Front Oncol:Lenvatinib(仑伐替尼,LEN)联合免疫检查点抑制剂(ICIs)治疗晚期肝细胞癌(HCC)患者的安全性和有效性

2021-11-16 yd2015 MedSci原创

研究表明,LEN联合ICIs是一种很有前景的治疗晚期HCC的新策略。然而,研究观察到严重的肝毒性,需要研究进一步的评价。

在晚期肝细胞癌(HCC)中,Nivolumabpembrolizumab临床有效并且安全性可控。然而,疗效仍然有限。Lenvatinib(仑伐替尼,LEN)联合免疫检查点抑制剂(ICIs)的初步结果显示临床有效,并且联合用药耐受性良好。近期,Frontiers in Oncology杂志上发表了来自中国科学医学院深圳医院团队的一项真实世界研究,研究旨在分析真实世界中LEN + ICIs治疗晚期HCC患者的安全性和有效性。

201764日至2019630日期间,回顾性分析29例进行联合治疗的晚期HCC患者,其中16例患者接受了LEN + nivolumab治疗,13例患者接受了LEN + pembrolizumab治疗。对临床参数和临床预后进行了评估。

所有患者均为BCLC-C期,其中HBV感染24(82.8%)HCV感染2例,HCVHBV同时感染2例。分别有7(24.1%)14(48.3%)8(27.6%)患者使用LEN联合ICIs作为全身二线、三线和四线治疗,所有患者均接受至少一种全身治疗,如索拉非尼或瑞戈非尼。此外,大多数患者之前接受了局部治疗,如肝切除术、消融、局部放疗和经肝动脉化疗栓塞(TACE)患者Child-Pugh评分为A, B, C,分别为79.3%13.8%6.9%在基线时,82.8%的患者有肉眼可见的门静脉侵犯,79.3%的患者有肝外扩散。

中位随访时间为12.0个月(96%CI: 7.5-17.0个月)在数据截止时,6(37.5%)患者仍在接受LEN联合nivolumab治疗,6(46.2%)患者接受LEN联合pembrolizumab治疗。ICIs治疗的中位持续时间为10.5个月(95% CI: 7.53-12.97个月)nivolumab7个月(95% CI: 3.19-11.38个月)pembrolizumab1个月(95% CI: 0.67-2.5个月)中断治疗最常见的原因是病情进展(PD) 11(37.9%)和严重的AEs 5(17.2%)PD后,7名患者继续接受替代治疗:1人接受单一LEN, 5人接受瑞戈非尼, 1人接受PD- L1抑制剂。

29名接受至少一剂ICIs的患者中,有7(25.9%)记录了客观反应。7名应答者中,最佳的整体应答者是1CR6PR。此外,12(44.5%)患者有稳定疾病(SD) 8(29.6%)PD27名接受治疗的患者中,有19(70.4%)报告了疾病控制率(DCR)。在数据截止时,中位缓解持续时间(DOR)为7个月(95% CI: 1.19-12.81个月)。中位TTP为7个月(95%CI:3.44-10.56) 6 和12个月OS率分别为62.6%和53.7%;6 和 12个月PFS率分别为43.5%和31.8%。

             疗效评估

            TTP

                OS

            PFS

24(82.8%)患者中至少报告了一个不良事件:12(41.4%)患者为1-2级,6(20.7%)患者为3级,2(6.9%)患者为4级,4(13.8%)患者为5

在亚组分析中,LEN + nivolumab的ORR最好,1例CR(7.14%), 5例PR(35.7%), 4例SD(28.6%)。LEN + pembrolizumab只有1个PR(7.7%)和8个SD(61.5%)。LEN + nivolumab组和LEN + pembrolizumab组的DCR分别为71.4%和69.2%。LEN + nivolumab组的6和12个月的PFS率分别为43.8%和30.0%,而LEN + pembrolizumab组的分别为49.2%和49.2%。LEN + nivolumab组6和12个月的OS率分别为62.5%和52.1%,而LEN + pembrolizumab组分别为51.3%和51.3%。

                          两组的OS

      两组的PFS

在安全性方面,两组发生任何级别(nivolumab vs pembrolizumab组,n = 15 [93.8%] vs n = 9[69.2%])或高级别(nivolumab vs pembrolizumab组,n = 7 [43.8%] vs n =5[38.5%])不良事件相似

综上,研究表明,LEN联合ICIs是一种很有前景的治疗晚期HCC的新策略。然而,研究观察到严重的肝毒性,需要研究进一步的评价。

原始出处:

Huang X, Xu L, Ma T, Yin X, Huang Z, Ran Y, Ni Y, Bi X and Che X (2021) Lenvatinib Plus Immune Checkpoint Inhibitors Improve Survival in Advanced Hepatocellular Carcinoma: A Retrospective Study. Front. Oncol. 11:751159. doi: 10.3389/fonc.2021.751159

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    2021-12-15 xjy02
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channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45709, encryptionId=1d3d45e090e, topicName=安全性和有效性)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/E33DC517C2EC449E463E3D01D81745BA/100, createdBy=75e12500157, createdName=ms1756883563247400, createdTime=Wed Apr 27 07:51:33 CST 2022, time=2022-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259552, encodeId=94d712595522a, content=<a href='/topic/show?id=2200854517' target=_blank style='color:#2F92EE;'>#HCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8545, encryptionId=2200854517, topicName=HCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=), 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topicList=[TopicDto(id=59863, encryptionId=a92e59863f2, topicName=晚期肝细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464254, encodeId=231d146425470, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=)]
    2022-03-02 minlingfeng
  4. 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topicList=[TopicDto(id=59863, encryptionId=a92e59863f2, topicName=晚期肝细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464254, encodeId=231d146425470, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=)]
    2022-02-12 jklm09
  5. 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  6. 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GetPortalCommentsPageByObjectIdResponse(id=1340590, encodeId=839e1340590b1, content=<a href='/topic/show?id=dd1a29055c8' target=_blank style='color:#2F92EE;'>#免疫检查点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29055, encryptionId=dd1a29055c8, topicName=免疫检查点)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKUdkK5dVTue7YQDvwqM1ugOuEpDZEzvXhoGClFiavehcrNAYDuPbks3MkKLPpyAEicgic80KguxwicYQ/132, createdBy=ec952500165, createdName=ms5187542471278033, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1368216, encodeId=9b611368216ac, content=<a href='/topic/show?id=a92e59863f2' target=_blank style='color:#2F92EE;'>#晚期肝细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59863, encryptionId=a92e59863f2, topicName=晚期肝细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464254, encodeId=231d146425470, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1979237, encodeId=b61219e923774, 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=29, 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=Sat Apr 16 05:51:33 CST 2022, time=2022-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1863626, encodeId=c6f018636269e, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, createdName=xjy02, createdTime=Wed Dec 15 03:51:33 CST 2021, time=2021-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866353, encodeId=7494186635329, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Wed Mar 02 20:51:33 CST 2022, time=2022-03-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852811, encodeId=5ed31852811bc, 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=32, 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=Sat Feb 12 18:51:33 CST 2022, time=2022-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1993627, encodeId=c31b199362e35, content=<a href='/topic/show?id=17124e60f1' target=_blank style='color:#2F92EE;'>#CIS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4760, encryptionId=17124e60f1, topicName=CIS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3b172500206, createdName=12498ebem19暂无昵称, createdTime=Mon Sep 19 03:51:33 CST 2022, time=2022-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2066693, encodeId=553820666938e, content=<a href='/topic/show?id=1d3d45e090e' target=_blank style='color:#2F92EE;'>#安全性和有效性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45709, encryptionId=1d3d45e090e, topicName=安全性和有效性)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/E33DC517C2EC449E463E3D01D81745BA/100, createdBy=75e12500157, createdName=ms1756883563247400, createdTime=Wed Apr 27 07:51:33 CST 2022, time=2022-04-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259552, encodeId=94d712595522a, content=<a href='/topic/show?id=2200854517' target=_blank style='color:#2F92EE;'>#HCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8545, encryptionId=2200854517, topicName=HCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1340590, encodeId=839e1340590b1, content=<a href='/topic/show?id=dd1a29055c8' target=_blank style='color:#2F92EE;'>#免疫检查点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=29055, encryptionId=dd1a29055c8, topicName=免疫检查点)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKUdkK5dVTue7YQDvwqM1ugOuEpDZEzvXhoGClFiavehcrNAYDuPbks3MkKLPpyAEicgic80KguxwicYQ/132, createdBy=ec952500165, createdName=ms5187542471278033, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1368216, encodeId=9b611368216ac, content=<a href='/topic/show?id=a92e59863f2' target=_blank style='color:#2F92EE;'>#晚期肝细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59863, encryptionId=a92e59863f2, topicName=晚期肝细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1464254, encodeId=231d146425470, content=<a href='/topic/show?id=90b91081205' target=_blank style='color:#2F92EE;'>#lenvatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10812, encryptionId=90b91081205, topicName=lenvatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0b506628012, createdName=tastas, createdTime=Thu Nov 18 12:51:33 CST 2021, time=2021-11-18, status=1, ipAttribution=)]
    2021-11-18 jiyangfei
  8. 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  9. 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  10. 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    2021-11-18 tastas

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