{"id":87678,"date":"2022-12-12T11:58:00","date_gmt":"2022-12-12T04:58:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2022121211580087678"},"modified":"2022-12-12T22:46:09","modified_gmt":"2022-12-12T14:46:09","slug":"enhertu%e5%9c%a8destiny-breast03%e4%b8%ad%e5%bb%b6%e9%95%bfher2%e9%98%b3%e6%80%a7%e8%bd%ac%e7%a7%bb%e6%80%a7%e4%b9%b3%e8%85%ba%e7%99%8c%e7%bb%9f%e8%ae%a1%e5%ad%a6%e6%84%8f%e4%b9%89%e4%b8%8a%e6%80%bb","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2022121211580087678","title":{"rendered":"Enhertu\u5728DESTINY-Breast03\u4e2d\u5ef6\u957fHER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u7edf\u8ba1\u5b66\u610f\u4e49\u4e0a\u603b\u751f\u5b58\uff0c\u6bd4T-DM1\u964d\u4f4e\u6b7b\u4ea1\u98ce\u966936%"},"content":{"rendered":"

\u963f\u65af\u5229\u5eb7\u548c\u7b2c\u4e00\u4e09\u5171\u7684<\/i>Enhertu<\/i>\u5728<\/i>DESTINY-Breast03 <\/i>III\u671f\u4e34\u5e8a\u7814\u7a76\u4e2d\uff0c\u4e0e<\/i>T-DM1<\/i>\u76f8\u6bd4\u5c06\u65e2\u5f80\u63a5\u53d7\u8fc7<\/i>HER2<\/i>\u9776\u5411\u7597\u6cd5\u60a3\u8005\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u5ef6\u957f\u4e86<\/i>22<\/i>\u4e2a\u6708<\/i><\/p>\n

Enhertu<\/i>\u5728<\/i>DESTINY-Breast02 <\/i>III\u671f\u7814\u7a76\u4e2d\uff0c\u4e0e\u5316\u7597\u76f8\u6bd4\u5728<\/i>HER2<\/i>\u9633\u6027\u60a3\u8005\u7684\u540e\u7ebf\u6cbb\u7597\u4e2d\u663e\u793a\u51fa\u663e\u8457\u7684\u65e0\u8fdb\u5c55\u548c\u603b\u751f\u5b58\u671f\u6539\u5584<\/i><\/p>\n

\u4e0a\u6d77<\/span>2022\u5e7412\u670812\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — DESTINY-Breast03 III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6700\u65b0\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u6069\u7f8e\u66f2\u59a5\u73e0\u5355\u6297\uff08T-DM1\uff09\u76f8\u6bd4\uff0cEnhertu\uff08\u901a\u7528\u540d\uff1a\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\uff09\u5728\u65e2\u5f80\u63a5\u53d7\u8fc7\u66f2\u59a5\u73e0\u5355\u6297\u548c\u7d2b\u6749\u70f7\u6cbb\u7597\u7684\u4e0d\u53ef\u5207\u9664\u548c\/\u6216\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u603b\u751f\u5b58\u671f\uff08OS\uff09\u65b9\u9762\u8868\u73b0\u51fa\u7edf\u8ba1\u5b66\u610f\u4e49\u4e0a\u663e\u8457\u4e14\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u6539\u5584\u3002\u8fd9\u4e9b\u7ed3\u679c\u548cDESTINY-Breast02 III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4e3b\u8981\u7ed3\u679c\u57282022\u5e74\u5723\u5b89\u4e1c\u5c3c\u5965\u4e73\u817a\u764c\u5927\u4f1a\uff08SABCS\uff09\u4e0a\u516c\u5e03\uff0cDESTINY-Breast03\u8bd5\u9a8c\u7684\u6700\u65b0\u7ed3\u679c\u540c\u671f\u53d1\u8868\u5728\u300a\u67f3\u53f6\u5200\u300b\u6742\u5fd7\u4e0a\u3002<\/p>\n

\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u662f\u7531\u963f\u65af\u5229\u5eb7\u548c\u65e5\u672c\u7b2c\u4e00\u4e09\u5171\u8054\u5408\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u7684\u4e00\u6b3e\u72ec\u7279\u8bbe\u8ba1\u9776\u5411HER2\u7684\u6297\u4f53\u5076\u8054\u836f\u7269\uff08ADC\uff09\u3002<\/p>\n

\u5728DESTINY-Breast03\u8bd5\u9a8c\u7684\u5173\u952e\u6b21\u8981\u7ec8\u70b9OS\u5206\u6790\u4e2d\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u4e0eT-DM1\u76f8\u6bd4\uff0c\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e\u4e8636%\uff08\u57fa\u4e8e\u98ce\u9669\u6bd4[HR]0.64\uff1b95%\u7f6e\u4fe1\u533a\u95f4[CI]0.47-0.87\uff1bP=0.0037\uff09\u3002\u5728\u4e24\u4e2a\u6cbb\u7597\u7ec4\u4e2d\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u7ec4\u7684\u4e2d\u4f4d\u968f\u8bbf\u65f6\u95f4\u4e3a28.4\u4e2a\u6708\uff0cT-DM1\u7ec4\u4e3a26.5\u4e2a\u6708\uff0c\u4f46\u5c1a\u672a\u8fbe\u5230\u4e2d\u4f4dOS\uff08\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u7ec4[40.5-NE]\uff0cT-DM1\u7ec4[34.0-NE]\uff09\u3002\u7ed3\u679c\u663e\u793a\uff1a\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u7ec4\u4e24\u5e74\u751f\u5b58\u7387\u4e3a77.4%\uff0c\u800cT-DM1\u7ec4\u5219\u4e3a69.9%\u3002\u5728\u6240\u6709\u4e9a\u7ec4\u4e2d\u5747\u89c2\u5bdf\u5230\u4e00\u81f4\u7684\u751f\u5b58\u83b7\u76ca\u8d8b\u52bf\uff0c\u5305\u62ec\u6709\u6216\u6ca1\u6709\u57fa\u7ebf\u8111\u8f6c\u79fb\u7684\u60a3\u8005\uff0c\u6709\u6216\u6ca1\u6709\u57fa\u7ebf\u5185\u810f\u75be\u75c5\u7684\u60a3\u8005\uff0c\u6fc0\u7d20\u53d7\u4f53\uff08HR\uff09\u9633\u6027\u6216\u9634\u6027\u7684\u60a3\u8005\uff0c\u4ee5\u53ca\u65e0\u8bba\u4e4b\u524d\u662f\u5426\u4f7f\u7528\u8fc7\u5e15\u59a5\u73e0\u5355\u6297\u4ee5\u53ca\u65e2\u5f80\u6cbb\u7597\u7ebf\u6570\u3002<\/p>\n

\u52a0\u5dde\u5927\u5b66\u6d1b\u6749\u77f6\u5206\u6821\u5927\u536b\u683c\u82ac\u533b\u5b66\u9662\u80bf\u7624\u5185\u79d1\u533b\u751f\u3001\u533b\u5b66\u6559\u6388\u3001\u8840\u6db2\u80bf\u7624\u79d1\u4e73\u817a\u764c\u4e34\u5e8a\u8bd5\u9a8c\u9879\u76ee\u4e3b\u4efb\uff0c\u52a0\u5dde\u5927\u5b66\u6d1b\u6749\u77f6\u5206\u6821\u5723\u83ab\u5c3c\u5361\u7efc\u5408\u764c\u75c7\u4e2d\u5fc3\u4e34\u5e8a\u7814\u7a76\u90e8\u7684\u533b\u5b66\u4e3b\u4efbSara Hurvitz\u8868\u793a\uff1a\u201c\u665a\u671f\u4e73\u817a\u764c\u6cbb\u7597\u7684\u4e3b\u8981\u76ee\u6807\u662f\u63a7\u5236\u75c5\u60c5\u548c\u63d0\u9ad8\u751f\u5b58\u7387\uff0c\u56e0\u6b64\u7ee7\u7eed\u6539\u8fdb\u73b0\u6709\u7684\u6cbb\u7597\u65b9\u6848\uff0c\u7279\u522b\u662f\u5728\u8f6c\u79fb\u6027\u6cbb\u7597\u4e2d\u81f3\u5173\u91cd\u8981\u3002\u5bf9\u4e8eHER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\uff0c\u5982\u679c\u5728\u8f6c\u79fb\u9636\u6bb5\u521d\u59cb\u6cbb\u7597\u60c5\u51b5\u4e0b\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u4e0eT-DM1\u76f8\u6bd4\uff0c\u751f\u5b58\u7387\u6709\u660e\u663e\u6539\u5584\uff0c\u8fdb\u4e00\u6b65\u8bc1\u5b9e\u8fd9\u79cd\u836f\u7269\u662f\u65b0\u7684\u6cbb\u7597\u6807\u51c6\u3002\u201d<\/p>\n

\u963f\u65af\u5229\u5eb7\u5168\u7403\u6267\u884c\u526f\u603b\u88c1\uff0c\u80bf\u7624\u6cbb\u7597\u9886\u57df\u7814\u53d1\u8d1f\u8d23\u4ebaSusan Galbraith\u8868\u793a\uff1a\u201cDESTINY-Breast03\u8bd5\u9a8c\u7684\u6700\u65b0\u7ed3\u679c\u663e\u793a\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u5ef6\u957f\u60a3\u8005\u751f\u547d\uff0c\u8fd8\u5c06\u75be\u75c5\u8fdb\u5c55\u65f6\u95f4\u5ef6\u7f13\u4e86\u8fd1\u4e24\u5e74\uff0c\u8fd9\u4f7f\u6211\u4eec\u66f4\u52a0\u76f8\u4fe1\uff0c\u8fd9\u79cd\u836f\u7269\u6709\u53ef\u80fd\u5efa\u7acb\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e8c\u7ebf\u6cbb\u7597\u7684\u65b0\u6807\u51c6\u3002\u52a0\u4e0aDESTINY-Breast02\u7814\u7a76\uff0c\u73b0\u5728\u6709\u4e24\u9879\u9488\u5bf9\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u7684III\u671f\u4e34\u5e8a\u7814\u7a76\u90fd\u8868\u660e\uff0c\u4e0e\u4ee5\u524d\u7684\u6cbb\u7597\u6807\u51c6\u76f8\u6bd4\uff0c\u60a3\u8005\u5728\u63a5\u53d7\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u65f6\u65e0\u8fdb\u5c55\u751f\u5b58\u65f6\u95f4\u66f4\u591a\uff0c\u603b\u751f\u5b58\u671f\u66f4\u957f\u3002\u201d<\/p>\n

\u7b2c\u4e00\u4e09\u5171\u516c\u53f8\u7814\u53d1\u90e8\u5168\u7403\u8d1f\u8d23\u4ebaKen Takeshita\u8868\u793a\uff1a\u201cDESTINY-Breast03\u548cDESTINY-Breast02\u8bd5\u9a8c\u4e2d\u663e\u793a\u7684\u603b\u751f\u5b58\u83b7\u76ca\u8fdb\u4e00\u6b65\u8bc1\u5b9e\u4e86\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u5728\u5ef6\u957f\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u7684HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u751f\u5b58\u65b9\u9762\u7684\u4f5c\u7528\u3002\u6b64\u5916\uff0c\u5728DESTINY-Breast03\u8bd5\u9a8c\u4e2d\uff0c\u4e0eT-DM1\u76f8\u6bd4\uff0c\u4f7f\u7528\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u60a3\u8005\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u5ef6\u957f\u4e864\u500d\uff0c1\/5\u7684\u60a3\u8005\u5b9e\u73b0\u80bf\u7624\u5b8c\u5168\u7f13\u89e3\uff0c\u8fd9\u5728\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u6cbb\u7597\u4e2d\u5c24\u5176\u8ba9\u4eba\u5370\u8c61\u6df1\u523b\u3002\u201c<\/p>\n

\u5728DESTINY-Breast03\u8bd5\u9a8c\u8fdb\u4e00\u6b65\u968f\u8bbf\u4e2d\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u4e5f\u6301\u7eed\u5728\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u4e0a\u663e\u793a\u51fa\u5177\u6709\u4e34\u5e8a\u610f\u4e49\u7684\u6539\u5584\uff0c\u4e0eT-DM1\u76f8\u6bd4\uff0c\u4e2d\u4f4dPFS\u6539\u5584\u4e8622\u4e2a\u6708\uff0c\u518d\u6b21\u8bc1\u5b9e\u4e86\u4e4b\u524d\u4e2d\u671f\u5206\u6790\u7ed3\u679c\u7684\u7edf\u8ba1\u5b66\u610f\u4e49\u3002\u65b0\u7684\u63a2\u7d22\u6027\u5206\u6790\u6ca1\u6709\u5c31\u7edf\u8ba1\u5b66\u610f\u4e49\u8fdb\u884c\u8003\u5bdf\uff0c\u6570\u636e\u4e5f\u6ca1\u6709\u663e\u793a\u6cbb\u7597\u7ec4\u4e4b\u95f4\u7684\u5dee\u5f02\u3002\u5728\u672c\u6b21\u4e8b\u540e\u5206\u6790\u4e2d\uff0c\u7ecf\u76f2\u6cd5\u72ec\u7acb\u4e2d\u5fc3\u8bc4\u5ba1\u59d4\u5458\u4f1a\uff08BICR\uff09\u8bc4\u4f30\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u7ec4\u60a3\u8005\u7684\u4e2d\u4f4dPFS\u4e3a28.8\u4e2a\u6708\uff0c\u800cT-DM1\u7ec4\u4e3a6.8\u4e2a\u6708\u3002\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u7ec4\u786e\u8ba4\u7684\u5ba2\u89c2\u53cd\u5e94\u7387\uff08ORR\uff09\u4e3a78.5%\uff0c\u5176\u4e2d21.1%\u7684\u60a3\u8005\u8868\u73b0\u4e3a\u5b8c\u5168\u7f13\u89e3\uff08CR\uff09\uff0c\u800cT-DM1\u7ec4\u7684ORR\u4e3a35.0%\uff0c\u5176\u4e2d9.5%\u7684\u60a3\u8005\u8fbe\u5230CR\u3002\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u7ec4\u7684\u4e2d\u4f4d\u6301\u7eed\u7f13\u89e3\u65f6\u95f4\uff08DoR\uff09\u4e3a36.6\u4e2a\u6708\uff0cT-DM1\u7ec4\u4e3a23.8\u4e2a\u6708\u3002  <\/p>\n

\u66f4\u65b0\u7ed3\u679c\u6458\u8981\uff1a<\/b>DESTINY-Breast03\u8bd5\u9a8c<\/b><\/p>\n

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u7597\u6548\u6307\u6807<\/b> <\/span><\/p>\n<\/td>\n

\n

\u5fb7\u66f2\u59a5\u73e0\u5355\u6297<\/b>(5.4mg\/kg)<\/b><\/span><\/p>\n

n=261<\/b><\/span><\/p>\n<\/td>\n

\n

T-DM1 (3.6mg\/kg)<\/b><\/span><\/p>\n

n=263<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u603b\u751f\u5b58\u671f\uff08<\/span>OS\uff09<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4e2d\u4f4d\u603b\u751f\u5b58\u671f<\/span>(\u6708) (95% CI)<\/span><\/p>\n<\/td>\n

\n

\u672a\u8fbe\u5230<\/span>(40.5-NE)<\/span><\/p>\n<\/td>\n

\n

\u672a\u8fbe\u5230<\/span>(34.0-NE)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

 <\/span>\u98ce\u9669\u6bd4<\/span>(95% CI)<\/span><\/p>\n<\/td>\n

\n

0.64 (0.47-0.87)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

P\u503c<\/span><\/p>\n<\/td>\n

\n

p=0.0037<\/span>i<\/sup><\/p>\n<\/td>\n<\/tr>\n

\n

\u603b\u751f\u5b58\u7387<\/span>(%) (95% CI)<\/span><\/p>\n<\/td>\n

<\/td>\n<\/tr>\n
\n

        12<\/span>\u4e2a\u6708<\/span><\/p>\n<\/td>\n

\n

94.1 (90.4-96.4)<\/span><\/p>\n<\/td>\n

\n

86.0 (81.1-89.8)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

       24<\/span>\u4e2a\u6708<\/span><\/p>\n<\/td>\n

\n

77.4 (71.7-82.1)<\/span><\/p>\n<\/td>\n

\n

69.9 (63.7-75.2)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

PFS\uff08BICR\uff09<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

      <\/span>\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08\u6708\uff09<\/span>(95% CI)<\/span><\/p>\n<\/td>\n

\n

28.8 (22.4-37.9)<\/span><\/p>\n<\/td>\n

\n

6.8 (5.6-8.2)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

    <\/span>\u98ce\u9669\u6bd4<\/span>(95% CI)<\/span><\/p>\n<\/td>\n

\n

0.33 (0.26-0.43)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

    <\/span>P\u503c<\/span><\/p>\n<\/td>\n

\n

p<0.000001<\/span>i,ii<\/sup><\/p>\n<\/td>\n<\/tr>\n

\n

PFS2(\u7814\u7a76\u8005\u8bc4\u4f30)<\/span>iii<\/sup><\/p>\n<\/td>\n<\/tr>\n

\n

    <\/span>\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f<\/span>2\uff08\u6708\uff09<\/span>(95% CI)<\/span><\/p>\n<\/td>\n

\n

40.5 (40.5-NE)<\/span><\/p>\n<\/td>\n

\n

25.7 (18.5-34.0)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

     <\/span>\u98ce\u9669\u6bd4<\/span>(95% CI)<\/span><\/p>\n<\/td>\n

\n

0.47 (0.35-0.62)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u786e\u8ba4<\/span>ORR (95% CI)<\/span><\/p>\n<\/td>\n

\n

78.5 (73.1-83.4)<\/span><\/p>\n<\/td>\n

\n

35.0 (29.2-41.1)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

      <\/span>P\u503c<\/span><\/p>\n<\/td>\n

\n

p<0.0001<\/span>i,ii<\/sup><\/p>\n<\/td>\n<\/tr>\n

\n

     <\/span>\u5b8c\u5168\u7f13\u89e3\uff08<\/span>%\uff09<\/span><\/p>\n<\/td>\n

\n

21.1 %<\/span><\/p>\n<\/td>\n

\n

9.5 %<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

     <\/span>\u90e8\u5206\u7f13\u89e3<\/span>(%)<\/span><\/p>\n<\/td>\n

\n

57.5 %<\/span><\/p>\n<\/td>\n

\n

25.5 %<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

     <\/span>\u75be\u75c5\u7a33\u5b9a<\/span>(%)<\/span><\/p>\n<\/td>\n

\n

18.0 %<\/span><\/p>\n<\/td>\n

\n

41.8 %<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

     <\/span>\u75be\u75c5\u8fdb\u5c55<\/span>(%)<\/span><\/p>\n<\/td>\n

\n

1.1 %<\/span><\/p>\n<\/td>\n

\n

17.9 %<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4e2d\u4f4d<\/span>DoR\uff08\u6708\uff09<\/span>(95% CI)<\/span>iv<\/sup><\/p>\n<\/td>\n

\n

36.6 (22.4-NE)<\/span><\/p>\n<\/td>\n

\n

23.8 (12.6-34.7)<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

OS\uff0c\u603b\u751f\u5b58\u671f\uff1bCI\uff0c\u7f6e\u4fe1\u533a\u95f4\uff1bPFS\uff0c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff1bPFS2\uff0c\u7b2c\u4e8c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff1bBICR\uff0c\u76f2\u6cd5\u72ec\u7acb\u4e2d\u5fc3\u8bc4\u5ba1\u59d4\u5458\u4f1a\uff1bORR\uff0c\u5ba2\u89c2\u53cd\u5e94\u7387\uff1bDoR\uff0c\u6301\u7eed\u7f13\u89e3\u65f6\u95f4<\/p>\n

i<\/sup> \u53cc\u8fb9
ii \u540d\u4e49P\u503c\u3002\u6700\u65b0\u7684\u63a2\u7d22\u6027\u5206\u6790\u6ca1\u6709\u8fdb\u884c\u7edf\u8ba1\u5b66\u610f\u4e49\u7684\u8003\u5bdf\uff0c\u4e5f\u6ca1\u6709\u663e\u793a\u6cbb\u7597\u7ec4\u4e4b\u95f4\u7684\u5dee\u5f02\u3002
iii<\/sup> \u4ece\u968f\u673a\u5206\u7ec4\u5230\u7b2c\u4e8c\u6b21\u8fdb\u5c55\u7684\u65f6\u95f4
iv<\/sup>\u57fa\u4e8e\u76f2\u6cd5\u72ec\u7acb\u4e2d\u5fc3\u8bc4\u5ba1\u59d4\u5458\u4f1a\u8bc4\u4f30<\/p>\n

\u5728DESTINY-Breast03\u8bd5\u9a8c\u4e2d\u89c2\u5bdf\u5230\u7684\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u7684\u5b89\u5168\u6027\u4e0e\u4e4b\u524d\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u81f4\uff0c\u6ca1\u6709\u53d1\u73b0\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u53f7\u3002\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u7ec4\u6700\u5e38\u89c1\u76843\u7ea7\u6216\u4ee5\u4e0a\u6cbb\u7597\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\uff08TEAEs\uff09\u662f\u4e2d\u6027\u7c92\u7ec6\u80de\u8ba1\u6570\u51cf\u5c11\uff0816.0%\uff09\u3001\u8d2b\u8840\uff089.3%\uff09\u3001\u8840\u5c0f\u677f\u8ba1\u6570\u51cf\u5c11\uff087.8%\uff09\u548c\u6076\u5fc3\uff087.0%\uff09\u3002\u7531\u72ec\u7acb\u8bc4\u5ba1\u59d4\u5458\u4f1a\u786e\u5b9a\u670939\u4f8b\uff0815.2%\uff09\u4e0e\u6cbb\u7597\u76f8\u5173\u7684\u95f4\u8d28\u6027\u80ba\u75c5\uff08ILD\uff09\u6216\u80ba\u708e\u7684\u62a5\u544a\uff0c\u5927\u591a\u6570\uff0814.4%\uff09\u662f\u4f4e\u7ea7\u522b\uff081\u7ea7\u62162\u7ea7\uff09\uff0c\u6709\u4e24\u4e2a3\u7ea7\uff080.8%\uff09\uff0c\u6ca1\u6709\u53d1\u751f4\u7ea7\u62165\u7ea7ILD\u6216\u80ba\u708e\u4e8b\u4ef6\u3002<\/p>\n

DESTINY-Breast02<\/b>\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff0c\u4e0e\u5316\u7597\u76f8\u6bd4\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u5728\u8f6c\u79fb\u6027<\/b>HER2<\/b>\u9633\u6027\u4e73\u817a\u764c\u7684\u540e\u7eed\u6cbb\u7597\u4e2d\u660e\u663e\u6539\u5584<\/b>PFS<\/b>\u548c<\/b>OS<\/b><\/p>\n

DESTINY-Breast02 III\u671f\u8bd5\u9a8c\u7684\u4e3b\u8981\u7ed3\u679c\u663e\u793a\uff0c\u5728\u65e2\u5f80\u63a5\u53d7\u8fc7T-DM1\u6cbb\u7597\u7684\u4e0d\u53ef\u5207\u9664\u548c\/\u6216\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\uff0c\u4e0e\u533b\u751f\u9009\u62e9\u7684\u6cbb\u7597\u65b9\u6cd5\uff08\u66f2\u59a5\u73e0\u5355\u6297+\u5361\u57f9\u4ed6\u6ee8\u6216\u62c9\u5e15\u66ff\u5c3c+\u5361\u57f9\u4ed6\u6ee8\uff09\u76f8\u6bd4\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u964d\u4f4e\u75be\u75c5\u8fdb\u5c55\u6216\u6b7b\u4ea1\u98ce\u966964%[HR=0.36\uff1b95% CI 0.28-0.45\uff1bp<0.000001]\u3002\u6839\u636eBICR\u8bc4\u4f30\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u7ec4\u60a3\u8005\u7684\u4e2d\u4f4dPFS\u4e3a17.8\u4e2a\u6708\uff0c\u800c\u533b\u751f\u9009\u62e9\u6cbb\u7597\u7ec4\u60a3\u8005\u7684PFS\u4e3a6.9\u4e2a\u6708\u3002\u4e0e\u533b\u751f\u9009\u62e9\u6cbb\u7597\u7ec4\u76f8\u6bd4\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u7684\u6b7b\u4ea1\u98ce\u9669\u4e5f\u964d\u4f4e\u4e8634%\uff08HR=0.66\uff1b95% CI 0.50-0.86\uff1bP=0.0021\uff09\uff0c\u4e2d\u4f4dOS\u4e3a39.2\u4e2a\u6708\uff0c\u800c\u533b\u751f\u9009\u62e9\u6cbb\u7597\u7ec4\u4e3a26.5\u4e2a\u6708\u3002<\/p>\n

DESTINY-Breast02\u8bd5\u9a8c\u6570\u636e\u8bc1\u5b9e\u4e86DESTINY-Breast01 II\u671f\u8bd5\u9a8c\u4e2d\u7684\u6570\u636e\uff0c\u652f\u6301\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u9996\u6b21\u83b7\u6279\u7528\u4e8e\u8f6c\u79fb\u6027HER2\u9633\u6027\u4e73\u817a\u764c\u60a3\u8005\uff0c\u8fd9\u4e9b\u60a3\u8005\u4e4b\u524d\u63a5\u53d7\u8fc7\u4e24\u79cd\u6216\u66f4\u591a\u6297HER2\u6cbb\u7597\u3002<\/p>\n

DESTINY-Breast02\u8bd5\u9a8c\u4e2d\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u7684\u5b89\u5168\u6027\u4e0e\u4e4b\u524d\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u81f4\uff0c\u6ca1\u6709\u53d1\u73b0\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u53f7\u3002\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u6cbb\u7597\u7ec4\u6700\u5e38\u89c1\u76843\u7ea7\u6216\u4ee5\u4e0a\u6cbb\u7597\u76f8\u5173\u7684TEAEs\u662f\u4e2d\u6027\u7c92\u7ec6\u80de\u8ba1\u6570\u51cf\u5c11\uff0810.6%\uff09\u3001\u8d2b\u8840\uff087.9%\uff09\u3001\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\uff087.7%\uff09\u548c\u6076\u5fc3\uff086.7%\uff09\u3002\u7531\u72ec\u7acb\u8bc4\u5ba1\u59d4\u5458\u4f1a\u786e\u5b9a\u670942\u4f8b\uff0810.4%\uff09\u4e0e\u6cbb\u7597\u76f8\u5173\u7684ILD\u6216\u80ba\u708e\u7684\u62a5\u544a\uff0c\u5927\u591a\u6570\uff089.1%\uff09\u662f\u4f4e\u7ea7\u522b\uff081\u7ea7\u62162\u7ea7\uff09\uff0c\u53d1\u751f3\u4e2a3\u7ea7\uff080.7%\uff09\u4e8b\u4ef6\uff0c\u6ca1\u67094\u7ea7\u4e8b\u4ef6\uff0c\u67092\u4e2a\uff080.5%\uff095\u7ea7ILD\u6216\u80ba\u708e\u4e8b\u4ef6\u3002<\/p>\n

\u5173\u4e8e\u4e73\u817a\u764c\u548c<\/b>HER2\u8868\u8fbe<\/b><\/p>\n

\u4e73\u817a\u764c\u662f\u6700\u5e38\u89c1\u7684\u764c\u75c7\uff0c\u4e5f\u662f\u5168\u7403\u548c\u7f8e\u56fd\u764c\u75c7\u76f8\u5173\u6b7b\u4ea1\u7684\u4e3b\u8981\u539f\u56e0\u4e4b\u4e00\u30022020\u5e74\u5168\u7403\u786e\u8bca\u4e73\u817a\u764c\u75c5\u4f8b\u8d85\u8fc7200\u4e07\uff0c\u5bfc\u81f4\u8fd168.5\u4e07\u4eba\u6b7b\u4ea1[1]<\/sup> \u3002\u5927\u7ea6\u4e94\u5206\u4e4b\u4e00\u7684\u4e73\u817a\u764c\u60a3\u8005\u88ab\u786e\u8bca\u4e3aHER2\u9633\u6027[2]<\/sup>\u3002<\/p>\n

HER2\u662f\u4e00\u79cd\u916a\u6c28\u9178\u6fc0\u9176\u53d7\u4f53\u4fc3\u751f\u957f\u86cb\u767d\uff0c\u5728\u591a\u79cd\u80bf\u7624\u8868\u9762\u8868\u8fbe\uff0c\u5305\u62ec\u4e73\u817a\u764c\u3001\u80c3\u764c\u3001\u80ba\u764c\u548c\u7ed3\u76f4\u80a0\u764c[3]<\/sup>\u3002HER2\u86cb\u767d\u8fc7\u5ea6\u8868\u8fbe\u53ef\u80fd\u662fHER2\u57fa\u56e0\u6269\u589e\u7684\u7ed3\u679c\uff0c\u5e76\u4e14\u901a\u5e38\u4e0e\u4e73\u817a\u764c\u4fb5\u88ad\u6027\u5f3a\u548c\u4e0d\u826f\u9884\u540e\u6709\u5173[4]<\/sup>\u3002<\/p>\n

\u5c3d\u7ba1\u4f7f\u7528\u66f2\u59a5\u73e0\u5355\u6297\u548c\u7d2b\u6749\u70f7\u8fdb\u884c\u521d\u59cb\u6cbb\u7597\uff0c\u4f46HER2\u9633\u6027\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u901a\u5e38\u8fd8\u662f\u4f1a\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55 \u3002\u9700\u8981\u66f4\u6709\u6548\u7684\u6cbb\u7597\u9009\u62e9\u6765\u8fdb\u4e00\u6b65\u5ef6\u7f13\u8fdb\u5c55\u5e76\u5ef6\u957f\u751f\u5b58\u671f[5,6]<\/sup>\u3002<\/p>\n

 \u5173\u4e8e<\/b>DESTINY-Breast03<\/b><\/p>\n

DESTINY-Breast03\u662f\u4e00\u9879\u5168\u7403\u3001\u968f\u673a\u3001\u5f00\u653e\u6807\u7b7e\u3001\u6ce8\u518cIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u65e8\u5728\u5934\u5bf9\u5934\u8bc4\u4f30\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\uff085.4mg\/kg\uff09\u76f8\u8f83\u4e8eT-DM1\u5bf9\u4e8eHER2\u9633\u6027\u3001\u65e2\u5f80\u63a5\u53d7\u8fc7\u66f2\u59a5\u73e0\u5355\u6297\u548c\u7d2b\u6749\u7c7b\u836f\u7269\u6cbb\u7597\u7684\u4e0d\u53ef\u5207\u9664\u548c\/\u6216\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n

DESTINY-Breast03\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\u662f\u57fa\u4e8e\u76f2\u6cd5\u72ec\u7acb\u4e2d\u5fc3\u8bc4\u5ba1\u59d4\u5458\u4f1a\u8bc4\u4f30\u7684PFS\u3002\u6b21\u8981\u7597\u6548\u7ec8\u70b9\u5305\u62ec \u603b\u751f\u5b58\u671f\u3001\u5ba2\u89c2\u7f13\u89e3\u7387\u3001\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u3001\u4e34\u5e8a\u83b7\u76ca\u7387\u3001\u57fa\u4e8e\u7814\u7a76\u8005\u8bc4\u4f30\u7684 PFS \u548c\u5b89\u5168\u6027\u3002<\/p>\n

DESTINY-Breast03 \u5728\u4e9a\u6d32\u3001\u6b27\u6d32\u3001\u5317\u7f8e\u6d32\u3001\u5927\u6d0b\u6d32\u548c\u5357\u7f8e\u6d32\u7684\u591a\u4e2a\u7814\u7a76\u4e2d\u5fc3\u62db\u52df\u4e86524 \u540d\u60a3\u8005\uff0c\u4e3b\u8981\u7814\u7a76\u7ed3\u679c\u53d1\u8868\u4e8e\u300a\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\u300b[7]<\/sup> \u3002\u6709\u5173\u8be5\u8bd5\u9a8c\u7684\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee ClinicalTrials.gov\u3002<\/p>\n

\u5173\u4e8e<\/b>DESTINY-Breast02<\/b><\/p>\n

DESTINY-Breast02\u662f\u4e00\u9879\u5168\u7403\u3001\u968f\u673a\u3001\u5f00\u653e\u6807\u7b7e\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u8bc4\u4f30\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\uff085.4mg\/kg\uff09\u4e0e\u533b\u751f\u9009\u62e9\u7684\u6cbb\u7597\u65b9\u6cd5\uff08\u66f2\u59a5\u73e0\u5355\u6297\/\u5361\u57f9\u4ed6\u6ee8\u6216\u62c9\u5e15\u66ff\u5c3c\/\u5361\u57f9\u4ed6\u6ee8\uff09\u5728\u66fe\u63a5\u53d7\u8fc7T-DM1\u6cbb\u7597\u7684HER2\u9633\u6027\u4e0d\u53ef\u5207\u9664\u548c\/\u6216\u8f6c\u79fb\u6027\u4e73\u817a\u764c\u60a3\u8005\u4e2d\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u60a3\u8005\u4ee52:1\u7684\u6bd4\u4f8b\u968f\u673a\u63a5\u53d7\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\u6216\u533b\u751f\u9009\u62e9\u7684\u6cbb\u7597\u3002<\/p>\n

DESTINY-Breast02\u8bd5\u9a8c\u7684\u4e3b\u8981\u7ec8\u70b9\u662f\u57fa\u4e8eBICR\u7684PFS\uff0c\u5173\u952e\u6b21\u8981\u7ec8\u70b9\u662fOS\u3002\u5176\u4ed6\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u57fa\u4e8eBICR\u548c\u7814\u7a76\u8005\u8bc4\u4f30\u7684ORR\u3001\u57fa\u4e8eBICR\u7684DoR\u3001\u57fa\u4e8e\u7814\u7a76\u8005\u8bc4\u4f30\u7684PFS\u548c\u5b89\u5168\u6027\u3002<\/p>\n

DESTINY-Breast02\u8bd5\u9a8c\u5728\u4e9a\u6d32\u3001\u6b27\u6d32\u3001\u5317\u7f8e\u6d32\u3001\u5927\u6d0b\u6d32\u548c\u5357\u7f8e\u6d32\u7684\u591a\u4e2a\u5730\u70b9\u62db\u52df\u4e86\u7ea6600\u540d\u60a3\u8005\u3002\u6709\u5173\u8be5\u8bd5\u9a8c\u7684\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95eeClinicalTrials.gov\u3002<\/p>\n

\u5173\u4e8e\u5fb7\u66f2\u59a5\u73e0\u5355\u6297<\/b><\/p>\n

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\u57fa\u4e8eDESTINY-Preast04\u8bd5\u9a8c\u7ed3\u679c\uff0c\u5fb7\u66f2\u59a5\u73e0\u5355\u6297\uff085.4mg\/kg\uff09\u5728\u5df4\u897f\u548c\u7f8e\u56fd\u88ab\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027HER2-low\uff08IHC 1+ \u6216 IHC 2+\/ISH \u9634\u6027\uff09\u4e73\u817a\u764c\u7684\u6210\u5e74\u60a3\u8005\uff0c\u8fd9\u4e9b\u60a3\u8005\u4e4b\u524d\u63a5\u53d7\u8fc7\u8f6c\u79fb\u6027\u7cfb\u7edf\u6cbb\u7597\uff0c\u6216\u5728\u5b8c\u6210\u8f85\u52a9\u5316\u7597\u671f\u95f4\u6216\u516d\u4e2a\u6708\u5185\u51fa\u73b0\u75be\u75c5\u590d\u53d1\u3002<\/p>\n

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\u58f0\u660e<\/b><\/p>\n

\u672c\u6587\u6d89\u53ca\u7814\u7a76\u4e2d\u7684\u836f\u54c1\u7528\u6cd5\u5c1a\u672a\u5728\u4e2d\u56fd\u83b7\u6279\u9002\u5e94\u75c7\uff0c\u963f\u65af\u5229\u5eb7\u4e0d\u63a8\u8350\u4efb\u4f55\u672a\u88ab\u6279\u51c6\u7684\u836f\u54c1\u4f7f\u7528\u3002<\/b><\/p>\n

References<\/b><\/p>\n

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1. <\/sup>Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin<\/i>. 2021; 10.3322\/caac.21660.<\/span><\/p>\n<\/td>\n<\/tr>\n

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2. <\/sup>Ahn S, et al. HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation. J Pathol Transl Med.<\/i> 2020; 54(1): 34-44.<\/span><\/p>\n<\/td>\n<\/tr>\n

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3. <\/sup>Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int<\/i>. 2014; 852748.<\/span><\/p>\n<\/td>\n<\/tr>\n

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4.<\/sup> Pillai R, et al. HER2 mutations in lung adenocarcinomas: A report from the Lung Cancer Mutation Consortium. Cancer<\/i>. 2017;1;123(21):4099-4105.<\/span><\/p>\n<\/td>\n<\/tr>\n

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5.<\/sup> Barok M, et al. Trastuzumab emtansine: mechanism of action and drug resistance. Breast Cancer Res.<\/i> 2014; 16(2):209.<\/span><\/p>\n<\/td>\n<\/tr>\n

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6. <\/sup>Nader-Marta G, et al. How we treat patients with metastatic HER2-positive breast cancer. ESMO Open<\/i>. 2022; 7:1.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

7.<\/sup> Cortes J, et al. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. N Engl J Med.<\/i> 2022; 386:1143-1154.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

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  \u66f4\u65b0\u7ed3\u679c\u6458\u8981\uff1aDESTINY-Breast03\u8bd5\u9a8c \u7597\u6548\u6307\u6807  \u5fb7\u66f2\u59a5\u73e0\u5355\u6297(5.4mg\/kg) n=261 T-DM1 (3.6mg\/kg) n=263 \u603b\u751f\u5b58\u671f\uff08OS\uff09 \u4e2d\u4f4d\u603b\u751f\u5b58\u671f(\u6708) (95% CI) \u672a\u8fbe\u5230(40.5-NE) \u672a\u8fbe\u5230(34.0-NE)  \u98ce\u9669\u6bd4(95% CI) 0.64 (0.47-0.87) P\u503c p=0.0037i \u603b\u751f\u5b58\u7387(%) (95% CI)         12\u4e2a\u6708 94.1 (90.4-96.4) 86.0 (81.1-89.8)        24\u4e2a\u6708 77.4 (71.7-82.1) 69.9 (63.7-75.2) PFS\uff08BICR\uff09      … Read 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