n to\u00e0n ho\u1eb7c lui b\u1ec7nh m\u1ed9t ph\u1ea7n s\u1edbm nh\u1ea5t, l\u00e0 6 tu\u1ea7n (trong kho\u1ea3ng t\u1eeb 5 \u0111\u1ebfn 39 tu\u1ea7n). Th\u1eddi gian trung v\u1ecb \u0111\u1ebfn khi c\u00f3 \u0111\u00e1p \u1ee9ng to\u00e0n b\u1ed9 t\u1ed1t nh\u1ea5t, \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a l\u00e0 th\u1eddi gian t\u1eeb li\u1ec1u \u0111\u1ea7u ti\u00ean cho \u0111\u1ebfn khi \u0111\u00e1p \u1ee9ng l\u00e2m s\u00e0ng t\u1ed1t nh\u1ea5t v\u1ec1 lui b\u1ec7nh ho\u00e0n to\u00e0n ho\u1eb7c lui b\u1ec7nh m\u1ed9t ph\u1ea7n, l\u00e0 11 tu\u1ea7n (trong kho\u1ea3ng t\u1eeb 5 \u0111\u1ebfn 60 tu\u1ea7n). Hai m\u01b0\u01a1i t\u00e1m b\u1ec7nh nh\u00e2n (47%) ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c sau trung v\u1ecb 7 chu k\u1ef3 (trong kho\u1ea3ng t\u1eeb 4 \u0111\u1ebfn 16 chu k\u1ef3) \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin. 32 b\u1ec7nh nh\u00e2n (53%) kh\u00f4ng \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c sau \u0111\u00f3 c\u0169ng \u0111\u01b0\u1ee3c d\u00f9ng brentuximab vedotin trong trung v\u1ecb 7 chu k\u1ef3 (trong kho\u1ea3ng t\u1eeb 1 \u0111\u1ebfn 16 chu k\u1ef3).<\/p>\n<p>Trong s\u1ed1 60 b\u1ec7nh nh\u00e2n c\u1ee7a nghi\u00ean c\u1ee9u, 49 b\u1ec7nh nh\u00e2n (82%) \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c &gt; 1 \u0111i\u1ec1u tr\u1ecb li\u00ean quan \u0111\u1ebfn ung th\u01b0 tr\u01b0\u1edbc \u0111\u00f3 v\u00e0 11 b\u1ec7nh nh\u00e2n (18%) \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c 1 \u0111i\u1ec1u tr\u1ecb li\u00ean quan \u0111\u1ebfn ung th\u01b0 tr\u01b0\u1edbc \u0111\u00f3. Theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF), t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau l\u00e0 51% (kho\u1ea3ng tin c\u1eady 95% [36%, 66%]) \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c &gt; 1 \u0111i\u1ec1u tr\u1ecb li\u00ean quan \u0111\u1ebfn ung th\u01b0 tr\u01b0\u1edbc \u0111\u00f3 v\u00e0 45% (Kho\u1ea3ng tin c\u1eady 95% [17%, 77%]) \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c 1 \u0111i\u1ec1u tr\u1ecb li\u00ean quan \u0111\u1ebfn ung th\u01b0 tr\u01b0\u1edbc \u0111\u00f3. \u0110\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c &gt; 1 \u0111i\u1ec1u tr\u1ecb li\u00ean quan \u0111\u1ebfn ung th\u01b0 tr\u01b0\u1edbc \u0111\u00f3, \u0111\u00e1p \u1ee9ng to\u00e0n b\u1ed9 t\u1ed1t nh\u1ea5t v\u1ec1 lui b\u1ec7nh ho\u00e0n to\u00e0n \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 6 b\u1ec7nh nh\u00e2n (12%); lui b\u1ec7nh m\u1ed9t ph\u1ea7n \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 19 b\u1ec7nh nh\u00e2n (39%). \u0110\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c 1 \u0111i\u1ec1u tr\u1ecb li\u00ean quan \u0111\u1ebfn ung th\u01b0, lui b\u1ec7nh ho\u00e0n to\u00e0n \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 1 b\u1ec7nh nh\u00e2n (9%) v\u00e0 lui b\u1ec7nh m\u1ed9t ph\u1ea7n \u0111\u00e3 \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 4 b\u1ec7nh nh\u00e2n (36%). Trong s\u1ed1 49 b\u1ec7nh nh\u00e2n \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c &gt; 1 d\u00f2ng \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3, 22 b\u1ec7nh nh\u00e2n (45%) \u0111\u00e3 \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c sau \u0111\u00f3; trong s\u1ed1 11 b\u1ec7nh nh\u00e2n \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c 1 \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3, 6 b\u1ec7nh nh\u00e2n (55%) \u0111\u00e3 \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c sau \u0111\u00f3.<\/p>\n<p>D\u1eef li\u1ec7u c\u0169ng \u0111\u01b0\u1ee3c thu th\u1eadp t\u1eeb nh\u1eefng b\u1ec7nh nh\u00e2n (n = 15) trong c\u00e1c nghi\u00ean c\u1ee9u pha 1 t\u0103ng li\u1ec1u v\u00e0 c\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 d\u01b0\u1ee3c l\u00fd l\u00e2m s\u00e0ng, v\u00e0 t\u1eeb nh\u1eefng b\u1ec7nh nh\u00e2n (n = 26) trong ch\u01b0\u01a1ng tr\u00ecnh NPP (Named-Patient Program) b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb kh\u00f4ng \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n, v\u00e0 nh\u1eefng ng\u01b0\u1eddi \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n.<\/p>\n<p>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n ban \u0111\u1ea7u cho th\u1ea5y th\u1ea5t b\u1ea1i v\u1edbi nhi\u1ec1u ph\u00e1c \u0111\u1ed3 h\u00f3a tr\u1ecb li\u1ec7u tr\u01b0\u1edbc \u0111\u00f3 (trung v\u1ecb l\u00e0 3, trong kho\u1ea3ng t\u1eeb 1 \u0111\u1ebfn 7) tr\u01b0\u1edbc khi d\u00f9ng brentuximab vedotin l\u1ea7n \u0111\u1ea7u ti\u00ean. N\u0103m m\u01b0\u01a1i ch\u00edn ph\u1ea7n tr\u0103m (59%) b\u1ec7nh nh\u00e2n c\u00f3 b\u1ec7nh giai \u0111o\u1ea1n ti\u1ebfn tri\u1ec3n (giai \u0111o\u1ea1n III ho\u1eb7c IV) l\u00fac ch\u1ea9n \u0111o\u00e1n ban \u0111\u1ea7u.<\/p>\n<p>K\u1ebft qu\u1ea3 t\u1eeb nh\u1eefng nghi\u00ean c\u1ee9u pha 1 n\u00e0y v\u00e0 t\u1eeb kinh nghi\u1ec7m c\u1ee7a ch\u01b0\u01a1ng tr\u00ecnh NPP cho th\u1ea5y \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb m\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n tr\u01b0\u1edbc \u0111\u00f3, c\u00e1c \u0111\u00e1p \u1ee9ng c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng c\u00f3 th\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c nh\u01b0 \u0111\u01b0\u1ee3c ch\u1ee9ng minh theo \u0111\u00e1nh gi\u00e1 c\u1ee7a m\u1ed9t nh\u00e0 nghi\u00ean c\u1ee9u, t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau l\u00e0 54% v\u00e0 t\u1ef7 l\u1ec7 lui b\u1ec7nh ho\u00e0n to\u00e0n l\u00e0 22% sau trung v\u1ecb 5 chu k\u1ef3 brentuximab vedotin.<\/p>\n<p>* Nghi\u00ean c\u1ee9u SGN35-005<\/p>\n<p>Hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ed9 an to\u00e0n c\u1ee7a brentuximab vedotin \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t th\u1eed nghi\u1ec7m ng\u1eabu nhi\u00ean, m\u00f9 \u0111\u00f4i, \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, 2 nh\u00f3m, \u0111a trung t\u00e2m \u1edf 329 b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin c\u00f3 nguy c\u01a1 t\u00e1i ph\u00e1t ho\u1eb7c ti\u1ebfn tri\u1ec3n sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n. Nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 bi\u1ebft b\u1ecb b\u1ec7nh n\u00e3o\/m\u00e0ng n\u00e3o, bao g\u1ed3m ti\u1ec1n s\u1eed b\u1ec7nh n\u00e3o ch\u1ea5t tr\u1eafng \u0111a \u1ed5 ti\u1ebfn tri\u1ec3n \u0111\u00e3 \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb kh\u1ecfi nghi\u00ean c\u1ee9u. Xem B\u1ea3ng 3 v\u1ec1 \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n. Trong s\u1ed1 329 b\u1ec7nh nh\u00e2n, 165 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c ph\u00e2n ng\u1eabu nhi\u00ean v\u00e0o nh\u00f3m \u0111i\u1ec1u tr\u1ecb v\u00e0 164 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c ph\u00e2n ng\u1eabu nhi\u00ean v\u00e0o nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. Trong nghi\u00ean c\u1ee9u n\u00e0y, c\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c nh\u1eadn li\u1ec1u \u0111\u1ea7u ti\u00ean sau khi h\u1ed3i ph\u1ee5c t\u1eeb gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n (t\u1eeb ng\u00e0y 30-45 sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n). C\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ADCETRIS 1,8 mg\/kg ho\u1eb7c gi\u1ea3 d\u01b0\u1ee3c ph\u00f9 h\u1ee3p truy\u1ec1n t\u0129nh m\u1ea1ch trong 30 ph\u00fat m\u1ed7i 3 tu\u1ea7n cho \u0111\u1ebfn 16 chu k\u1ef3.<\/p>\n<p>Nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u ph\u1ea3i c\u00f3 \u00edt nh\u1ea5t m\u1ed9t trong c\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1 sau \u0111\u00e2y:<\/p>\n<p>&#8211; U lympho Hodgkin kh\u00e1ng tr\u1ecb v\u1edbi \u0111i\u1ec1u tr\u1ecb \u0111\u1ea7u tay<\/p>\n<p>&#8211; U lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c ti\u1ebfn tri\u1ec3n x\u1ea3y ra &lt; 12 th\u00e1ng t\u1eeb l\u00fac k\u1ebft th\u00fac \u0111i\u1ec1u tr\u1ecb \u0111\u1ea7u tay<\/p>\n<p>&#8211; S\u1ef1 tham gia ngo\u00e0i h\u1ea1ch b\u1ea1ch huy\u1ebft t\u1ea1i th\u1eddi \u0111i\u1ec3m t\u00e1i ph\u00e1t tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n, bao g\u1ed3m s\u1ef1 lan r\u1ed9ng ngo\u00e0i h\u1ea1ch b\u1ea1ch huy\u1ebft c\u1ee7a c\u00e1c kh\u1ed1i u h\u1ea1ch b\u1ea1ch huy\u1ebft v\u00e0o c\u00e1c c\u01a1 quan s\u1ed1ng c\u00f2n l\u00e2n c\u1eadn<\/p>\n<p>&#8211; xem B\u1ea3ng 3.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"3\">B\u1ea3ng 3. T\u00f3m t\u1eaft c\u00e1c \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n v\u00e0 \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh ban \u0111\u1ea7u trong nghi\u00ean c\u1ee9u pha 3 v\u1ec1 u lympho Hodgkin sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n<\/strong><\/td>\n<td><strong>Brentuximab vedotin<\/strong><\/p>\n<p><strong>N = 165<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c<\/strong><\/p>\n<p><strong>N = 164<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Tu\u1ed5i trung v\u1ecb, n\u0103m (kho\u1ea3ng)<\/td>\n<td>33 tu\u1ed5i (18-71)<\/td>\n<td>32 tu\u1ed5i (18-76)<\/td>\n<\/tr>\n<tr>\n<td>Gi\u1edbi t\u00ednh<\/td>\n<td>76 nam (46%)\/89 n\u1eef (54%)<\/td>\n<td>97 nam (59%)\/67 n\u1eef (41%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">T\u00ecnh tr\u1ea1ng ho\u1ea1t \u0111\u1ed9ng c\u01a1 th\u1ec3 theo thang \u0111i\u1ec3m c\u1ee7a ECOG<\/td>\n<\/tr>\n<tr>\n<td>0<\/td>\n<td>87 (53%)<\/td>\n<td>97 (59%)<\/td>\n<\/tr>\n<tr>\n<td>1<\/td>\n<td>77 (47%)<\/td>\n<td>67 (41%)<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>1 (1%)<\/td>\n<td>0<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><strong>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh<\/strong><\/td>\n<\/tr>\n<tr>\n<td>S\u1ed1 l\u01b0\u1ee3ng trung v\u1ecb c\u00e1c ph\u00e1c \u0111\u1ed3 h\u00f3a tr\u1ecb li\u1ec7u tr\u01b0\u1edbc \u0111\u00f3 (kho\u1ea3ng)<\/td>\n<td>2 (2-8)<\/td>\n<td>2 (2-7)<\/td>\n<\/tr>\n<tr>\n<td>Th\u1eddi gian trung v\u1ecb t\u1eeb l\u00fac ch\u1ea9n \u0111o\u00e1n u lympho Hodgkin \u0111\u1ebfn li\u1ec1u \u0111\u1ea7u ti\u00ean (kho\u1ea3ng)<\/td>\n<td>18,7 th\u00e1ng (6,1-204,0)<\/td>\n<td>18,8 th\u00e1ng (7,4-180,8)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">Giai \u0111o\u1ea1n b\u1ec7nh l\u00fac ch\u1ea9n \u0111o\u00e1n u lympho Hodgkin ban \u0111\u1ea7u<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n I<\/td>\n<td>1 (1%)<\/td>\n<td>5 (3%)<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n II<\/td>\n<td>73 (44%)<\/td>\n<td>61 (37%)<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n III<\/td>\n<td>48 (29%)<\/td>\n<td>45 (27%)<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n IV<\/td>\n<td>43 (26%)<\/td>\n<td>51 (31%)<\/td>\n<\/tr>\n<tr>\n<td>Kh\u00f4ng r\u00f5<\/td>\n<td>0<\/td>\n<td>2 (1%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">T\u00ecnh tr\u1ea1ng ch\u1ee5p c\u1eaft l\u1edbp ph\u00e1t x\u1ea1 positron (PET) tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n<\/td>\n<\/tr>\n<tr>\n<td>FDG-AVID<\/td>\n<td>64 (39%)<\/td>\n<td>51 (31%)<\/td>\n<\/tr>\n<tr>\n<td>FDG-\u00c2M T\u00cdNH<\/td>\n<td>56 (34%)<\/td>\n<td>57 (35%)<\/td>\n<\/tr>\n<tr>\n<td>KH\u00d4NG \u0110\u01af\u1ee2C TH\u1ef0C HI\u1ec6N<\/td>\n<td>45 (27%)<\/td>\n<td>56 (34%)<\/td>\n<\/tr>\n<tr>\n<td>S\u1ef1 tham gia ngo\u00e0i h\u1ea1ch b\u1ea1ch huy\u1ebft t\u1ea1i th\u1eddi \u0111i\u1ec3m t\u00e1i ph\u00e1t tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n<\/td>\n<td>54 (33%)<\/td>\n<td>53 (32%)<\/td>\n<\/tr>\n<tr>\n<td>Tri\u1ec7u ch\u1ee9ng Ba<\/td>\n<td>47 (28%)<\/td>\n<td>40 (24%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">\u0110\u00e1p \u1ee9ng t\u1ed1t nh\u1ea5t v\u1edbi \u0111i\u1ec1u tr\u1ecb c\u1ee9u nguy tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n<sup>b<\/sup><\/td>\n<\/tr>\n<tr>\n<td>\u0110\u00e1p \u1ee9ng ho\u00e0n to\u00e0n<\/td>\n<td>61 (37%)<\/td>\n<td>62 (38%)<\/td>\n<\/tr>\n<tr>\n<td>\u0110\u00e1p \u1ee9ng m\u1ed9t ph\u1ea7n<\/td>\n<td>57 (35%)<\/td>\n<td>56 (34%)<\/td>\n<\/tr>\n<tr>\n<td>\u0110\u00e1p \u1ee9ng b\u1ec1n v\u1eefng<\/td>\n<td>47 (28%)<\/td>\n<td>46 (28%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">T\u00ecnh tr\u1ea1ng u lympho Hodgkin sau khi k\u1ebft th\u00fac h\u00f3a tr\u1ecb li\u1ec7u chu\u1ea9n \u0111\u1ea7u tay<sup>b<\/sup><\/td>\n<\/tr>\n<tr>\n<td>Kh\u00e1ng tr\u1ecb<\/td>\n<td>99 (60%)<\/td>\n<td>97 (59%)<\/td>\n<\/tr>\n<tr>\n<td>Kh\u00e1ng tr\u1ecb x\u1ea3y ra &lt;12 th\u00e1ng<\/td>\n<td>53 (32%)<\/td>\n<td>54 (33%)<\/td>\n<\/tr>\n<tr>\n<td>T\u00e1i ph\u00e1t x\u1ea3y ra &gt;12 th\u00e1ng<\/td>\n<td>13 (8%)<\/td>\n<td>13(8%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">a \u0110\u1ed1i v\u1edbi b\u1ec7nh kh\u00e1ng tr\u1ecb, ho\u1eb7c khi ti\u1ebfn tri\u1ec3n ho\u1eb7c t\u00e1i ph\u00e1t sau li\u1ec7u ph\u00e1p \u0111\u1ea7u tay.<\/p>\n<p>b C\u00e1c y\u1ebfu t\u1ed1 ph\u00e2n t\u1ea7ng l\u00fac ph\u00e2n ng\u1eabu nhi\u00ean.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>K\u1ebft qu\u1ea3 v\u1ec1 hi\u1ec7u qu\u1ea3 \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n \u1edf B\u1ea3ng 4. Ti\u00eau ch\u00ed \u0111\u00e1nh gi\u00e1 ch\u00ednh v\u1ec1 th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n (PFS) \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng v\u00e0 cho th\u1ea5y s\u1ef1 kh\u00e1c bi\u1ec7t v\u1ec1 th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n trung v\u1ecb 18,8 th\u00e1ng c\u00f3 l\u1ee3i cho nh\u00f3m \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p>&#8211; xem B\u1ea3ng 4.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"4\">B\u1ea3ng 4. K\u1ebft qu\u1ea3 v\u1ec1 hi\u1ec7u qu\u1ea3 \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin c\u00f3 t\u0103ng nguy c\u01a1 t\u00e1i ph\u00e1t ho\u1eb7c ti\u1ebfn tri\u1ec3n sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><strong>Brentuximab vedotin<\/strong><\/p>\n<p><strong>N = 165<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c<\/strong><\/p>\n<p><strong>N = 164<\/strong><\/td>\n<td><strong>T\u1ef7 s\u1ed1 nguy c\u01a1 ph\u00e2n t\u1ea7ng<\/strong><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"4\"><strong>Th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n<sup>a<\/sup><\/strong><\/td>\n<td colspan=\"2\"><strong>Gi\u00e1 tr\u1ecb trung v\u1ecb theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF)<\/strong><\/p>\n<p>&nbsp;<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>42,9 th\u00e1ng<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [30,4, 42,9])<\/td>\n<td>24,1 th\u00e1ng<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [11,5, -])<\/td>\n<td>0,57<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [0,40, 0,81])<\/p>\n<p>Ki\u1ec3m \u0111\u1ecbnh log-rank ph\u00e2n t\u1ea7ng p=0,001<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong>Gi\u00e1 tr\u1ecb trung v\u1ecb theo Nh\u00e0 nghi\u00ean c\u1ee9u<\/strong><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Kh\u00f4ng \u0111\u1ea1t \u0111\u01b0\u1ee3c (Kho\u1ea3ng tin c\u00e2y 95% [26,4, -])<\/td>\n<td>15,8 th\u00e1ng<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [8,5, -])<\/td>\n<td>0,5<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [0,36, 0,70])<sup>b<\/sup><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"2\"><strong>S\u1ed1ng c\u00f2n to\u00e0n b\u1ed9<\/strong><\/td>\n<td colspan=\"2\"><strong>S\u1ed1 tr\u01b0\u1eddng h\u1ee3p t\u1eed vong (%)<\/strong><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>28(17)<\/td>\n<td>25 (15)<\/td>\n<td>1,15<\/p>\n<p>(Kho\u1ea3ng tin c\u1eady 95% [0,67, 1,97])<\/td>\n<\/tr>\n<tr>\n<td colspan=\"4\">a T\u1ea1i th\u1eddi \u0111i\u1ec3m ph\u00e2n t\u00edch ban \u0111\u1ea7u, th\u1eddi gian theo d\u00f5i trung v\u1ecb \u0111\u1ed1i v\u1edbi c\u1ea3 hai nh\u00f3m l\u00e0 30 th\u00e1ng [trong kho\u1ea3ng t\u1eeb 0 \u0111\u1ebfn 50].<\/p>\n<p>b Ki\u1ec3m \u0111\u1ecbnh log-rank ph\u00e2n t\u1ea7ng \u0111\u00e3 kh\u00f4ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n v\u1ec1 th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n theo Nh\u00e0 nghi\u00ean c\u1ee9u.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Ph\u00e2n t\u00edch c\u00e1c ph\u00e2n nh\u00f3m \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc v\u1ec1 th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo \u0111\u00e1p \u1ee9ng t\u1ed1t nh\u1ea5t c\u1ee7a b\u1ec7nh nh\u00e2n \u0111\u1ed1i v\u1edbi li\u1ec7u ph\u00e1p c\u1ee9u nguy tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n, t\u00ecnh tr\u1ea1ng u lympho Hodgkin sau li\u1ec7u ph\u00e1p \u0111\u1ea7u tay, tu\u1ed5i, gi\u1edbi t\u00ednh, c\u00e2n n\u1eb7ng ban \u0111\u1ea7u, t\u00ecnh tr\u1ea1ng ho\u1ea1t \u0111\u1ed9ng c\u01a1 th\u1ec3 theo thang \u0111i\u1ec3m c\u1ee7a OCOG ban \u0111\u1ea7u, s\u1ed1 l\u01b0\u1ee3ng c\u00e1c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n, v\u00f9ng \u0111\u1ecba l\u00fd, t\u00ecnh tr\u1ea1ng ch\u1ee5p c\u1eaft l\u1edbp ph\u00e1t x\u1ea1 positron (PET) tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n, t\u00ecnh tr\u1ea1ng tri\u1ec7u ch\u1ee9ng B sau th\u1ea5t b\u1ea1i c\u1ee7a li\u1ec7u ph\u00e1p \u0111\u1ea7u tay v\u00e0 t\u00ecnh tr\u1ea1ng b\u1ec7nh ngo\u00e0i h\u1ea1ch b\u1ea1ch huy\u1ebft tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n. C\u00e1c ph\u00e2n t\u00edch \u0111\u00e3 cho th\u1ea5y m\u1ed9t xu h\u01b0\u1edbng \u0111\u1ed3ng nh\u1ea5t h\u01b0\u1edbng \u0111\u1ebfn l\u1ee3i \u00edch cho nh\u1eefng b\u1ec7nh nh\u00e2n d\u00f9ng brentuximab vedotin so v\u1edbi b\u1ec7nh nh\u00e2n d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c ngo\u1ea1i tr\u1eeb b\u1ec7nh nh\u00e2n \u2265 65 tu\u1ed5i (n = 8).<\/p>\n<p>Kh\u00f4ng quan s\u00e1t th\u1ea5y s\u1ef1 kh\u00e1c bi\u1ec7t v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng gi\u1eefa nh\u00f3m \u0111i\u1ec1u tr\u1ecb v\u00e0 nh\u00f3m d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c. Ph\u00e2n t\u00edch s\u1eed d\u1ee5ng ngu\u1ed3n l\u1ef1c y t\u1ebf (MRU) cho th\u1ea5y s\u1ed1 l\u1ea7n nh\u1eadp vi\u1ec7n v\u00e0 s\u1ed1 l\u1ea7n kh\u00e1m ngo\u1ea1i tr\u00fa, c\u0169ng nh\u01b0 s\u1ed1 ng\u00e0y l\u00e0m vi\u1ec7c\/c\u00e1c ho\u1ea1t \u0111\u1ed9ng kh\u00e1c b\u1ecb b\u1ecf qua c\u1ee7a b\u1ec7nh nh\u00e2n v\u00e0 ng\u01b0\u1eddi ch\u0103m s\u00f3c th\u1ea5p h\u01a1n v\u1edbi brentuximab vedotin so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin c\u00f3 t\u0103ng nguy c\u01a1 t\u00e1i ph\u00e1t.<\/p>\n<p>M\u1ed9t ph\u00e2n t\u00edch c\u1eadp nh\u1eadt \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh sau 3 n\u0103m theo d\u00f5i \u0111\u00e3 cho th\u1ea5y s\u1ef1 c\u1ea3i thi\u1ec7n b\u1ec1n v\u1eefng v\u1ec1 th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) (T\u1ef7 s\u1ed1 nguy c\u01a1 (HR) = 0,58 [Kho\u1ea3ng tin c\u1eady 95% (0,41, 0,81)]).<\/p>\n<p>Ph\u00e2n t\u00edch h\u1eadu ki\u1ec3m (post-hoc) c\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1<\/p>\n<p>C\u00e1c ph\u00e2n t\u00edch h\u1eadu ki\u1ec3m \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 \u1ea3nh h\u01b0\u1edfng c\u1ee7a s\u1ef1 t\u0103ng nguy c\u01a1 (S\u1ed1 y\u1ebfu t\u1ed1 nguy c\u01a1) \u0111\u1ed1i v\u1edbi l\u1ee3i \u00edch l\u00e2m s\u00e0ng (B\u1ea3ng 5). C\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1 \u0111\u1ea1i di\u1ec7n cho c\u00e1c ph\u00e2n t\u00edch n\u00e0y l\u00e0:<\/p>\n<p>&#8211; U lympho Hodgkin x\u1ea3y ra &lt; 12 th\u00e1ng ho\u1eb7c u lympho Hodgkin kh\u00e1ng tr\u1ecb v\u1edbi li\u1ec7u ph\u00e1p \u0111\u1ea7u tay<\/p>\n<p>&#8211; \u0110\u00e1p \u1ee9ng t\u1ed1t nh\u1ea5t v\u1ec1 lui b\u1ec7nh m\u1ed9t ph\u1ea7n (PR) ho\u1eb7c b\u1ec7nh \u1ed5n \u0111\u1ecbnh (SD) v\u1edbi li\u1ec7u ph\u00e1p c\u1ee9u nguy g\u1ea7n nh\u1ea5t \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng ch\u1ee5p c\u1eaft l\u1edbp vi t\u00ednh (CT) v\u00e0\/ho\u1eb7c ch\u1ee5p c\u1eaft l\u1edbp ph\u00e1t x\u1ea1 positron (PET)<\/p>\n<p>&#8211; B\u1ec7nh ngo\u00e0i h\u1ea1ch b\u1ea1ch huy\u1ebft l\u00fac t\u00e1i ph\u00e1t tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n<\/p>\n<p>&#8211; Tri\u1ec7u ch\u1ee9ng B l\u00fac t\u00e1i ph\u00e1t tr\u01b0\u1edbc khi gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n<\/p>\n<p>&#8211; Hai ho\u1eb7c nhi\u1ec1u li\u1ec7u ph\u00e1p c\u1ee9u nguy tr\u01b0\u1edbc \u0111\u00f3.<\/p>\n<p>K\u1ebft qu\u1ea3 c\u1ee7a c\u00e1c ph\u00e2n t\u00edch h\u1eadu ki\u1ec3m n\u00e0y cho th\u1ea5y l\u1ee3i \u00edch l\u00e2m s\u00e0ng t\u0103ng l\u00ean \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 hai ho\u1eb7c nhi\u1ec1u y\u1ebfu t\u1ed1 nguy c\u01a1 nh\u01b0ng kh\u00f4ng c\u00f3 s\u1ef1 kh\u00e1c bi\u1ec7t d\u1ef1a tr\u00ean b\u1ea5t k\u1ef3 y\u1ebfu t\u1ed1 nguy c\u01a1 n\u00e0o. Kh\u00f4ng quan s\u00e1t th\u1ea5y l\u1ee3i \u00edch v\u1ec1 s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n ho\u1eb7c s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9 \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 m\u1ed9t y\u1ebfu t\u1ed1 nguy c\u01a1 v\u1ec1 t\u00e1i ph\u00e1t ho\u1eb7c ti\u1ebfn tri\u1ec3n.<\/p>\n<p>&#8211; xem B\u1ea3ng 5.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"8\">B\u1ea3ng 5. T\u00f3m t\u1eaft v\u1ec1 s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) v\u00e0 s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9 theo s\u1ed1 y\u1ebfu t\u1ed1 nguy c\u01a1 trong nghi\u00ean c\u1ee9u pha 3 v\u1ec1 u lympho Hodgkin sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"8\"><strong>S\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF)\u00a0<\/strong><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"2\"><\/td>\n<td colspan=\"2\"><strong>S\u1ed1 y\u1ebfu t\u1ed1 nguy c\u01a1 = 1<\/strong><\/td>\n<td colspan=\"2\"><strong>S\u1ed1 y\u1ebfu t\u1ed1 nguy c\u01a1 &gt; 2<\/strong><\/td>\n<td colspan=\"2\"><strong>S\u1ed1 y\u1ebfu t\u1ed1 nguy c\u01a1 &gt; 3<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Brentuximab vedotin<\/strong><\/p>\n<p><strong>N = 21<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c<\/strong><\/p>\n<p><strong>N = 28<\/strong><\/td>\n<td><strong>Brentuximab vedotin<\/strong><\/p>\n<p><strong>N = 144<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c<\/strong><\/p>\n<p><strong>N = 136<\/strong><\/td>\n<td><strong>Brentuximab vedotin<\/strong><\/p>\n<p><strong>N = 82<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c N = 84<\/strong><\/td>\n<\/tr>\n<tr>\n<td>S\u1ed1 b\u1ec7nh nh\u00e2n ti\u1ebfn tri\u1ec3n b\u1ec7nh ho\u1eb7c t\u1eed vong<sup>a <\/sup>(%)<\/td>\n<td>9(43)<\/td>\n<td>7(25)<\/td>\n<td>51 (35)<\/td>\n<td>68 (50)<\/td>\n<td>32 (39)<\/td>\n<td>49 (58)<\/td>\n<\/tr>\n<tr>\n<td>T\u1ef7 s\u1ed1 nguy c\u01a1 ph\u00e2n t\u1ea7ng<\/td>\n<td colspan=\"2\">1,65<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [0,60, 4,55])b<\/td>\n<td colspan=\"2\">0,49<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [0,34, 0,71])<\/td>\n<td colspan=\"2\">0,43<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [0,27, 0,68])<\/td>\n<\/tr>\n<tr>\n<td colspan=\"8\"><strong>S\u1ed1ng c\u00f2n to\u00e0n b\u1ed9<\/strong><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"2\">&nbsp;<\/p>\n<p>&nbsp;<\/td>\n<td colspan=\"2\"><strong>S\u1ed1 y\u1ebfu t\u1ed1 nguy c\u01a1 = 1<\/strong><\/td>\n<td colspan=\"2\"><strong>S\u1ed1 y\u1ebfu t\u1ed1 nguy c\u01a1 &gt; 2<\/strong><\/td>\n<td colspan=\"2\"><strong>S\u1ed1 y\u1ebfu t\u1ed1 nguy c\u01a1 &gt; 3<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Brentuximab vedotin <\/strong><\/p>\n<p><strong>N = 21<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c N = 28<\/strong><\/td>\n<td><strong>Brentuximab vedotin <\/strong><\/p>\n<p><strong>N = 144<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c <\/strong><\/p>\n<p><strong>N = 136<\/strong><\/td>\n<td><strong>Brentuximab vedotin <\/strong><\/p>\n<p><strong>N = 82<\/strong><\/td>\n<td><strong>Gi\u1ea3 d\u01b0\u1ee3c <\/strong><\/p>\n<p><strong>N = 84<\/strong><\/td>\n<\/tr>\n<tr>\n<td>S\u1ed1 t\u1eed vong<sup>c<\/sup>(%)<\/td>\n<td>5(24)<\/td>\n<td>1 (4)<\/td>\n<td>23(16)<\/td>\n<td>24(18)<\/td>\n<td>15 (18)<\/td>\n<td>16 (19)<\/td>\n<\/tr>\n<tr>\n<td>T\u1ef7 s\u1ed1 nguy c\u01a1 ph\u00e2n t\u1ea7ng<\/td>\n<td colspan=\"2\">7,94<\/p>\n<p>(Kho\u1ea3ng tin c\u1eady 95% [0,93, 68,06])<sup>b<\/sup><\/td>\n<td colspan=\"2\">0,94<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [0,53, 1,67])<\/td>\n<td colspan=\"2\">0,92<\/p>\n<p>(Kho\u1ea3ng tin c\u00e2y 95% [0,45, 1,88])<\/td>\n<\/tr>\n<tr>\n<td colspan=\"8\">a T\u1eed vong m\u00e0 kh\u00f4ng c\u00f3 ti\u1ebfn tri\u1ec3n tr\u01b0\u1edbc \u0111\u00f3 ho\u1eb7c h\u01a1n m\u1ed9t l\u1ea7n th\u0103m kh\u00e1m \u0111\u00e1nh gi\u00e1 b\u1ecb b\u1ecf qua.<\/p>\n<p>b Ch\u1ec9 ra k\u1ebft qu\u1ea3 t\u1eeb ph\u00e2n t\u00edch kh\u00f4ng ph\u00e2n t\u1ea7ng.<\/p>\n<p>c Bi\u1ebfn c\u1ed1 l\u00e0 t\u1eed vong do b\u1ea5t k\u1ef3 nguy\u00ean nh\u00e2n n\u00e0o.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>T\u1ea1i th\u1eddi \u0111i\u1ec3m ph\u00e2n t\u00edch h\u1eadu ki\u1ec3m (3 n\u0103m theo d\u00f5i) \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 t\u1eeb 2 y\u1ebfu t\u1ed1 nguy c\u01a1 tr\u1edf l\u00ean, t\u1ef7 s\u1ed1 nguy c\u01a1 \u0111\u1ed1i v\u1edbi th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) l\u00e0 0,49 (Kho\u1ea3ng tin c\u1eady 95% [0,34, 0,71]) v\u00e0 t\u1ef7 s\u1ed1 nguy c\u01a1 \u0111\u1ed1i v\u1edbi th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n theo nh\u00e0 nghi\u00ean c\u1ee9u l\u00e0 0,41 (Kho\u1ea3ng tin c\u1eady 95% [0,29, 0,58]).<\/p>\n<p>&#8211; xem H\u00ecnh 1 v\u00e0 2.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-60495\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-2.png\" alt=\"Adcetris 1\" width=\"846\" height=\"492\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-2.png 846w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-2-300x174.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-2-768x447.png 768w\" sizes=\"auto, (max-width: 846px) 100vw, 846px\" \/><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-60496\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-3.png\" alt=\"Adcetris 2\" width=\"868\" height=\"517\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-3.png 868w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-3-300x179.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-3-768x457.png 768w\" sizes=\"auto, (max-width: 868px) 100vw, 868px\" \/><\/p>\n<p>* Nghi\u00ean c\u1ee9u SGN35-006 (Nghi\u00ean c\u1ee9u t\u00e1i \u0111i\u1ec1u tr\u1ecb)<\/p>\n<p>Hi\u1ec7u qu\u1ea3 c\u1ee7a vi\u1ec7c t\u00e1i \u0111i\u1ec1u tr\u1ecb \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n tr\u01b0\u1edbc \u0111\u00e2y \u0111\u00e3 \u0111\u00e1p \u1ee9ng (lui b\u1ec7nh ho\u00e0n to\u00e0n (CR) ho\u1eb7c lui b\u1ec7nh m\u1ed9t ph\u1ea7n (CR)) v\u1edbi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t th\u1eed nghi\u1ec7m pha 2, nh\u00e3n m\u1edf, \u0111a trung t\u00e2m. Hai m\u01b0\u01a1i b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb \u0111\u01b0\u1ee3c d\u00f9ng li\u1ec1u kh\u1edfi \u0111\u1ea7u 1,8 mg\/kg v\u00e0 m\u1ed9t b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c d\u00f9ng li\u1ec1u kh\u1edfi \u0111\u1ea7u 1,2 mg\/kg ADCETRIS truy\u1ec1n t\u0129nh m\u1ea1ch trong 30 ph\u00fat m\u1ed7i 3 tu\u1ea7n. S\u1ed1 chu k\u1ef3 trung v\u1ecb l\u00e0 7 (trong kho\u1ea3ng t\u1eeb 2 \u0111\u1ebfn 37 chu k\u1ef3). Trong s\u1ed1 20 b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin c\u00f3 th\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u01b0\u1ee3c, 6 b\u1ec7nh nh\u00e2n (30%) \u0111\u1ea1t \u0111\u01b0\u1ee3c lui b\u1ec7nh ho\u00e0n to\u00e0n v\u00e0 6 b\u1ec7nh nh\u00e2n (30%) \u0111\u1ea1t \u0111\u01b0\u1ee3c lui b\u1ec7nh m\u1ed9t ph\u1ea7n v\u1edbi vi\u1ec7c t\u00e1i \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin, v\u1edbi t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (ORR) l\u00e0 60%. Th\u1eddi gian \u0111\u00e1p \u1ee9ng trung v\u1ecb l\u00e0 9,2 th\u00e1ng \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u1ea1t \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (lui b\u1ec7nh ho\u00e0n to\u00e0n + lui b\u1ec7nh m\u1ed9t ph\u1ea7n) v\u00e0 9,4 th\u00e1ng \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u1ea1t \u0111\u01b0\u1ee3c lui b\u1ec7nh ho\u00e0n to\u00e0n.<\/p>\n<p><strong><em>U lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn<\/em><\/strong><\/p>\n<p>* Nghi\u00ean c\u1ee9u SG035-0004<\/p>\n<p>Hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ed9 an to\u00e0n c\u1ee7a brentuximab vedotin d\u01b0\u1edbi d\u1ea1ng m\u1ed9t thu\u1ed1c \u0111\u01a1n \u0111\u1ed9c \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t nghi\u00ean c\u1ee9u nh\u00e3n m\u1edf, m\u1ed9t nh\u00f3m, \u0111a trung t\u00e2m \u1edf 58 b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb. Xem B\u1ea3ng 6 d\u01b0\u1edbi \u0111\u00e2y v\u1ec1 t\u00f3m t\u1eaft \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n v\u00e0 \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh ban \u0111\u1ea7u.<\/p>\n<p>&#8211; xem B\u1ea3ng 6.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\">B\u1ea3ng 6. T\u00f3m t\u1eaft \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n v\u00e0 \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh ban \u0111\u1ea7u trong nghi\u00ean c\u1ee9u pha 2 v\u1ec1 u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n<\/strong><\/td>\n<td><strong>N = 58<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Tu\u1ed5i trung v\u1ecb, n\u0103m (kho\u1ea3ng)<\/td>\n<td>52 tu\u1ed5i (14-76)<\/td>\n<\/tr>\n<tr>\n<td>Gi\u1edbi t\u00ednh<\/td>\n<td>33 nam (57%)\/25 n\u1eef (43%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">T\u00ecnh tr\u1ea1ng ho\u1ea1t \u0111\u1ed9ng c\u01a1 th\u1ec3 theo thang \u0111i\u1ec3m c\u1ee7a ECOG<sup>a<\/sup><\/td>\n<\/tr>\n<tr>\n<td>0<\/td>\n<td>19 (33%)<\/td>\n<\/tr>\n<tr>\n<td>1<\/td>\n<td>38 (66%)<\/td>\n<\/tr>\n<tr>\n<td>Gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n tr\u01b0\u1edbc \u0111\u00f3<\/td>\n<td>15(26%)<\/td>\n<\/tr>\n<tr>\n<td>Ph\u00e1c \u0111\u1ed3 h\u00f3a tr\u1ecb li\u1ec7u tr\u01b0\u1edbc \u0111\u00f3 (kho\u1ea3ng)<\/td>\n<td>2 (1-6)<\/td>\n<\/tr>\n<tr>\n<td>B\u1ec7nh c\u00f3 bi\u1ec3u hi\u1ec7n CD30 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng m\u00f4 h\u1ecdc<\/td>\n<td>57 (98%)<\/td>\n<\/tr>\n<tr>\n<td>B\u1ec7nh c\u00f3 kinase u lympho tho\u00e1i bi\u1ebfn (ALK) \u00e2m t\u00ednh<\/td>\n<td>42 (72%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh <\/strong><\/td>\n<\/tr>\n<tr>\n<td>Kh\u00e1ng tr\u1ecb ti\u00ean ph\u00e1t v\u1edbi li\u1ec7u ph\u00e1p \u0111\u1ea7u tay<sup>b<\/sup><\/td>\n<td>36 (62%)<\/td>\n<\/tr>\n<tr>\n<td>Kh\u00e1ng tr\u1ecb v\u1edbi li\u1ec7u ph\u00e1p g\u1ea7n nh\u1ea5t<\/td>\n<td>29 (50%)<\/td>\n<\/tr>\n<tr>\n<td>T\u00e1i ph\u00e1t v\u1edbi li\u1ec7u ph\u00e1p g\u1ea7n nh\u1ea5t<\/td>\n<td>29 (50%)<\/td>\n<\/tr>\n<tr>\n<td>Tri\u1ec7u ch\u1ee9ng B ban \u0111\u1ea7u<\/td>\n<td>17 (29%)<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n III t\u1ea1i l\u1ea7n ch\u1ea9n \u0111o\u00e1n \u0111\u1ea7u ti\u00ean<\/td>\n<td>8 (14%)<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n IV t\u1ea1i l\u1ea7n ch\u1ea9n \u0111o\u00e1n \u0111\u1ea7u ti\u00ean<\/td>\n<td>21 (36%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">a M\u1ed9t b\u1ec7nh nh\u00e2n c\u00f3 t\u00ecnh tr\u1ea1ng ho\u1ea1t \u0111\u1ed9ng c\u01a1 th\u1ec3 theo thang \u0111i\u1ec3m c\u1ee7a ECOG ban \u0111\u1ea7u l\u00e0 2, b\u1ecb c\u1ea5m b\u1edfi \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u v\u00e0 \u0111\u01b0\u1ee3c ghi l\u1ea1i d\u01b0\u1edbi d\u1ea1ng Ti\u00eau chu\u1ea9n thu nh\u1eadn kh\u00f4ng \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng.<\/p>\n<p>b u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn kh\u00e1ng tr\u1ecb ti\u00ean ph\u00e1t \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a l\u00e0 th\u1ea5t b\u1ea1i trong vi\u1ec7c \u0111\u1ea1t \u0111\u01b0\u1ee3c lui b\u1ec7nh ho\u00e0n to\u00e0n, ho\u1eb7c ti\u1ebfn tri\u1ec3n trong v\u00f2ng 3 th\u00e1ng sau khi ho\u00e0n th\u00e0nh li\u1ec7u ph\u00e1p \u0111\u1ea7u tay.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Th\u1eddi gian trung v\u1ecb t\u1eeb khi ch\u1ea9n \u0111o\u00e1n u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ban \u0111\u1ea7u \u0111\u1ebfn khi d\u00f9ng li\u1ec1u \u0111\u1ea7u ti\u00ean b\u1eb1ng brentuximab vedotin l\u00e0 16,8 th\u00e1ng.<\/p>\n<p>M\u01b0\u1eddi (10) b\u1ec7nh nh\u00e2n (17%) nh\u1eadn \u0111\u01b0\u1ee3c 16 chu k\u1ef3 brentuximab vedotin; s\u1ed1 chu k\u1ef3 trung v\u1ecb nh\u1eadn \u0111\u01b0\u1ee3c l\u00e0 7 (trong kho\u1ea3ng t\u1eeb 1 \u0111\u1ebfn 16).<\/p>\n<p>\u0110\u00e1p \u1ee9ng v\u1edbi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1edfi C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) s\u1eed d\u1ee5ng Ti\u00eau chu\u1ea9n \u0111\u00e1p \u1ee9ng s\u1eeda \u0111\u1ed5i \u0111\u1ed1i v\u1edbi u lympho \u00e1c t\u00ednh (Cheson, 2007). \u0110\u00e1p \u1ee9ng \u0111i\u1ec1u tr\u1ecb \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1eb1ng ch\u1ee5p c\u1eaft l\u1edbp vi t\u00ednh (CT) xo\u1eafn \u1ed1c ng\u1ef1c, c\u1ed5, b\u1ee5ng v\u00e0 x\u01b0\u01a1ng ch\u1eadu; ch\u1ee5p c\u1eaft l\u1edbp ph\u00e1t x\u1ea1 positron (PET) v\u00e0 d\u1eef li\u1ec7u l\u00e2m s\u00e0ng. \u0110\u00e1nh gi\u00e1 v\u1ec1 \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n t\u1ea1i c\u00e1c chu k\u1ef3 2, 4, 7, 10, 13 v\u00e0 16 v\u1edbi PET \u1edf chu k\u1ef3 4 v\u00e0 7.<\/p>\n<p>T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau theo \u0111\u00e1nh gi\u00e1 c\u1ee7a C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) l\u00e0 86% (50 trong s\u1ed1 58 b\u1ec7nh nh\u00e2n \u1edf nh\u00f3m ITT). T\u1ef7 l\u1ec7 lui b\u1ec7nh ho\u00e0n to\u00e0n l\u00e0 59% (34 trong s\u1ed1 58 b\u1ec7nh nh\u00e2n \u1edf nh\u00f3m ITT) v\u00e0 gi\u1ea3m kh\u1ed1i u (\u1edf m\u1ecdi m\u1ee9c \u0111\u1ed9) \u0111\u00e3 \u0111\u1ea1t \u0111\u01b0\u1ee3c \u1edf 97% b\u1ec7nh nh\u00e2n. T\u1ef7 l\u1ec7 s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9 \u01b0\u1edbc t\u00ednh l\u00fac 5 n\u0103m l\u00e0 60% (kho\u1ea3ng tin c\u1eady 95% [47%, 73%]). Th\u1eddi gian quan s\u00e1t trung v\u1ecb (th\u1eddi gian cho \u0111\u1ebfn khi t\u1eed vong ho\u1eb7c l\u1ea7n ti\u1ebfp x\u00fac cu\u1ed1i c\u00f9ng) t\u1eeb li\u1ec1u \u0111\u1ea7u ti\u00ean l\u00e0 71,4 th\u00e1ng. \u0110\u00e1nh gi\u00e1 c\u1ee7a nh\u00e0 nghi\u00ean c\u1ee9u n\u00f3i chung ph\u00f9 h\u1ee3p v\u1edbi \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp v\u1ec1 c\u00e1c h\u00ecnh \u1ea3nh ch\u1ee5p. Trong s\u1ed1 nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb, 9 b\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng \u0111\u00e3 ti\u1ebfp t\u1ee5c nh\u1eadn \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c (SCT) c\u00f9ng lo\u00e0i v\u00e0 9 b\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng \u0111\u00e3 ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n. \u0110\u1ec3 bi\u1ebft k\u1ebft qu\u1ea3 v\u1ec1 hi\u1ec7u qu\u1ea3 th\u00eam, xem B\u1ea3ng 7 v\u00e0 H\u00ecnh 3.<\/p>\n<p>&#8211; xem B\u1ea3ng 7 v\u00e0 H\u00ecnh 3.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"3\">B\u1ea3ng 7. K\u1ebft qu\u1ea3 v\u1ec1 hi\u1ec7u qu\u1ea3 \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0110\u00e1p \u1ee9ng l\u00e2m s\u00e0ng t\u1ed1t nh\u1ea5t (N = 58 )<\/strong><\/td>\n<td><strong>C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF)<\/strong><\/p>\n<p><strong>N (%)<\/strong><\/td>\n<td><strong>Kho\u1ea3ng tin c\u1eady <\/strong><\/p>\n<p><strong>CI 95%<\/strong><\/td>\n<\/tr>\n<tr>\n<td>T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (CR + PR)<\/td>\n<td>50 (86)<\/td>\n<td>74,6, 93,9<\/td>\n<\/tr>\n<tr>\n<td>Lui b\u1ec7nh ho\u00e0n to\u00e0n (CR)<\/td>\n<td>34 (59)<\/td>\n<td>44,9, 71,4<\/td>\n<\/tr>\n<tr>\n<td>Lui b\u1ec7nh m\u1ed9t ph\u1ea7n (PR)<\/td>\n<td>16(28)<\/td>\n<td>NA<\/td>\n<\/tr>\n<tr>\n<td>T\u1ef7 l\u1ec7 ki\u1ec3m so\u00e1t b\u1ec7nh (CR + PR + SD)<\/td>\n<td>52 (90)<\/td>\n<td>78,8, 96,1<\/td>\n<\/tr>\n<tr>\n<td><strong>Th\u1eddi gian \u0111\u00e1p \u1ee9ng<\/strong><\/td>\n<td><strong>Gi\u00e1 tr\u1ecb trung v\u1ecb theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp<\/strong><\/td>\n<td><strong>Kho\u1ea3ng tin c\u1eady CI 95%<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u0110\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (CR + PR)<sup>a<\/sup><\/td>\n<td>13,2<\/td>\n<td>5,7, 26,3<\/td>\n<\/tr>\n<tr>\n<td>Lui b\u1ec7nh ho\u00e0n to\u00e0n (CR)<\/td>\n<td>26,3<\/td>\n<td>13,2, NE<sup>b<\/sup><\/td>\n<\/tr>\n<tr>\n<td><strong>Th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n<\/strong><\/td>\n<td><strong>Gi\u00e1 tr\u1ecb trung v\u1ecb theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp<\/strong><\/td>\n<td><strong>Kho\u1ea3ng tin c\u1eady 95%<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Trung v\u1ecb<\/td>\n<td>14,6<\/td>\n<td>6,9, 20,6<\/td>\n<\/tr>\n<tr>\n<td>Th\u1eddi gian s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9<\/td>\n<td>Trung v\u1ecb<\/td>\n<td>Kho\u1ea3ng tin c\u1eady 95%<\/td>\n<\/tr>\n<tr>\n<td>Trung v\u1ecb<\/td>\n<td>Kh\u00f4ng \u0111\u1ea1t \u0111\u01b0\u1ee3c<\/td>\n<td>21,3, NE<sup>b<\/sup><\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">a.\u00a0\u00a0 Kho\u1ea3ng th\u1eddi gian \u0111\u00e1p \u1ee9ng (DOR) l\u00e0 t\u1eeb 0,1 th\u00e1ng \u0111\u1ebfn 39,1 th\u00e1ng tr\u1edf l\u00ean v\u00e0 th\u1eddi gian theo d\u00f5i trung v\u1ecb t\u1eeb li\u1ec1u \u0111\u1ea7u ti\u00ean \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u1ea1t \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (OR) theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) l\u00e0 15,5 th\u00e1ng.<\/p>\n<p>b. Kh\u00f4ng th\u1ec3 \u01b0\u1edbc t\u00ednh \u0111\u01b0\u1ee3c.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-60497\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-4.png\" alt=\"Adcetris 3\" width=\"894\" height=\"509\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-4.png 894w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-4-300x171.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2020\/05\/word-image-18070-4-768x437.png 768w\" sizes=\"auto, (max-width: 894px) 100vw, 894px\" \/><\/p>\n<p>M\u1ed9t ph\u00e2n t\u00edch th\u0103m d\u00f2 tr\u00ean c\u00f9ng m\u1ed9t b\u1ec7nh nh\u00e2n cho th\u1ea5y kho\u1ea3ng 69% b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin nh\u01b0 l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng SG035-0004 \u0111\u00e3 c\u00f3 c\u1ea3i thi\u1ec7n v\u1ec1 l\u1ee3i \u00edch l\u00e2m s\u00e0ng nh\u01b0 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1eb1ng th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n (PFS) d\u00e0i h\u01a1n so v\u1edbi h\u1ea7u h\u1ebft d\u00f2ng \u0111i\u1ec1u tr\u1ecb g\u1ea7n nh\u1ea5t tr\u01b0\u1edbc \u0111\u00f3 c\u1ee7a h\u1ecd.<\/p>\n<p>Trong s\u1ed1 17 b\u1ec7nh nh\u00e2n (29%) c\u00f3 tri\u1ec7u ch\u1ee9ng B l\u00fac ban \u0111\u1ea7u, 14 b\u1ec7nh nh\u00e2n (82%) \u0111\u00e3 c\u00f3 thuy\u00ean gi\u1ea3m t\u1ea5t c\u1ea3 tri\u1ec7u ch\u1ee9ng B trong th\u1eddi gian trung v\u1ecb t\u1eeb khi b\u1eaft \u0111\u1ea7u d\u00f9ng brentuximab vedotin l\u00e0 0,7 th\u00e1ng.<\/p>\n<p>* Nghi\u00ean c\u1ee9u SGN35-006 (Nghi\u00ean c\u1ee9u t\u00e1i \u0111i\u1ec1u tr\u1ecb)<\/p>\n<p>Hi\u1ec7u qu\u1ea3 c\u1ee7a vi\u1ec7c t\u00e1i \u0111i\u1ec1u tr\u1ecb \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n tr\u01b0\u1edbc \u0111\u00e2y \u0111\u00e3 \u0111\u00e1p \u1ee9ng (lui b\u1ec7nh ho\u00e0n to\u00e0n (CR) ho\u1eb7c lui b\u1ec7nh m\u1ed9t ph\u1ea7n (CR)) v\u1edbi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t th\u1eed nghi\u1ec7m pha 2, nh\u00e3n m\u1edf, \u0111a trung t\u00e2m. B\u1ea3y b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t \u0111\u01b0\u1ee3c d\u00f9ng li\u1ec1u kh\u1edfi \u0111\u1ea7u 1,8 mg\/kg v\u00e0 m\u1ed9t b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c d\u00f9ng li\u1ec1u kh\u1edfi \u0111\u1ea7u 1,2 mg\/kg ADCETRIS truy\u1ec1n t\u0129nh m\u1ea1ch trong 30 ph\u00fat m\u1ed7i 3 tu\u1ea7n. S\u1ed1 chu k\u1ef3 trung v\u1ecb l\u00e0 8,5 (trong kho\u1ea3ng t\u1eeb 2 \u0111\u1ebfn 30 chu k\u1ef3). Trong s\u1ed1 8 b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn, 3 b\u1ec7nh nh\u00e2n \u0111\u00e3 \u0111\u01b0\u1ee3c t\u00e1i \u0111i\u1ec1u tr\u1ecb 2 l\u1ea7n trong t\u1ed5ng s\u1ed1 11 l\u1ea7n t\u00e1i \u0111i\u1ec1u tr\u1ecb. T\u00e1i \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin d\u1eabn \u0111\u1ebfn 6 b\u1ec7nh nh\u00e2n lui b\u1ec7nh ho\u00e0n to\u00e0n (55%) v\u00e0 4 b\u1ec7nh nh\u00e2n lui b\u1ec7nh m\u1ed9t ph\u1ea7n (36%), v\u1edbi t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (ORR) l\u00e0 91%. Th\u1eddi gian \u0111\u00e1p \u1ee9ng trung v\u1ecb l\u00e0 8,8 th\u00e1ng \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u1ea1t \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau (lui b\u1ec7nh ho\u00e0n to\u00e0n + lui b\u1ec7nh m\u1ed9t ph\u1ea7n) v\u00e0 12,3 th\u00e1ng \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u1ea1t \u0111\u01b0\u1ee3c lui b\u1ec7nh ho\u00e0n to\u00e0n.<\/p>\n<p><strong><em>U lympho \u1edf da t\u1ebf b\u00e0o T<\/em><\/strong><\/p>\n<p>* Nghi\u00ean c\u1ee9u C25001<\/p>\n<p>Hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ed9 an to\u00e0n c\u1ee7a brentuximab vedotin d\u01b0\u1edbi d\u1ea1ng m\u1ed9t thu\u1ed1c \u0111\u01a1n \u0111\u1ed9c \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t nghi\u00ean c\u1ee9u then ch\u1ed1t pha 3, nh\u00e3n m\u1edf, ng\u1eabu nhi\u00ean, \u0111a trung t\u00e2m \u1edf 128 b\u1ec7nh nh\u00e2n b\u1ecb u lympho \u1edf da t\u1ebf b\u00e0o T CD30+ \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng m\u00f4 h\u1ecdc. CD30 d\u01b0\u01a1ng t\u00ednh \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a l\u00e0 \u226510% t\u1ebf b\u00e0o d\u1ea1ng lympho m\u1ee5c ti\u00eau th\u1ec3 hi\u1ec7n m\u00f4 h\u00ecnh nhu\u1ed9m m\u00e0ng t\u1ebf b\u00e0o, t\u1ebf b\u00e0o ch\u1ea5t v\u00e0\/ho\u1eb7c Golgi d\u1ef1a tr\u00ean x\u00e9t nghi\u1ec7m h\u00f3a m\u00f4 mi\u1ec5n d\u1ecbch (Ventana anti-CD30 [Ber-H2]). Nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ea9n \u0111o\u00e1n u s\u00f9i d\u1ea1ng n\u1ea5m [MF] ho\u1eb7c u lympho \u1edf da t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u00ean ph\u00e1t [pcALCL] \u0111\u01b0\u1ee3c xem l\u00e0 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n cho nghi\u00ean c\u1ee9u. C\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c ph\u00e2n t\u1ea7ng theo c\u00e1c lo\u1ea1i b\u1ec7nh n\u00e0y v\u00e0 \u0111\u01b0\u1ee3c ph\u00e2n ng\u1eabu nhi\u00ean 1:1 d\u00f9ng brentuximab vedotin ho\u1eb7c theo l\u1ef1a ch\u1ecdn c\u1ee7a b\u00e1c s\u0129 d\u00f9ng methotrexate ho\u1eb7c bexarotene. C\u00e1c b\u1ec7nh nh\u00e2n b\u1ecb u lympho \u1edf da t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u00ean ph\u00e1t \u0111\u01b0\u1ee3c x\u1ea1 tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3 ho\u1eb7c \u0111\u01b0\u1ee3c d\u00f9ng \u00edt nh\u1ea5t m\u1ed9t li\u1ec7u ph\u00e1p to\u00e0n th\u00e2n tr\u01b0\u1edbc \u0111\u00f3 v\u00e0 c\u00e1c b\u1ec7nh nh\u00e2n b\u1ecb u s\u00f9i d\u1ea1ng n\u1ea5m \u0111\u01b0\u1ee3c d\u00f9ng \u00edt nh\u1ea5t m\u1ed9t li\u1ec7u ph\u00e1p to\u00e0n th\u00e2n tr\u01b0\u1edbc \u0111\u00f3. C\u00e1c b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ea9n \u0111o\u00e1n \u0111\u1ed3ng th\u1eddi v\u1ec1 u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn, h\u1ed9i ch\u1ee9ng Sezary v\u00e0 u lympho kh\u00f4ng Hodgkin kh\u00e1c (ngo\u1ea1i tr\u1eeb b\u1ec7nh s\u1ea7n d\u1ea1ng u lympho [LyP]) \u0111\u00e3 \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb kh\u1ecfi nghi\u00ean c\u1ee9u n\u00e0y. C\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin 1,8 mg\/kg truy\u1ec1n t\u0129nh m\u1ea1ch trong 30 ph\u00fat m\u1ed7i 3 tu\u1ea7n cho \u0111\u1ebfn 16 chu k\u1ef3 ho\u1eb7c theo l\u1ef1a ch\u1ecdn c\u1ee7a b\u00e1c s\u0129 cho \u0111\u1ebfn 48 tu\u1ea7n. S\u1ed1 chu k\u1ef3 trung v\u1ecb v\u00e0o kho\u1ea3ng 12 chu k\u1ef3 \u1edf nh\u00f3m \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin. \u1ede nh\u00f3m theo l\u1ef1a ch\u1ecdn c\u1ee7a b\u00e1c s\u0129, th\u1eddi gian \u0111i\u1ec1u tr\u1ecb trung v\u1ecb (s\u1ed1 chu k\u1ef3) \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n \u0111ang d\u00f9ng bexarotene v\u00e0o kho\u1ea3ng 16 tu\u1ea7n (5,5 chu k\u1ef3) v\u00e0 11 tu\u1ea7n (3 chu k\u1ef3) \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n d\u00f9ng methotrexate. B\u1ea3ng 8 cung c\u1ea5p t\u00f3m t\u1eaft \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n v\u00e0 \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh.<\/p>\n<p>&#8211; xem B\u1ea3ng 8.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"3\">B\u1ea3ng 8. T\u00f3m t\u1eaft \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n v\u00e0 \u0111\u1eb7c \u0111i\u1ec3m b\u1ec7nh ban \u0111\u1ea7u trong nghi\u00ean c\u1ee9u pha 3 v\u1ec1 u lympho \u1edf da t\u1ebf b\u00e0o T (nh\u00f3m b\u1ec7nh nh\u00e2n ITT)<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh nh\u00e2n<\/strong><\/td>\n<td><strong>Brentuximab vedotin <\/strong><\/p>\n<p><strong>N = 64<\/strong><\/td>\n<td><strong>L\u1ef1a ch\u1ecdn c\u1ee7a b\u00e1c s\u0129 (Methotrexate ho\u1eb7c Bexarotene) <\/strong><\/p>\n<p><strong>N= 64<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Tu\u1ed5i trung v\u1ecb (kho\u1ea3ng)<\/td>\n<td>62 tu\u1ed5i (22-83)<\/td>\n<td>58,5 tu\u1ed5i (22-83)<\/td>\n<\/tr>\n<tr>\n<td>B\u1ec7nh nh\u00e2n &gt; 65 tu\u1ed5i n (%)<\/td>\n<td>28 (44%)<\/td>\n<td>24 (38%)<\/td>\n<\/tr>\n<tr>\n<td>Gi\u1edbi t\u00ednh n (%)<\/td>\n<td>33 nam (52%)\/31 n\u1eef (48%)<\/td>\n<td>37 nam (58%)\/27 n\u1eef (42%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">T\u00ecnh tr\u1ea1ng ho\u1ea1t \u0111\u1ed9ng c\u01a1 th\u1ec3 theo thang \u0111i\u1ec3m c\u1ee7a ECOG n (%)<\/td>\n<\/tr>\n<tr>\n<td>0<\/td>\n<td>43 (67)<\/td>\n<td>46 (72)<\/td>\n<\/tr>\n<tr>\n<td>1<\/td>\n<td>18 (28)<\/td>\n<td>16 (25)<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>3 (5)<\/td>\n<td>\u00a02 (3)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><strong>\u0110\u1eb7c \u0111i\u1ec3m b\u1ec7nh\u00a0\u00a0<\/strong><\/td>\n<\/tr>\n<tr>\n<td>S\u1ed1 l\u01b0\u1ee3ng trung v\u1ecb c\u1ee7a c\u00e1c li\u1ec7u ph\u00e1p tr\u01b0\u1edbc \u0111\u00f3 (kho\u1ea3ng)<\/td>\n<td>4(0-13)<\/td>\n<td>3,5(1-15)<\/td>\n<\/tr>\n<tr>\n<td>S\u1ed1 l\u01b0\u1ee3ng trung v\u1ecb c\u1ee7a li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb da (kho\u1ea3ng)<\/td>\n<td>1 (0-6)<\/td>\n<td>1 (0-9)<\/td>\n<\/tr>\n<tr>\n<td>S\u1ed1 l\u01b0\u1ee3ng trung v\u1ecb c\u1ee7a li\u1ec7u ph\u00e1p to\u00e0n th\u00e2n (kho\u1ea3ng)<\/td>\n<td>2 (0-11)<\/td>\n<td>2 (1-8)<\/td>\n<\/tr>\n<tr>\n<td>u s\u00f9i d\u1ea1ng n\u1ea5m, n (%)<\/td>\n<td>48 (75)<\/td>\n<td>49 (77)<\/td>\n<\/tr>\n<tr>\n<td>Giai \u0111o\u1ea1n s\u1edbm (IA-IIA)<\/td>\n<td>15 (31)<\/td>\n<td>18 (37)<\/td>\n<\/tr>\n<tr>\n<td>Ti\u1ebfn tri\u1ec3n (IIB-IVB3)<\/td>\n<td>32 (67)<\/td>\n<td>30 (61)<\/td>\n<\/tr>\n<tr>\n<td>U lympho \u1edf da t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u00ean ph\u00e1t, n (%)<\/td>\n<td>16 (25)<\/td>\n<td>15 (23)<\/td>\n<\/tr>\n<tr>\n<td>Ch\u1ec9 \u1edf da<\/td>\n<td>9 (56)<\/td>\n<td>11 (73)<\/td>\n<\/tr>\n<tr>\n<td>B\u1ec7nh ngo\u00e0i da<\/td>\n<td>7(44)<\/td>\n<td>4(27)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">a M\u1ed9t b\u1ec7nh nh\u00e2n trong m\u1ed7i nh\u00f3m c\u00f3 d\u1eef li\u1ec7u \u0111\u1ecbnh giai \u0111o\u1ea1n kh\u00f4ng \u0111\u1ea7y \u0111\u1ee7 v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c bao g\u1ed3m trong b\u1ea3ng<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>C\u00e1c li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb da th\u00f4ng th\u01b0\u1eddng nh\u1ea5t tr\u01b0\u1edbc \u0111\u00e2y \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n ITT l\u00e0 x\u1ea1 tr\u1ecb (64%), li\u1ec7u ph\u00e1p \u00e1nh s\u00e1ng (48%) v\u00e0 steroid d\u00f9ng t\u1ea1i ch\u1ed7 (17%). C\u00e1c li\u1ec7u ph\u00e1p to\u00e0n th\u00e2n th\u00f4ng th\u01b0\u1eddng nh\u1ea5t tr\u01b0\u1edbc \u0111\u00e2y \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n ITT l\u00e0 h\u00f3a tr\u1ecb li\u1ec7u (71%), li\u1ec7u ph\u00e1p mi\u1ec5n d\u1ecbch (43%) v\u00e0 bexarotene (38%).<\/p>\n<p>Ti\u00eau ch\u00ed \u0111\u00e1nh gi\u00e1 ch\u00ednh l\u00e0 t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau k\u00e9o d\u00e0i \u00edt nh\u1ea5t 4 th\u00e1ng (ORR4) (th\u1eddi gian t\u1eeb \u0111\u00e1p \u1ee9ng \u0111\u1ea7u ti\u00ean \u0111\u1ebfn \u0111\u00e1p \u1ee9ng cu\u1ed1i c\u00f9ng \u2265 4 th\u00e1ng), \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1edfi m\u1ed9t \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp v\u1ec1 \u0110i\u1ec3m s\u1ed1 \u0111\u00e1p \u1ee9ng to\u00e0n b\u1ed9 (GRS) bao g\u1ed3m \u0111\u00e1nh gi\u00e1 v\u1ec1 da (c\u00f4ng c\u1ee5 \u0111\u00e1nh gi\u00e1 c\u00f3 tr\u1ecdng s\u1ed1 v\u1ec1 m\u1ee9c \u0111\u1ed9 n\u1eb7ng \u0111\u00e3 s\u1eeda \u0111\u1ed5i [mSWAT] \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 theo nh\u00e0 nghi\u00ean c\u1ee9u), \u0111\u00e1nh gi\u00e1 b\u1eb1ng ch\u1ee5p X-quang h\u1ea1ch b\u1ea1ch huy\u1ebft v\u00e0 n\u1ed9i t\u1ea1ng, v\u00e0 ph\u00e1t hi\u1ec7n c\u00e1c t\u1ebf b\u00e0o S\u00e9zary tu\u1ea7n ho\u00e0n (Olsen 2011). B\u1ea3ng 9 bao g\u1ed3m c\u00e1c k\u1ebft qu\u1ea3 v\u1ec1 ORR4 v\u00e0 c\u00e1c ti\u00eau ch\u00ed ph\u1ee5 ch\u1ee7 y\u1ebfu kh\u00e1c.<\/p>\n<p>&#8211; xem B\u1ea3ng 9.<\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"4\">B\u1ea3ng 9. K\u1ebft qu\u1ea3 v\u1ec1 hi\u1ec7u qu\u1ea3 \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho \u1edf da t\u1ebf b\u00e0o T \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin 1,8 mg\/kg m\u1ed7i 3 tu\u1ea7n (nh\u00f3m b\u1ec7nh nh\u00e2n ITT)<\/td>\n<\/tr>\n<tr>\n<td>\u00a0.<\/td>\n<td><strong>Brentuximab vedotin<\/strong><\/p>\n<p><strong>N=64<\/strong><\/td>\n<td><strong>.\u00a0<\/strong><\/td>\n<td><strong>L\u1ef1a ch\u1ecdn c\u1ee7a b\u00e1c s\u0129 <\/strong><\/p>\n<p><strong>(Methotrexate ho\u1eb7c Bexarotene) N=64<\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"4\"><strong>T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau k\u00e9o d\u00e0i \u00edt nh\u1ea5t 4 th\u00e1ng (ORR4) theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF)\u00a0\u00a0<\/strong><\/td>\n<\/tr>\n<tr>\n<td>N (%)<\/td>\n<td>36 (56,3)<\/td>\n<td><\/td>\n<td>8(12,5)<\/td>\n<\/tr>\n<tr>\n<td>Ph\u1ea7n tr\u0103m kh\u00e1c bi\u1ec7t (Kho\u1ea3ng tin c\u1eady 95%)<\/td>\n<td><\/td>\n<td>43,8 (29,1,58,4)<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Gi\u00e1 tr\u1ecb p<\/td>\n<td><\/td>\n<td>&lt;0,001<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td colspan=\"4\"><strong>\u0110\u00e1p \u1ee9ng ho\u00e0n to\u00e0n (CR) theo IRF<\/strong><\/td>\n<\/tr>\n<tr>\n<td>N (%)<\/td>\n<td>10(15,6)<\/td>\n<td><\/td>\n<td>1 (1,6)<\/td>\n<\/tr>\n<tr>\n<td>Ph\u1ea7n tr\u0103m kh\u00e1c bi\u1ec7t (Kho\u1ea3ng tin c\u1eady 95%)<\/td>\n<td><\/td>\n<td>14,1 (-4,0,31,5)<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Gi\u00e1 tr\u1ecb p \u0111i\u1ec1u ch\u1ec9nh<sup>a<\/sup><\/td>\n<td><\/td>\n<td>0,0046<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td colspan=\"4\">Th\u1eddi gian s\u1ed1ng c\u00f2n b\u1ec7nh kh\u00f4ng ti\u1ebfn tri\u1ec3n (PFS) theo c\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF)<\/td>\n<\/tr>\n<tr>\n<td>Trung v\u1ecb (th\u00e1ng)<\/td>\n<td>16,7<\/td>\n<td><\/td>\n<td>3,5<\/td>\n<\/tr>\n<tr>\n<td>T\u1ef7 s\u1ed1 nguy c\u01a1<\/td>\n<td><\/td>\n<td>0,27<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Kho\u1ea3ng tin c\u1eady 95%<\/td>\n<td><\/td>\n<td>(0,17, 0,43)<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Gi\u00e1 tr\u1ecb p \u0111i\u1ec1u ch\u1ec9nh<sup>a<\/sup><\/td>\n<td><\/td>\n<td>&lt;0,001<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td colspan=\"4\">a \u0110\u01b0\u1ee3c t\u00ednh t\u1eeb quy tr\u00ecnh c\u1ee7a Holm c\u00f3 tr\u1ecdng s\u1ed1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Ph\u00e2n t\u00edch c\u00e1c ph\u00e2n nh\u00f3m \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc v\u1ec1 t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau k\u00e9o d\u00e0i \u00edt nh\u1ea5t 4 th\u00e1ng theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo subtype u lympho \u1edf da t\u1ebf b\u00e0o T c\u1ee7a b\u1ec7nh nh\u00e2n, l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb c\u1ee7a b\u00e1c s\u0129, t\u00ecnh tr\u1ea1ng ho\u1ea1t \u0111\u1ed9ng c\u01a1 th\u1ec3 theo \u0111\u00e1nh gi\u00e1 c\u1ee7a ECOG ban \u0111\u1ea7u, tu\u1ed5i, gi\u1edbi t\u00ednh v\u00e0 v\u00f9ng \u0111\u1ecba l\u00fd. C\u00e1c ph\u00e2n t\u00edch \u0111\u00e3 cho th\u1ea5y m\u1ed9t xu h\u01b0\u1edbng \u0111\u1ed3ng nh\u1ea5t h\u01b0\u1edbng \u0111\u1ebfn l\u1ee3i \u00edch cho nh\u1eefng b\u1ec7nh nh\u00e2n d\u00f9ng brentuximab vedotin so v\u1edbi b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb theo l\u1ef1a ch\u1ecdn c\u1ee7a b\u00e1c s\u0129. T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng m\u1ee5c ti\u00eau k\u00e9o d\u00e0i \u00edt nh\u1ea5t 4 th\u00e1ng theo th\u1ee9 t\u1ef1 l\u00e0 50% v\u00e0 75% \u1edf nh\u00f3m d\u00f9ng brentuximab vedotin so v\u1edbi 10,2% v\u00e0 20% \u1edf nh\u00f3m theo l\u1ef1a ch\u1ecdn c\u1ee7a b\u00e1c s\u0129 v\u1ec1 u s\u00f9i d\u1ea1ng n\u1ea5m (MF) v\u00e0 u lympho \u1edf da t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u00ean ph\u00e1t (pcALCL).<\/p>\n<p>Kh\u00f4ng quan s\u00e1t th\u1ea5y s\u1ef1 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129a v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng (\u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1eb1ng b\u1ea3ng c\u00e2u h\u1ecfi 5 kh\u00eda c\u1ea1nh EuroQol [EQ-5D] v\u00e0 \u0110\u00e1nh gi\u00e1 ch\u1ee9c n\u0103ng v\u1ec1 \u0111i\u1ec1u tr\u1ecb ung th\u01b0-t\u1ed5ng qu\u00e1t [FACT-G]) gi\u1eefa c\u00e1c nh\u00f3m \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p>Hi\u1ec7u qu\u1ea3 v\u00e0 \u0111\u1ed9 an to\u00e0n c\u1ee7a ADCETRIS \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong hai nghi\u00ean c\u1ee9u b\u1ed5 sung nh\u00e3n m\u1edf \u1edf 108 b\u1ec7nh nh\u00e2n b\u1ecb u lympho \u1edf da t\u1ebf b\u00e0o T CD30+ t\u00e1i ph\u00e1t (bao g\u1ed3m m\u00f4 h\u1ecdc v\u1ec1 u s\u00f9i d\u1ea1ng n\u1ea5m v\u00e0 u lympho \u1edf da t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u00ean ph\u00e1t c\u0169ng nh\u01b0 h\u1ed9i ch\u1ee9ng S\u00e9zary (SS), b\u1ec7nh s\u1ea7n d\u1ea1ng u lympho (LyP) v\u00e0 u lympho \u1edf da t\u1ebf b\u00e0o T h\u1ed7n h\u1ee3p), b\u1ea5t k\u1ec3 m\u1ee9c bi\u1ec3u hi\u1ec7n CD30. C\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ADCETRIS 1,8 mg\/kg truy\u1ec1n t\u0129nh m\u1ea1ch trong 30 ph\u00fat m\u1ed7i 3 tu\u1ea7n cho \u0111\u1ebfn 16 chu k\u1ef3. K\u1ebft qu\u1ea3 v\u1ec1 \u0111\u1ed9 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 trong c\u00e1c nghi\u00ean c\u1ee9u n\u00e0y ph\u00f9 h\u1ee3p v\u1edbi k\u1ebft qu\u1ea3 trong nghi\u00ean c\u1ee9u C25001. T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng t\u1ed5ng th\u1ec3 \u0111\u1ed1i v\u1edbi u s\u00f9i d\u1ea1ng n\u1ea5m l\u00e0 54-66%; u lympho \u1edf da t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u00ean ph\u00e1t l\u00e0 67%; h\u1ed9i ch\u1ee9ng S\u00e9zary l\u00e0 50%; b\u1ec7nh s\u1ea7n d\u1ea1ng u lympho l\u00e0 92%; v\u00e0 m\u00f4 h\u1ecdc u lympho \u1edf da t\u1ebf b\u00e0o T h\u1ed7n h\u1ee3p l\u00e0 82-85%.<\/p>\n<p><strong><em>Nh\u00f3m b\u1ec7nh nhi<\/em><\/strong><\/p>\n<p>\u0110\u1ed9 an to\u00e0n, d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc v\u00e0 ho\u1ea1t t\u00ednh ch\u1ed1ng kh\u1ed1i u c\u1ee7a brentuximab vedotin \u1edf 36 b\u1ec7nh nhi (7-17 tu\u1ed5i) b\u1ecb u lympho Hodgkin v\u00e0 u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb (tr\u1ebb em t\u1eeb 7-11 tu\u1ed5i, n = 12 v\u00e0 thi\u1ebfu ni\u00ean t\u1eeb 12 \u0111\u1ebfn 17 tu\u1ed5i, n = 24) \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 trong m\u1ed9t nghi\u00ean c\u1ee9u pha 1\/2 nh\u00e3n m\u1edf, m\u1ed9t thu\u1ed1c \u0111\u01a1n \u0111\u1ed9c, t\u0103ng li\u1ec1u, \u0111a trung t\u00e2m (C25002). Pha 1 c\u1ee7a nghi\u00ean c\u1ee9u \u0111\u00e1nh gi\u00e1 h\u1ed3 s\u01a1 v\u1ec1 an to\u00e0n (xem ph\u1ea7n T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n), x\u00e1c \u0111\u1ecbnh li\u1ec1u t\u1ed1i \u0111a \u0111\u01b0\u1ee3c dung n\u1ea1p \u0111\u1ed1i v\u1edbi tr\u1ebb em (MTD) v\u00e0\/ho\u1eb7c li\u1ec1u khuy\u1ebfn c\u00e1o pha 2 (RP2D), v\u00e0 \u0111\u00e1nh gi\u00e1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a brentuximab vedotin (xem ph\u1ea7n D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc). Pha 1 bao g\u1ed3m nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi li\u1ec1u 1,4 mg\/kg v\u00e0 9 b\u1ec7nh nh\u00e2n (7 b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin v\u00e0 2 b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb) \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi li\u1ec1u 1,8 mg\/kg. Li\u1ec1u t\u1ed1i \u0111a \u0111\u01b0\u1ee3c dung n\u1ea1p (MTD) kh\u00f4ng \u0111\u1ea1t \u0111\u01b0\u1ee3c. Li\u1ec1u khuy\u1ebfn c\u00e1o pha 2 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh l\u00e0 1,8 mg\/kg. Trong nghi\u00ean c\u1ee9u, t\u1ed5ng c\u1ed9ng c\u00f3 16 b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb v\u00e0 17 b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb, trong \u0111\u00f3 10 b\u1ec7nh nh\u00e2n t\u00e1i ph\u00e1t l\u1ea7n \u0111\u1ea7u ti\u00ean, \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin 1,8 mg\/kg. T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng to\u00e0n b\u1ed9 (ORR) theo C\u01a1 quan \u0111\u00e1nh gi\u00e1 \u0111\u1ed9c l\u1eadp (IRF) \u0111\u01b0\u1ee3c ph\u00e2n t\u00edch trong c\u1ea3 hai pha nghi\u00ean c\u1ee9u \u1edf li\u1ec1u khuy\u1ebfn c\u00e1o pha 2. Trong s\u1ed1 33 b\u1ec7nh nh\u00e2n d\u00f9ng li\u1ec1u khuy\u1ebfn c\u00e1o pha 2, 32 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 l\u00e0 c\u00f3 \u0111\u00e1p \u1ee9ng. T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng to\u00e0n b\u1ed9 l\u00e0 47% \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb c\u00f3 th\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u00e1p \u1ee9ng, 53% \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn t\u00e1i ph\u00e1t ho\u1eb7c kh\u00e1ng tr\u1ecb v\u00e0 60% \u1edf b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn trong l\u1ea7n t\u00e1i ph\u00e1t \u0111\u1ea7u ti\u00ean. T\u00e1m b\u1ec7nh nh\u00e2n b\u1ecb u lympho Hodgkin v\u00e0 9 b\u1ec7nh nh\u00e2n b\u1ecb u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c sau khi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng brentuximab vedotin.<\/p>\n<p>C\u01a1 quan Qu\u1ea3n l\u00fd D\u01b0\u1ee3c ph\u1ea9m ch\u00e2u \u00c2u \u0111\u00e3 ho\u00e3n l\u1ea1i ngh\u0129a v\u1ee5 \u0111\u1ec7 tr\u00ecnh k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u v\u1edbi ADCETRIS \u1edf m\u1ed9t ho\u1eb7c nhi\u1ec1u ph\u00e2n nh\u00f3m b\u1ec7nh nhi trong \u0111i\u1ec1u tr\u1ecb u lympho Hodgkin v\u00e0 u lympho t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn (xem ph\u1ea7n \u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc \u0111\u1ec3 bi\u1ebft th\u00f4ng tin v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng cho tr\u1ebb em).<\/p>\n<p>Thu\u1ed1c n\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh theo m\u1ed9t k\u1ebf ho\u1ea1ch g\u1ecdi l\u00e0 \u2018ph\u00ea duy\u1ec7t c\u00f3 \u0111i\u1ec1u ki\u1ec7n\u2019. \u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 c\u00e1c b\u1eb1ng ch\u1ee9ng th\u00eam v\u1ec1 thu\u1ed1c n\u00e0y \u0111ang \u0111\u01b0\u1ee3c ch\u1edd \u0111\u1ee3i.<\/p>\n<p>C\u01a1 quan Qu\u1ea3n l\u00fd D\u01b0\u1ee3c ph\u1ea9m ch\u00e2u \u00c2u s\u1ebd xem x\u00e9t th\u00f4ng tin m\u1edbi v\u1ec1 thu\u1ed1c n\u00e0y \u00edt nh\u1ea5t l\u00e0 m\u1ed7i n\u0103m v\u00e0 T\u00f3m t\u1eaft \u0111\u1eb7c t\u00ednh s\u1ea3n ph\u1ea9m (SmPC) n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c c\u1eadp nh\u1eadt khi c\u1ea7n thi\u1ebft.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"54-du-lieu-tien-lam-sang\"><\/span>5.4. D\u1eef li\u1ec7u ti\u1ec1n l\u00e2m s\u00e0ng:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>MMAE \u0111\u00e3 cho th\u1ea5y l\u00e0 c\u00f3 \u0111\u1eb7c t\u00ednh g\u00e2y l\u1ec7ch b\u1ed9i trong m\u1ed9t nghi\u00ean c\u1ee9u v\u1ec1 nh\u00e2n nh\u1ecf \u1edf t\u1ee7y x\u01b0\u01a1ng chu\u1ed9t c\u1ed1ng in vivo. K\u1ebft qu\u1ea3 n\u00e0y ph\u00f9 h\u1ee3p v\u1edbi t\u00e1c d\u1ee5ng d\u01b0\u1ee3c l\u00fd c\u1ee7a MMAE tr\u00ean b\u1ed9 m\u00e1y ph\u00e2n b\u00e0o (ph\u00e1 v\u1ee1 m\u1ea1ng l\u01b0\u1edbi vi c\u1ea5u tr\u00fac h\u00ecnh \u1ed1ng) trong t\u1ebf b\u00e0o.<\/p>\n<p>\u1ea2nh h\u01b0\u1edfng c\u1ee7a brentuximab vedotin \u0111\u1ebfn ch\u1ee9c n\u0103ng sinh s\u1ea3n c\u1ee7a nam v\u00e0 n\u1eef \u1edf ng\u01b0\u1eddi ch\u01b0a \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u. Tuy nhi\u00ean, k\u1ebft qu\u1ea3 c\u1ee7a c\u00e1c nghi\u00ean c\u1ee9u \u0111\u1ed9c t\u00ednh li\u1ec1u l\u1eb7p l\u1ea1i tr\u00ean chu\u1ed9t c\u1ed1ng cho th\u1ea5y c\u00f3 kh\u1ea3 n\u0103ng brentuximab vedotin l\u00e0m suy gi\u1ea3m ch\u1ee9c n\u0103ng sinh s\u1ea3n v\u00e0 kh\u1ea3 n\u0103ng sinh s\u1ea3n \u1edf chu\u1ed9t \u0111\u1ef1c. Teo tinh ho\u00e0n v\u00e0 tho\u00e1i h\u00f3a tinh ho\u00e0n c\u00f3 th\u1ec3 h\u1ed3i ph\u1ee5c m\u1ed9t ph\u1ea7n sau m\u1ed9t th\u1eddi gian ng\u1eebng \u0111i\u1ec1u tr\u1ecb 16 tu\u1ea7n.<\/p>\n<p>Brentuximab vedotin g\u00e2y ch\u1ebft ph\u00f4i-thai tr\u00ean chu\u1ed9t c\u00e1i mang thai.<\/p>\n<p>Trong c\u00e1c nghi\u00ean c\u1ee9u phi l\u00e2m s\u00e0ng, gi\u1ea3m t\u1ebf b\u00e0o d\u1ea1ng lympho v\u00e0 gi\u1ea3m tr\u1ecdng l\u01b0\u1ee3ng tuy\u1ebfn \u1ee9c \u0111\u00e3 \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y, ph\u00f9 h\u1ee3p v\u1edbi s\u1ef1 ph\u00e1 h\u1ee7y vi c\u1ea5u tr\u00fac h\u00ecnh \u1ed1ng do t\u00e1c d\u1ee5ng d\u01b0\u1ee3c l\u00fd, g\u00e2y ra b\u1edfi MMAE c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb brentuximab vedotin.<\/p>\n<p><strong><em>*L\u01b0u \u00fd:<\/em><\/strong><\/p>\n<p><strong><em>C\u00e1c th\u00f4ng tin v\u1ec1 thu\u1ed1c tr\u00ean Pharmog.com ch\u1ec9 mang t\u00ednh ch\u1ea5t tham kh\u1ea3o &#8211; Khi d\u00f9ng thu\u1ed1c c\u1ea7n tuy\u1ec7t \u0111\u1ed1i tu\u00e2n theo theo h\u01b0\u1edbng d\u1eabn c\u1ee7a B\u00e1c s\u0129 <\/em><\/strong><\/p>\n<p><strong><em>Ch\u00fang t\u00f4i kh\u00f4ng ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 b\u1ea5t c\u1ee9 h\u1eadu qu\u1ea3 n\u00e0o x\u1ea3y ra do t\u1ef1 \u00fd d\u00f9ng thu\u1ed1c d\u1ef1a theo c\u00e1c th\u00f4ng tin tr\u00ean Pharmog.com<\/em><\/strong><\/p>\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\n<h2><span class=\"ez-toc-section\" id=\"6-phan-thong-tin-kem-theo-cua-thuoc\"><\/span><strong>6. Ph\u1ea7n th\u00f4ng tin k\u00e8m theo c\u1ee7a thu\u1ed1c:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"61-danh-muc-ta-duoc\"><\/span>6.1. Danh m\u1ee5c t\u00e1 d\u01b0\u1ee3c:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>T\u00e1 d\u01b0\u1ee3c: Acid citric monohydrate, natri citrate dihydrate, \u03b1,\u03b1-trehalose dehydrate, polysorbate 80.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"62-tuong-ky\"><\/span>6.2. T\u01b0\u01a1ng k\u1ef5 :<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Khi kh\u00f4ng c\u00f3 nghi\u00ean c\u1ee9u v\u1ec1 s\u1ef1 t\u01b0\u01a1ng h\u1ee3p, kh\u00f4ng \u0111\u01b0\u1ee3c tr\u1ed9n l\u1eabn thu\u1ed1c n\u00e0y v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c ngo\u1ea1i tr\u1eeb nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c \u0111\u1ec1 c\u1eadp trong ph\u1ea7n Th\u1eadn tr\u1ecdng \u0111\u1eb7c bi\u1ec7t khi h\u1ee7y b\u1ecf v\u00e0 x\u1eed l\u00fd kh\u00e1c.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"63-bao-quan\"><\/span>6.3. B\u1ea3o qu\u1ea3n:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>B\u1ea3o qu\u1ea3n trong t\u1ee7 l\u1ea1nh (2\u00b0C-8\u00b0C). Kh\u00f4ng \u0111\u1ec3 \u0111\u00f4ng l\u1ea1nh.<\/p>\n<p>Gi\u1eef l\u1ecd thu\u1ed1c trong h\u1ed9p carton g\u1ed1c \u0111\u1ec3 tr\u00e1nh \u00e1nh s\u00e1ng.<\/p>\n<p>Sau khi pha\/pha lo\u00e3ng, theo quan \u0111i\u1ec3m vi sinh h\u1ecdc, n\u00ean s\u1eed d\u1ee5ng thu\u1ed1c ngay. Tuy nhi\u00ean, \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh v\u1ec1 l\u00fd h\u00f3a trong khi s\u1eed d\u1ee5ng \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh trong 24 gi\u1edd \u1edf nhi\u1ec7t \u0111\u1ed9 2\u00b0C-8\u00b0C.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"64-thong-tin-khac\"><\/span>6.4. Th\u00f4ng tin kh\u00e1c :<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><em>M\u00f4 t\u1ea3:<\/em><\/p>\n<p>D\u1ea1ng b\u00e1nh ho\u1eb7c b\u1ed9t m\u00e0u tr\u1eafng \u0111\u1ebfn tr\u1eafng nh\u1ea1t.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"65-tai-lieu-tham-khao\"><\/span>6.5 T\u00e0i li\u1ec7u tham kh\u1ea3o:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>HDSD Thu\u1ed1c Adcetris do BSP Pharmaceuticals S.p.A. s\u1ea3n xu\u1ea5t (2023).<\/p>\n<p><a href=\"https:\/\/drugbank.vn\/\">Ng\u00e2n h\u00e0ng d\u1eef li\u1ec7u ng\u00e0nh D\u01b0\u1ee3c<\/a>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"7-nguoi-dang-tai-tac-gia\"><\/span><strong>7. Ng\u01b0\u1eddi \u0111\u0103ng t\u1ea3i \/T\u00e1c gi\u1ea3:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>B\u00e0i vi\u1ebft \u0111\u01b0\u1ee3c s\u01b0u t\u1ea7m ho\u1eb7c vi\u1ebft b\u1edfi: <a href=\"https:\/\/pharmog.com\/wp\/thong-tin-tac-gia-bac-sy-do-my-linh\/\">B\u00e1c s\u0129 nhi khoa &#8211; \u0110\u1ed7 M\u1ef9 Linh.<\/a><\/p>\n<p>Ki\u1ec3m duy\u1ec7t , hi\u1ec7u \u0111\u00ednh v\u00e0 \u0111\u0103ng t\u1ea3i: <a href=\"https:\/\/pharmog.com\/wp\/thong-tin-ve-pharmog-team\/\">PHARMOG TEAM<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Adcetris (Brentuximab) l\u00e0 thu\u1ed1c ph\u00e1t minh do c\u00f4ng ty Takeda s\u1ea3n xu\u1ea5t, thu\u1ed1c c\u00f3 ch\u1ee9a th\u00e0nh ph\u1ea7n ch\u00ednh l\u00e0 d\u01b0\u1ee3c ch\u1ea5t Brentuximab vedotin. Brentuximab \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u1edf ng\u01b0\u1eddi l\u1edbn \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1ec7nh u lympho Hodgkin v\u00e0 u lympho to\u00e0n th\u00e2n t\u1ebf b\u00e0o l\u1edbn tho\u00e1i bi\u1ebfn ho\u1eb7c u lympho \u1edf da t\u1ebf b\u00e0o T. <\/p>\n","protected":false},"author":8612,"featured_media":60494,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[419],"tags":[611],"class_list":["post-18070","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biet-duoc","tag-brentuximab"],"_links":{"self":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/18070","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/users\/8612"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/comments?post=18070"}],"version-history":[{"count":8,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/18070\/revisions"}],"predecessor-version":[{"id":60506,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/18070\/revisions\/60506"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/media\/60494"}],"wp:attachment":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/media?parent=18070"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/categories?post=18070"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/tags?post=18070"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}