NICE推荐pembrolizumab单药作为3期黑色素瘤的辅助疗法

2021-12-19 Allan MedSci原创

NICE 已发布指南,推荐 Merck/MSD 的 Keytruda (pembrolizumab) 作为单一疗法用于辅助治疗已接受完全切除的淋巴结受累的 3 期黑色素瘤成人患者。

NICE 已发布指南,推荐 Merck/MSD 的 Keytruda (pembrolizumab) 作为单一疗法用于辅助治疗已接受完全切除的淋巴结受累的 3 期黑色素瘤成人患者。

黑色素瘤是男性第二常见的癌症,女性第三常见的癌症。英国每年大约有 16,700 例新的黑色素瘤皮肤癌病例,使其成为该国最流行的癌症之一。大约 7% 的患者在第 3 阶段被诊断出来,这个疾病阶段的五年生存率估计约为 50-55%。完全切除的 3 期黑色素瘤处于疾病复发的高风险中,五年无复发生存率为 28-44%。

在过去十年中,黑色素瘤领域取得了巨大的医学进步,免疫疗法治疗已成为其中不可或缺的一部分。对癌症复发的恐惧是患者和家属的巨大心理负担,尤其是对于越来越多的黑色素瘤患者来说,这些患者在年轻时被诊断出来,他们的大部分生命都终结在15 至 44 岁之间。

在辅助治疗成为某些患者的可用选择之前,黑色素瘤的标准术后实践是主动监测,密切监测患者以检查癌症复发。根据该批准所依据的III期 EORTC1325/KEYNOTE-054 试验,这些患者中有超过四分之三的人在初始治疗后的一年内不会出现癌症复发。

这项双盲、随机、对照、III期试验在 23 个国家的 123 个学术中心和社区医院进行。2015 年 8 月 26 日至 2016 年 11 月 14 日期间,1019 名患者被分配接受pembrolizumab(n=514)或安慰剂(n=505)。在 42.3 个月的总体中位随访中,pembrolizumab组的 3.5 年无远端转移生存率高于安慰剂组(p<0.0001)(图)。在 853 名 PD-L1 阳性肿瘤患者中,pembrolizumab组的 3.5 年无远端转移生存率为 66.7%,安慰剂组为51.6%(p<0.0001)。在这 3.5 年,pembrolizumab组的无复发生存率比安慰剂组显著更高。

图.无远端转移生存率

 

原始出处:

https://www.pharmatimes.com/news/nice_recommends_monotherapy_for_adjuvant_treatment_of_stage_3_melanoma_1385586

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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=30, 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=Tue Dec 21 07:42:58 CST 2021, time=2021-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565119, encodeId=cd3315651196a, 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=34, 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=Tue Dec 21 07:42:58 CST 2021, time=2021-12-21, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1787037, encodeId=b5d61e8703754, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, createdName=chendoc242, createdTime=Tue Apr 26 13:42:58 CST 2022, time=2022-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912739, encodeId=681c1912e391d, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, 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objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14028, encryptionId=4323140286a, topicName=Pembrolizumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Tue Dec 21 07:42:58 CST 2021, time=2021-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1289107, encodeId=7563128910e3c, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Tue Dec 21 07:42:58 CST 2021, time=2021-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559110, encodeId=9dc81559110ed, 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=30, 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=Tue Dec 21 07:42:58 CST 2021, time=2021-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565119, encodeId=cd3315651196a, 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=34, 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=Tue Dec 21 07:42:58 CST 2021, time=2021-12-21, status=1, ipAttribution=)]
    2022-09-16 sunylz
  6. 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  7. 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2021, time=2021-12-21, status=1, ipAttribution=)]
    2021-12-21 fusion
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