JAMA Oncol:Pembrolizumab为晚期胃或胃食管交界部腺癌三线治疗带来新希望

2018-03-19 肿瘤资讯编辑部 肿瘤资讯

晚期胃癌目前缺乏标准的三线治疗方案。KEYNOTE-059研究评估了Pembrolizumab单药用于经治的晚期胃癌或胃食管交界部癌三线或以上治疗的疗效和安全性。目前研究的初步结果发表在《JAMA Oncology》杂志。

晚期胃癌目前缺乏标准的三线治疗方案。KEYNOTE-059研究评估了Pembrolizumab单药用于经治的晚期胃癌或胃食管交界部癌三线或以上治疗的疗效和安全性。目前研究的初步结果发表在《JAMA Oncology》杂志。

背景

胃癌是全球第5大常见肿瘤;2013年,胃癌相关的死亡人数达723,100例。在西方国家,大多数的胃腺癌患者诊断时已经是晚期,可供选择的治疗手段有限。一线化疗常用的方案为铂类联合氟尿嘧啶,患者的中位OS为8-17个月左右。大多数的患者在一线化疗后都会进展,二线治疗可选择的方案包括ramucirumab单药或联合紫衫类或伊立替康。目前,三线治疗没有标准方案可推荐,亟需深入了解胃癌的分子生物学特征,探寻潜在的新的治疗方案。

癌症基因组图谱(The Cancer Genome Atlas)项目中,对295例胃腺癌患者进行了全面的分子生物学分析,发现有一部分肿瘤中编码PD-L1/2的基因扩增,此外,其他的一些研究检测到部分胃癌患者有PD-L1表达。Pembrolizumab是一个高选择的人源化IgG4单抗,靶向PD-1。在既往I期研究KEYNOTE-012中,39例PD-L1阳性的晚期胃癌或胃食管交界部腺癌患者接受pembrolizumab单药治疗的ORR为22%。基于这些研究背景,进行了II期研究KEYNOTE-059,研究包括3个队列,其中队列1旨在继续探索pembrolizumab单药用于晚期胃癌或胃食管交界部腺癌三线或以上治疗的安全性和疗效。

方法

KEYNOTE-059研究是一个多中心,开放,非随机,3个队列的II期研究,入组晚期胃癌或胃食管交界部腺癌患者。队列1中的患者接受pembrolizumab单药200mg,D1,q3w治疗,旨在确认的疾病进展,不可耐受的毒性,研究者或患者决定出组,不遵循研究方案,或用药达35个周期(约2年)。考虑到假性进展,在第一次影像学评估进展(RECIST 1.1标准)后患者可亟需用药。但影像学再次评估确认进展后,采用irRECIST标准来指导患者后续但治疗决策。 

队列1入组了年龄>=18岁,组织学或细胞学确诊为复发或转移性胃或胃食管交界部腺癌,有可测量病灶,既往接受过2线或以上治疗,且既往但化疗放哪包括氟尿嘧啶联合铂类,HER2阴性,ECOG PS评分0-1分,有足够的器官功能,预计生存时间3个月或以上。所有入组患者在入组前必须提供组织标本进行PD-L1检测。 

所有接受过至少1次pembrolizumab治疗的患者都纳入疗效和安全性分析。主要研究终点为ORR。将根据患者既往的治疗线数,PD-L1表达状态和MSI状态来进行探索性疗效分析。 

探索性的生物标志物分析包括:1. 肿瘤组织PD-L1表达,如果PD-L1阳性细胞比例>=1%则定义为肿瘤PD-L1表达阳性。2. DNA错配修复状态分析,包括NR21,NR24,BAT25,BAT26,MONO27。3. 免疫相关的基因表达谱,包括18个基因(CCL5, CD27, CD274 [PD-L1], CD-276 [B7-H3], CD8A, CMKLR1, CXCL9, CXCR6, HLA-DQA1, HLA-DRB1, HLA-E, IDO1, LAG3,NKG7, PDCD1LG2[PD-L2], PSMB10, STAT1, TGIT)。

结果

2015年3月2日至2016年5月26日,队列1中共入组259例患者,如下图1. 入组患者的中位年龄为62岁(范围:24-89岁),大多数为男性(198例,76.4%)和白人(200例,77.2%)。大约一半的患者(134例,51.7%)既往接受过二线治疗,其余患者接受过三线或以上治疗。133例(51.4%)患者为胃食管交界部腺癌。进行PD-L1表达检测的标本类型包括:手术标本(47例,18.1%),原发肿瘤穿刺活检(148例,57.1%)和转移灶穿刺活检(71例,27.4%)。259例患者中,148例(57.1%)患者PD-L1表达阳性,109例(42.1%)患者PD-L1表达阴性,2例(0.8%)患者PD-L1表达状态未知。至数据截止日期(2017年1月16日),患者的中位随访时间为5.8个月,28例(10.8%)患者仍在接受研究药物治疗。最常见的停药原因为疾病进展(168例,64.9%)。26例(10%)患者死亡,20例(7.7%)患者因为不良事件(AE)而终止治疗。



图1. 研究入组流程图

在259例患者中,30例(11.6%)患者根据中心影像学评估确认为客观缓解(RECIST 1.1标准评价),其中6例(2.3%)患者为CR,疗效总结见下表1.中位至客观缓解时间为2.1个月。



在223例有接受过至少一次治疗后的影像学评估的患者中,95例(42.6%)患者可测量肿瘤大小缩小,见下图2A。中位疗效持续时间为8.4个月(1.6+~17.3+)。30例取得客观缓解的患者中,16例(53.3%)患者仍持续有疗效,见下图2B。且在后续几次评估中,降低的肿瘤负荷仍然维持,见下图2C。



图2A.疗效评价瀑布图;2B.疗效持续时间;2C. 靶病灶最大径的动态变化。

经中心影像学评估(RECIST 1.1标准),患者的中位PFS为2.0个月(95%CI,2.0-2.1),6个月的PFS率为14.1%(95%CI,10.1%-18.7%)。中位OS为5.6个月(95%CI,4.3-6.9),6个月的OS率为46.5%(95%CI:40.2%-52.6%),12个月的OS率为23.4%(95%CI:17.6%-29.7%)。 

研究者进一步根据患者的特征进行疗效评价。在PD-L1阳性的肿瘤中,ORR为15.5%,CR率为2.0%;在PD-L1阴性的肿瘤中,ORR为6.4%,CR率为2.8%。中位疗效持续时间分别为16.3个月和6.9个月。Pembrolizumab作为第3线治疗和作为4线或以上治疗的ORR分别为16.4%和6.4%。PD-L1表达阳性,且pembrolizumab作为第3线治疗的患者,ORR为22.7%,CR率为2.7%,中位疗效持续时间为8.1个月。PD-L1阴性,pembrolizumab作为第3线治疗的患者,ORR为8.6%,CR率为3.4%,中位疗效持续时间为6.9个月。 

在259例入组的患者中,174例(64.2%)患者有配对的组织和血浆标本可以进行MSI状态分析,其中7例(4%)患者为MSI-高。在这7例MSI-高的患者中,4例(57.1%)取得了客观缓解;其余167例非MSI-高的患者中,15例(9%)取得客观缓解。 

进一步18个T细胞炎症基因表达谱评分,结果发现评分较高的患者主要聚集在有响应者。采用回顾分析发现,基因表达分数高的患者于显著更好的ORR和PFS相关。 

结论和讨论

晚期胃癌患者,目前缺乏标准的三线治疗。这一多中心、开放、单臂的II期临床研究显示,pembrolizumab用于经治的转移性胃或胃食管交界部腺癌患者显示出可管理的毒性和有前景的抗肿瘤疗效,且对治疗有响应的患者,疗效持续时间较长。这一研究提示,pembrolizumab有望成为晚期胃或胃食管交界部腺癌患者三线治疗新选择。但这一研究只是一个单臂研究,不能和其他目前可选择的治疗方案进行疗效对比,且进行后续分子标志物分析的样本量较小。期待后续pembrolizumab联合化疗用于晚期胃食管交界部腺癌患者更早线治疗的疗效数据。 

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createdName=三生有幸9135, createdTime=Sat Mar 24 15:52:17 CST 2018, time=2018-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=298993, encodeId=0cb429899394, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Mar 23 18:53:35 CST 2018, time=2018-03-23, status=1, ipAttribution=)]
    2018-12-25 chendoc242
  3. [GetPortalCommentsPageByObjectIdResponse(id=1911951, encodeId=08d61911951fe, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Tue Jul 24 09:45:00 CST 2018, time=2018-07-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1786976, encodeId=c3ae1e8697636, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, 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topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Sun Apr 15 07:45:00 CST 2018, time=2018-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1809333, encodeId=22a7180933363, content=<a href='/topic/show?id=0c6b8340307' target=_blank style='color:#2F92EE;'>#胃食管交界部腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83403, encryptionId=0c6b8340307, topicName=胃食管交界部腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Nov 01 11:45:00 CST 2018, time=2018-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865377, encodeId=6f4218653e7fa, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sun Feb 10 04:45:00 CST 2019, time=2019-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1948550, encodeId=a386194855041, 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=25, 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=Sat Jun 16 02:45:00 CST 2018, time=2018-06-16, status=1, ipAttribution=), 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createdName=三生有幸9135, createdTime=Sat Mar 24 15:52:17 CST 2018, time=2018-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=298993, encodeId=0cb429899394, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Mar 23 18:53:35 CST 2018, time=2018-03-23, status=1, ipAttribution=)]
    2018-09-24 珙桐
  4. 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createdName=三生有幸9135, createdTime=Sat Mar 24 15:52:17 CST 2018, time=2018-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=298993, encodeId=0cb429899394, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Mar 23 18:53:35 CST 2018, time=2018-03-23, status=1, ipAttribution=)]
    2018-04-15 feather89
  5. 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level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sun Feb 10 04:45:00 CST 2019, time=2019-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1948550, encodeId=a386194855041, 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=25, 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=Sat Jun 16 02:45:00 CST 2018, time=2018-06-16, status=1, ipAttribution=), 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createdName=三生有幸9135, createdTime=Sat Mar 24 15:52:17 CST 2018, time=2018-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=298993, encodeId=0cb429899394, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Mar 23 18:53:35 CST 2018, time=2018-03-23, status=1, ipAttribution=)]
  6. 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createdName=三生有幸9135, createdTime=Sat Mar 24 15:52:17 CST 2018, time=2018-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=298993, encodeId=0cb429899394, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Mar 23 18:53:35 CST 2018, time=2018-03-23, status=1, ipAttribution=)]
    2019-02-10 minlingfeng
  7. 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  8. 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createdName=三生有幸9135, createdTime=Sat Mar 24 15:52:17 CST 2018, time=2018-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=298993, encodeId=0cb429899394, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Mar 23 18:53:35 CST 2018, time=2018-03-23, status=1, ipAttribution=)]
    2018-03-30 zanzaifeng

    胃食管交界处的癌到底现在是以内科治疗还是外科手术为主?如果是手术的话.是应该胃肠科.还是食管科

    0

  9. 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createdName=三生有幸9135, createdTime=Sat Mar 24 15:52:17 CST 2018, time=2018-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=298993, encodeId=0cb429899394, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Mar 23 18:53:35 CST 2018, time=2018-03-23, status=1, ipAttribution=)]
    2018-03-24 三生有幸9135

    学习一下谢谢分享

    0

  10. 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    2018-03-23 三生有幸9135

    学习一下谢谢分享

    0

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