来那替尼治疗晚期肝细胞癌的有效性和安全性：一项在中国

StephenW

Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China
Dong-Xu Wang  1 , Xu Yang  1 , Jian-Zhen Lin  1 , Yi Bai  1 , Jun-Yu Long  1 , Xiao-Bo Yang  1 , Samuel Seery  2 , Hai-Tao Zhao  3
Affiliations

    PMID: 32874058 PMCID: PMC7438196 DOI: 10.3748/wjg.v26.i30.4465

Abstract

Background: Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma (aHCC). Several recent real-world studies appear to have confirmed this; however, there are etiological differences. This necessitates further real-world studies of lenvatinib across diverse populations, such as in China.

Aim: To investigate the efficacy and safety of lenvatinib in a Chinese HCC patient population under real-world conditions.

Methods: This is a retrospective and multiregional study involving patients with aHCC receiving lenvatinib monotherapy. Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1. Baseline characteristics and adverse events (AEs) were recorded throughout the entire study.

Results: In total, 54 HCC patients treated with lenvatinib monotherapy were included for final analysis. The objective response rate was 22% (n = 12) with a progression-free survival (PFS) of 168 d; however, AEs occurred in 92.8% of patients. Multivariate analysis showed that the Barcelona Clinic Liver Cancer stage [hazard ratio (HR) 0.465; 95%CI: 0.23-0.93; P = 0.031], portal vein tumor thrombus (HR 0.38; 95%CI: 0.15-0.94; P = 0.037) and Child-Pugh classifications (HR 0.468; 95%CI: 0.22-0.97; P = 0.042) were significant factors affecting PFS. The sensitivity (56.7%) and specificity (83.3%) of decreasing serum biomarkers including alpha-fetoprotein were calculated in order to predict tumor size reduction. Gene sequencing also provided insights into potential gene mutation signatures related to the effect of lenvatinib.

Conclusion: Our findings confirm previous evidence from the phase III REFLECT study. The majority of patients in this Chinese sample were suffering from concomitant hepatitis B virus-related HCC. However, further analysis suggested that baseline characteristics, changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses. Further large-scale prospective studies that incorporate more basic medical science measures should be conducted.

Keywords: Efficacy; Hepatocellular carcinoma; Lenvatinib; Real-world study; Safety; Treatment.

©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.

StephenW

来那替尼治疗晚期肝细胞癌的有效性和安全性：一项在中国进行的回顾性，现实世界研究
王东旭1，徐阳1，林建珍1，伊百1，龙俊宇1，杨晓波1，塞缪尔·西瑞2，赵海涛3
隶属关系

    PMID：32874058 PMCID：PMC7438196 DOI：10.3748 / wjg.v26.i30.4465

抽象

背景：Lenvatinib已成为晚期肝细胞癌（aHCC）患者治疗方案中必不可少的部分。最近的一些现实世界研究似乎已经证实了这一点。但是，在病因上存在差异。这就需要进一步对诸如中国这样的不同人群进行来伐替尼的现实世界研究。

目的：研究雷伐替尼在现实条件下对中国肝癌患者的疗效和安全性。

方法：这是一项回顾性和多区域研究，涉及接受lenvatinib单药治疗的aHCC患者。使用实体瘤版本1.1中的反应评估标准评估疗效。在整个研究中记录了基线特征和不良事件（AE）。

结果：总共包括54例接受lenvatinib单药治疗的HCC患者进行最终分析。客观缓解率为22％（n = 12），无进展生存期（PFS）为168 d；然而，AEs发生在92.8％的患者中。多因素分析表明，巴塞罗那临床肝癌分期[危险比（HR）为0.465； 95％CI：0.23-0.93； P = 0.031]，门静脉肿瘤血栓（HR 0.38; 95％CI：0.15-0.94; P = 0.037）和Child-Pugh分类（HR 0.468; 95％CI：0.22-0.97; P = 0.042）是影响疾病的重要因素PFS。计算了包括甲胎蛋白在内的血清生物标志物下降的敏感性（56.7％）和特异性（83.3％），以预测肿瘤的大小。基因测序还提供了与伦伐替尼作用有关的潜在基因突变特征的见解。

结论：我们的发现证实了III期REFLECT研究的先前证据。中国样本中的大多数患者都患有乙型肝炎病毒相关的肝癌。但是，进一步的分析表明，基线特征，血清生物标志物的变化和基因测序可能是预测lenvatinib反应的关键。应当进行进一步的前瞻性研究，纳入更多的基础医学科学措施。

关键字：功效；肝细胞癌；伦伐替尼;现实世界的研究；安全;治疗。

©作者2020。由百世登出版集团有限公司出版。保留所有权利。

StephenW

https://www.wjgnet.com/1007-9327/full/v26/i30/4465.htm