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Lancet Respir Med:检测血浆循环肿瘤DNA的EGFR突变作为晚期肺腺癌一线吉非替尼治疗的选择标准(BENEFIT)

2018-07-14 xiangting MedSci原创

检测ctDNA中的EGFR突变是识别一线吉非替尼治疗受益患者的有效方法。

检测肿瘤组织中的EGFR突变是确定患者是否能从EGFR酪氨酸激酶抑制剂治疗中获益的金标准。然而,如果组织不充足,另一种策略是使用循环性肿瘤DNA(ctDNA),但这种方法需要在临床试验中进行验证。研究人员进行了一项前瞻性临床试验,以评估基于ctDNA的EGFR突变检测作为肺腺癌患者接受吉非替尼作为一线治疗的选择标准。

BENEFIT是一项在中国15个中心进行的多中心、单组、2期临床试验。检测年龄18-75岁的IV期转移性肺腺癌患者ctDNA中的EGFR突变,并给予口服吉非替尼250mg每日1次作为一线治疗。主要终点是实现客观反应的比例。次要终点包括中位无进展生存期和安全性。使用168基因组的新一代测序(NGS)对基线血液样品进行遗传分析。在有至少一次基线后肿瘤评估的患者中进行意向治疗来完成主要疗效分析。在接受至少一剂研究治疗的所有患者中进行安全性分析。该试验在ClinicalTrials.gov注册,编号为NCT02282267。

2014年12月25日和2016年1月16日之间,对426名患者进行筛选,其中188名有ctDNA EGFR突变的患者被纳入,并接受吉非替尼治疗。183名患者进行了一次或多次基线后肿瘤评估,被纳入主要疗效分析。中位随访时间为14.5个月(IQR 12.2-16.5)。在数据截止时(2017年1月31日),152名患者疾病进展或已死亡。达到客观反应的比例为72.1%(95%CI 65.0-78.5)。中位无进展生存期为9.5个月(95%CI 9.07-11.04)。在167名有可用血样的患者中,147名(88%)在第8周时ctDNA 中的EGFR突变清除,这些患者的中位无进展生存期比20名第8周时EGFR突变持续的患者更长(11.0个月[95%CI 9.43-12.85] vs 2.1个月[1.81-3.65];风险比[HR] 0.14,95 %CI 0.08-0.23;p<0.0001)。根据179名患者的基线NGS数据,研究确定了3个亚组患者:只有EGFR突变的患者(n=58)、EGFR和肿瘤抑制基因突变的患者(n=97)、以及EGFR和癌基因突变的患者(n=24)。这些亚组的中位无进展生存期分别为13.2个月(95%CI 11.5-15.0),9.3个月(7.6-11.0)和4.7个月(1.9-9.3)(只有EGFR突变 vs EGFR和肿瘤抑制基因突变,HR 1.78,95%CI 1.23-2.58;p=0.002;只有EGFR突变 vs EGFR和癌基因突变,2.66,1.58-4.49;p=0.0003)。最常见的3级或4级不良事件是肝功能异常(n=24)。17名(9%)患者报告了严重不良事件。没有发现吉非替尼的意外安全事件。

检测ctDNA中的EGFR突变是识别一线吉非替尼治疗受益患者的有效方法。进一步分析EGFR突变的动态改变和伴随的基因畸变可以预测吉非替尼耐药性。

原始出处:

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    2018-12-25 howi
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    2018-07-16 liuyiping
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content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Sat Jul 14 20:58:05 CST 2018, time=2018-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331595, encodeId=896f33159574, content=学习了.谢谢分享., beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Sat Jul 14 20:17:58 CST 2018, time=2018-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331585, encodeId=f9363315856f, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jul 14 19:16:08 CST 2018, time=2018-07-14, status=1, ipAttribution=)]
    2018-07-15 131****1460

    学习了受益匪浅

    0

  8. 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objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Mon Jul 16 08:02:00 CST 2018, time=2018-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331762, encodeId=27f5331e624c, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sun Jul 15 11:36:18 CST 2018, time=2018-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331601, encodeId=0a1733160134, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Sat Jul 14 20:58:05 CST 2018, time=2018-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331595, encodeId=896f33159574, content=学习了.谢谢分享., beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Sat Jul 14 20:17:58 CST 2018, time=2018-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331585, encodeId=f9363315856f, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jul 14 19:16:08 CST 2018, time=2018-07-14, status=1, ipAttribution=)]
    2018-07-14 orangesking

    看看

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1829716, encodeId=50551829e16d4, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Tue Dec 25 07:02:00 CST 2018, time=2018-12-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1943240, encodeId=a08a194324044, content=<a href='/topic/show?id=40875986ec9' target=_blank style='color:#2F92EE;'>#晚期肺腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59867, encryptionId=40875986ec9, topicName=晚期肺腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e72268, 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objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Mon Jul 16 08:02:00 CST 2018, time=2018-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331762, encodeId=27f5331e624c, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sun Jul 15 11:36:18 CST 2018, time=2018-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331601, encodeId=0a1733160134, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Sat Jul 14 20:58:05 CST 2018, time=2018-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331595, encodeId=896f33159574, content=学习了.谢谢分享., beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Sat Jul 14 20:17:58 CST 2018, time=2018-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331585, encodeId=f9363315856f, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jul 14 19:16:08 CST 2018, time=2018-07-14, status=1, ipAttribution=)]
    2018-07-14 惠映实验室

    学习了.谢谢分享.

    0

  10. 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content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Sat Jul 14 20:58:05 CST 2018, time=2018-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331595, encodeId=896f33159574, content=学习了.谢谢分享., beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Sat Jul 14 20:17:58 CST 2018, time=2018-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=331585, encodeId=f9363315856f, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sat Jul 14 19:16:08 CST 2018, time=2018-07-14, status=1, ipAttribution=)]
    2018-07-14 131****1460

    学习了受益匪浅

    0

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中央型肺癌1例

男,80岁,查体发现右上方占位2周

Sci Rep:肺癌患者生活质量的社会人口学、临床和遗传决定因素

多种因素影响肺癌患者的QOL,基线QOL可以影响生存率。

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Baidu
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Baidu
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