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Lancet oncol:顺铂+卡培他滨联合化疗方案添加雷莫芦单抗并不能延长转移性胃癌患者的无进展存活期

2019-02-08 MedSci MedSci原创

VEGF和VEGF受体2 (VEGFR-2)介导的信号通路和血管生成参与胃癌的发病和进展。现研究人员对一线化疗中添加VEGFR-2拮抗剂单克隆抗体雷莫芦单抗是否可改善转移性胃癌或胃食管交界处腺癌患者的预后进行研究。研究人员在20个国际的126个中心开展一双盲的随机的安慰剂为对照的3期临床试验,招募年满18岁的HER2阴性的转移的胃癌或胃食管交界处腺癌患者,且要求ECOG表现状态0-1分,器官功能尚

VEGF和VEGF受体2 (VEGFR-2)介导的信号通路和血管生成参与癌的发病和进展。现研究人员对一线化疗中添加VEGFR-2拮抗剂单克隆抗体雷莫芦单抗是否可改善转移性癌或胃食管交界处腺癌患者的预后进行研究。

研究人员在20个国际的126个中心开展一双盲的随机的安慰剂为对照的3期临床试验,招募年满18岁的HER2阴性的转移的胃癌或胃食管交界处腺癌患者,且要求ECOG表现状态0-1分,器官功能尚可。将招募的患者(1:1)随机分至实验组(顺铂 80mg/m2[第1天]+卡培他滨 1000mg/m2[2次/日,持续14天]+雷莫芦单抗 8mg/kg[第1天和第8天])或对照组(顺铂+卡培他滨+安慰剂),21天一疗程。不能耐受卡培他滨的患者予以5-氟尿嘧啶(800mg/m2,第1-5天静滴)。主要结点是无进展存活期。同时对主要结点进行敏感性分析。

2015年1月28日-2016年9月16日,共有645位患者被随机分至实验组(326人)或对照组(319人)。实验组的无进展存活期明显长于对照组(中位无进展存活期分别是5.7个月[5.5-6.5] vs [4.5-5.7];风险比[HR]0.753,95% CI 0.607-0.935,p=0.106)。敏感性分析不能验证无进展存活期差异(HR 0.961,95% CI 0.768-1.203,p=0.74)。两组之间的总体存活期无差异(实验组和对照组的总体存活期中位值分别是11.2个月[9.9-11.9] vs 10.7个月[9.5-11.9];HR 0.962,[0.801-1.156],p=0.6757)。最常见的3-4级副反应是中性粒细胞减少(实验组 vs 对照组:26% vs 27%)、贫血(12% vs 14%)和高血压(10% vs 2%)。实验组和对照组所有副反应的发生率分别是50%和47%。实验组和对照组最常见的重度副反应:呕吐(14例[4%] vs 21例[7%])和腹泻(11例[3%] vs 19例[6%])。

两组各有7位患者死于治疗相关的副反应。实验组的7位患者分别是死于急性肾损伤、心肌梗死、胃出血、腹膜炎、气胸、感染性休克和猝死。对照组的7位分别死于脑血管意外、多器官功能障碍综合征(2例)、肺栓塞(2例)、败血症和小肠穿孔。

虽然主要结点——无进展存活期——具有统计学意义,但该结果在敏感性分析中未得到证实,而且总体生存期无明显差异。因此,不推荐在顺铂与卡培他滨的联合化疗方案中添加雷莫芦单抗治疗转移性胃癌或胃食管交界处腺癌患者。


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    2019-09-08 howi
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encodeId=15661411e3728, content=<a href='/topic/show?id=a53e806837f' target=_blank style='color:#2F92EE;'>#联合化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80683, encryptionId=a53e806837f, topicName=联合化疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ebf32807001, createdName=oliver170, createdTime=Sun Feb 10 08:56:00 CST 2019, time=2019-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621200, encodeId=56da162120061, content=<a href='/topic/show?id=5ddb45343ef' target=_blank style='color:#2F92EE;'>#存活期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=98, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45343, encryptionId=5ddb45343ef, topicName=存活期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=498620204611, createdName=hukaixun, createdTime=Sun Feb 10 08:56:00 CST 2019, time=2019-02-10, status=1, ipAttribution=)]
    2019-04-28 minlingfeng
  5. 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encodeId=15661411e3728, content=<a href='/topic/show?id=a53e806837f' target=_blank style='color:#2F92EE;'>#联合化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80683, encryptionId=a53e806837f, topicName=联合化疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ebf32807001, createdName=oliver170, createdTime=Sun Feb 10 08:56:00 CST 2019, time=2019-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621200, encodeId=56da162120061, content=<a href='/topic/show?id=5ddb45343ef' target=_blank style='color:#2F92EE;'>#存活期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=98, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45343, encryptionId=5ddb45343ef, topicName=存活期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=498620204611, createdName=hukaixun, createdTime=Sun Feb 10 08:56:00 CST 2019, time=2019-02-10, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1829956, encodeId=d3d51829956e5, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sun Sep 08 05:56:00 CST 2019, time=2019-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737602, encodeId=34551e3760222, content=<a href='/topic/show?id=292f965e5b5' target=_blank style='color:#2F92EE;'>#铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96575, encryptionId=292f965e5b5, topicName=铂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca4034296500, 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encodeId=15661411e3728, content=<a href='/topic/show?id=a53e806837f' target=_blank style='color:#2F92EE;'>#联合化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80683, encryptionId=a53e806837f, topicName=联合化疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ebf32807001, createdName=oliver170, createdTime=Sun Feb 10 08:56:00 CST 2019, time=2019-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621200, encodeId=56da162120061, content=<a href='/topic/show?id=5ddb45343ef' target=_blank style='color:#2F92EE;'>#存活期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=98, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45343, encryptionId=5ddb45343ef, topicName=存活期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=498620204611, createdName=hukaixun, createdTime=Sun Feb 10 08:56:00 CST 2019, time=2019-02-10, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1829956, encodeId=d3d51829956e5, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sun Sep 08 05:56:00 CST 2019, time=2019-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737602, encodeId=34551e3760222, content=<a href='/topic/show?id=292f965e5b5' target=_blank style='color:#2F92EE;'>#铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96575, encryptionId=292f965e5b5, topicName=铂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca4034296500, 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10 08:56:00 CST 2019, time=2019-02-10, status=1, ipAttribution=)]
  8. 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