Lancet Oncol:派姆单抗辅助治疗可显著提高晚期高危黑色素瘤的长期无远处复发存活率!

2021-04-13 MedSci原创 MedSci原创

派姆单抗辅助治疗显著提高了晚期黑色素瘤患者的无远处复发存活率

免疫检查点抑制剂伊匹单抗、纳武单抗和派姆单抗,以及BRAF-MEK抑制剂联合达拉非尼和曲美替尼用于晚期黑色素瘤患者的疗效在这些治疗在辅助措施背景下的阳性结果所反映。而且,在高复发风险的患者中也已证实了上述药物可延长无进展存活期。

欧洲癌症研究与治疗组织(EORTC)1325/KEYNOTE-054试验评估了派姆单抗 vs 安慰剂在高危型III期黑色素瘤切除患者中的作用。中位随访15个月,派姆单抗相比安慰剂显著提高了患者的无进展存活率(HR 0.57,P<0.0001),促使派姆单抗在美国和欧洲获批。

本文报道了该临床适应次要疗效终点的最终分析结果:无远处转移存活率和无复发存活率的最新数据。

EORTC 1325-MG/KEYNOTE-054试验是一项双盲、随机、安慰剂为对照的3期研究,在23个国家的123个学术中心和医院开展的,招募了年满18岁的手术完全切除了的有淋巴结转移的皮肤黑色素瘤患者(IIIA-IIIC)。受试患者被随机分至两组,接受派姆单抗(200 mg)或安慰剂,3周一次,共18次,或出现疾病复发及不可耐受的毒副作用。主要终点是无复发存活率。次要终点是无远处复发存活率。

不同分期患者的无远处复发存活率(A图 IIIA、B图 IIIB、C图 IIIC)

2015年8月26日-2016年11月14日,共招募了1019位患者,其中514位接受了派姆单抗治疗,505位接受了安慰剂。中位随访42.3个月时,在意向治疗人群中,派姆单抗组的3.5年无远处转移存活率明显高于安慰剂组(65.3% vs 49.4%;HR 0.60, P<0.0001)。在853位PD-L1阳性患者中,派姆单抗组和安慰剂组的3.5年无远处转移存活率分别为66.7% vs 51.6%(HR 0.61,P<0.0001)

无复发存活率

无论是在意向治疗人群还是在PD-L1阳性患者中,派姆单抗组的无复发存活率均高于安慰剂组:59.8% vs 41.4%(HR 0.59)和61.4% vs 44.1%(0.59)

综上所述,在中位随访3.5年时间里,派姆单抗辅助治疗显著提高了晚期黑色素瘤患者的无远处复发存活率,与无复发存活率的提高相一致。该研究结果支持采用派姆单抗作为切除的高危的III期皮肤黑色素瘤患者的术后辅助治疗。

原始出处:

Alexander M M Eggermont, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial. The Lancet Oncology. April 12, 2021. https://doi.org/10.1016/S1470-2045(21)00065-6

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    2021-04-15 sunylz
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    2021-11-26 howi
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    2021-05-14 minlingfeng
  4. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Thu Apr 15 02:18:57 CST 2021, time=2021-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565065, encodeId=78dd156506564, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Thu Apr 15 02:18:57 CST 2021, time=2021-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025960, encodeId=78931025960f2, content=肿瘤免疫是大家关心的话题,K药与其它药对比,值得关注!, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=健康达人, createdTime=Tue Apr 13 14:18:57 CST 2021, time=2021-04-13, status=1, ipAttribution=)]
  5. 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GetPortalCommentsPageByObjectIdResponse(id=1025960, encodeId=78931025960f2, content=肿瘤免疫是大家关心的话题,K药与其它药对比,值得关注!, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=健康达人, createdTime=Tue Apr 13 14:18:57 CST 2021, time=2021-04-13, status=1, ipAttribution=)]
    2021-04-22 科研科研科研

    单抗辅助治疗

    0

  6. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Thu Apr 15 02:18:57 CST 2021, time=2021-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565065, encodeId=78dd156506564, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Thu Apr 15 02:18:57 CST 2021, time=2021-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1025960, encodeId=78931025960f2, content=肿瘤免疫是大家关心的话题,K药与其它药对比,值得关注!, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=健康达人, createdTime=Tue Apr 13 14:18:57 CST 2021, time=2021-04-13, status=1, ipAttribution=)]
    2021-04-15 科研科研科研

    辅助治疗

    0

  7. 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    2021-04-13 健康达人

    肿瘤免疫是大家关心的话题,K药与其它药对比,值得关注!

    0

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