{"id":34795,"date":"2024-05-25T04:01:03","date_gmt":"2024-05-25T04:01:03","guid":{"rendered":"https:\/\/zydq.1006ss.com\/?p=34795"},"modified":"2024-05-25T04:01:03","modified_gmt":"2024-05-25T04:01:03","slug":"%e5%88%98%e5%81%a5%e6%95%99%e6%8e%88%ef%bc%9a%e4%b8%80%e6%96%87%e9%80%9f%e6%8e%a22023-asco-her2%e9%98%b3%e6%80%a7%e6%99%9a%e6%9c%9f%e4%b9%b3%e8%85%ba%e7%99%8c%e6%b2%bb%e7%96%97%e6%9c%80%e6%96%b0","status":"publish","type":"post","link":"http:\/\/zydq.1006ss.com\/?p=34795","title":{"rendered":"\u5218\u5065\u6559\u6388\uff1a\u4e00\u6587\u901f\u63a22023 ASCO HER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u6cbb\u7597\u6700\u65b0\u8fdb\u5c55\u4e0e\u683c\u5c40\u53d8\u8fc1"},"content":{"rendered":"

\u5bfc\u8bed<\/p>\n

\u65b0\u836f\u53ca\u65b0\u7684\u6cbb\u7597\u6a21\u5f0f\u4e0d\u65ad\u4e3aHER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u7684\u5f81\u9014\u5f00\u521b\u65b0\u7684\u6cbb\u7597\u683c\u5c40\uff0c\u4e3a\u4e34\u5e8a\u7b56\u7565\u5e26\u6765\u65b0\u7684\u601d\u8003\u3002<\/p>\n

HER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u4fb5\u88ad\u6027\u5f3a\uff0c\u590d\u53d1\u98ce\u9669\u9ad8\uff0c\u9884\u540e\u5dee\uff0c\u7ea6\u5360\u6574\u4f53\u4e73\u817a\u764c15%-20%[1]<\/sup>\u3002\u7136\u800c\uff0c\u66f2\u59a5\u73e0\u5355\u6297\u7684\u95ee\u4e16\u53ca\u6297HER2\u836f\u7269\u7684\u4e0d\u65ad\u66f4\u8fed\uff0c\u6781\u5927\u7a0b\u5ea6\u5730\u6539\u5584\u4e86HER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u7684\u9884\u540e\u5e76\u63d0\u9ad8\u5176\u751f\u5b58\u8d28\u91cf\uff0c\u5176\u4e2d\u5305\u62ec\u5355\u514b\u9686\u6297\u4f53\u3001\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\uff08TKI\uff09\u4ee5\u53ca\u6297\u4f53\u836f\u7269\u5076\u8054\u7269\uff08ADC\uff09\u7b49\u3002\u968f\u7740HER2\u9633\u6027\u4e73\u817a\u764c\u9886\u57df\u63a2\u7d22\u7684\u4e0d\u65ad\u62d3\u5c55\uff0c\u6cbb\u7597\u9009\u62e9\u6301\u7eed\u589e\u52a0\uff0c\u6cbb\u7597\u683c\u5c40\u4e5f\u5728\u4e0d\u65ad\u6539\u53d8\u30022023\u5e74\u7f8e\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08ASCO\uff09\u521a\u521a\u843d\u4e0b\u5e37\u5e55\uff0c\u591a\u9879\u5173\u4e8eHER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u6cbb\u7597\u7684\u6700\u65b0\u8fdb\u5c55\u91cd\u78c5\u53d1\u5e03\u3002\u4e3a\u8fdb\u4e00\u6b65\u4e86\u89e3HER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u7684\u6700\u65b0\u5b66\u672f\u52a8\u6001\uff0c\u63a2\u7d22\u524d\u6cbf\u6cbb\u7597\u7b56\u7565\u5e26\u6765\u7684\u53ef\u80fd\u53d8\u5316\u53ca\u5bf9\u6cbb\u7597\u6392\u5175\u5e03\u9635\u7684\u5f71\u54cd\uff0c\u73b0\u7279\u9080\u798f\u5efa\u7701\u80bf\u7624\u533b\u9662\u5218\u5065\u6559\u6388\u5bf9\u6700\u65b0\u8fdb\u5c55\u5bf9\u6700\u65b0\u8fdb\u5c55\u8fdb\u884c\u68b3\u7406\u603b\u7ed3\uff0c\u4ee5\u98e8\u8bfb\u8005\u3002<\/p>\n

\u592f\u5b9e\u7ed3\u679c\uff0c\u5355\u514b\u9686\u6297\u4f53\u518d\u6cbb\u7597\u5e26\u6765\u751f\u5b58\u6539\u5584<\/p>\n

\u65e2\u5f80\u4e34\u5e8aIII\u671fPRECIOUS\u7814\u7a76\u8868\u660e[2]<\/sup>\uff0c\u5728\u5e15\u59a5\u73e0\u5355\u6297\uff08P\uff09\u7ecf\u6cbb\u7684HER2\u9633\u6027\u5c40\u90e8\u665a\u671f\/\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\uff0cP\u518d\u6cbb\u7597\u8054\u5408\u66f2\u59a5\u73e0\u5355\u6297\uff08T\uff09+\u57fa\u4e8e\u533b\u751f\u9009\u62e9\u7684\u5316\u7597\uff08C\uff09\uff08PTC\uff09\u76f8\u8f83\u4e8eT+C\uff08TC\uff09\uff0c\u663e\u8457\u6539\u5584\u4e86\u7814\u7a76\u8005\u8bc4\u4f30\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u3002<\/p>\n

2023\u5e74ASCO\u5927\u4f1a\u4e0a\uff0cJBCRG-M05: PRECIOUS\u7814\u7a76\u66f4\u65b0\u5176\u4e2d\u4f4d\u968f\u8bbf27.4\u4e2a\u6708\u7684\u603b\u751f\u5b58\u671f\uff08OS\uff09\u7ed3\u679c\u3002\u5728\u5165\u7ec4\u7684219\u4f8b\u60a3\u8005\u4e2d\uff0c217\u4f8b\uff08108\u4f8bPTC\uff0c109\u4f8bTC\uff09\u88ab\u7eb3\u5165\u610f\u5411\u6cbb\u7597\u5206\u6790\u3002\u7ed3\u679c\u663e\u793a[3]<\/sup>\uff0c\u81f3\u6570\u636e\u622a\u6b62\u65e5\u671f\uff082021\u5e7412\u670831\u65e5\uff09\uff0cOS\u548cPFS\u4e8b\u4ef6\u5206\u522b\u4e3a138\u4f8b\uff0863.6%\uff09\u548c190\u4f8b\uff0887.6%\uff09\u3002PTC\u7ec4\u66f4\u65b0\u540e\u7684\u4e2d\u4f4dOS\u663e\u8457\u5ef6\u957f\uff0c\u4e2d\u4f4dOS\u4e3a36.2 vs. 26.5\u4e2a\u6708\uff08HR=0.73 [\u5355\u4fa795%CI\u4e0a\u9650\uff0c0.97]\uff1bp=0.0323\uff09\u3002<\/p>\n

\u56fe1\uff1aJBCRG-M05: PRECIOUS\u7814\u7a76\u7684OS\u7ed3\u679c<\/p>\n

\u76f8\u8f83\u4e8eTC\u7ec4\uff0cPTC\u5728\u5927\u591a\u6570\u4e9a\u7ec4\u4e2d\u7684OS\u66f4\u4f18\u3002<\/p>\n

\u56fe2.\uff1aJBCRG-M05: PRECIOUS\u7814\u7a76\u7684\u4e9a\u7ec4\u6570\u636e<\/p>\n

\u6b64\u5916\uff0c\u66f4\u65b0\u540e\u7684\u7814\u7a76\u8005\u8bc4\u4f30\u7684\u4e2d\u4f4dPFS\u4e3a5.5 vs. 4.2\u4e2a\u6708\uff08HR=0.81\uff09\u3002\u72ec\u7acb\u5ba1\u67e5\u59d4\u5458\u4f1a\u8bc4\u4f30\u7684\u4e2d\u4f4dPFS\u672a\u663e\u793a\u4e24\u7ec4\u4e4b\u95f4\u7684\u5dee\u5f02\uff084.4 vs. 4.4\u4e2a\u6708\uff09\u3002\u7ec4\u95f4\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u65e0\u5dee\u5f02\uff0819.0% vs. 23.1%\uff09\u3002\u4e24\u7ec4\u5747\u672a\u51fa\u73b0\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u53f7\u3002<\/p>\n

\u56fe3.\uff1aJBCRG-M05: PRECIOUS\u7814\u7a76\u7684\u5176\u4ed6\u5173\u952e\u7ed3\u679c<\/p>\n

\u8be5\u7814\u7a76\u63d0\u793a\uff0c\u4e0eTC\u65b9\u6848\u76f8\u6bd4\uff0cP\u8054\u5408TC\u518d\u6cbb\u7597\u663e\u793a\u51faOS\u7684\u663e\u8457\u6539\u5584\u3002PT\u7684HER2\u53cc\u91cd\u963b\u65ad\u6709\u52a9\u4e8e\u6539\u5584\u65e2\u5f80HER2\u9633\u6027\u5c40\u90e8\u665a\u671f\/\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u4e00\u7ebf\/\u4e8c\u7ebf\u542bP\u7ecf\u6cbb\u60a3\u8005\u7684\u751f\u5b58\u3002\u672a\u6765\uff0cP\u518d\u6cbb\u7597\u7684\u4f18\u52bf\u4eba\u7fa4\u8fd8\u6709\u5f85\u7b5b\u9009\uff0cHER2\u53cc\u9776\u963b\u65ad\u8f83HER2\u5355\u9776\u963b\u65ad\u6539\u5584OS\u7684\u673a\u5236\u4e5f\u9700\u8fdb\u4e00\u6b65\u63a2\u7d22\u4e0e\u9610\u660e\u3002<\/p>\n

\u4e0d\u65ad\u63a2\u7d22\uff0cTKI\u5728HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u6cbb\u7597\u4e2d\u7684\u6700\u65b0\u8fdb\u5c55<\/p>\n

\u56fe\u5361\u66ff\u5c3c\u8054\u5408\u65b9\u6848\u5bf9T-DXd\u7ecf\u6cbb\u7684\u4e73\u817a\u764c\u4eba\u7fa4\u6709\u6548<\/p>\n

\u8fd1\u5e74\u6765\uff0c\u5c0f\u5206\u5b50TKI\u4e3aHER2\u9633\u6027\u4e73\u817a\u764c\u7684\u6cbb\u7597\u5e26\u6765\u66f4\u591a\u9009\u62e9\u3002\u5176\u4e2d\uff0c\u4ee5\u5421\u54af\u66ff\u5c3c\u3001\u56fe\u5361\u66ff\u5c3c\u4e3a\u4ee3\u8868\u7684\u591a\u79cdTKI\u836f\u7269\u5728\u591a\u4e2a\u4e34\u5e8a\u7814\u7a76\u4e2d\u5c55\u73b0\u51fa\u826f\u597d\u7597\u6548\u3002\u6700\u8fd1\uff0c\u591a\u9879\u6307\u5357\u5c06T-DXd\u4f5c\u4e3aHER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u4e8c\u7ebf\u6cbb\u7597\u7684\u9996\u9009\u63a8\u8350\uff08\u6d3b\u52a8\u6027\u8111\u8f6c\u79fb\u8005\u9664\u5916\uff09\uff0c\u800c\u5bf9\u4e8eT-DXd\u7ecf\u6cbb\u540e\u7684\u6cbb\u7597\u9009\u62e9\u4e5f\u5f15\u8d77\u4eba\u4eec\u66f4\u591a\u7684\u5173\u6ce8\u30022023\u5e74ASCO\u4f1a\u8bae\u4e0a\u516c\u5e03\u7684\u4e00\u9879\u6cd5\u56fd\u591a\u4e2d\u5fc3\u56de\u987e\u6027\u7814\u7a76\uff0c\u63a2\u7d22\u4e86\u56fe\u5361\u66ff\u5c3c+\u66f2\u59a5\u73e0\u5355\u6297+\u5361\u57f9\u4ed6\u6ee8\uff08TTC\uff09\u5728T-DXd\u7ecf\u6cbb\u540e\u7684HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u7597\u6548\u3002<\/p>\n

\u8be5\u7814\u7a76\u5171\u7eb3\u5165101\u4f8bT-DXd\u7ecf\u6cbb\u7684HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\uff0c\u5176\u4e2d39\u4f8b\uff0838.9%\uff09\u5b58\u5728\u8111\u8f6c\u79fb\u3002<\/p>\n

\u56fe4.\uff1a\u60a3\u8005\u7684\u57fa\u7ebf\u7279\u5f81<\/p>\n

\u968f\u8bbf11.6\u4e2a\u6708\u663e\u793a[4]<\/sup>\uff0cTTC\u65b9\u6848mPFS\u4e3a4.7\u4e2a\u6708\uff0cmOS\u4e3a13.4\u4e2a\u6708\uff1bT-DXd\u540e\u76f4\u63a5\u884cTTC\u6cbb\u7597\u7684\u60a3\u8005\uff0cmPFS\u4e3a5.0\u4e2a\u6708\uff0cmOS\u4e3a13.4\u4e2a\u6708\u3002\u975e\u8111\u8f6c\u79fb\u60a3\u8005mPFS\u4e3a4.4\u4e2a\u6708\uff0c\u8111\u8f6c\u79fb\u60a3\u8005\uff08BM\uff09mPFS\u4e3a5.0\u4e2a\u6708\u3002<\/p>\n

\u56fe5.\uff1a\u5168\u4eba\u7fa4\u7684\u751f\u5b58\u7ed3\u679c<\/p>\n

\u56fe6\uff1aT-DXd\u5e8f\u8d2fTTC\u6cbb\u7597\u7684\u60a3\u8005\u751f\u5b58\u7ed3\u679c<\/p>\n

\u56fe7\uff1a\u8111\u8f6c\u79fb\u60a3\u8005\u7684PFS\u7ed3\u679c<\/p>\n

\u8be5\u7814\u7a76\u663e\u793a\u4e86TTC\u5bf9T-DXd\u7ecf\u6cbbHER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u6709\u6548\uff0c\u5e76\u4e14\u65e0\u8bba\u60a3\u8005\u662f\u5426\u5b58\u5728\u8111\u8f6c\u79fb\u3002\u671f\u5f85\u8fdb\u4e00\u6b65\u6570\u636e\u7684\u516c\u5e03\uff0c\u4e3aT-DXd\u7ecf\u6cbb\u4eba\u7fa4\u63d0\u4f9b\u66f4\u591a\u5faa\u8bc1\u533b\u5b66\u8bc1\u636e\uff0c\u6307\u5bfc\u4e34\u5e8a\u5b9e\u8df5\u3002<\/p>\n

\u5421\u54af\u66ff\u5c3c\u8054\u5408\u5316\u7597\u5bf9\u4e73\u817a\u764c\u4f34\u8111\u8f6c\u79fb\u60a3\u8005\u7597\u6548\u53ef\u89c2<\/p>\n

HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u8111\u8f6c\u79fb\u98ce\u9669\u9ad8\u8fbe30%\u4ee5\u4e0a\uff0c\u8fd9\u5bfc\u81f4\u6b64\u7c7b\u60a3\u8005\u7684\u751f\u5b58\u7387\u8f83\u4f4e\u3002II\u671fPERMEATE\u7814\u7a76\u663e\u793a[5]<\/sup>\uff0c\u5421\u54af\u66ff\u5c3c+\u5361\u57f9\u4ed6\u6ee8\u5728HER2\u9633\u6027\u8111\u8f6c\u79fb\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u7684\u6cbb\u7597\u524d\u666f\u53ef\u89c2\uff0c\u5728\u672a\u7ecf\u653e\u7597\uff08\u961f\u5217A\uff09\u548c\u653e\u7597\u540e\u8fdb\u5c55\uff08\u961f\u5217B\uff09\u7684\u8111\u8f6c\u79fb\u60a3\u8005\u4e2d\uff0c\u9885\u5185ORR\u5206\u522b\u4e3a74.6%\uff0844\/59\uff09\u548c42.1%\uff088\/19\uff09\u30022023\u5e74ASCO\u5927\u4f1a\u4e0a\uff0c\u8be5\u9879\u7814\u7a76\u66f4\u65b0\u4e86\u51763\u5e74\u968f\u8bbf\u7ed3\u679c\u3002<\/p>\n

\u56fe8\uff1aPERMEATE\u7814\u7a76\u8bbe\u8ba1<\/p>\n

\u4e2d\u4f4d\u968f\u8bbf42.8\u4e2a\u6708\uff0c\u961f\u5217A\u7684\u4e2d\u4f4dPFS\u4e3a10.8\u4e2a\u6708\uff0895%CI\uff1a7.6-13.9\uff09\uff0c\u4e2d\u4f4dOS\u4e3a36.0\u4e2a\u6708\uff0895%CI\uff1a24.5-\u672a\u8fbe\u5230\uff09\uff1b\u961f\u5217B\u7684\u4e2d\u4f4dPFS\u4e3a5.6\u4e2a\u6708\uff0895%CI\uff1a3.5-10.7\uff09\uff0c\u4e2d\u4f4dOS\u4e3a31.5\u4e2a\u6708\uff0895%CI\uff1a12.6-\u672a\u8fbe\u5230\uff09\u3002\u961f\u5217A\u4e2d14\u4f8b\u8111\u8f6c\u79fb\u5b64\u7acb\u6027\u8fdb\u5c55\u7684\u60a3\u8005\u5728\u5c40\u90e8\u6cbb\u7597\u540e\u91cd\u65b0\u5f00\u59cb\u7814\u7a76\u6cbb\u7597\uff0c\u4e2d\u4f4dPFS2\u4e3a11.0\u4e2a\u6708\uff0895% CI\uff1a6.1-18.8\uff09[6]<\/sup>\u3002<\/p>\n

\u56fe9\uff1aPERMEATE\u7814\u7a76\u4e24\u961f\u5217\u7684PFS\u7ed3\u679c<\/p>\n

\u56fe10\uff1aPERMEATE\u7814\u7a76\u4e24\u961f\u5217\u7684OS\u7ed3\u679c<\/p>\n

\u8fd9\u4e9b\u7ed3\u679c\u8868\u660e\uff0c\u5728HER2\u9633\u6027\u8111\u8f6c\u79fb\u4e73\u817a\u764c\u60a3\u8005\uff0c\u5c24\u5176\u662f\u672a\u7ecf\u8111\u653e\u7597\u7684\u60a3\u8005\u4e2d\uff0c\u5421\u54af\u66ff\u5c3c+\u5361\u57f9\u4ed6\u6ee8\u53ef\u5e26\u6765\u957f\u671f\u751f\u5b58\u83b7\u76ca\u3002<\/p>\n

\u65b0\u578b\u53cc\u53e3\u670d\u65e0\u5316\u7597\u65b9\u6848\u8fbe\u5c14\u897f\u5229+\u5421\u54af\u66ff\u5c3c\u4e3aHER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u6cbb\u7597\u63d0\u4f9b\u65b0\u601d\u8def<\/p>\n

DAP-HER-01\u7814\u7a76\u65e8\u5728\u8bc4\u4f30CDK4\/6\u6291\u5236\u5242\u8fbe\u5c14\u897f\u5229+\u5421\u54af\u66ff\u5c3c\u7684\u65b0\u578b\u53cc\u53e3\u670d\u65e0\u5316\u7597\u65b9\u6848\u5728HER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u4e2d\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u30022020\u5e744\u6708\u81f32021\u5e745\u6708\uff0c\u7814\u7a76\u5171\u5165\u7ec441\u4f8b\u65e2\u5f80\u63a5\u53d7\u22641\u7ebf\u7cfb\u7edf\u6cbb\u7597\u7684\u60a3\u8005\uff0c\u5176\u4e2d40\u4f8b\u53ef\u8bc4\u4ef7\u7597\u6548\u3002\u65e2\u5f80\u5df2\u62a5\u9053\u7684\u4e3b\u8981\u7ec8\u70b9[7]<\/sup>\uff0c\u5373\u603b\u4f53ORR\u4e3a70%\uff0cHR\u9634\u6027\u548cHR\u9633\u6027\u60a3\u8005\u7684ORR\u5206\u522b\u4e3a81.8%\u548c55.6%\u3002\u672c\u6b21ASCO\u5927\u4f1a\u62a5\u544a\u4e86DAP-HER-01\u7814\u7a76\u7684\u6700\u65b0\u6570\u636e\u3002<\/p>\n

\u66f4\u65b0\u7684\u7ed3\u679c\u663e\u793a[8]<\/sup>\uff0c\u4e2d\u4f4d\u968f\u8bbf19.2\u4e2a\u6708\uff0c\u4e2d\u4f4dPFS\u4e3a11.0\u4e2a\u6708\uff0895%CI 7.3-19.3\uff09\u3002HR-\u60a3\u8005\u7684 PFS \u6570\u636e\u5c1a\u672a\u6210\u719f\uff0c\u4f46\u4ecd\u663e\u793a\u51fa\u4f18\u4e8eHR+ \u60a3\u8005\u7684\u8d8b\u52bf\u3002\u57fa\u7ebf\u65f6\u6709\u8111\u8f6c\u79fb\u7684\u60a3\u8005\u4e5f\u53ef\u4ece\u8be5\u6cbb\u7597\u4e2d\u83b7\u76ca\uff0c\u4e2d\u4f4dPFS\u4e3a11.0\u4e2a\u6708\uff0895%CI\uff1a5.4-NA\uff09\u3002<\/p>\n

\u56fe11\uff1aDAP-HER-01\u7814\u7a76\u66f4\u65b0\u7684PFS\u7ed3\u679c<\/p>\n

\u5728\u5b89\u5168\u6027\u65b9\u9762\uff0cDAP-HER-01\u7814\u7a76\u4e0e\u65e2\u5f80\u62a5\u544a\u7684\u6570\u636e\u4e00\u81f4\uff0c\u6700\u5e38\u89c1\u76843\u7ea7\u62164\u7ea7\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u4e3a\u767d\u7ec6\u80de\u51cf\u5c11\uff0868.3%\uff09\u3001\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\uff0865.9%\uff09\u3001\u8d2b\u8840\u548c\u8179\u6cfb\uff08\u5747\u4e3a19.5%\uff09\u3002\u5927\u591a\u6570\u4e0d\u826f\u4e8b\u4ef6\u53ef\u63a7\uff0c\u672a\u62a5\u544a\u7814\u7a76\u76f8\u5173\u6b7b\u4ea1\u3002<\/p>\n

\u56fe12\uff1aDAP-HER-01\u7814\u7a76\u5b89\u5168\u6027\u7ed3\u679c<\/p>\n

DAP-HER-01\u7814\u7a76\u8868\u660e\uff0c\u8fbe\u5c14\u897f\u5229+\u5421\u54af\u66ff\u5c3c\u5728HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\uff08\u5305\u62ec\u8111\u8f6c\u79fb\uff09\u60a3\u8005\u4e2d\u8fbe\u5230\u4e86\u9884\u671f\u7597\u6548\uff0c\u5e76\u5177\u6709\u53ef\u63a7\u7684\u6bd2\u6027\uff0c\u8fd9\u79cd\u65e0\u5316\u7597\u7684\u53e3\u670d\u8054\u5408\u7b56\u7565\u53ef\u4f5c\u4e3aHER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u6cbb\u7597\u66ff\u4ee3\u65b9\u6848\u4e4b\u4e00\uff0c\u540e\u7eed\u6709\u5f85\u6df1\u5165\u7814\u7a76\uff0c\u671f\u5f85\u65b0\u7684\u7ed3\u679c\u4e3a\u60a3\u8005\u5e26\u6765\u66f4\u591a\u559c\u8baf\uff0c\u4e3a\u4e34\u5e8a\u63d0\u4f9b\u66f4\u591a\u6cbb\u7597\u6b66\u5668\u3002<\/p>\n

\u7efc\u4e0a\u6240\u8ff0\uff0c2023ASCO\u5927\u4f1a\u516c\u5e03\u7684TKI\u8054\u5408\u6cbb\u7597\u65b9\u6848\u6216\u53ef\u4e3aHER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u7684\u6cbb\u7597\u63d0\u4f9b\u65b0\u7684\u6cbb\u7597\u7b56\u7565\u548c\u7814\u7a76\u65b9\u5411\uff0c\u4ee5\u671f\u4e3a\u665a\u671f\u4e73\u817a\u764c\u60a3\u8005\u63d0\u4f9b\u66f4\u591a\u89e3\u6551\u6cbb\u7597\u673a\u4f1a\u3002<\/p>\n

\u524d\u666f\u65e0\u9650\uff0cADC\u5728HER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u6cbb\u7597\u4e2d\u7684\u6700\u65b0\u8fdb\u5c55<\/p>\n

T-DXd\u53ef\u4f5c\u4e3a\u6240\u6709\u5e74\u9f84\u4e9a\u7ec4\u60a3\u8005\u7684\u6709\u6548\u9009\u62e9<\/p>\n

\u4f17\u6240\u5468\u77e5\uff0cADC\u836f\u7269\u5728HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u9886\u57df\u7684\u6cbb\u7597\u8868\u73b0\u6781\u4e3a\u4eae\u773c\uff0c\u5c24\u5176\u662fDESTINY-Breast\uff08\u7b80\u79f0\u201cDB\u201c\uff0903\u7814\u7a76\u7ed3\u679c\u7684\u516c\u5e03[9]<\/sup>\uff0c\u65b0\u578bADC\u836f\u7269T-DXd\u7a81\u7834\u65e2\u5f80\u6297HER2\u4e8c\u7ebf\u6cbb\u7597PFS\u83b7\u76ca\u4ec5\u7ea61\u5e74\u7684\u751f\u5b58\u56f0\u5883\uff0c\u83b7\u6279\u7528\u4e8e\u65e2\u5f80\u63a5\u53d7\u8fc7\u6297HER2\u6cbb\u7597\u7684HER2\u9633\u6027\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\uff0c\u81ea\u6b64\u5960\u5b9aT-DXd\u4f5c\u4e3aHER2\u9633\u6027\u665a\u671f\u4e73\u817a\u764c\u4e8c\u7ebf\u6807\u51c6\u6cbb\u7597\u7684\u5730\u4f4d\uff0c\u91cd\u5851\u4e73\u817a\u764c\u6cbb\u7597\u683c\u5c40\u30022023\u5e74ASCO\u5927\u4f1a\u7684\u53e3\u5934\u6458\u8981\uff0c\u5206\u6790\u4e86DB\u7cfb\u5217\uff08DB01\u3001DB02\u548cDB03\uff09\u7814\u7a76\u4e2d\u63a5\u53d7T-DXd\u6cbb\u7597HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u5e74\u9f84\uff0c\u5e76\u6c47\u62a5\u4e86<65\u5c81\u548c\u226565\u5c81\u60a3\u8005\u7684\u5e74\u9f84\u7279\u5f02\u6027\u7597\u6548\u548c\u5b89\u5168\u6027\u6c47\u603b\u5206\u6790\u7ed3\u679c\uff0c\u4ee5\u53ca\u226575\u5c81\u60a3\u8005\u7684\u63a2\u7d22\u6027\u6570\u636e\u3002<\/p>\n

\u56fe13\uff1a\u8be5\u9879\u6c47\u603b\u5206\u6790\u8bbe\u8ba1\u65b9\u6848<\/p>\n

\u7ed3\u679c\u663e\u793a[10]<\/sup>\uff0c\u5728\u6570\u636e\u622a\u6b62\u65e5\u671f\u65f6\uff0c\uff1c65\u5c81\u7684\u60a3\u8005\u63a5\u53d7T-DXd\u7684\u4e2d\u4f4d\u6cbb\u7597\u6301\u7eed\u65f6\u95f4\u4e3a13.1\u4e2a\u6708\uff08\u8303\u56f40.7-44.0\uff09\uff0c\u226565\u5c81\u7684\u60a3\u8005\u4e3a12.4\u4e2a\u6708\uff08\u8303\u56f40.7-45.1\uff09\u3002\u5bf9\u4e8e\u5e74\u9f84<65\u5c81\u548c\u226565\u5c81\u60a3\u8005\u63a5\u53d7T-DXd\u6cbb\u7597\u7684\u7597\u6548\uff0c\u867d\u7136\u6ca1\u6709\u8fdb\u884c\u6b63\u5f0f\u6bd4\u8f83\uff0c\u4f46\u4ece\u6570\u636e\u53ef\u89c1T-DXd \u5728\u5e74\u9f84 <65 \u5c81\u548c\u226565 \u5c81\u60a3\u8005\u4e2d\u7684\u7597\u6548\uff08PFS\u3001OS\u3001ORR\uff09\u76f8\u4f3c\u3002<\/p>\n

\u56fe14\uff1a<65\u5c81\u548c\u226565\u5c81\u60a3\u8005\u63a5\u53d7T-DXd\u7684\u751f\u5b58\u6570\u636e\u5bf9\u6bd4<\/p>\n

\u56fe15\uff1a<65\u5c81\u548c\u226565\u5c81\u60a3\u8005\u63a5\u53d7T-DXd\u7684\u786e\u8ba4\u7684ORR\u6570\u636e\u5bf9\u6bd4<\/p>\n

\u6b64\u5916\uff0c\u65e0\u8bba\u63a5\u53d7\u4f55\u79cd\u6cbb\u7597\uff0c<65\u5c81\u548c\u226565\u5c81\u5e74\u9f84\u7ec4\u4e4b\u95f4\u7684\u76f8\u5bf9\u5242\u91cf\u5f3a\u5ea6\u76f8\u5f53\u3002<\/p>\n

\u56fe16\uff1a<65\u5c81\u548c\u226565\u5c81\u5e74\u9f84\u7ec4\u4e4b\u95f4\u7684\u76f8\u5bf9\u5242\u91cf\u5f3a\u5ea6<\/p>\n

\u5728\u5b89\u5168\u6027\u65b9\u9762\uff0c\u4efb\u4f55\u7ea7\u522b\u6cbb\u7597\u671f\u95f4\u51fa\u73b0\u7684\u4e0d\u826f\u4e8b\u4ef6\uff08TEAE\uff09\u3001\u22653\u7ea7TEAE\u3001\u4e25\u91cdAE\uff0c\u5728\uff1c65\u5c81\u60a3\u8005\u4e2d\u5206\u522b\u4e3a99.6%\u300153.6%\u300124.3%\uff0c\u5728\u226565\u5c81\u60a3\u8005\u4e2d\u5206\u522b\u4e3a100%\u300165.5%\u300132.2%\u3002\u4e0e\u505c\u836f\u76f8\u5173\u7684TEAE\uff0c\u5728<65\u5c81\u548c\u226565\u5c81\u60a3\u8005\u4e2d\u5206\u522b\u6709125\u4f8b\uff0818.7%\uff09\u548c45\u4f8b\uff0825.4%\uff09\u3002\u226565 \u5c81\u7684\u60a3\u8005ILD\/\u80ba\u708e\u7684\u53d1\u751f\u7387\u8f83<65 \u5c81\u7684\u60a3\u8005\u9ad8\uff0817.5% vs. 11.8%\uff09\uff0c \u5927\u591a\u6570\u4e0e\u836f\u7269\u76f8\u5173\u7684ILD\/\u80ba\u708e\u75c5\u4f8b\u5747\u4e3a\u4f4e\u7ea7\u522b\u3002<\/p>\n

\u56fe17\uff1a\u4e0d\u540c\u5e74\u9f84\u7ec4\u4e4b\u95f4\u7684TEAE<\/p>\n

\u56fe18\uff1a\u4e0d\u540c\u5e74\u9f84\u7ec4\u4e4b\u95f4\u7684ILD\/\u80ba\u708e\u53d1\u751f\u7387<\/p>\n

\u8be5\u6c47\u603b\u5206\u6790\u7684\u7ed3\u679c\u8868\u660e\uff0cT-DXd\u4ecd\u7136\u662f\u226565\u5c81\u60a3\u8005\u7684\u6709\u6548\u6cbb\u7597\u9009\u62e9\u3002\u5728\u6bcf\u4e2a\u8bd5\u9a8c\u7684\u5e74\u9f84<65\u5c81\u548c\u226565\u5c81\u60a3\u8005\u4e2d\uff0c\u4e2d\u4f4dPFS\u548c\u7ecf\u76f2\u6001\u72ec\u7acb\u4e2d\u5fc3\u8bc4\u4f30\u786e\u8ba4\u7684ORR\u76f8\u4f3c\u3002\u5176\u6b21\uff0cT-DXd\u5728\u6240\u6709\u5e74\u9f84\u4e9a\u7ec4\u4e2d\u7684\u5b89\u5168\u6027\u53ef\u63a5\u53d7\u3002\u5728\u6240\u6709\u8bd5\u9a8c\u4e2d\uff0c\u226565\u5c81\u7684\u60a3\u8005\u53d1\u751f\u22653\u7ea7TEAE\u66f4\u5e38\u89c1\u3002\u7531\u6b64\u53ef\u89c1\uff0cT-DXd\u53ef\u4f5c\u4e3a\u6240\u6709\u5e74\u9f84\u4e9a\u7ec4\u60a3\u8005\u7684\u6709\u6548\u9009\u62e9\u3002<\/p>\n

\u4e0a\u4e0b\u6c42\u7d22\uff0c\u514d\u75ab\u8054\u5408\u6cbb\u7597\u5728HER2\u9633\u6027\u4e73\u817a\u764c\u540e\u7ebf\u6cbb\u7597\u4e2d\u7684\u65b0\u63a2\u7d22<\/p>\n

\u672c\u6b21ASCO\u5927\u4f1a\u4e0a\uff0cICU\u7814\u7a76\u516c\u5e03\u4e86\u4f0a\u5c3c\u59a5\u5355\u6297+\u5361\u745e\u5229\u73e0\u5355\u6297+\u4f18\u66ff\u5fb7\u9686\u5728HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u4e2d\u7684\u6cbb\u7597\u7ed3\u679c\u3002\u8fd9\u662f\u4e00\u9879\u63a2\u7d22PD-1\u6291\u5236\u5242\u8054\u5408HER2\u9776\u5411\u6cbb\u7597\u5728HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u540e\u7ebf\u6cbb\u7597\u4e2d\u7684\u7597\u6548\u4e0e\u5b89\u5168\u7684\u2161\u671f\u7814\u7a76\u3002<\/p>\n

\u56fe19\uff1aICU\u7814\u7a76\u7684\u8bbe\u8ba1\u548c\u57fa\u7ebf\u7279\u5f81<\/p>\n

ICU\u7814\u7a76\u7ed3\u679c\u663e\u793a[11]<\/sup>\uff0c\u5165\u7ec4\u768446\u4f8bHER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u80053\u4e2a\u6708PFS\u53d1\u751f\u7387\u4e3a71.84%\uff0c\u4e2d\u4f4dPFS\u4e3a5.59\u4e2a\u6708\uff0895%CI\uff0c4.04-8.25\uff09\u3002\u786e\u8ba4\u7684ORR\u4e3a28%\uff0813\/46\uff09\uff0c\u5176\u4e2d1\u4f8b\uff082.17%\uff09\u8fbe\u5230CR\u3002<\/p>\n

\u5728\u5b89\u5168\u6027\u65b9\u9762\uff0c\u22653\u7ea7TRAE\u5305\u62ec\u76ae\u75b9\uff083[6.52% ]\uff09\uff0c\u5468\u56f4\u795e\u7ecf\u75c5\u53d8\uff081[2.17% ]\uff09\u548c\u8c37\u8349\u8f6c\u6c28\u9176\u5347\u9ad8\uff081[2.17% ]\uff09\u3002\u6b64\u5916\uff0c\u6ca1\u6709\u22654\u7ea7\u7684TRAE\u53d1\u751f\u3002\u6ca1\u6709\u53d1\u751f\u76f8\u5173\u7684\u6cbb\u7597\u4e2d\u65ad\u6216\u6b7b\u4ea1\u3002<\/p>\n

\u56fe20\uff1aICU\u7814\u7a76\u7684PFS\u3001ORR\u548cTRAE\u7ed3\u679c<\/p>\n

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\u603b\u7ed3<\/p>\n

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[1] Kreutzfeldt J,et al.The trastuzumab era:current and upcoming targeted HER2+breast cancer therapies.Am J Cancer Res.2020.10(4):1045-1067.<\/p>\n

[2] Yamamoto Y, Iwata H, Taira N, et al. Pertuzumab retreatment for HER2-positive advanced breast cancer: A randomized, open-label phase III study (PRECIOUS). Cancer Sci. 2022 Sep;113(9):3169-3179.<\/p>\n

[3] Yamamoto Y, Iwata H, Takahashi M, et al. Pertuzumab retreatment in patients with HER2-positive locally advanced\/metastatic breast cancer: Overall survival results of a phase III randomized trial (JBCRG-M05:PRECIOUS). 2023ASCO, abs 1015.<\/p>\n

[4] Frenel JS, Zeghondy J, Guerin C, et al. Efficacy of tucatinib+trastuzumab+capecitabine (TTC) after trastuzumab-deruxtecan (T-DXd) exposure in Her2-positive metastatic breast cancer: A French multicentre retrospective study. 2023ASCO, abs 1014.<\/p>\n

 [5] Yan M, Ouyang Q, Sun T, et al. Pyrotinib plus capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases (PERMEATE): a multicentre, single-arm, two-cohort, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):353-361.<\/p>\n

[6] Yan M, Ouyang Q, Sun T, et al. Pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer and brain metastases: 3-year follow-up results from the phase 2 PERMEATE trial. 2023ASCO, abs 1048.<\/p>\n

[7] Yan M, et al. Dalpiciclib, a novel CDK4\/6 inhibitor, combined with pyrotinib for HER2+ advanced breast cancer: Interim results of a phase II trial. ESMO 2021, Poster 276P.<\/p>\n

[8] Yan M, Niu LM, Lv HM, et al. Updated results from a phase 2 study on dalpiciclib and pyrotinib, a dual-oral chemotherapy-free regimen in HER2-positive advanced breast cancer (DAP-HER-01). 2023ASCO, abs 1045.<\/p>\n

 [9] Hurvitz SA, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated results of the randomized, phase 3 study DESTINY-Breast03. 2022 SABCS. GS2-02.<\/p>\n

[10] Krop IE, Wildiers H, Hurvitz SA, et al. An age-specific pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) from DESTINY-Breast01, -02, and-03. 2023ASCO, abs 1006.<\/p>\n

 [11] Lv HM, Yan M, Sun T, et al. Anti-HER2 antibody inetetamab plus camrelizumab and utidelone for pretreated HER2-positive metastatic breast cancer: Final results from the phase 2 ICU trial. 2023ASCO, abs 1042.<\/p>\n

ADC Academy Online<\/p>\n

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