{"id":5009,"date":"2022-12-21T06:59:56","date_gmt":"2022-12-21T06:59:56","guid":{"rendered":"https:\/\/aceoncology.org\/?p=5009"},"modified":"2023-05-24T09:44:18","modified_gmt":"2023-05-24T09:44:18","slug":"fda-new-cancer-indications-approvals-oct-nov-2022","status":"publish","type":"post","link":"https:\/\/aceoncology.org\/zh-hans\/fda-new-cancer-indications-approvals-oct-nov-2022\/","title":{"rendered":"2022\u5e7410-11\u6708FDA\u6279\u51c6\u4e867\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5"},"content":{"rendered":"\n<p>\u572810-11\u6708\uff0c\u7f8e\u56fdFDA\u6279\u51c6\u4e867\u9879\u65b0\u7684\u80bf\u7624\u7597\u6cd5\u3002\u5176\u4e2d\u5305\u62ec\u4e86\u4e00\u9879\u5df2\u83b7\u6279\u6cbb\u7597\u7684\u65b0\u5242\u91cf\u65b9\u6848\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Mirvetuximab Soravtansine<\/strong><strong>\u7528\u4e8e\u53f6\u9178\u53d7\u4f53<\/strong><strong>\u03b1<\/strong><strong>\uff08<\/strong><strong>FR\u03b1<\/strong><strong>\uff09<\/strong><strong>\u9633\u6027\u3001\u94c2<\/strong><strong>\u7c7b<\/strong><strong>\u8010\u836f\u5375\u5de2\u764c\u3001\u8f93\u5375\u7ba1\u764c\u6216\u8179\u819c\u764c\u3002<\/strong>FR\u03b1\u5b9a\u5411\u6297\u4f53\u548c\u5fae\u7ba1\u6291\u5236\u5242\u7ed3\u5408\u7269mirvetuximab soravtansine\uff08Elahere\u2122\uff0cImmunoGen\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant\">\u52a0\u901f\u6279\u51c6<\/a>\u7528\u4e8eFR\u03b1\u9633\u6027\u3001\u94c2\u7c7b\u8010\u836f\u4e0a\u76ae\u6027\u5375\u5de2\u764c\u3001\u8f93\u5375\u7ba1\u764c\u6216\u539f\u53d1\u6027\u8179\u819c\u764c\u7684\u6210\u4eba\u60a3\u8005\uff0c\u65e2\u5f80\u63a5\u53d7\u8fc7\u4e00\u5230\u4e09\u79cd\u5168\u8eab\u6027\u6cbb\u7597\u65b9\u6848\u3002\u6b64\u5916\uff0c\u6279\u51c6\u4e86\u4e00\u79cd\u57fa\u4e8e\u514d\u75ab\u7ec4\u5316\u7684\u7528\u4e8e\u68c0\u6d4bFR1\u86cb\u767d\u7684\u4f34\u53d1\u8bca\u65ad\u65b9\u6cd5\uff08Ventana FOLR1 [FOLR1-2.1]\uff1bVentana\u533b\u7597\u7cfb\u7edf\u516c\u53f8\uff09\u3002Mirvetuximab\u7684\u6279\u51c6\u57fa\u4e8e\u5355\u81c2<a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2022.40.16_suppl.5512\">SORAYA\u7814\u7a76<\/a>\uff08\u4e5f\u79f0\u4e3a0417\u7814\u7a76\uff09\u7684\u7597\u6548\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u7eb3\u5165\u4e86106\u4f8b\u65e2\u5f80\u6cbb\u7597\u8fc7\u7684FR\u03b1\u9633\u6027\u3001\u94c2\u7c7b\u8010\u836f\u4e0a\u76ae\u6027\u5375\u5de2\u764c\u3001\u8f93\u5375\u7ba1\u764c\u6216\u539f\u53d1\u6027\u8179\u819c\u764c\u60a3\u8005\u3002\u6240\u6709\u60a3\u8005\u5747\u63a5\u53d7\u8d1d\u4f10\u5355\u6297\u6cbb\u7597\u3002\u603b\u7f13\u89e3\u7387\uff08ORR\uff09\u4e3a31.7%\uff0c\u4e2d\u4f4d\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DoR\uff09\u4e3a6.9\u4e2a\u6708\u3002\u5efa\u8bae\u7684mirvetuximab soravtansine\u5242\u91cf\u4e3a6mg\/kg\uff0c\u8c03\u6574\u7406\u60f3\u4f53\u91cd\uff0c\u6bcf3\u5468\u9759\u8109\u8f93\u6ce8\u4e00\u6b21\uff0c\u76f4\u5230\u75be\u75c5\u8fdb\u5c55\u6216\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u3002\u4ea7\u54c1\u8bf4\u660e\u4e66\u5305\u62ec\u5bf9\u773c\u90e8\u6bd2\u6027\u7684\u9ed1\u6846\u8b66\u544a\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Tremelimumab +\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u6cbb\u7597\u4e0d\u53ef\u5207\u9664\u7684HCC\u3002<\/strong>Tremelimumab\uff08Imjudo\u00ae\uff0c\u963f\u65af\u5229\u5eb7\uff09\u8054\u5408\u5ea6\u4f10\u5229\u5c24\u5355\u6297\uff08\u82f1\u98de\u51e1\u00ae\uff0c\u963f\u65af\u5229\u5eb7\uff09\u83b7\u5f97<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-tremelimumab-combination-durvalumab-unresectable-hepatocellular-carcinoma\">\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u4e0d\u53ef\u5207\u9664\u7684\u809d\u7ec6\u80de\u764c\uff08uHCC\uff09\u60a3\u8005\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u6765\u81ea\u968f\u673a\u3001\u5f00\u653e\u6807\u7b7e\u3001\u591a\u4e2d\u5fc3<a href=\"https:\/\/evidence.nejm.org\/doi\/full\/10.1056\/EVIDoa2100070\">HIMALAYA\u7814\u7a76<\/a>\u7684\u7597\u6548\u6570\u636e\uff0c\u8be5\u7814\u7a76\u9488\u5bf9\u4e4b\u524d\u672a\u63a5\u53d7\u5168\u8eab\u6027\u6cbb\u7597\u7684\u786e\u8bcauHCC\u60a3\u8005\u3002\u60a3\u8005\u88ab\u968f\u673a\u5206\u4e3a\u4e09\u7ec4\uff1atremelimumab 300 mg\u4e00\u6b21\u6027\u5355\u6b21\u9759\u8109\u8f93\u6ce8\uff0c\u540c\u4e00\u5929\u52a0\u5ea6\u4f10\u5229\u5c24\u5355\u6297 1500 mg IV\uff0c\u968f\u540e\u6bcf4\u5468\u6ce8\u5c04\u5ea6\u4f10\u5229\u5c24\u5355\u6297 1500 mg IV\uff1b\u5ea6\u4f10\u5229\u5c24\u5355\u6297 1500 mg IV\uff0c\u6bcf4\u5468\uff1b\u6216\u7d22\u62c9\u975e\u5c3c400\u6beb\u514b\u53e3\u670d\uff0c\u6bcf\u5929\u4e24\u6b21\uff0c\u76f4\u5230\u75be\u75c5\u8fdb\u5c55\u6216\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u968f\u673a\u7ec4tremelimumab + \u5ea6\u4f10\u5229\u5c24\u5355\u6297\uff08n=393\uff09\u6216\u7d22\u62c9\u975e\u5c3c\uff08n=389\uff09\u60a3\u8005\u7684\u6bd4\u8f83\u3002\u4e0e\u7d22\u62c9\u975e\u5c3c\u76f8\u6bd4\uff0ctremelimumab\u8054\u5408\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u5728\u603b\u751f\u5b58\u671f\uff08OS\uff09\u65b9\u9762\u6709\u663e\u8457\u548c\u4e34\u5e8a\u610f\u4e49\u7684\u6539\u5584\uff08\u98ce\u9669\u6bd4[HR]\uff0c 0.78\uff1bP = 0.0035\uff09\uff1b\u4e2d\u4f4dOS\u4e3a16.4 vs. 13.8\u4e2a\u6708\u3002Tremelimumab + \u5ea6\u4f10\u5229\u5c24\u5355\u6297\u7ec4\u548c\u7d22\u62c9\u975e\u5c3c\u7ec4\u7684\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u5206\u522b\u4e3a3.8\u4e2a\u6708\u548c4.1\u4e2a\u6708\uff08HR, 0.90\uff09\u3002Tremelimumab + \u5ea6\u4f10\u5229\u5c24\u5355\u6297\u7ec4ORR\u4e3a20.1%\uff0c\u7d22\u62c9\u975e\u5c3c\u7ec4ORR\u4e3a5.1%\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Tremelimumab<\/strong><strong>\u3001<\/strong><strong>\u5ea6\u4f10\u5229\u5c24\u5355\u6297<\/strong><strong>\u8054\u5408\u5316\u7597\u6cbb\u7597\u8f6c\u79fb\u6027<\/strong><strong>\u975e\u5c0f\u7ec6\u80de\u80ba\u764c<\/strong><strong>\u3002<\/strong>Tremelimumab\uff08Imjudo\u00ae\uff0c\u963f\u65af\u5229\u5eb7\uff09\u8054\u5408\u5ea6\u4f10\u5229\u5c24\u5355\u6297\uff08\u82f1\u98de\u51e1\u00ae\uff0c\u963f\u65af\u5229\u5eb7\uff09\u548c\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u7597\u4e5f<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-tremelimumab-combination-durvalumab-and-platinum-based-chemotherapy-metastatic-non\">\u83b7\u5f97\u6279\u51c6<\/a>\uff0c\u7528\u4e8e\u65e0\u654f\u611f\u6027EGFR\u7a81\u53d8\u6216ALK\u57fa\u56e0\u7ec4\u80bf\u7624\u5f02\u5e38\u7684\u8f6c\u79fb\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u60a3\u8005\u3002\u5176\u7597\u6548\u5728\u8f6c\u79fb\u6027NSCLC\u521d\u6cbb\u60a3\u8005\u7684\u968f\u673a\u3001\u4e09\u671f\u3001\u4e09\u81c2\u3001\u4e3b\u52a8\u5bf9\u7167\u3001\u5f00\u653e\u6807\u7b7e<a href=\"https:\/\/ascopubs.org\/doi\/full\/10.1200\/JCO.22.00975\">POSEIDON\u7814\u7a76<\/a>\u4e2d\u8fdb\u884c\u8bc4\u4f30\u3002\u60a3\u8005\u88ab\u968f\u673a\u5206\u4e3a\u4e09\u4e2a\u6cbb\u7597\u7ec4\uff1a\uff081\uff09tremelimumab + \u5ea6\u4f10\u5229\u5c24\u5355\u6297\u548c\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u75974\u4e2a\u5468\u671f\uff0c\u968f\u540e\u6bcf4\u5468\u8fdb\u884c\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u548c\u7ef4\u6301\u5316\u7597\uff1b\uff082\uff09\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u548c\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u75974\u4e2a\u5468\u671f\uff0c\u968f\u540e\u5ea6\u4f10\u5229\u5c24\u5355\u6297\u548c\u7ef4\u6301\u5316\u7597\uff1b\u6216\uff083\uff09\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u75976\u4e2a\u5468\u671f\uff0c\u968f\u540e\u7ef4\u6301\u5316\u7597\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8e\u6cbb\u7597\u7ec41\u548c\u6cbb\u7597\u7ec43\u7684\u6bd4\u8f83\uff0c\u5176\u4e2d\u5305\u62ec675\u4f8b\u60a3\u8005\u3002\u4e0e\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u7597\u76f8\u6bd4\uff0ctremelimumab + \u5ea6\u4f10\u5229\u5c24\u5355\u6297\u548c\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u7597\u5728OS\u65b9\u9762\u6709\u663e\u8457\u548c\u4e34\u5e8a\u610f\u4e49\u7684\u6539\u5584\uff08HR\uff0c0.77\uff1bP = 0.00304\uff09\uff1a\u6cbb\u7597\u7ec41\u548c\u6cbb\u7597\u7ec43\u7684\u4e2d\u4f4dOS\u5206\u522b\u4e3a14\u548c11.7\u4e2a\u6708\uff1b\u4e2d\u4f4dPFS\u5206\u522b\u4e3a6.2\u548c4.8\u4e2a\u6708\uff08HR\uff0c0.72\uff1bP = 0.00031\uff09\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Cemiplimab<\/strong><strong>\u7528\u4e8e\u665a\u671f<\/strong><strong>\u975e\u5c0f\u7ec6\u80de\u80ba\u764c<\/strong><strong>\u3002<\/strong>FDA<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-cemiplimab-rwlc-combination-platinum-based-chemotherapy-non-small-cell-lung-cancer\">\u6279\u51c6<\/a>\u6297PD -1\u6297\u4f53cemiplimab\uff08Libtayo\u00ae\uff0c\u518d\u751f\u5143\u5236\u836f\uff09\u8054\u5408\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u7597\u7528\u4e8e\u65e0EGFR\u3001ALK\u6216ROS1\u53d8\u5f02\u7684\u665a\u671fNSCLC\u60a3\u8005\u3002\u6765\u81ea\u5168\u7403\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7684III\u671f<a href=\"https:\/\/www.nature.com\/articles\/s41591-022-01977-y\">EMPOWER-Lung3\u7814\u7a76<\/a>\u7684\u7ed3\u679c\u7528\u4e8e\u8bc4\u4f30\u7597\u6548\uff0c\u8be5\u7814\u7a76\u5171\u7eb3\u5165466\u4f8b\u65e2\u5f80\u672a\u63a5\u53d7\u5168\u8eab\u6cbb\u7597\u7684\u665a\u671fNSCLC\u60a3\u8005\u3002\u60a3\u8005\u63a5\u53d7cemiplimab \uff08n=312\uff09\u6216\u5b89\u6170\u5242\uff08n=154\uff09\u6bcf3\u5468\u65b9\u6848\uff0c\u8054\u54084\u4e2a\u5468\u671f\u533b\u751f\u9009\u62e9\u7684\u94c2\u7c7b\u4e3a\u57fa\u7840\u7684\u5316\u7597\u3002\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0cCemiplimab\u4e3a\u57fa\u7840\u7684\u6cbb\u7597\u7ec4\u4e2d\u4f4dOS\u663e\u8457\u6539\u5584\uff0821.9\u4e2a\u6708\u5bf913.0\u4e2a\u6708\uff1bHR\uff0c0.71\uff1b<em>P<\/em> = 0.014\uff09\u3002Cemiplimab\u7ec4\u7684\u4e2d\u4f4dPFS\u4e3a8.2\u4e2a\u6708\uff0c\u5b89\u6170\u5242\u7ec4\u4e3a5.0\u4e2a\u6708\uff08HR\uff0c0.56\uff1b<em>P <\/em>&lt; 0.0001\uff09\u3002\u4e24\u7ec4\u786e\u5b9a\u7684ORR\u5206\u522b\u4e3a43.3%\u548c22.7%\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u83ca\u6b27\u6c0f\u6746\u83cc\u5929\u51ac\u9170\u80fa\u9176\u7684\u65b0\u5242\u91cf\u3002<\/strong>\u91cd\u7ec4\u83ca\u6b27\u6c0f\u6746\u83cc\u5929\u51ac\u9170\u80fa\u9176\uff08Rylaze\u2122\uff0cJazz\u5236\u836f\uff09\u5df2\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-new-dosing-regimen-asparaginase-erwinia-chrysanthemi-recombinant\">\u6279\u51c6<\/a>\u7528\u4e8e\u65b0\u7684\u5468\u4e00-\u5468\u4e09-\u5468\u4e94\u7ed9\u836f\u65b9\u6848\uff0c\u5176\u4e2d\u5305\u62ec\u5468\u4e00\u548c\u5468\u4e09\u4e0a\u5348\u808c\u8089\u6ce8\u5c0425mg \/m2\uff0c\u5468\u4e94\u4e0b\u5348\u808c\u8089\u6ce8\u5c0450mg \/m2\u30022021\u5e746\u6708\uff0cFDA\u6279\u51c6\u4e86\u83ca\u6b27\u6c0f\u6746\u83cc\u5929\u51ac\u9170\u80fa\u9176\u4f5c\u4e3a\u5bf9\u5927\u80a0\u6746\u83cc\u6e90\u6027\u5929\u51ac\u9170\u80fa\u9176\u8fc7\u654f\u76841\u4e2a\u6708\u6216\u4ee5\u4e0a\u6210\u4eba\u548c\u513f\u7ae5\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\uff08ALL\uff09\u548c\u6dcb\u5df4\u7ec6\u80de\u6dcb\u5df4\u7624\uff08LBL\uff09\u591a\u836f\u5316\u7597\u65b9\u6848\u7684\u7ec4\u6210\u90e8\u5206\uff1b\u63a8\u8350\u5242\u91cf\u4e3a25mg \/m2\uff0c\u6bcf48\u5c0f\u65f6\u808c\u6ce8\u4e00\u6b21\u3002\u65b0\u7684\u7ed9\u836f\u65b9\u6848\u662f\u57fa\u4e8e\u5f00\u653e\u6807\u7b7e\u3001\u591a\u4e2d\u5fc3<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8212713\/\">JZP458-201\u7814\u7a76<\/a>\u4e2d225\u4f8b\u60a3\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u5206\u6790\u800c\u6279\u51c6\u7684\uff0c\u5728\u8be5\u7814\u7a76\u4e2d\uff0c\u83ca\u6b27\u6c0f\u6746\u83cc\u5929\u51ac\u9170\u80fa\u9176\u4ee5\u4e0d\u540c\u9014\u5f84\u548c\u4e0d\u540c\u5242\u91cf\u7ed9\u836f\uff0c\u5e76\u5c06\u7ed3\u679c\u7528\u4e8e\u5f00\u53d1\u4e00\u4e2a\u6a21\u578b\u6765\u9884\u6d4b\u7279\u5b9a\u65f6\u95f4\u70b9\u7684\u8840\u6e05\u5929\u51ac\u9170\u80fa\u9176\u6d3b\u6027\u3002\u7597\u6548\u7684\u786e\u5b9a\u662f\u57fa\u4e8e\u5728\u865a\u62df\u4eba\u7fa4\u4e2d\u6a21\u62df\u8840\u6e05\u5929\u51ac\u9170\u80fa\u9176\u6700\u4f4e\u6d3b\u6027\u8fbe\u5230\u5e76\u7ef4\u6301\u57280.1 U\/mL\u4ee5\u4e0a\u6c34\u5e73\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Teclistamab<\/strong><strong>\u6cbb\u7597\u590d\u53d1\/<\/strong><strong>\u96be\u6cbb\u6027\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u3002<\/strong>Teclistamab\uff08Tecvayli\u00ae\uff0c\u6768\u68ee\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma\">\u52a0\u901f\u6279\u51c6<\/a>\u7528\u4e8eR\/R\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\uff0c\u8fd9\u4e9b\u60a3\u8005\u4e4b\u524d\u5df2\u7ecf\u63a5\u53d7\u4e86\u81f3\u5c11\u56db\u79cd\u6cbb\u7597\u65b9\u6848\uff0c\u5305\u62ec\u86cb\u767d\u9176\u4f53\u6291\u5236\u5242\u3001\u514d\u75ab\u8c03\u8282\u5242\u548cCD 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REMS\u3002<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>\u7ef4\u5e03\u59a5\u6614\u5355\u6297<\/strong><strong>+<\/strong><strong>\u5316\u7597\u6cbb\u7597\u513f\u7ae5\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u3002<\/strong>CD30\u9776\u5411\u6297\u4f53\u5076\u8054\u7269\u7ef4\u5e03\u59a5\u6614\u5355\u6297\uff08\u5b89\u9002\u5229\u00ae\uff0cSeagen\/\u6b66\u7530\uff09\u8054\u5408AVE-PC\u5316\u7597\uff08\u963f\u9709\u7d20\u3001\u957f\u6625\u65b0\u78b1\u3001\u4f9d\u6258\u6cca\u82f7\u3001\u5f3a\u7684\u677e\u548c\u73af\u78f7\u9170\u80fa\uff09\u88ab<a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-brentuximab-vedotin-combination-chemotherapy-pediatric-patients-classical-hodgkin\">\u6279\u51c6<\/a>\u7528\u4e8e\u65e2\u5f80\u672a\u6cbb\u7597\u7684\u22652\u5c81\u9ad8\u5371\u7ecf\u5178\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u513f\u7ae5\u60a3\u8005\u3002\u8fd9\u662f\u7ef4\u5e03\u59a5\u6614\u5355\u6297\u9996\u6b21\u83b7\u5f97\u513f\u7ae5\u6279\u51c6\u3002\u5176\u7597\u6548\u5728\u968f\u673a\u3001\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u7684III\u671f<a href=\"Brentuximab%20Vedotin%20with%20Chemotherapy%20in%20Pediatric%20High-Risk%20Hodgkin\u2019s%20Lymphoma%20|%20NEJM\">AHOD1331\u7814\u7a76<\/a>\u4e2d\u8fdb\u884c\u4e86\u8bc4\u4f30\uff0c\u8be5\u7814\u7a76\u5305\u62ec600\u540d2 &#8211; 21\u5c81\u3001\u65e2\u5f80\u672a\u6cbb\u7597\u7684\u9ad8\u98ce\u9669\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u60a3\u8005\u3002\u9ad8\u5371\u88ab\u5b9a\u4e49\u4e3aAnn Arbor IIB\u671f\u4f34\u5de8\u5927\u80bf\u7624\u3001III\u671f\u3001IVA\u671f\u548cIVB\u671f\u3002\u60a3\u8005\u88ab\u5206\u914d\u63a5\u53d75\u4e2a\u5468\u671f\u7684\u7ef4\u5e03\u59a5\u6614\u5355\u6297+AVE-PC\u6216\u6807\u51c6\u7684\u513f\u7ae5\u65b9\u6848ABVE-PC\uff08\u963f\u9709\u7d20\u3001\u535a\u83b1\u9709\u7d20\u3001\u957f\u6625\u65b0\u78b1\u3001\u4f9d\u6258\u6cca\u82f7\u3001\u5f3a\u7684\u677e\u548c\u73af\u78f7\u9170\u80fa\uff09\u3002\u4e3b\u8981\u7597\u6548\u6307\u6807\u4e3a\u65e0\u4e8b\u4ef6\u751f\u5b58\u671f\uff08EFS\uff09\u3002\u4e24\u79cd\u6cbb\u7597\u5747\u672a\u8fbe\u5230\u4e2d\u4f4dEFS\uff0c\u7ef4\u5e03\u59a5\u6614\u5355\u6297\u7ec4\u590d\u53d1\u7387\u4e3a8%\uff0cABVE-PC\u7ec4\u590d\u53d1\u7387\u4e3a17%\u3002\u4e2d\u4f4d\u968f\u8bbf43.1\u4e2a\u6708\uff0c\u7ef4\u5e03\u59a5\u6614\u5355\u6297\u7ec43\u5e74EFS\u4e3a92.1%\uff0c\u5728\u6807\u51c6\u5316\u7597\u7ec4\u4e3a82.5% \uff08HR\uff0c0.41\uff1bP = 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