Oncologist:Pembrolizumab(帕博利珠单抗)联合CAPOX(奥沙利铂+卡培他滨)治疗晚期胆管癌(BTC)的疗效和安全性

2022-03-19 yd2015 网络

研究表明,卡培他滨+奥沙利铂联合帕博利珠单抗可耐受,是难治性晚期BTC的一种潜在有效治疗方法。

近期,Oncologist杂志上发表了一项II期临床研究结果,主要评估晚期胆管癌(BTC)使用PD-1抑制剂pembrolizumab(帕博利珠单抗)联合CAPOX(奥沙利铂+卡培他滨)治疗的疗效和安全性。

研究的患者经组织学证实为BTC,帕博利珠单抗+奥沙利铂 d1,卡培他滨 bid d1-d14,共6周期。从第7周期开始,使用帕博利珠单抗单药维持治疗,直到疾病进展。主要终点为无进展生存期(PFS)。次要终点是安全性、耐受性、可行性和有效率。

研究纳入11例患者,中位年龄为67岁(51 - 81岁),55%的患者为女性。11例患者中有7例(64%)ECOG评分为0,其余患者为1。超过三分之一的患者(36%)有转移性疾病,54%的患者在参与研究前接受过两次或更多的全身化疗。只有一名患者有治疗相关的基因改变:FGFR融合。所有患者均为pMMR状态。

PD患者平均接受5.5个周期的治疗,SD患者平均接受6.5个周期的治疗,部分缓解(PR)的患者平均接受8.5个周期的治疗。所有患者的中位随访时间为34.8个月。所有患者的反应均可评估。2例(18.2%)患者以PD为最佳治疗反应,6例(54.6%)患者以SD为最佳治疗反应,3例(27.3%)患者以PR为最佳治疗反应。在参与研究前接受治疗的8名患者中,4名患有SD, 2名患有PR。3名既往未接受治疗患者,2例为SD, 1例为PR。3例胆囊癌患者中,1例为PR, 2例为SD。包括PR和SD在内的总体疾病控制率为81.8%。

中位无进展生存期为4.1个月(95% CI: 2.5-6.9个月),6个月PFS率为45.5% (95% CI: 16.7-70.7%), 12个月PFS率为9.1% (95% CI: 0.5-33.3%)。11例患者中有5例超过5个月才进展(45%;95%CI:16.8 -76.6%)。中位OS为9.9个月(95% CI: 5.1-15.1个月),6个月的OS率为81.8% (95% CI: 44.7-95.1%), 12个月的OS率为45.5% (95% CI: 16.7-70.7%), 18个月的OS率为18.2% (95% CI: 2.9-44.2%)。

最常见的3级和4级不良事件是淋巴细胞计数下降(64%)、贫血(36%)、血小板计数下降(27%)和低钠血症(27%)。无免疫介导的不良事件或治疗相关的死亡。

综上,研究表明,卡培他滨+奥沙利铂联合帕博利珠单抗可耐受,是难治性晚期BTC的一种潜在有效治疗方法。

原始出处:

Cecilia Monge, Erica C. Pehrsson, Changqing Xie, et al. A Phase II Study of Pembrolizumab in Combination with Capecitabine and Oxaliplatin with Molecular Profiling in Patients with Advanced Biliary Tract Carcinoma. The Oncologist, 2022, 27, e273–e285. https://doi.org/10.1093/oncolo/oyab073. 

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    2022-12-27 heli0118
  3. 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    2022-10-14 minlingfeng
  4. 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createdTime=Mon Mar 21 11:02:18 CST 2022, time=2022-03-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1293540, encodeId=233f1293540d5, content=<a href='/topic/show?id=a82f36493c4' target=_blank style='color:#2F92EE;'>#卡培他滨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36493, encryptionId=a82f36493c4, topicName=卡培他滨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c8c241, createdName=w363522449, createdTime=Mon Mar 21 11:02:18 CST 2022, time=2022-03-21, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=2056895, encodeId=2b532056895b4, 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=42, 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=Sat Dec 24 11:02:18 CST 2022, time=2022-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787041, encodeId=380d1e870416e, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=null, 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encodeId=97441e37786ad, content=<a href='/topic/show?id=292f965e5b5' target=_blank style='color:#2F92EE;'>#铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96575, encryptionId=292f965e5b5, topicName=铂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca4034296500, createdName=ms3153534357578991, createdTime=Sun Sep 11 20:02:18 CST 2022, time=2022-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272582, encodeId=279b12e25826e, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14028, encryptionId=4323140286a, topicName=Pembrolizumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Mon Mar 21 11:02:18 CST 2022, time=2022-03-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1293540, encodeId=233f1293540d5, content=<a href='/topic/show?id=a82f36493c4' target=_blank style='color:#2F92EE;'>#卡培他滨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36493, encryptionId=a82f36493c4, topicName=卡培他滨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c8c241, createdName=w363522449, createdTime=Mon Mar 21 11:02:18 CST 2022, time=2022-03-21, status=1, ipAttribution=)]
    2022-12-11 feather89
  6. [GetPortalCommentsPageByObjectIdResponse(id=2056895, encodeId=2b532056895b4, 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=42, 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=Sat Dec 24 11:02:18 CST 2022, time=2022-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787041, encodeId=380d1e870416e, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=null, 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encodeId=97441e37786ad, content=<a href='/topic/show?id=292f965e5b5' target=_blank style='color:#2F92EE;'>#铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96575, encryptionId=292f965e5b5, topicName=铂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca4034296500, createdName=ms3153534357578991, createdTime=Sun Sep 11 20:02:18 CST 2022, time=2022-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272582, encodeId=279b12e25826e, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14028, encryptionId=4323140286a, topicName=Pembrolizumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Mon Mar 21 11:02:18 CST 2022, time=2022-03-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1293540, encodeId=233f1293540d5, content=<a href='/topic/show?id=a82f36493c4' target=_blank style='color:#2F92EE;'>#卡培他滨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36493, encryptionId=a82f36493c4, topicName=卡培他滨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c8c241, createdName=w363522449, createdTime=Mon Mar 21 11:02:18 CST 2022, time=2022-03-21, status=1, ipAttribution=)]
    2023-03-05 smlt2008
  7. 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    2022-09-03 snf701207
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