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NCCN更新：帕博利珠单抗联合化疗——晚期肺鳞癌患者一线治疗新选择

2018-08-29 佚名 肿瘤资讯

帕博利珠单抗联合化疗晚期肺鳞癌患者一线治疗
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晚期肺鳞癌患者的一线治疗一直以铂类为基础的双药化疗为主，治疗方式相对较局限，近年来进展相对缓慢，直至免疫治疗的出现。2018年美国肿瘤学年会（ASCO）上首次公布了KEYNOTE-407，结果喜人，为晚期肺鳞癌患者一线治疗提供了新的治疗选择。近期更新的非小细胞肺癌NCCN指南V6版基于KEYNOTE-407研究结果将免疫联合化疗推荐作为PS评分0-1分患者一线治疗方式，证据级别2A级。自此，免疫治

晚期肺鳞癌患者的一线治疗一直以铂类为基础的双药化疗为主，治疗方式相对较局限，近年来进展相对缓慢，直至免疫治疗的出现。2018年美国肿瘤学年会（ASCO）上首次公布了KEYNOTE-407，结果喜人，为晚期肺鳞癌患者一线治疗提供了新的治疗选择。近期更新的非小细胞肺癌NCCN指南V6版基于KEYNOTE-407研究结果将免疫联合化疗推荐作为PS评分0-1分患者一线治疗方式，证据级别2A级。自此，免疫治疗联合化疗成为晚期肺鳞癌患者一线治疗新方案。

近年来，免疫治疗在黑色素瘤、肺癌以及其他多个瘤种中取得了突破性进展，极大改善了肿瘤患者的预后。在晚期NSCLC患者中开展的KEYNOTE-010、KEYNOTE-024、KEYNOTE-042、KEYNOTE-189和KEYNOTE-407等5项III期临床研究中，帕博利珠单抗(pembrolizumab， PD-1抑制剂) 均显示出总生存获益，上述研究共同引领着晚期NSCLC的一线和二线治疗变革。2018年ASCO会议对KEYNOTE-407研究结果进行了口头报道，研究结果显示，对于晚期肺鳞癌而言，一线帕博利珠单抗联合化疗（紫杉醇+卡铂）可以显着改善患者的ORR，这一研究结论揭示为晚期肺鳞癌治疗带来了新希望。基于KEYNOTE-407研究， 2018年更新的V6版NCCN指南推荐帕博利珠单抗联合化疗紫杉或白蛋白紫杉醇用于晚期肺鳞癌患者一线治疗。

KEYNOTE-407 (NCT02775435)是一项多中心、随机、安慰剂对照研究，研究共纳入560例初治晚期肺鳞癌患者，ECOG评分0-1分。分层因素包括紫杉醇类型、PD-L1表达水平(TPS<1% vs. ≥1%)和地域(东亚与其他)。患者被随机分为2组，一组接受4周期卡铂（6mg/ml/min）+紫杉醇（200mg/m2，每三周一次）或白蛋白紫杉醇（100mg/m2，每周一次）联合帕博利珠单抗治疗；而另一组接受4周期化疗+安慰剂对照。4周期联合治疗后继续使用帕博利珠单抗或安慰剂维持治疗，总疗程为35次。研究的主要终点为PFS和OS，疗效评估采用RECIST1.1标准。

在第一次中期分析时，共有204例患者完成随机，其中101例接受化疗+帕博利珠单抗治疗，103例接受化疗+安慰剂治疗；中位随访时间为7.7月(0.4-13.9月)。在第二次中期分析中，559例患者接受随机，其中278例患者帕博利珠单抗(Keytruda)+化疗组，281例进行化疗+安慰剂组。PD-L1为TPS<1%在两组分别为24.2%和35.2%。帕博利珠单抗+化疗组和化疗+安慰剂组患者的ORR分别为58.4%和35.0% (p=0.0004)。

两组患者的中位缓解时间分别为7.7个月和4.8个月。65.8%接受帕博利珠单抗+化疗治疗患者的中位缓解时间超过6个月，而这一数字在单纯化疗组中仅为45.6%。此外，帕博利珠单抗+化疗组和单纯化疗组3-4级的AE发生率分别为64.4%和74.5%。帕博利珠单抗+化疗组和安慰剂+化疗组患者的中位OS分别为15.9个月和11.3个月（P=0.0008）。

联合免疫治疗已经成为晚期NSCLC一线治疗的研究热点。KEYNOTE-407研究结果表明，帕博利珠单抗+化疗，或联合化疗可以显着提高晚期肺鳞癌患者ORR，并且安全性良好。NCCN指南的更新，进一步明确了化疗联合帕博利珠单抗对于晚期肺鳞癌患者的治疗地位。而靶向治疗和免疫治疗领域研究的不断进步，使得肺癌可选择的治疗手段越来越多，患者的获益程度也越来越大，也使得肺癌在往慢性病转变的过程中又前进了一大步。

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    2019-08-05 木头人513

    #鳞癌患者#

    0

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    2019-06-13 yankaienglish

    #帕博利珠#

    0

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    2018-08-31 旅苦化文_208

    #NCCN#

    0

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    2018-08-31 ms9476844295372110

    #肺鳞癌#

    0

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    2018-08-31 oliver170

    #联合化疗#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1822425, encodeId=5fb31822425de, content=<a href='/topic/show?id=1cdd10294572' target=_blank style='color:#2F92EE;'>#鳞癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102945, encryptionId=1cdd10294572, topicName=鳞癌患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0045169, createdName=木头人513, createdTime=Mon Aug 05 14:44:00 CST 2019, time=2019-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056852, encodeId=b1262056852af, content=<a href='/topic/show?id=7ca2484816b' target=_blank style='color:#2F92EE;'>#帕博利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48481, encryptionId=7ca2484816b, topicName=帕博利珠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8ebc122, createdName=yankaienglish, createdTime=Thu Jun 13 19:44:00 CST 2019, time=2019-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1319991, encodeId=982113199911f, content=<a href='/topic/show?id=c806125e30b' target=_blank style='color:#2F92EE;'>#NCCN#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12573, encryptionId=c806125e30b, topicName=NCCN)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e572480, createdName=旅苦化文_208, createdTime=Fri Aug 31 12:44:00 CST 2018, time=2018-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1391476, encodeId=4eaa13914e649, content=<a href='/topic/show?id=e944823960d' target=_blank style='color:#2F92EE;'>#肺鳞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82396, encryptionId=e944823960d, topicName=肺鳞癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqIKWggTpsfaibibH2TPcmkicia1NoYyf3xCJ4RecQWjM1HibataOErQgyoRaXFwicVMKO4xkcPIMN7skbw/132, createdBy=91c62500083, createdName=ms9476844295372110, createdTime=Fri Aug 31 12:44:00 CST 2018, time=2018-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1411728, encodeId=f22e1411e28ba, 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=26, 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=Fri Aug 31 12:44:00 CST 2018, time=2018-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1484645, encodeId=1ef314846451f, content=<a href='/topic/show?id=3502102944e7' target=_blank style='color:#2F92EE;'>#鳞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102944, encryptionId=3502102944e7, topicName=鳞癌)], attachment=null, authenticateStatus=null, createdAvatar=Bioon/avatar/20171006/a73877485ccdf6add82293e671bebe21.jpg, createdBy=745a7977375, createdName=1696533704_45270456, createdTime=Fri Aug 31 12:44:00 CST 2018, time=2018-08-31, status=1, ipAttribution=)]
    2018-08-31 1696533704_45270456

    #鳞癌#

    0

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