Liver Cancer:卡博替尼(Cabozantinib)治疗不可手术切除肝细胞癌的疗效和安全性:真实世界研究结果

2021-06-23 yd2015 MedSci原创

该研究表明,在西方国家的真实世界研究数据(大多为三线治疗),卡博替尼(Cabozantinib)的疗效和安全性数据与注册试验中报道的数据相当。

肝细胞癌(HCC)是常见的恶性肿瘤之一。卡博替尼是一种多靶点的酪氨酸激酶抑制剂,包括MET, VEGFR-2/KDR, 和RET。III期CELESTIAL临床研究表明,对于索拉菲尼或不能耐受的患者,卡博替尼治疗较安慰剂明显延长总生存期(OS)(10.2个月vs 8.0个月;HR=0.76, 95% CI 0.63–0.92, p = 0.005)和无进展生存期(5.2个月vs 1.9个月,HR=0.44, 95% CI 0.36–0.52, p < 0.001)。但是,卡博替尼在真实世界用应用的疗效和安全性仍不失很明确。因此,来自意大利的研究团队开展了一项真实世界回顾性研究,评估卡博替尼治疗不可切除肝细胞癌的疗效和安全性。研究成果发表在Liver Cancer杂志上。

该研究纳入意大利15个研究中心的96例患者,多数患者伴有肝硬化(94.8%)。原发性肝病的病因:非病毒性肝炎占40.6%,丙型肝炎病毒感染占32.3%,乙肝病毒感染占27.1%。大多数患者(79.1%)使用卡博替尼作为三线药物。所有患者肝功能分级均为Child-Pugh A。体能评分(PS)>0,大血管浸润(MVI),肝外转移和AFP >400 ng/mL的患者比例分别为50.0%, 30.2%, 67.7%, 和 44.8%。

中位随访时间为8.6个月(IQR 5.0–12.9),中位总生存和无进展生存分别为12.1个月 (95% CI 9.4–14.8)和5.1个月(95%CI 3.3–6.9)。中位治疗至进展的时间为5.2个月(95% CI 3.1–7.3)。

             治疗OS和PFS

疾病控制率为63.5%, 其中4例患者达到部分缓解(4.2%)。

                 疗效评估

最常用的续观治疗方式为索拉非尼-瑞戈非尼-卡博替尼,一共51例患者使用该续观方式,其中位累计生存为35.4个月(95% CI 27.9–43.0)。其次为索拉非尼-卡博替尼,一共20例患者使用该续观治疗方式,中位累计生存为20.8个月(95% CI 14.1–27.5)。

61例患者(63.5%)因为AEs需要降低卡博替尼剂量至40mg/天。服用卡博替尼的77例患者(80.2%)停止治疗,常见原因为疾病进展(80.5%), 毒性不能耐受 (11.7%), 和肝功能不全(7.8%)。最常见的治疗相关严重不良事件(AEs)为疲劳(67.7%),腹泻(54.2%)、厌食(45.8%)、手足综合征(43.8%)、体重(24.0%),和高血压(24.0%)。最常见的与治疗相关的3-4级AEs是疲劳(6.3%)、手足综合征(6.3%)和转氨酶升高(6.3%)。

            治疗相关不良事件

MVI, ECOG-PS > 0, 和AFP >400 ng/mL与较差的OS有关。而因不能耐受而停止治疗或进展时无新的肝外病变则与较好的预后相关。

                预后相关因素

综上,该研究表明,在西方国家的真实世界研究数据(大多为三线治疗),卡博替尼(Cabozantinib)的疗效和安全性数据与注册试验中报道的数据相当。有关预后因素的数据可能有助于患者的治疗选择和临床试验的设计。

原始出处:

Francesco Tovoli, Vincenzo Dadduzio, Stefania De Lorenzo,et al. Real-Life Clinical Data of Cabozantinib for Unresectable Hepatocellular Carcinoma. Liver Cancer. DOI: 10.1159/000515551. Published online: June 15, 2021.

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    2021-09-03 xjy02
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  8. 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time=2021-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=976218, encodeId=66329e6218b2, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08d45173659, createdName=146e09a9m59暂无昵称, createdTime=Wed Jun 23 14:26:19 CST 2021, time=2021-06-23, status=1, ipAttribution=)]
    2021-06-25 仁心济世
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time=2021-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=976218, encodeId=66329e6218b2, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08d45173659, createdName=146e09a9m59暂无昵称, createdTime=Wed Jun 23 14:26:19 CST 2021, time=2021-06-23, status=1, ipAttribution=)]
    2021-06-23 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

  10. 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encodeId=a09b159812198, content=<a href='/topic/show?id=6c6f1e62c5' target=_blank style='color:#2F92EE;'>#ABO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1762, encryptionId=6c6f1e62c5, topicName=ABO)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Fri Jun 25 05:02:43 CST 2021, time=2021-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032971, encodeId=aad210329e1cd, 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=32, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Wed Jun 23 17:02:43 CST 2021, time=2021-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=976218, encodeId=66329e6218b2, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08d45173659, createdName=146e09a9m59暂无昵称, createdTime=Wed Jun 23 14:26:19 CST 2021, time=2021-06-23, status=1, ipAttribution=)]
    2021-06-23 146e09a9m59暂无昵称

    学习了

    0

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