JAMA |我国学者:卡瑞丽珠单抗降低晚期食管癌患者3成生存率、4成无进展生存!

2021-09-17 MedSci原创 MedSci原创

在晚期或转移性食管鳞状细胞癌患者中,在化疗的基础上加用卡瑞丽珠可显著改善总生存期和无进展生存期。

晚期或转移性食管癌的标准一线疗法是化疗,但预后仍然不佳。卡瑞丽珠单抗是一种抗程序化死亡受体1[PD-1]的抗体。先前的研究表明,卡瑞丽珠治疗的晚期或转移性食管鳞状细胞癌显示出抗肿瘤活性。

为了评价在标准化疗基础上加用卡瑞丽珠单抗对晚期或转移性食管鳞状细胞癌一线治疗的疗效和不良事件,来自我国中山大学肿瘤中心、华南地区肿瘤学国家重点实验室的专家开展了随机、双盲、安慰剂对照的多中心3期试验(ESCORT-1st研究),结果发表在JAMA杂志上。

该研究在2018年12月3日至2020年5月12日(最终随访,2020年10月30日)期间招募了来自中国60家医院的患者。共筛选了751名患者,对596名符合条件的未经治疗的晚期或转移性食管鳞癌患者按1:1的比例随机接受卡瑞丽珠200mg(n = 298)或安慰剂(n = 298)治疗,同时进行最多六个周期的紫杉醇(175毫克/平方米)和顺铂(75毫克/平方米)。所有治疗都是每3周静脉注射一次。该研究的首要终点是总生存期(OS)和无进展生存期(PFS)。

结果在596名随机接受治疗的患者中(中位年龄,62岁[四分位数范围,56-67岁];523名男性[87.8%]),安慰剂-化疗组的1名患者没有接受计划治疗。共有490名患者(82.2%)中止了研究治疗。随访的中位数为10.8个月。卡瑞丽珠-化疗组的总生存期中位数为15.3个月(95%CI,12.8-17.3;135人死亡),而安慰剂-化疗组的中位数为12.0个月(95%CI,11.0-13.3;174人死亡)。总得来说,加用卡瑞丽珠降低30%的死亡率(HR=0.70[95%CI,0.56-0.88])。

两组患者随访期间OS比较

另一方面,卡瑞丽珠加化疗的PFS中位数为6.9个月(95%CI,5.8-7.4;199例进展或死亡),而安慰剂-化疗组为5.6个月(95%CI,5.5-5.7;229例进展或死亡),进展或死亡风险降低44%(HR=0.56[95%CI,0.46-0.68])。

卡瑞丽珠-化疗组的189名患者(63.4%)和安慰剂-化疗组的201名患者(67.7%)发生了3级或以上的治疗相关不良事件,包括分别有9名患者(3.0%)和11名患者(3.7%)的治疗相关死亡。

综上,在晚期或转移性食管鳞状细胞癌患者中,在化疗的基础上加用卡瑞丽珠可显著改善总生存期和无进展生存期。

 

 

参考文献:

Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021;326(10):916–925. doi:10.1001/jama.2021.12836

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    2022-06-03 ms4408957580485341

    这题目起的……

    0

  4. 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    2021-10-31 ms6000001097213183

    题目应该是降低3成死亡率

    0

  5. 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    2021-09-19 zhouqu_8
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  8. 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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJibu7hwJqpmHiaJgLLmJmcwp0WDTxWI3vqPBO1Mloq21VBOPqziapyibYatvd2QWHWicolL1vbVZHgpRQ/132, createdBy=d16a2107341, createdName=JZ Yang, createdTime=Fri Sep 17 23:51:02 CST 2021, time=2021-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1052448, encodeId=d2ae1052448b8, content=降低生存率。。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7faf2272723, createdName=121ab173m18暂无昵称, createdTime=Fri Sep 17 22:58:13 CST 2021, time=2021-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1052625, encodeId=0b1d1052625ac, 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=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Fri Sep 17 17:47:41 CST 2021, time=2021-09-17, status=1, ipAttribution=)]
    2021-09-17 JZ Yang

    感谢分享

    0

  9. 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    2021-09-17 121ab173m18暂无昵称

    降低生存率。。。

    0

  10. 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    2021-09-17 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

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肺跃2年,艾满中华:卡瑞利珠单抗联合化疗在脑转移和KRAS突变NSCLC患者中同样可带来长生存获益

本期特邀北京大学肿瘤医院胡维亨教授及其团队进行病例分享与点评。

JAMA:卡瑞丽珠单抗联合化疗一线治疗明显改善晚期食管鳞状细胞癌患者的预后:3期临床研究ESCORT-1st

该研究表明,卡瑞丽珠单抗联合化疗一线治疗明显改善晚期食管鳞状细胞癌患者的预后。