JCO:Pembrolizumab 联合Ipilimumab治疗PD1/PDL1抑制剂失败黑素色瘤的疗效和安全性

2021-05-09 MedSci原创 MedSci原创

Pembrolizumab 联合Ipilimumab治疗PD1/PDL1抑制剂失败黑素色瘤具有良好疗效和安全性

免疫检查点抑制剂明显改善晚期黑素色瘤的预后。抗CTLA4和抗PD1抑制剂的使用,让黑素色瘤5年的总生存(OS)从34提高到52%。两者的联合能够改善患者的缓解率(RR),无进展生存期(PFS)和OS。但是3-4级的毒性明显升高。因此,一线治疗失败后,大部分会在二线选择单药(PD1抑制剂或Ipilimumab)。目前没有前瞻性研究评估抗PD1抑制剂联合抗CTLA4抑制剂治疗PD1/PL1抑制剂失败黑素色瘤的疗效与安全性。

 

本研究旨在Pembrolizumab 联合Ipilimumab治疗PD1/PDL1抑制剂失败黑素色瘤的疗效和安全性。

该研究为开放性、单臂多中心的II期研究,纳入了70例既往PD1/PDL1抑制剂治疗失败黑素色瘤患者。予pembrolizumab (200 mg) 联合低剂量ipilimumab (1 mg/kg) /3周,共4周期,接着予pembrolizumab 200 mg/次/3周维持治疗直到2年。

研究发现,20例患者(20/70,29%)达到临床缓解,包括5例患者完全缓解(7.2%)和15例患者部分缓解(21.4%)。

                                                                         临床获益程度

中位PFS 为5 个月 (95% CI, 2.8 to 8.3)。 对于临床有效患者,中位缓解时间(DOR)为 16.6 个月 (95% CI, 7.9 to未达到)。中位 OS 为 24.7个月(95% CI, 15.2 to未达到)。截止数据锁定分析时,20例临床相应患者仍有14例(70%) 在治疗。

                                                       无进展时间和临床响应持续时间

 

87%(62/70)的患者发生了任何程度治疗相关的不良事件,常见是皮肤瘙痒、皮疹、腹泻、疲劳、恶心和转氨酶升高27%(19/70)的患者发生3-4级治疗相关不良反应事件,最常见的是结肠炎、腹泻、皮疹和转氨酶升高。

                                                治疗相关不良事件

综上,这是这是首个针对黑素色瘤PD1/L1抑制剂治疗失败后应用Pembrolizumab 联合低剂量Ipilimumab治疗的前瞻性研究,该联合方案显示出显著的抗肿瘤活性和耐受性。

 

原始出处:

Daniel J Olson, Zeynep Eroglu, Bruce Brockstein, et al. Pembrolizumab Plus Ipilimumab Following Anti-PD-1/L1 Failure in Melanoma. J Clin Oncol. 2021 May 4; JCO2100079.  doi: 10.1200/JCO.21.00079. Online ahead of print.

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createdName=jklm09, createdTime=Mon Oct 18 16:15:05 CST 2021, time=2021-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787021, encodeId=0b431e87021f0, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, createdName=chendoc242, createdTime=Sun Jul 25 07:15:05 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912596, encodeId=846619125960f, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Apr 10 12:15:05 CST 2022, time=2022-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1721014, encodeId=b07c1e21014cf, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Mon Jan 24 11:15:05 CST 2022, time=2022-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1891653, encodeId=63e418916533d, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Thu Oct 21 02:15:05 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272562, encodeId=73e612e256251, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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 May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365767, encodeId=15331365e67ce, content=<a href='/topic/show?id=8d16999eda' target=_blank style='color:#2F92EE;'>#Ipilimumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9997, encryptionId=8d16999eda, topicName=Ipilimumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Tue May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1538765, encodeId=57ac1538e6560, content=<a href='/topic/show?id=6b2c13962d1' target=_blank style='color:#2F92EE;'>#PDL1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13962, encryptionId=6b2c13962d1, topicName=PDL1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Tue May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032903, encodeId=ff011032903de, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 00:15:05 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2022-04-10 snf701207
  5. 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channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Thu Oct 21 02:15:05 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272562, encodeId=73e612e256251, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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 May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365767, encodeId=15331365e67ce, content=<a href='/topic/show?id=8d16999eda' target=_blank style='color:#2F92EE;'>#Ipilimumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9997, encryptionId=8d16999eda, topicName=Ipilimumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Tue May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1538765, encodeId=57ac1538e6560, content=<a href='/topic/show?id=6b2c13962d1' target=_blank style='color:#2F92EE;'>#PDL1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13962, encryptionId=6b2c13962d1, topicName=PDL1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Tue May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032903, encodeId=ff011032903de, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 00:15:05 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1728938, encodeId=d2fb1e2893844, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Wed Jul 07 15:15:05 CST 2021, time=2021-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852651, encodeId=efd81852651a3, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, 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encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sun Apr 10 12:15:05 CST 2022, time=2022-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1721014, encodeId=b07c1e21014cf, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Mon Jan 24 11:15:05 CST 2022, time=2022-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1891653, encodeId=63e418916533d, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Thu Oct 21 02:15:05 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272562, encodeId=73e612e256251, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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 May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365767, encodeId=15331365e67ce, content=<a href='/topic/show?id=8d16999eda' target=_blank style='color:#2F92EE;'>#Ipilimumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9997, encryptionId=8d16999eda, topicName=Ipilimumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Tue May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1538765, encodeId=57ac1538e6560, content=<a href='/topic/show?id=6b2c13962d1' target=_blank style='color:#2F92EE;'>#PDL1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13962, encryptionId=6b2c13962d1, topicName=PDL1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Tue May 11 12:15:05 CST 2021, time=2021-05-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032903, encodeId=ff011032903de, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 00:15:05 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2021-10-21 lidong40
  7. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032903, encodeId=ff011032903de, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 00:15:05 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
  8. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032903, encodeId=ff011032903de, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 00:15:05 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2021-05-11 柳叶一刀
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032903, encodeId=ff011032903de, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Mon May 10 00:15:05 CST 2021, time=2021-05-10, status=1, ipAttribution=)]
    2021-05-10 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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