NEJM:奥希替尼作为EGFR突变阳性NSCLC术后辅助治疗,患者显著获益

2020-09-20 AZ AZ

ADAURA研究以及肺癌患者术后辅助治疗的相关话题近期一直是备受国内外专家学者热切关注和讨论的话题。第三代EGFR-TKI奥希替尼是临床中治疗EGFR突变阳性晚期NSCLC患者的一线治疗方案,ADAU

ADAURA研究以及肺癌患者术后辅助治疗的相关话题近期一直是备受国内外专家学者热切关注和讨论的话题。第三代EGFR-TKI奥希替尼是临床中治疗EGFR突变阳性晚期NSCLC患者的一线治疗方案,ADAURA研究将奥希替尼的角色转移到术后辅助治疗,为奥希替尼增添了更多的临床角色,更多患者从中获益。

ADAURA研究是一项全球多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究,旨在对比奥希替尼和安慰剂用于EGFR基因突变阳性ⅠB~ⅢA期NSCLC患者在肿瘤完整切除后的辅助治疗的疗效和安全性。入组患者将接受奥希替尼或安慰剂治疗持续3年或直至疾病复发。研究的主要终点为研究者评估的Ⅱ~ⅢA期患者的无疾病生存期(DFS)。次要研究终点包括总生存期(OS)和安全性等。微信截图_20200920003622 - 副本.png

ADAURA研究设计

在2020年美国临床肿瘤学会(ASCO)年会上,ADAURA研究结果首次公布,数据显示,在Ⅱ~ⅢA期患者人群中,奥希替尼组1年、2年、3年的DFS率分别为97%、90%、80%,而安慰剂组则为61%、44%、28%。奥希替尼使患者疾病复发或死亡风险降低83%(HR=0.17,P<0.0001)。在所有人群中(ⅠB~ⅢA),奥希替尼组1年、2年、3年的DFS率分别为97%、89%、79%,而安慰剂组则为69%、53%、41%。奥希替尼使患者疾病复发或死亡风险降低79%(HR=0.21,P<0.0001)。

微信截图_20200920003352 - 副本.png

ADAURA研究DFS数据 

本次ESMO虚拟年会上,ADAURA研究CNS疾病复发数据公布。数据截止2020年1月17日,奥希替尼组和安慰剂组分别有11%和46%的患者出现疾病复发。在出现疾病复发的患者中,奥希替尼组主要以局部复发为主(62%),而安慰剂组则主要为远处复发(61%)。其中奥希替尼组只有1%的患者出现CNS复发,而安慰剂组为10%。

微信截图_20200920003735 - 副本.png

疾病复发类型

微信截图_20200920003823 - 副本.png

疾病复发部位

在所有人群中,共有45例患者出现CNS DFS事件,其中奥希替尼组6例:4例(1%)出现CNS复发,2例(1%)死亡;安慰剂组为39例:33例(10%)CNS复发,6例(2%)死亡。

微信截图_20200920003922 - 副本.pngCNS DFS事件

在所有人群中,奥希替尼组的中位CNS DFS尚未达到,而安慰剂组为48.2个月,奥希替尼降低CNS疾病复发或死亡风险达82%(HR=0.18,P<0.0001);3年的CNS DFS率,两组分别为98%和82%。

微信截图_20200920003937 - 副本.png

ADAURA研究所有人群的CNS DFS数据

预估的18个月时的CNS疾病复发几率,奥希替尼组为<1%,而安慰剂组为9%。同时CNS复发的累计发生率,奥希替尼组始终低于安慰剂组。

微信截图_20200920004051 - 副本.png

假定的CNS和非CNS复发率 

ADAURA研究更新的数据表明,局部和远处复发风险的降低,以及CNS DFS的改善,进一步给予奥希替尼辅助治疗作为一种高效、改变实践的治疗策略用于肿瘤完整切除后的EGFR基因突变阳性ⅠB~ⅢA期NSCLC患者更多的支持。

在EGFR基因突变阳性NSCLC的术后辅助靶向治疗探索上,中国专家学者贡献巨大,在ADAURA研究发表之前,ADJUVANT和EVAN研究均已先后发表。同时在ADAURA研究,来自国内的多家医院均有参与,在《新英格兰医学杂志》上公布的ADAURA研究者名单中,广东省人民医院吴一龙教授、国家癌症中心/中国医学科学院肿瘤医院赫捷院士,上海交通大学附属胸科医院陆舜教授赫然在列,此外在研究背后,还有更多中国专家学者的默默付出。期待未来在中国肿瘤学界专家学者的共同努力下,能够在世界的舞台上发出更多的中国声音。

事实上,ADAURA研究与以前设计不同。在ADJUVANT研究基础上,进一步开展的研究。在ADJUVANT研究基础上,ADAURA研究设计有所改进。第一,ADAURA研究将辅助靶向的时间从2年延长至3年,先前证据提示奥希替尼具有较高的入脑浓度,而脑转移是术后常见的复发部位,因此奥希替尼用于术后辅助将会为患者带来更大获益。第二,ADJUVANT研究为靶向治疗与化疗的头对头研究,入组人群为复发风险更高的人群。ADAURA研究入组人群涵盖ⅠB-ⅢA期,按照当前临床实践标准,ⅠB期患者不接受辅助化疗,Ⅱ~ⅢA期有淋巴结转移的患者则先完成标准的辅助化疗,再给予靶向治疗。这种研究设计将会对辅助靶向治疗的获益有更深入的探索,ⅠB期与Ⅱ/Ⅲ期患者的治疗获益是否存在差异,是十分令人期待的亚组分析结果。此外,术后给予或不给予辅助化疗,与后续使用靶向治疗方案所带来的获益是否有所差异,也同样令人期待

参考文献

Tsuboi M,Wu YL,He J,et al.Osimertinib adjuvant therapy in patients(pts) with resected EGFR mutated(EGFRm) NSCLC(ADAURA):Central nervous system(CNS) disease recurrence[EB/OL].ESMO 2020,abstract LBA1.

Wu YL,Tsuboi M,He J,et al.Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer[EB/OL].N Engl J Med,2020 Sep 19.DOI:10.1056/NEJMoa2027071. 

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    2021-08-12 ms6554388223732251

    学习了

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  4. 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  5. 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authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=)]
    2021-03-19 mengjiala999

    稳定

    0

  6. 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topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Tue Sep 22 06:16:21 CST 2020, time=2020-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035421, encodeId=e10f103542154, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039786, encodeId=eda91039e86a5, content=NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1007323, encodeId=153b100e32333, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/CBFPmSnMe9HXB9ZfuoibLbiaREDTTyLOkW9nNUQVyscb0NFK8ssePjiceYP2SWlhCuISa01JaB5CPDx9icxPyL8Nlg/132, createdBy=77c22479203, createdName=ms6554388223732251, createdTime=Thu Aug 12 17:06:13 CST 2021, time=2021-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1816350, encodeId=1f3c181635053, content=<a href='/topic/show?id=28dd9e5029b' target=_blank style='color:#2F92EE;'>#阳性NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97502, encryptionId=28dd9e5029b, topicName=阳性NSCLC)], attachment=null, authenticateStatus=null, 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style='color:#2F92EE;'>#EGFR突变阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6599, encryptionId=0b4f65992c, topicName=EGFR突变阳性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Sun Jan 17 09:16:21 CST 2021, time=2021-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=949446, encodeId=5e7b949446f7, content=稳定, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=af205461939, createdName=mengjiala999, createdTime=Fri Mar 19 10:15:56 CST 2021, time=2021-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1803561, encodeId=c1251803561be, content=<a href='/topic/show?id=0b3fe551971' target=_blank style='color:#2F92EE;'>#突变阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75519, encryptionId=0b3fe551971, topicName=突变阳性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKjqGDO7icVKUiaT7urgwXvnvzWtp0fMFU46Xfib8oavFKygiaWtibXReS6ZUh3PImsNicGAwTO5HXxoicnA/132, createdBy=ee262500130, createdName=ms7474195563676018, createdTime=Thu Apr 22 12:16:21 CST 2021, time=2021-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534520, encodeId=570e1534520a3, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, 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=Tue Sep 22 06:16:21 CST 2020, time=2020-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035421, encodeId=e10f103542154, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039786, encodeId=eda91039e86a5, content=NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=)]
    2020-09-22 liuyiping
  8. [GetPortalCommentsPageByObjectIdResponse(id=1007323, encodeId=153b100e32333, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/CBFPmSnMe9HXB9ZfuoibLbiaREDTTyLOkW9nNUQVyscb0NFK8ssePjiceYP2SWlhCuISa01JaB5CPDx9icxPyL8Nlg/132, createdBy=77c22479203, createdName=ms6554388223732251, createdTime=Thu Aug 12 17:06:13 CST 2021, time=2021-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1816350, encodeId=1f3c181635053, content=<a href='/topic/show?id=28dd9e5029b' target=_blank style='color:#2F92EE;'>#阳性NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97502, encryptionId=28dd9e5029b, topicName=阳性NSCLC)], attachment=null, authenticateStatus=null, 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topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Tue Sep 22 06:16:21 CST 2020, time=2020-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035421, encodeId=e10f103542154, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039786, encodeId=eda91039e86a5, content=NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=)]
    2020-09-20 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

  9. 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topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Tue Sep 22 06:16:21 CST 2020, time=2020-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035421, encodeId=e10f103542154, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039786, encodeId=eda91039e86a5, content=NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Sun Sep 20 18:16:21 CST 2020, time=2020-09-20, status=1, ipAttribution=)]
    2020-09-20 肿肿

    NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了

    0

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