Front Oncol: 一线化疗的基础上联合PD-1抑制剂可改善晚期胆道癌患者的预后

2021-10-24 yd2015 MedSci原创

研究表明,晚期BTC患者在一线化疗的基础上加入PD-1抑制剂能改善患者的PFS,并且毒性可控。未来需要更多的临床随机研究去进一步证实。

晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。

研究回顾性分析中国人民解放军总医院肿瘤科接受PD-1抑制剂联合化疗(抗PD-1+C组)或单独化疗(C组)的晚期BTC患者。采用倾向评分匹配(PSM)(1:1)来平衡潜在基线混淆因素。采用Kaplan Meier生存曲线和log-rank检验分析无进展生存(PFS)、客观缓解率(ORR)、疾病控制率(DCR)和安全性。

研究期间,59例患者接受单独化疗,75例患者接受化疗+ PD-1抑制剂治疗。倾向评分匹配(PSM)前,抗PD -1+化疗组(抗pd -1+C组)女性患者多于化疗组(C组)(40% vs. 23.7%;P = 0.04)。抗PD-1+C组多器官转移患者多于C组(2例以上)(44.0% vs. 27.1%, P=0.045)。抗PD-1+C组无肝转移患者多于C组(57.3% vs. 32.2%, P=0.004)。两组间其他变量的基线差异无统计学意义。经1:1配对后,46对患者入选本研究。

抗PD-1+C组患者的中位PFS为5.8个月, C组患者的中位PFS为3.2个月(HR: 0.47, 95% CI: 0.29 ~ 0.76, P=0.004)。肿瘤消退方面,C组46例患者中PR 7例,SD 25例,PD 14例。从而ORR为15.2%,DCR为69.6%。抗PD-1+C组46例患者中PR 10例,SD 27例,PD 9例。ORR为21.7%,DCR为80.4%。两组之间的肿瘤应答(ORR, DCR)无显著性差异(P=0.423, P=0.231)。由于随访失败,研究没有获得OS。

              PFS

              疗效评估

研究进一步评估肿瘤原发部位、肝转移、转移器官数量的差异是否会影响两组(C组和抗PD -1+C组)的PFS。在肝外胆管癌亚组,两组PFS无差异(P=0.323),而在肝内胆管癌亚组,抗PD-1+C组患者的中位PFS明显长于C组(4.5个月 vs. 2.4个月, P=0.005)。对于肝转移患者,与单纯化疗相比,抗PD-1+C延长了患者的PFS (8.8个月vs. 3.2个月, P=0.006)。抗PD-1+C治疗对少于2个转移器官的患者更有益(7.3个月vs. 3.2个月,P=0.008),但对转移器官更多的患者无效(4.9个月vs. 2.4个月,P=0.075)。

非血液学1-2级AE最高为脱发(C组为41.3%,抗PD-1+C组为50%),其次为周围感觉神经病变(21.7%,26.1%)。抗PD-1+C组甲状腺功能减退(13%)、皮疹(10.9%)、发热(13%)发生率较高。抗PD-1+C组3或4级治疗相关AEs包括甲状腺功能减退(n=3, 6.5%)、皮疹(n=2, 4.3%)和肝炎(n=1, 2.2%),而C组中只有1例患者3-4级肝炎。两组血液学AEs发生率相似,特别是1-2级骨髓抑制(分别为32.6%和41.3%)。未发现与AE相关的死亡。

             不良反应

综上,研究表明,晚期BTC患者在一线化疗的基础上加入PD-1抑制剂能改善患者的PFS,并且毒性可控。未来需要更多的临床随机研究去进一步证实。

原始出处:

Gou M, Zhang Y, Liu T, Si H, Wang Z, Yan H, Qian N and Dai G (2021) PD-1 Inhibitors Could Improve the Efficacy of Chemotherapy as First-Line Treatment in Biliary Tract Cancers: A Propensity Score Matching Based Analysis. Front. Oncol. 11:648068. doi: 10.3389/fonc.2021.648068

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    2022-06-17 jklm09
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    2022-08-12 minlingfeng
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  4. [GetPortalCommentsPageByObjectIdResponse(id=1852790, encodeId=66ad1852e9028, 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=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Jun 17 04:15:27 CST 2022, time=2022-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866318, encodeId=c2151866318b1, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Aug 12 15:15:27 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1924709, encodeId=82501924e09d7, content=<a href='/topic/show?id=74ed1941207' target=_blank style='color:#2F92EE;'>#一线化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19412, encryptionId=74ed1941207, topicName=一线化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ea6321, createdName=okhuali, createdTime=Sat May 07 10:15:27 CST 2022, time=2022-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1278952, encodeId=707e12e895205, content=<a href='/topic/show?id=70e6139138a' target=_blank style='color:#2F92EE;'>#PD-1抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13913, encryptionId=70e6139138a, topicName=PD-1抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=84fb152, createdName=xiongliangxl, createdTime=Tue Oct 26 10:15:27 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063562, encodeId=aa1e106356281, content=非血液学1-2级AE最高为脱发(C组为41.3%,抗PD-1+C组为50%),其次为周围感觉神经病变(21.7%,26.1%)。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 21:02:16 CST 2021, time=2021-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063546, encodeId=e75310635461d, content=晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 20:58:04 CST 2021, time=2021-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063535, encodeId=f20f106353594, content=晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 20:54:19 CST 2021, time=2021-10-24, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1852790, encodeId=66ad1852e9028, 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=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Jun 17 04:15:27 CST 2022, time=2022-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866318, encodeId=c2151866318b1, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Aug 12 15:15:27 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1924709, encodeId=82501924e09d7, content=<a href='/topic/show?id=74ed1941207' target=_blank style='color:#2F92EE;'>#一线化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19412, encryptionId=74ed1941207, topicName=一线化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ea6321, createdName=okhuali, createdTime=Sat May 07 10:15:27 CST 2022, time=2022-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1278952, encodeId=707e12e895205, content=<a href='/topic/show?id=70e6139138a' target=_blank style='color:#2F92EE;'>#PD-1抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13913, encryptionId=70e6139138a, topicName=PD-1抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=84fb152, createdName=xiongliangxl, createdTime=Tue Oct 26 10:15:27 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063562, encodeId=aa1e106356281, content=非血液学1-2级AE最高为脱发(C组为41.3%,抗PD-1+C组为50%),其次为周围感觉神经病变(21.7%,26.1%)。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 21:02:16 CST 2021, time=2021-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063546, encodeId=e75310635461d, content=晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 20:58:04 CST 2021, time=2021-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063535, encodeId=f20f106353594, content=晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 20:54:19 CST 2021, time=2021-10-24, status=1, ipAttribution=)]
    2021-10-24 ms9000000212834100

    非血液学1-2级AE最高为脱发(C组为41.3%,抗PD-1+C组为50%),其次为周围感觉神经病变(21.7%,26.1%)。

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1852790, encodeId=66ad1852e9028, 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=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Fri Jun 17 04:15:27 CST 2022, time=2022-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866318, encodeId=c2151866318b1, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Aug 12 15:15:27 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1924709, encodeId=82501924e09d7, content=<a href='/topic/show?id=74ed1941207' target=_blank style='color:#2F92EE;'>#一线化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19412, encryptionId=74ed1941207, topicName=一线化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ea6321, createdName=okhuali, createdTime=Sat May 07 10:15:27 CST 2022, time=2022-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1278952, encodeId=707e12e895205, content=<a href='/topic/show?id=70e6139138a' target=_blank style='color:#2F92EE;'>#PD-1抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13913, encryptionId=70e6139138a, topicName=PD-1抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=84fb152, createdName=xiongliangxl, createdTime=Tue Oct 26 10:15:27 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063562, encodeId=aa1e106356281, content=非血液学1-2级AE最高为脱发(C组为41.3%,抗PD-1+C组为50%),其次为周围感觉神经病变(21.7%,26.1%)。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 21:02:16 CST 2021, time=2021-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063546, encodeId=e75310635461d, content=晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 20:58:04 CST 2021, time=2021-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1063535, encodeId=f20f106353594, content=晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54e5645039, createdName=ms9000000212834100, createdTime=Sun Oct 24 20:54:19 CST 2021, time=2021-10-24, status=1, ipAttribution=)]
    2021-10-24 ms9000000212834100

    晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。

    0

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    2021-10-24 ms9000000212834100

    晚期胆道癌(BTC, 包括肝内胆管癌、肝外胆管癌、胆囊癌)的治疗选择比较有限。中国人民解放军总医院的团队开展了回顾性研究,评估晚期BTC患者一线化疗的基础上加入PD-1抑制剂能否改善患者的预后,以及安全性如何。相关结果发表在Frontiers in Oncology杂志上。

    0

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