NEJM:Nivolumab可延长复发性头颈鳞状细胞癌患者的总生存期

2016-10-10 MedSci MedSci原创

复发或转移性鳞状细胞癌患者经过铂类化疗后预后较差,并且治疗选择有限。研究人员评估了Nivolumab——抗程序性死亡-1(PD-1)的单克隆抗体治疗这种疾病的疗效。在这项随机,开放性,3期临床试验中,研究人员以2:1的比例分配361例铂类化疗后6个月内的复发性头颈鳞状细胞癌患者接受nivolumab(剂量为每公斤体重3毫克,每2周一次)或标准,单药系统治疗(甲氨蝶呤,多西紫杉醇,或西妥昔单抗)。主

复发或转移性鳞状细胞癌患者经过铂类化疗后预后较差,并且治疗选择有限。研究人员评估了Nivolumab——抗程序性死亡-1(PD-1)的单克隆抗体治疗这种疾病的疗效。

在这项随机,开放性,3期临床试验中,研究人员以2:1的比例分配361例铂类化疗后6个月内的复发性头颈鳞状细胞癌患者接受nivolumab(剂量为每公斤体重3毫克,每2周一次)或标准,单药系统治疗(甲氨蝶呤,多西紫杉醇,或西妥昔单抗)。主要终点是总生存期。其他终点包括无进展生存期,客观缓解率,安全性和患者报告的生活质量。

nivolumab组中位总生存期为7.5个月(95%可信区间[CI],5.5至9.1),接受标准治疗组的患者为5.1个月(95%CI,4.0至6.0)。nivolumab组患者的总生存期显著长于标准治疗组患者(死亡风险比,0.70; 97.73%CI,0.51至0.96; P=0.01),nivolumab组患者的1年估计生存率大约比标准治疗组患者高19个百分点(36.0% vs 16.6%)。nivolumab组的中位无进展生存期为2.0个月(95%CI,1.9至2.1),标准治疗组为2.3个月(95%CI,1.9至3.1)(疾病进展或死亡危险比为,0.89; 95%CI, 0.70至1.13; P=0.32)。在6个月时,nivolumab组的无进展生存率为19.7%,标准治疗组为9.9%。nivolumab组与标准治疗组的反应率分别为13.3% vs 5.8%。nivolumab组与标准治疗组3级或4级治疗相关的不良事件发生率分别为13.1% vs 35.1%。nivolumab组患者的物理,角色和社会功能稳定,而这些情况在标准治疗组更差。

在铂类难治性、复发性头颈部鳞状细胞癌患者中,与标准单药治疗相比,nivolumab治疗组患者的总生存期更长。

原始出处:

Robert L. Ferris,George Blumenschein,Jerome Fayette,et al.Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck,NEJM,2016.10.10

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createdBy=674961, createdName=tamgche, createdTime=Wed Dec 21 22:12:00 CST 2016, time=2016-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1978457, encodeId=9f8819e845798, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Sat Nov 19 21:12:00 CST 2016, time=2016-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=151525, encodeId=4d29151525d6, content=Bravo!, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8a891651942, 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createdTime=Thu Oct 13 09:33:40 CST 2016, time=2016-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378115, encodeId=00cf13e811533, content=<a href='/topic/show?id=c29b69004f9' target=_blank style='color:#2F92EE;'>#生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69004, encryptionId=c29b69004f9, topicName=生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Wed Oct 12 01:12:00 CST 2016, time=2016-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516009, encodeId=c91c15160093d, content=<a href='/topic/show?id=bd0152e64f1' target=_blank style='color:#2F92EE;'>#总生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52764, encryptionId=bd0152e64f1, topicName=总生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bdf610907545, createdName=12498cb5m16暂无昵称, createdTime=Wed Oct 12 01:12:00 CST 2016, time=2016-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1614090, encodeId=11e816140901f, content=<a href='/topic/show?id=17244443870' target=_blank style='color:#2F92EE;'>#头颈鳞状细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44438, encryptionId=17244443870, topicName=头颈鳞状细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=54d419484077, createdName=ms55066533437992, createdTime=Wed Oct 12 01:12:00 CST 2016, time=2016-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=145214, encodeId=1d9514521416, content=好文章,受益, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Tue Oct 11 20:08:28 CST 2016, time=2016-10-11, status=1, ipAttribution=)]
    2016-10-27 whitehorse13

    Bravo!

    0

  5. 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createdTime=Thu Oct 13 09:33:40 CST 2016, time=2016-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378115, encodeId=00cf13e811533, content=<a href='/topic/show?id=c29b69004f9' target=_blank style='color:#2F92EE;'>#生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69004, encryptionId=c29b69004f9, topicName=生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Wed Oct 12 01:12:00 CST 2016, time=2016-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516009, encodeId=c91c15160093d, content=<a href='/topic/show?id=bd0152e64f1' target=_blank style='color:#2F92EE;'>#总生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52764, encryptionId=bd0152e64f1, topicName=总生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bdf610907545, createdName=12498cb5m16暂无昵称, createdTime=Wed Oct 12 01:12:00 CST 2016, time=2016-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1614090, encodeId=11e816140901f, content=<a href='/topic/show?id=17244443870' target=_blank style='color:#2F92EE;'>#头颈鳞状细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44438, encryptionId=17244443870, topicName=头颈鳞状细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=54d419484077, createdName=ms55066533437992, createdTime=Wed Oct 12 01:12:00 CST 2016, time=2016-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=145214, encodeId=1d9514521416, content=好文章,受益, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Tue Oct 11 20:08:28 CST 2016, time=2016-10-11, status=1, ipAttribution=)]
  6. 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attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bdf610907545, createdName=12498cb5m16暂无昵称, createdTime=Wed Oct 12 01:12:00 CST 2016, time=2016-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1614090, encodeId=11e816140901f, content=<a href='/topic/show?id=17244443870' target=_blank style='color:#2F92EE;'>#头颈鳞状细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44438, encryptionId=17244443870, topicName=头颈鳞状细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=54d419484077, createdName=ms55066533437992, createdTime=Wed Oct 12 01:12:00 CST 2016, time=2016-10-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=145214, encodeId=1d9514521416, content=好文章,受益, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Tue Oct 11 20:08:28 CST 2016, time=2016-10-11, status=1, ipAttribution=)]
    2016-10-13 lietome1

    学习了,赞一个!

    0

  7. 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  8. 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  9. 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  10. 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    2016-10-11 1e10c84am36(暂无匿称)

    好文章,受益

    0

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