Lancet oncol:Cemiplimab在局部晚期基底细胞癌中的抗肿瘤活性令人可期

2021-05-15 Nebula MedSci原创

西米普利单抗在HHI治疗后的局部晚期基底细胞癌患者中表现出了具有临床意义的抗肿瘤活性和可接受的安全性

在2021年2月前,一线hedgehog抑制剂(HHI)治疗后的局部晚期基底细胞癌尚无标准治疗方案。西米普利单抗(Cemiplimab)是一种PD-1抗体,已获批用于治疗晚期皮肤鳞状细胞癌,而且还显示出了作为非小细胞肺癌一线单一疗法的临床活性

本文报道了西米普利单抗用于HHI治疗后的局部晚期基底细胞癌患者的主要结果分析。

这是一项在多个国家的38个医疗学术中心开展的开放标签、多中心、单臂的2期临床试验,招募了年满18岁的、ECOG表现状态评分0-1分的、组织学确诊的转移性基底细胞癌(第一组)或经HHI治疗后进展或对HHI治疗耐药的局部晚期基底细胞癌(第二组)患者。予以西米普利单抗 350 mg/3周,静滴,长达93周或直到病程进展或出现不可耐受的毒性。主要终点是客观缓解率。

每次评估时的缓解情况

2017年11月16日-2019年1月7日,共招募了84位患者,均接受了西米普利单抗治疗。截止2020年2月14日,中位随访了15个月(IQR 8-18)。在这84位患者中,有26位(31%)获得了客观缓解,包括2例在截止日期前肿瘤评估时出现的部分缓解。总体上,5位(6%)患者获得了完全缓解,21位(25%)获得了部分缓解

无进展生存期

40位(48%)患者发生了3-4级的需紧急治疗的不良反应事件,最常见的是高血压(5%,4/84)和结肠炎(5%,4/84)。29位(35%)患者发生了严重的需紧急治疗的不良反应。无治疗相关死亡。

总之,西米普利单抗在HHI治疗后的局部晚期基底细胞癌患者中表现出了具有临床意义的抗肿瘤活性和可接受的安全性,值得进一步研究。

原始出处:

Alexxander J Stratigos, et al. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. The Lancet Oncology. May 14, 2021. https://doi.org/10.1016/S1470-2045(21)00126-1

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createdName=qingting, createdTime=Sun Mar 27 18:08:26 CST 2022, time=2022-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1674968, encodeId=77cd16e49689a, content=<a href='/topic/show?id=5521556518b' target=_blank style='color:#2F92EE;'>#抗肿瘤活性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55651, encryptionId=5521556518b, topicName=抗肿瘤活性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cf5227147934, createdName=cmj17wellington, createdTime=Mon Aug 09 06:08:26 CST 2021, time=2021-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650803, encodeId=5fc81650803cd, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406048, encodeId=5540140604835, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Mon May 17 10:08:26 CST 2021, time=2021-05-17, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1994096, encodeId=a8cb199409677, content=<a href='/topic/show?id=a6c4420601d' target=_blank style='color:#2F92EE;'>#基底细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42060, encryptionId=a6c4420601d, topicName=基底细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Thu Jul 08 19:08:26 CST 2021, time=2021-07-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1979121, encodeId=9ea019e912195, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Sun Mar 27 18:08:26 CST 2022, time=2022-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1674968, encodeId=77cd16e49689a, content=<a href='/topic/show?id=5521556518b' target=_blank style='color:#2F92EE;'>#抗肿瘤活性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55651, encryptionId=5521556518b, topicName=抗肿瘤活性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cf5227147934, createdName=cmj17wellington, createdTime=Mon Aug 09 06:08:26 CST 2021, time=2021-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650803, encodeId=5fc81650803cd, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, 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channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Thu Nov 25 12:08:26 CST 2021, time=2021-11-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2034546, encodeId=17c0203454615, content=<a href='/topic/show?id=3a9382989a2' target=_blank style='color:#2F92EE;'>#肿瘤活性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82989, encryptionId=3a9382989a2, topicName=肿瘤活性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=af60254, createdName=mhm289, createdTime=Mon Jan 31 17:08:26 CST 2022, time=2022-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831163, encodeId=ba231831163b4, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sat Aug 07 06:08:26 CST 2021, time=2021-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866087, encodeId=ec79186608e6b, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Fri Jun 11 15:08:26 CST 2021, time=2021-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406048, encodeId=5540140604835, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Mon May 17 10:08:26 CST 2021, time=2021-05-17, status=1, ipAttribution=)]
    2022-04-21 zlawrance
  6. [GetPortalCommentsPageByObjectIdResponse(id=1994096, encodeId=a8cb199409677, content=<a href='/topic/show?id=a6c4420601d' target=_blank style='color:#2F92EE;'>#基底细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42060, encryptionId=a6c4420601d, topicName=基底细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Thu Jul 08 19:08:26 CST 2021, time=2021-07-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1979121, encodeId=9ea019e912195, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, 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href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sat Aug 07 06:08:26 CST 2021, time=2021-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866087, encodeId=ec79186608e6b, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Fri Jun 11 15:08:26 CST 2021, time=2021-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406048, encodeId=5540140604835, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Mon May 17 10:08:26 CST 2021, time=2021-05-17, status=1, ipAttribution=)]
    2021-11-25 snf701207
  7. 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  8. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406048, encodeId=5540140604835, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Mon May 17 10:08:26 CST 2021, time=2021-05-17, status=1, ipAttribution=)]
    2021-08-07 howi
  9. 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    2021-06-11 minlingfeng
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    2021-05-17 chg122

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