{"id":39872,"date":"2026-05-29T11:03:20","date_gmt":"2026-05-29T03:03:20","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=39872"},"modified":"2026-05-29T13:39:17","modified_gmt":"2026-05-29T05:39:17","slug":"fda%e9%87%8d%e7%a3%85%e6%89%b9%e5%87%86%ef%bc%9at-dxd%e7%94%a8%e4%ba%8eher2%e9%98%b3%e6%80%a7%e6%97%a9%e6%9c%9f%e4%b9%b3%e8%85%ba%e7%99%8c%e6%96%b0%e8%be%85%e5%8a%a9%e4%b8%8e%e8%be%85%e5%8a%a9","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/fda%e9%87%8d%e7%a3%85%e6%89%b9%e5%87%86%ef%bc%9at-dxd%e7%94%a8%e4%ba%8eher2%e9%98%b3%e6%80%a7%e6%97%a9%e6%9c%9f%e4%b9%b3%e8%85%ba%e7%99%8c%e6%96%b0%e8%be%85%e5%8a%a9%e4%b8%8e%e8%be%85%e5%8a%a9\/","title":{"rendered":"FDA\u91cd\u78c5\u6279\u51c6\uff1aT- DXd\u7528\u4e8eHER2\u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u65b0\u8f85\u52a9\u4e0e\u8f85\u52a9\u6cbb\u7597"},"content":{"rendered":"\n

2026\u5e745\u670815\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6b63\u5f0f\u6279\u51c6fam<\/strong>– <\/strong>trastuzumab deruxtecan<\/strong>– <\/strong>nxki\uff08T<\/strong>– <\/strong>DXd\uff09<\/strong>\u7528\u4e8eHER2\u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u6210\u4eba\u60a3\u8005<\/strong>\u7684\u4e24\u9879\u72ec\u7acb\u9002\u5e94\u75c7\uff0c\u5206\u522b\u8986\u76d6\u672f\u524d\u65b0\u8f85\u52a9\u6cbb\u7597<\/strong>\u4e0e\u672f\u540e\u8f85\u52a9\u5f3a\u5316\u6cbb\u7597<\/strong>\u8fd9\u4e24\u9879\u9002\u5e94\u75c7\u3002<\/p>\n\n\n\n

\u6b64\u6b21\u83b7\u6279\u57fa\u4e8eDESTINY- Breast11\uff08DB11\uff09\u4e0eDESTINY- Breast05\uff08DB05\uff09\u4e24\u9879\u5168\u7403\u591a\u4e2d\u5fc3III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u9633\u6027\u7ed3\u679c\uff0c\u540c\u6b65\u83b7\u5f97\u7f8e\u56fd\u764c\u75c7\u534f\u4f1a\uff08ACS\uff09\u3001\u7f8e\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08ASCO\uff09\u53ca\u300a\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\u300b\u7b49\u6743\u5a01\u673a\u6784\u4e0e\u671f\u520a\u7684\u8ba4\u53ef\uff0c\u6807\u5fd7\u7740ADC\u836f\u7269\u6b63\u5f0f\u8fdb\u5165\u65e9\u671f\u4e73\u817a\u764c\u6cbb\u6108\u6027\u6cbb\u7597\u7684\u6838\u5fc3\u9886\u57df\u3002<\/p>\n\n\n\n

1. <\/strong>\u83b7\u6279\u9002\u5e94\u75c7\u4e0e\u9002\u7528\u4eba\u7fa4<\/strong><\/strong><\/p>\n\n\n\n

\u672c\u6b21FDA\u6279\u51c6\u7684\u4e24\u9879\u9002\u5e94\u75c7\u5747\u9488\u5bf9HER2 \u9633\u6027\uff08IHC3+\u6216ISH+\uff09<\/strong>\u65e9\u671f\u4e73\u817a\u764c\uff0c\u9700\u7ecfFDA\u6279\u51c6\u7684\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u786e\u8ba4HER2\u72b6\u6001\u3002<\/p>\n\n\n\n

1. \u65b0\u8f85\u52a9\u6cbb\u7597\uff08\u672f\u524d\uff09<\/strong><\/strong><\/p>\n\n\n\n

\u25ab \u9002\u7528\u4eba\u7fa4\uff1a<\/strong>II\/III \u671f HER2 \u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u6210\u4eba\u60a3\u8005<\/p>\n\n\n\n

\u25ab \u6cbb\u7597\u65b9\u6848\uff1a<\/strong>T- DXd 5.4 mg\/kg\uff0c\u6bcf3\u54681\u6b21\uff0c\u4f7f\u75284\u5468\u671f\uff0c\u7d2b\u6749\u70f7+\u66f2\u59a5\u73e0\u5355\u6297+\u5e15\u59a5\u73e0\u5355\u6297\uff08THP\uff09\u63a5\u7eed\u4f7f\u75284\u5468\u671f<\/p>\n\n\n\n

\u25ab \u5ba1\u6279\u4f9d\u636e\uff1a<\/strong>DB11 \u7814\u7a76\uff08\u6807\u51c6\u5ba1\u8bc4\uff09<\/p>\n\n\n\n

2. \u8f85\u52a9\u6cbb\u7597\uff08\u672f\u540e\uff09<\/strong><\/strong><\/p>\n\n\n\n

\u25ab \u9002\u7528\u4eba\u7fa4\uff1a<\/strong>\u65b0\u8f85\u52a9\u6297 HER2 \u6cbb\u7597\u540e\u4ecd\u6709\u6b8b\u7559\u6d78\u6da6\u6027\u75c5\u7076\u7684 HER2 \u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u6210\u4eba\u60a3\u8005<\/p>\n\n\n\n

\u25ab \u6cbb\u7597\u65b9\u6848\uff1a<\/strong>T- DXd 5.4 mg\/kg\uff0c\u6bcf3\u54681\u6b21\uff0c\u6700\u591a14\u5468\u671f<\/p>\n\n\n\n

\u25ab \u5ba1\u6279\u4f9d\u636e\uff1a<\/strong>DB05\u7814\u7a76\uff08\u4f18\u5148\u5ba1\u8bc4+\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff09<\/p>\n\n\n\n

2. <\/strong>\u5173\u952e\u4e34\u5e8a\u6570\u636e\uff08\u6765\u81eaDB11\u4e0eDB05\u7814\u7a76\uff09<\/strong><\/strong><\/p>\n\n\n\n

1. DESTINY<\/strong>– <\/strong>Breast11\uff08\u65b0\u8f85\u52a9\u6cbb\u7597\uff09<\/strong><\/strong><\/p>\n\n\n\n

\u2022 \u7814\u7a76\u8bbe\u8ba1\uff1a<\/strong>\u5168\u7403\u968f\u673a\u3001\u5f00\u653e\u3001\u591a\u4e2d\u5fc3III\u671f\uff0c\u5165\u7ec4927\u4f8bII\/III\u671f HER2 \u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u60a3\u8005<\/p>\n\n\n\n

\u2022 \u4e3b\u8981\u7ec8\u70b9\uff1a<\/strong>\u75c5\u7406\u5b8c\u5168\u7f13\u89e3\u7387\uff08pCR\uff0c\u4e73\u817a + \u814b\u7a9d\u65e0\u6d78\u6da6\u764c\uff09<\/p>\n\n\n\n

\u2022 \u6838\u5fc3\u7ed3\u679c\uff1a<\/strong><\/strong><\/p>\n\n\n\n

\u25ab T- DXd- THP\u7ec4\uff1a67.3%\uff0895%CI\uff1a61.9%\u201372.4%\uff09<\/p>\n\n\n\n

\u25ab \u6807\u51c6\u65b9\u6848\uff08ddAC- THP\uff09\u7ec4\uff1a56.3%\uff0895%CI\uff1a50.6%\u201361.8%\uff09<\/p>\n\n\n\n

\u25ab \u7edd\u5bf9\u83b7\u76ca\uff1a+11.2%\uff0cP=0.003\uff0c\u5dee\u5f02\u5177\u6709\u7edf\u8ba1\u5b66\u610f\u4e49<\/p>\n\n\n\n

\u2022 \u4e9a\u7ec4\u5206\u6790\uff1a<\/strong>\u6fc0\u7d20\u53d7\u4f53\uff08HR\uff09\u9634\u6027\u60a3\u8005 pCR \u7387\u8fbe83.1%\uff0c\u83b7\u76ca\u66f4\u663e\u8457<\/p>\n\n\n\n

\u2022 \u5b89\u5168\u6027\uff1a<\/strong>T- DXd\u65b9\u6848\u4e0d\u542b\u84bd\u73af\u7c7b\u836f\u7269\uff0c\u4e25\u91cd\u8840\u6db2\u5b66\u6bd2\u6027\u4e0e\u5fc3\u810f\u6bd2\u6027\u53d1\u751f\u7387\u4f4e\u4e8e\u4f20\u7edf\u65b9\u6848\uff0c\u5b89\u5168\u6027\u66f4\u4f18<\/p>\n\n\n\n

2. DESTINY<\/strong>– <\/strong>Breast05\uff08\u8f85\u52a9\u5f3a\u5316\u6cbb\u7597\uff09<\/strong><\/strong><\/p>\n\n\n\n

\u2022 \u7814\u7a76\u8bbe\u8ba1\uff1a<\/strong>\u5168\u7403\u968f\u673a\u3001\u5f00\u653e\u3001\u591a\u4e2d\u5fc3III\u671f\uff0c\u5165\u7ec41635\u4f8b\u65b0\u8f85\u52a9\u540e\u6b8b\u7559\u75c5\u7076\u7684\u9ad8\u5371 HER2 \u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u60a3\u8005<\/p>\n\n\n\n

\u2022 \u4e3b\u8981\u7ec8\u70b9\uff1a<\/strong>\u65e0\u6d78\u6da6\u6027\u75be\u75c5\u751f\u5b58\u671f\uff08iDFS\uff09<\/p>\n\n\n\n

\u2022 \u6838\u5fc3\u7ed3\u679c<\/strong>\uff08\u4e2d\u4f4d\u968f\u8bbf\u7ea630\u4e2a\u6708\uff09\uff1a<\/p>\n\n\n\n

\u25ab 3\u5e74iDFS \u7387\uff1aT- DXd \u7ec492.4% vs T- DM1\u7ec483.7%<\/p>\n\n\n\n

\u25ab \u98ce\u9669\u6bd4\uff08HR\uff09=0.47\uff0895%CI\uff1a0.34\u20130.66\uff09\uff0cP<0.0001<\/p>\n\n\n\n

\u25ab \u590d\u53d1\/\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e 53%\uff0c\u5404\u4e9a\u7ec4\u83b7\u76ca\u4e00\u81f4<\/p>\n\n\n\n

\u2022 \u6b21\u8981\u7ec8\u70b9\uff1a<\/strong>\u65e0\u75c5\u751f\u5b58\u671f\uff08DFS\uff09\u3001\u65e0\u8fdc\u5904\u590d\u53d1\u751f\u5b58\u671f\uff08DRFS\uff09\u7ed3\u679c\u4e0e iDFS \u4e00\u81f4\uff0c\u5747\u663e\u793a T- DXd \u663e\u8457\u83b7\u76ca<\/p>\n\n\n\n

3. <\/strong>\u6743\u5a01\u673a\u6784\u4e0e\u671f\u520a\u8bc4\u4ef7<\/strong><\/strong><\/p>\n\n\n\n

1. FDA\uff1a<\/strong>\u672c\u6b21\u6279\u51c6\u91c7\u7528Project Orbis\u591a\u56fd\u540c\u6b65\u5ba1\u8bc4\u673a\u5236\uff0c\u8ba4\u53ef T- DXd \u5728\u65e9\u671f\u4e73\u817a\u764c\u4e2d\u7684\u6cbb\u6108\u6027\u4ef7\u503c\uff0c\u5e76\u5f3a\u8c03HER2 \u7cbe\u51c6\u68c0\u6d4b\u7684\u5fc5\u8981\u6027\u3002 <\/p>\n\n\n\n

2. ASCO\/ESMO\uff1a<\/strong>\u4e24\u9879\u7814\u7a76\u7ed3\u679c\u5747\u57282025\u5e74ESMO\u5e74\u4f1a\u4e3b\u5e2d\u7814\u8ba8\u4f1a\u53d1\u5e03\uff0c\u88abASCO\u8bc4\u4e3a\u65e9\u671f\u4e73\u817a\u764c\u6cbb\u7597\u7684\u91cd\u5927\u7a81\u7834\uff0cNCCN\u6307\u5357\u5df2\u5c06 T- DXd \u8f85\u52a9\u6cbb\u7597\u5217\u4e3a1 \u7c7b\u63a8\u8350\u3002<\/p>\n\n\n\n

3. \u7f8e\u56fd\u764c\u75c7\u534f\u4f1a\uff08ACS\uff09\uff1a<\/strong>\u6307\u51faHER2\u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u5360\u5168\u90e8\u4e73\u817a\u764c\u7684 15%\u201320%\uff0c\u4fb5\u88ad\u6027\u5f3a\u3001\u590d\u53d1\u98ce\u9669\u9ad8\uff1bT- DXd\u7684\u83b7\u6279\u4e3a\u9ad8\u5371\u60a3\u8005\u63d0\u4f9b\u4e86\u7597\u6548\u66f4\u5f3a\u3001\u6bd2\u6027\u66f4\u4f4e\u7684\u65b0\u9009\u62e9\u3002 <\/p>\n\n\n\n

4. \u671f\u520a\u6742\u5fd7\uff1a<\/strong>\u300a\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\u300b\u300a\u67f3\u53f6\u5200\u30fb\u80bf\u7624\u5b66\u300b\u540c\u6b65\u53d1\u8868 DB11\/05\u7814\u7a76\u5168\u6587\uff0c\u8bc1\u5b9eT- DXd\u5728\u65b0\u8f85\u52a9\u964d\u671f\u4e0e\u8f85\u52a9\u9632\u590d\u53d1\u4e2d\u7684\u53cc\u91cd\u4ef7\u503c\u3002<\/p>\n\n\n\n

4. <\/strong>\u5b89\u5168\u6027\u63d0\u793a<\/strong><\/strong><\/p>\n\n\n\n

T- DXd\u5904\u65b9\u4fe1\u606f\u542b\u9ed1\u6846\u8b66\u544a\uff1a<\/strong><\/p>\n\n\n\n

\u25b6 \u95f4\u8d28\u6027\u80ba\u75c5\uff08ILD\uff09\/\u80ba\u708e\uff1a<\/strong>\u53ef\u80fd\u81f4\u547d\uff0c\u9700\u76d1\u6d4b\u54b3\u55fd\u3001\u6c14\u77ed\u7b49\u75c7\u72b6\uff0c\u53ca\u65f6\u505c\u836f\u5e76\u4e88\u6fc0\u7d20\u6cbb\u7597\u3002<\/p>\n\n\n\n

\u25b6 \u5176\u4ed6\u91cd\u8981\u4e0d\u826f\u53cd\u5e94\uff1a<\/strong>\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3001\u5de6\u5fc3\u5ba4\u529f\u80fd\u4e0d\u5168\uff0c\u9700\u5b9a\u671f\u76d1\u6d4b\u8840\u5e38\u89c4\u4e0e\u5fc3\u810f\u529f\u80fd\u3002<\/p>\n\n\n\n

5. <\/strong>\u4e34\u5e8a\u610f\u4e49<\/strong><\/strong><\/p>\n\n\n\n

1. \u6cbb\u7597\u683c\u5c40\u91cd\u6784\uff1a<\/strong>T- DXd\u4ece\u665a\u671f\u4e73\u817a\u764c\u540e\u7ebf\u6cbb\u7597\u524d\u79fb\u81f3\u65e9\u671f\u6cbb\u6108\u4e00\u7ebf\uff0c\u8986\u76d6\u65b0\u8f85\u52a9\u4e0e\u8f85\u52a9\u5168\u5468\u671f\uff0c\u6210\u4e3aHER2\u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u9ad8\u5371\u60a3\u8005\u7684\u6807\u51c6\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n

2. \u7cbe\u51c6\u5206\u5c42\u83b7\u76ca\uff1a<\/strong>\u65b0\u8f85\u52a9\u9636\u6bb5\u63d0\u5347 pCR \u7387\uff0c\u52a9\u529b\u964d\u671f\u4e0e\u4fdd\u4e73\uff1b\u8f85\u52a9\u9636\u6bb5\u663e\u8457\u964d\u4f4e\u6b8b\u7559\u75c5\u7076\u60a3\u8005\u7684\u590d\u53d1\u98ce\u9669\uff0c\u89e3\u51b3non- pCR\u9ad8\u5371\u4eba\u7fa4\u7684\u4e34\u5e8a\u75db\u70b9\u3002<\/p>\n\n\n\n

3. \u51cf\u6bd2\u589e\u6548\u4f18\u52bf\uff1a<\/strong>\u65b0\u8f85\u52a9\u65b9\u6848\u907f\u514d\u84bd\u73af\u7c7b\u836f\u7269\uff0c\u964d\u4f4e\u5fc3\u810f\u4e0e\u8840\u6db2\u5b66\u6bd2\u6027\uff0c\u6539\u5584\u60a3\u8005\u751f\u6d3b\u8d28\u91cf\u3002<\/p>\n\n\n\n

\u7ed3\u8bed<\/strong><\/strong><\/p>\n\n\n\n

T- DXd\u7684\u672c\u6b21\u83b7\u6279\uff0c\u662f\u57fa\u4e8e\u5168\u7403\u6570\u5341\u4e07\u60a3\u8005\u6570\u636e\u4e0e\u9876\u7ea7\u7814\u7a76\u8bc1\u636e\u7684\u4e25\u8c28\u51b3\u7b56\uff0c\u4e3aHER2\u9633\u6027\u65e9\u671f\u4e73\u817a\u764c\u60a3\u8005\u5e26\u6765\u4e86\u66f4\u9ad8\u6cbb\u6108\u6982\u7387<\/strong>\u4e0e\u66f4\u5b89\u5168\u6cbb\u7597\u9009\u62e9<\/strong>\u3002\u4e34\u5e8a\u5b9e\u8df5\u4e2d\u9700\u4e25\u683c\u9075\u5faa\u9002\u5e94\u75c7\uff0c\u89c4\u8303\u8fdb\u884cHER2\u68c0\u6d4b\u4e0e\u5b89\u5168\u6027\u76d1\u6d4b\uff0c\u786e\u4fdd\u836f\u7269\u5408\u7406\u5e94\u7528\u3002<\/p>\n\n\n\n

\u8f6c\u8f7d\u8bf7\u8054\u7cfb\u6388\u6743\uff0c\u6216\u6ce8\u660e\u6765\u6e90<\/p>\n","protected":false},"excerpt":{"rendered":"

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