JAMA Oncol:伊匹单抗 vs FOLFOX联合纳武单抗和曲妥珠单抗治疗ERBB2阳性胃食管腺癌

2022-06-27 MedSci原创 MedSci原创

曲妥珠单抗、纳武单抗和FOLFOX的联合方案在ERBB2阳性胃食管腺癌中表现出了优于既往数据和曲妥珠单抗+纳武单抗+伊匹单抗方案的疗效

全球每年约有170万新发胃食管腺癌 (EGA) 病例,每年超过130万人死于EGA。复发或转移性EGA约占所有EGA患者的75%。在化疗中加用程序性细胞死亡1 (PD-1) 抑制剂可改善选定的转移性GEA患者群体的预后。

该研究旨在评估曲妥珠单抗联合PD-1抑制剂和细胞毒性T淋巴细胞相关抗原4(CTLA-4)抑制剂或FOLFOX作为晚期ERBB2阳性EGA的一线治疗的效果。

这是一项在德国21个地点开展的多中心、随机的2期门诊临床试验,招募了既往为治疗过的、有合适的器官功能、不适合免疫治疗的转移性ERBB2阳性EGA患者,随机接受曲妥珠单抗+纳武单抗(1mg/kg x 4/240mg,长达12个月)+mFOLFOX6(FOLFOX组)或伊匹单抗(3mg/kg x 4,长达12个月)(伊匹单抗组)治疗。主要终点是生存预后的改善情况。

共招募了97位患者,其中88位(中位年龄61岁)被随机分至两组。66位(75%)患者的胃食管交界处局限性EGA,22位(25%)是胃EGA。59位(72%)患者的PD-L1联合阳性评分≥1分,46位(56%)患者的PD-L1联合阳性评分≥5分。76位患者为ERBB2阳性。


两组的总生存率和无进展生存率

中位随访了14.3个月,FOLFOX组和伊匹单抗组的中位总生存期分别是21.8个月和16.4个月;中位无进展生存期分别是10.7个月和3.2个月。FOLFOX组和伊匹单抗组的12个月总生存率分别是70%和57%。


两组的毒性反应

FOLFOX组有29位患者经历了≥3级的不良反应(AE),有15位患者经历了严重AE,而伊匹单抗组各有20位和17位;伊匹单抗组自身免疫相关AE和FOLFOX组神经病变发生率较高。

总之,该试验结果表明,曲妥珠单抗、纳武单抗和FOLFOX的联合方案在ERBB2阳性胃食管腺癌中表现出了优于既往数据和曲妥珠单抗+纳武单抗+伊匹单抗方案的疗效。

原始出处:

Stein A, Paschold L, Tintelnot J, et al. Efficacy of Ipilimumab vs FOLFOX in Combination With Nivolumab and Trastuzumab in Patients With Previously Untreated ERBB2-Positive Esophagogastric Adenocarcinoma: The AIO INTEGA Randomized Clinical Trial. JAMA Oncol. Published online June 23, 2022. doi:10.1001/jamaoncol.2022.2228

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topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Wed Jun 07 17:08:48 CST 2023, time=2023-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662186, encodeId=7a6b16621862a, content=<a href='/topic/show?id=a9556923d7' target=_blank style='color:#2F92EE;'>#ErbB2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6923, encryptionId=a9556923d7, topicName=ErbB2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=612025370618, createdName=ms7514935887898259, createdTime=Wed Aug 17 03:08:48 CST 2022, time=2022-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866651, encodeId=10761866651a5, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, 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content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1455479, encodeId=6f7814554e9aa, content=<a href='/topic/show?id=d0cee572e9' target=_blank style='color:#2F92EE;'>#FOLFOX#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7572, encryptionId=d0cee572e9, topicName=FOLFOX)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=12f25658567, createdName=linlin2314, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1512302, encodeId=84371512302a1, content=<a href='/topic/show?id=f797101120d6' target=_blank style='color:#2F92EE;'>#食管腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101120, encryptionId=f797101120d6, topicName=食管腺癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6a7410453390, createdName=ms7899726347904398, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243584, encodeId=34121243584b6, content=JAMA上文章都是顶级的,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Mon Jun 27 01:08:48 CST 2022, time=2022-06-27, status=1, ipAttribution=)]
    2023-04-03 minlingfeng
  5. [GetPortalCommentsPageByObjectIdResponse(id=1948643, encodeId=dc26194864356, content=<a href='/topic/show?id=87828339e7a' target=_blank style='color:#2F92EE;'>#胃食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83397, encryptionId=87828339e7a, topicName=胃食管)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Wed Jan 25 12:08:48 CST 2023, time=2023-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648203, encodeId=30831648203ff, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Wed Jun 07 17:08:48 CST 2023, time=2023-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662186, encodeId=7a6b16621862a, content=<a href='/topic/show?id=a9556923d7' target=_blank style='color:#2F92EE;'>#ErbB2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6923, encryptionId=a9556923d7, topicName=ErbB2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=612025370618, createdName=ms7514935887898259, createdTime=Wed Aug 17 03:08:48 CST 2022, time=2022-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866651, encodeId=10761866651a5, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, 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content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1455479, encodeId=6f7814554e9aa, content=<a href='/topic/show?id=d0cee572e9' target=_blank style='color:#2F92EE;'>#FOLFOX#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7572, encryptionId=d0cee572e9, topicName=FOLFOX)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=12f25658567, createdName=linlin2314, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1512302, encodeId=84371512302a1, content=<a href='/topic/show?id=f797101120d6' target=_blank style='color:#2F92EE;'>#食管腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101120, encryptionId=f797101120d6, topicName=食管腺癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6a7410453390, createdName=ms7899726347904398, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243584, encodeId=34121243584b6, content=JAMA上文章都是顶级的,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Mon Jun 27 01:08:48 CST 2022, time=2022-06-27, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1948643, encodeId=dc26194864356, content=<a href='/topic/show?id=87828339e7a' target=_blank style='color:#2F92EE;'>#胃食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83397, encryptionId=87828339e7a, topicName=胃食管)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Wed Jan 25 12:08:48 CST 2023, time=2023-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648203, encodeId=30831648203ff, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, 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content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1455479, encodeId=6f7814554e9aa, content=<a href='/topic/show?id=d0cee572e9' target=_blank style='color:#2F92EE;'>#FOLFOX#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7572, encryptionId=d0cee572e9, topicName=FOLFOX)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=12f25658567, createdName=linlin2314, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1512302, encodeId=84371512302a1, content=<a href='/topic/show?id=f797101120d6' target=_blank style='color:#2F92EE;'>#食管腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101120, encryptionId=f797101120d6, topicName=食管腺癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6a7410453390, createdName=ms7899726347904398, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243584, encodeId=34121243584b6, content=JAMA上文章都是顶级的,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Mon Jun 27 01:08:48 CST 2022, time=2022-06-27, status=1, ipAttribution=)]
    2022-06-28 zhouqu_8
  7. [GetPortalCommentsPageByObjectIdResponse(id=1948643, encodeId=dc26194864356, content=<a href='/topic/show?id=87828339e7a' target=_blank style='color:#2F92EE;'>#胃食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83397, encryptionId=87828339e7a, topicName=胃食管)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=循证小兵, createdTime=Wed Jan 25 12:08:48 CST 2023, time=2023-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648203, encodeId=30831648203ff, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Wed Jun 07 17:08:48 CST 2023, time=2023-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1662186, encodeId=7a6b16621862a, content=<a href='/topic/show?id=a9556923d7' target=_blank style='color:#2F92EE;'>#ErbB2#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6923, encryptionId=a9556923d7, topicName=ErbB2)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=612025370618, createdName=ms7514935887898259, createdTime=Wed Aug 17 03:08:48 CST 2022, time=2022-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866651, encodeId=10761866651a5, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Mon Apr 03 20:08:48 CST 2023, time=2023-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1821026, encodeId=cbb81821026e4, content=<a href='/topic/show?id=3488101119e7' target=_blank style='color:#2F92EE;'>#食管腺#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101119, encryptionId=3488101119e7, topicName=食管腺)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bb182500058, createdName=yuhaisheng_ibp_32061711, createdTime=Fri May 05 14:08:48 CST 2023, time=2023-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1437749, encodeId=35b3143e7491a, content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1455479, encodeId=6f7814554e9aa, content=<a href='/topic/show?id=d0cee572e9' target=_blank style='color:#2F92EE;'>#FOLFOX#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7572, encryptionId=d0cee572e9, topicName=FOLFOX)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=12f25658567, createdName=linlin2314, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1512302, encodeId=84371512302a1, content=<a href='/topic/show?id=f797101120d6' target=_blank style='color:#2F92EE;'>#食管腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101120, encryptionId=f797101120d6, topicName=食管腺癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6a7410453390, createdName=ms7899726347904398, createdTime=Tue Jun 28 13:08:48 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243584, encodeId=34121243584b6, content=JAMA上文章都是顶级的,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Mon Jun 27 01:08:48 CST 2022, time=2022-06-27, status=1, ipAttribution=)]
    2022-06-28 linlin2314
  8. 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attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Mon Jun 27 01:08:48 CST 2022, time=2022-06-27, status=1, ipAttribution=)]
    2022-06-27 肿瘤克星

    JAMA上文章都是顶级的,谢谢梅斯及时上新

    0

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