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Transl Lung Cancer Res: 真实世界研究评估afatinib(阿法替尼)一线治疗晚期EGFR敏感突变的非小细胞肺癌(NSCLC)患者的疗效

2022-02-08 yd2015 MedSci原创

研究表明Afatinib耐受性良好,没有新的安全信号,在韩国EGFRm + NSCLC患者中,包括那些有基线脑转移和/或罕见EGFR突变的患者,其疗效令人鼓舞。

Afatinib(阿法替尼)是第二代EGFR-TKI,被批准用于晚期EGFR敏感突变的非小细胞肺癌NSCLC)患者一线治疗。近期,韩国团队开展了真实世界研究,评估afatinib(阿法替尼)一线治疗晚期EGFR敏感突变的非小细胞肺癌(NSCLC)患者的疗效。相关结果发表在Translational Lung Cancer Research杂志上。

该研究结果指标包括基线特征、总缓解率(ORR)、治疗至停药时间(TTD)和总生存期(OS)。亚组为:基线时有无脑转移、剂量减少和基线EGFR突变类型。

研究纳入422例患者,54.3%的患者为男性,52.1%从未吸烟,95.3%为腺癌,82.9%的患者接受了批准的40 mg阿法替尼作为起始剂量。在afatinib治疗开始时,249例(59.0%)患者有Del19突变,106例(25.1%)患者为L858R突变;其余患者为复合突变[n=42(10.0%)]、罕见突变[n=21(5.0%)]、状态不明[n=3(0.7%)]或新的T790M突变[1(0.2%)]的NSCLC患者。8例(1.9%)患者在初始活检时存在T790M突变(新+复合突变)。共有168例(39.8%)患者在基线时出现脑转移,在有资料的145例患者中,60例(41.5%)患者仅接受了阿法替尼治疗(即未接受脑手术或放疗),51例(35.2%)患者接受了全脑放疗,21例(14.5%)患者接受了伽玛刀放疗。其余13例(9.0%)患者接受了基线脑转移的其他治疗。

在分析时,273例(64.7%)患者已停止服用阿法替尼,149例(35.3%)仍在治疗。停药最常见的原因是疾病进展[n=171(62.6%)]、毒性[n=34(12.5%)]和随访失败[n=30(11.0%)]。

366例可评估患者中,6例CR, 223例PR,总缓解率(ORR)为62.6%。另107例(29.2%)患者为SD;疾病控制率(DCR)为91.8%。与仅存在18、19和21外显子突变的患者相比,存在20外显子突变的肿瘤患者(单独或作为复合突变)的ORR更低[26.7%(15名患者中有1个CR和3个PRs)]。Afatinib对复合突变表现出很强的活性,包括4例在外显子18和21均有突变的肿瘤患者的ORR为100%。在168例基线脑转移患者中,122例(72.6%)患者在接受阿法替尼治疗后不再有脑转移,28例(16.7%)患者仍有脑转移,其余18例(10.7%)患者是否存在脑转移尚不清楚。

剂量减少似乎没有影响疗效;剂量减少的患者的ORR为65.7%,相比之下,剂量未减少的患者的ORR为57.1%。在至少一次剂量减少的患者中,接受最终剂量30mg /d的阿法替尼患者的ORR最高(69.2%)。

在419例有资料的患者中,中位TTD为17.8个月[95%可信区间(CI): 15.6 -20.53],3年和5年TTD率分别为28.7%和15.9%。Del19突变患者的中位TTD显著长于无Del19突变的患者(20.5 vs. 15.4个月;P = 0.0086;相反,L858R突变的肿瘤患者的中位TTD较无L858R突变的患者短(15.4个月vs 19.6个月;P = 0.0166)。初发T790M突变的患者的中位TTD也明显短于那些没有T790M突变的患者(8.1个月vs. 18.2个月;P = 0.0174)。在基线时,无脑转移患者的中位TTD明显长于有脑转移的患者(22.9个月vs. 14.8个月;P=0.001);剂量减少的患者优于未减少剂量的患者(22.2 vs 14.2个月;P = 0.0004)。60例基线脑转移患者仅接受afatinib一线治疗(即未接受颅脑手术或放疗),中位TTD为14.2个月(95% CI: 11.2-19.0)。

                                TTD

中位随访15.6个月后,治疗组(95% CI: 40.3个月NR)的中位OS未达到(NR);3年和5年的OS率分别为67.2%和52.9%。与未发生Del19、L858R和T790M突变的患者相比,发生Del19、L858R和T790M突变的患者,EGFR突变类型的中位OS也是未达到。此外,与罕见突变(G719X, S7681和L861Q)患者相比,无罕见突变的患者的中位OS未达到。与TTD相似,在基线时,无脑转移患者的中位OS显著长于有脑转移的患者(NR vs. 40.3个月;P=0.0009),减少剂量患者中位OS显著长于未减少剂量患者(NR vs. 40.3个月;P = 0.0117)。

                    OS

253例(60.0%)患者有至少1种TRAE, 92例(21.8%)患者有3级TRAE(117次事件)。最常见的TRAE(任何级别/ 3级)为腹泻(n=132, 31.3%;N =36, 8.5%)和皮疹(N =97, 23.0%;n = 34, 8.1%;2例4级TRAEs(高钾血症和急性肾损伤),4例5级TRAEs(肺炎(n=2),肺炎(n=1),呼吸衰竭(n=1))。

共有138例患者在afatinib进展后接受二线治疗。最常见的后续治疗是培美曲塞[65例(47.1%)],其次是奥希替尼[21例(15.2%)]和吉西他滨[16例(11.6%)]。阿法替尼进展后接受细胞毒性化疗的患者中位OS为30.5个月(95% CI: 27.5 NR) (n=90);3年生存率为49.1%。对于接受序贯阿法替尼和奥希替尼治疗的患者,中位OS为37.7个月(95% CI: 23.4 47.6),中位TTD为32.0个月(95% CI: 14.6 49.4),3年生存率为72.7%。

综上,研究表明Afatinib耐受性良好,没有新的安全信号,在韩国EGFRm + NSCLC患者中,包括那些有基线脑转移和/或罕见EGFR突变的患者,其疗效令人鼓舞。

原始出处:

Lee SY, Choi CM, Chang YS, Lee KY, Kim SJ, Yang SH, Ryu JS, Lee JE, Lee SY, Park JY, Kim YC, Oh IJ, Jung CY, Lee SH, Yoon SH, Choi J, Jang TW. Real-world experience of afatinib as first-line therapy for advanced EGFR mutation-positive non-small cell lung cancer in Korea. Transl Lung Cancer Res 2021;10(12):4353-4367. doi: 10.21037/tlcr-21-501

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  4. 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encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Wed Feb 09 23:48:52 CST 2022, time=2022-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534613, encodeId=65e315346130a, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Wed Feb 09 23:48:52 CST 2022, time=2022-02-09, status=1, ipAttribution=)]
    2022-03-05 bsmagic9140
  5. 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  6. 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  7. [GetPortalCommentsPageByObjectIdResponse(id=1785078, encodeId=478b1e8507823, content=<a href='/topic/show?id=3f75658990' target=_blank style='color:#2F92EE;'>#EGFR敏感突变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6589, encryptionId=3f75658990, topicName=EGFR敏感突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=38232500109, createdName=1249898am15暂无昵称, createdTime=Fri Nov 25 11:48:52 CST 2022, time=2022-11-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2067608, encodeId=c10a206e60802, content=<a href='/topic/show?id=d0841e75535' target=_blank style='color:#2F92EE;'>#Transl#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17755, encryptionId=d0841e75535, topicName=Transl)], attachment=null, authenticateStatus=null, 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  8. 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encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Wed Feb 09 23:48:52 CST 2022, time=2022-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534613, encodeId=65e315346130a, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Wed Feb 09 23:48:52 CST 2022, time=2022-02-09, status=1, ipAttribution=)]
    2022-02-14 那个谁

    学习

    0

  9. 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  10. 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    2022-02-09 liuyiping

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