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burden\uff09\uff0c\u662f\u4e00\u79cd\u5305\u62ec\u80ba\u764c\u5728\u5185\u7684\u6cdb\u5b9e\u4f53\u7624\u514d\u75ab\u6cbb\u7597\u65b0\u5174\u4e14\u72ec\u7acb\u7684\u9884\u6d4b\u751f\u7269\u6807\u5fd7\u7269\uff0c\u5373\u6bcf\u5146\u78b1\u57fa\uff08\u6bcf1\u767e\u4e07\u4e2a\u78b1\u57fa\uff09\u4e2d\u4f53\u7ec6\u80de\u7a81\u53d8\u7684\u6570\u76ee\uff08mut\/Mb\uff09\u3002\u80bf\u7624\u7a81\u53d8\u8d1f\u8377\u9ad8\uff08TMB-H\uff09\u7684\u80bf\u7624\u60a3\u8005\u5177\u6709\u83b7\u5f97\u66f4\u591a\u65b0\u751f\u6297\u539f\u7684\u6f5c\u529b\uff0c\u5e76\u4e14\u4e0e\u80bf\u7624\u5185\u5f02\u8d28\u6027\u6709\u5173\uff0c\u7406\u8bba\u4e0a\u9ad8TMB\u80fd\u589e\u5f3a\u80bf\u7624\u514d\u75ab\u539f\u6027\u4ee5\u53ca\u4e0e\u514d\u75ab\u68c0\u67e5\u70b9\u6291\u5236\u5242\uff08ICI\uff09\u7684\u53cd\u5e94\u3002TMB\u503c\u5728\u4e0d\u540c\u764c\u79cd\u4e2d\u5b58\u5728\u663e\u8457\u5dee\u5f02\u3002\u76ee\u524dTMB\u68c0\u6d4b\u65b9\u6cd5\u4e3b\u8981\u662f\u57fa\u4e8eNGS\u7684\u5168\u5916\u663e\u5b50\u6d4b\u5e8f\uff08WES\uff09\u548c\u9776\u5411Panel\u6d4b\u5e8f\u3002\u5404\u764c\u79cd\u4e2dTMB\u503c 2020\u5e746\u670816\u65e5\uff0cFDA\u52a0\u901f\u6279\u51c6\u5e15\u535a\u5229\u73e0\u5355\u6297\uff08Pembrolizumab\uff0c\u53ef\u745e\u8fbe\uff09\u7528\u4e8e\u6cbb\u7597\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027tTMB-H\uff08\u7ec4\u7ec7TMB\u226510\u4e2a\u7a81\u53d8\/\u5146\u78b1\u57fa\uff09\u7684\u6210\u4eba\u548c\u513f\u7ae5\u5b9e\u4f53\u7624\u60a3\u8005\uff0c\u5728\u5148\u524d\u6cbb\u7597\u540e\u8fdb\u5c55\u4e14\u6ca1\u6709\u4ee4\u4eba\u6ee1\u610f\u7684\u66ff\u4ee3\u6cbb\u7597\u65b9\u6848\u3002\u6b64\u6b21\u83b7\u6279\uff0c\u662fTMB\u9996\u6b21\u83b7\u5f97FDA\u6279\u51c6\u6210\u4e3a\u6307\u5bfc\u80bf\u7624\u60a3\u8005\u6cbb\u7597\u7684\u751f\u7269\u6807\u5fd7\u7269\uff0c\u4e5f\u662f\u7ee7MSI-H\/dMMR\u540e\u7b2c\u4e8c\u4e2a\u514d\u75ab\u6cbb\u7597\u6cdb\u764c\u79cd\u4f34\u968f\u8bca\u65ad\u6807\u5fd7\u7269\u3002 \u672c\u6b21\u83b7\u6279\u662f\u57fa\u4e8e\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u975e\u968f\u673a\u3001\u5f00\u653e\u6807\u7b7e\u7684II\u671fKEYNOTE-158\u8bd5\u9a8c\uff0c\u7528\u4e8e\u8bc4\u4f30\u6cdb\u5b9e\u4f53\u7624\u60a3\u8005\u4e2dTMB-H\u4e0e\u5e15\u535a\u5229\u73e0\u5355\u6297\u4e4b\u95f4\u7684\u5173\u7cfb\u3002\u60a3\u8005\u5fc5\u987bECOG\u8868\u73b0\u72b6\u6001\u4e3a0\u62161\uff0c\u5e76\u4e14\u81f3\u5c11\u5df2\u7ecf\u63a5\u53d7\u6216\u4e0d\u8010\u53d71\u6761\u5148\u524d\u7684\u6807\u51c6\u6cbb\u7597\u65b9\u6848\u3002\u5728790\u4f8b\u53ef\u8bc4\u4f30\u7684\u60a3\u8005\u4e2d\uff0c102\u4f8b\uff0813%\uff09\u60a3\u8005\u4e3aTMB-H\u3002\u672c\u6b21\u7814\u7a76\u4e3b\u8981\u7ec8\u70b9\u4e3aORR\uff0c\u6b21\u8981\u7ec8\u70b9\u4e3aDOR\u3001PFS\u3001OS\u548c\u5b89\u5168\u6027\u3002\u7ecf\u8fc7\u4e00\u5e74\u7684\u968f\u8bbf\u7ed3\u679c\u663e\u793a\uff0c\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9ORR\u5728TMB-H\u7684\u4eba\u7fa4\u4e2d\u8fbe\u523029%\uff0c\u5176\u4e2dCR\u4e3a4%\uff0cPR\u4e3a25%\u3002DOR\u672a\u8fbe\u5230\uff0c12\u4e2a\u6708\u7f13\u89e3\u7387\u4e3a57%\uff0c24\u4e2a\u6708\u7f13\u89e3\u7387\u4e3a50%\u3002KEYNOTE-158\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e \u5176\u4ed6\u6f5c\u5728\u5206\u5b50\u6807\u5fd7\u7269\u9664\u4e86\u4e0a\u8ff0\u63d0\u5230\u7684\u5df2\u83b7\u6279\u6cdb\u5b9e\u4f53\u7624\u7597\u6cd5\uff0c\u76ee\u524d\uff0c\u8fd8\u6709\u5176\u4ed6\u751f\u7269\u6807\u5fd7\u7269\u88ab\u7528\u4e8e\u5f00\u53d1\u201c\u4e0d\u9650\u764c\u79cd\u201d\u7597\u6cd5\uff0c\u5305\u62ecFGFR\u57fa\u56e0\u3002 FGFRFGFR\uff08\u6210\u7ea4\u7ef4\u7ec6\u80de\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff09\uff0c\u4e0eEGFR\u540c\u5c5e\u4e8e\u53d7\u4f53\u916a\u6c28\u9178\u6fc0\u9176\u5bb6\u65cf\uff0c\u5305\u62ecFGFR1\u3001FGFR2\u3001FGFR3\u3001FGFR4\u56db\u79cd\u53d7\u4f53\u4e9a\u578b\uff0c12\u79cd\u914d\u4f53\u3002FGFR\u5206\u5b50\u6539\u53d8\u53ef\u5bfc\u81f4\u5f02\u5e38\u7684FGF\/FGFR\u4fe1\u53f7\uff0c\u4fc3\u8fdb\u7ec6\u80de\u589e\u6b96\u3001\u65b0\u8840\u7ba1\u751f\u6210\u3001\u4fb5\u88ad\u3001\u8f6c\u79fb\u3001\u6297\u51cb\u4ea1\u7b49\uff0c\u8fd9\u4e0e\u5e7f\u6cdb\u7684\u4eba\u7c7b\u6076\u6027\u80bf\u7624\u6709\u5173\u3002FGFR\u53d8\u5f02\u5f62\u5f0f\u8f83\u591a\uff0c\u5305\u62ecFGFR2\/3\u878d\u5408\u3001FGFR2\/3\u70b9\u7a81\u53d8\u3001FGFR1\u6269\u589e\u7b49\u3002\u76ee\u524d\u5728\u80c6\u7ba1\u764c\u3001\u5c3f\u8def\u4e0a\u76ae\u764c\u3001\u4e73\u817a\u764c\u3001\u5934\u9888\u764c\u3001\u80ba\u764c\u3001\u80c3\u764c\u3001\u80f0\u817a\u764c\u3001\u7ed3\u76f4\u80a0\u764c\u3001\u80be\u764c\u3001\u5b50\u5bab\u5185\u819c\u764c\u3001\u5375\u5de2\u764c\u548c\u5bab\u9888\u764c\u4e2d\u5747\u62a5\u9053\u8fc7FGFR\u7a81\u53d8\uff0c\u6574\u4f53\u7a81\u53d8\u9891\u7387\u7ea6\u4e3a0.7%\uff0c\u4f46\u5728\u5404\u764c\u79cd\u4e2d\u7684\u7a81\u53d8\u9891\u7387\u5dee\u5f02\u8f83\u5927\uff0c\u5176\u4e2d\u5728\u809d\u5185\u80c6\u7ba1\u764c\u60a3\u8005\u4e2dFGFR2\u7684\u7a81\u53d8\u68c0\u51fa\u7387\u4e3a13~14%\uff0c\u5c3f\u8def\u4e0a\u76ae\u764c\u4e2d\uff0cFGFR\u7a81\u53d8\u68c0\u51fa\u7387\u7ea6\u4e3a23%\uff0cFGFR\u878d\u5408\u68c0\u51fa\u7387\u7ea6\u4e3a6%\u3002FGFR\u57fa\u56e0\u53d8\u5f02\u5728\u5404\u764c\u79cd\u4e2d\u7684\u53d1\u751f\u9891\u7387 2019\u5e744\u6708\uff0cFDA\u52a0\u901f\u6279\u51c6\u5384\u8fbe\u66ff\u5c3c\uff08Erdafitinib\uff09\u7528\u4e8e\u6cbb\u7597\u643a\u5e26FGFR3\u6216FGFR2\u7a81\u53d8\u7684\u94c2\u7c7b\u5316\u7597\u540e\u75be\u75c5\u8fdb\u5c55\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\u6210\u4eba\u60a3\u8005\u3002\u968f\u540e\uff0cFDA\u57282020\u5e744\u6708\u30012021\u5e745\u6708\u548c2022\u5e7410\u6708\u4e5f\u5206\u522b\u83b7\u6279\u4e86\u57f9\u7f8e\u66ff\u5c3c\uff08Pemigatinib\uff09\u3001Infigratinib\uff08Truseltiq\uff09\u548cFutibatinib\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u8fc7\u6cbb\u7597\u7684\u643a\u5e26FGFR2\u878d\u5408\u6216\u91cd\u6392\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u80c6\u7ba1\u764c\u60a3\u8005\u3002 \u76ee\u524d\uff0c\u9488\u5bf9\u5b9e\u4f53\u7624\u60a3\u8005\u7684\u591a\u9879\u4e34\u5e8a\u8bd5\u9a8c\u6b63\u5728\u8fdb\u884c\u548c\u62db\u52df\u4e2d\uff0c\u5305\u62ecICP-192\u62df\u7528\u4e8e\u6cbb\u7597FGF\/FGFR\u57fa\u56e0\u5f02\u5e38\u7684\u665a\u671f\u5b9e\u4f53\u7624\u7684II\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff08CTR20212797\uff09\u548cInfigratinib\u80f6\u56ca\u7528\u4e8e\u6cbb\u7597\u4f34\u6709FGFR2\u57fa\u56e0\u6269\u589e\u6216\u4f34\u6709\u5176\u4ed6FGFR\u57fa\u56e0\u7a81\u53d8\u7684\u665a\u671f\u5b9e\u4f53\u7624\u60a3\u8005\u7684II\u671f\u4e34\u5e8a\u7814\u7a76\uff08CTR20210272\u3001CTR20210275\uff09\u3002 \u5b89\u9f99\u57fa\u56e0\u68c0\u6d4b\u5957\u9910\u5b89\u9f99\u57fa\u56e0\u63a8\u51fa\u4e00\u7cfb\u5217\u9002\u7528\u4e8e\u6cdb\u764c\u79cd\u751f\u7269\u6807\u5fd7\u7269\u68c0\u6d4b\u7684NGS\u4ea7\u54c1\u548c\u5355\u9879\u5957\u9910\uff0cNGS\u4ea7\u54c1\u4e3b\u8981\u5305\u62ec\u5b89\u660e\u5eb7\u00ae-NGS 30\/50\u57fa\u56e0\uff0c\u5b89\u53f8\u5eb7\u00ae-NGS 139\/269\u57fa\u56e0\uff0c\u5b89\u62e9\u5eb7\u00ae-NGS 550TMB\/1028\u57fa\u56e0\uff0c\u5355\u9879\u5957\u9910\u6709BRAF V600E\u548cMSI\u68c0\u6d4b\u3002\u5404NGS\u4ea7\u54c1\u5747\u53ef\u5168\u9762\u68c0\u6d4bBRAF\u3001RET\u3001NTRK\u57fa\u56e0\uff0c\u5728\u514d\u75ab\u6807\u5fd7\u7269\u65b9\u9762\u5b89\u53f8\u5eb7\u00ae\u548c\u5b89\u62e9\u5eb7\u00ae\u5747\u53ef\u68c0\u6d4bMSI\uff0c\u5176\u4e2d\u5b89\u62e9\u5eb7\u00ae\u7cfb\u5217\u8fd8\u53ef\u68c0\u6d4bTMB\u3002\u4e00\u7cfb\u5217\u5957\u9910\u5747\u53ef\u6307\u5bfc\u4e34\u5e8a\u7cbe\u51c6\u7528\u836f\uff0c\u6539\u5584\u80bf\u7624\u60a3\u8005\u7684\u9884\u540e\uff0c\u63d0\u9ad8\u5176\u751f\u6d3b\u8d28\u91cf\uff0c\u5ef6\u957f\u751f\u5b58\u671f\u3002\u5404\u5957\u9910\u7684\u8be6\u7ec6\u4fe1\u606f\u89c1\u4e0b\u8868\uff0c\u9001\u68c0\u65f6\u9700\u63d0\u524d\u54a8\u8be2\u6837\u672c\u5177\u4f53\u8981\u6c42\u3002 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