仑伐替尼治疗晚期肝细胞癌患者的疗效和安全性：日本开展的一项回顾性真实世界研究。

Efficacy and Safety of Lenvatinib for Patients With Advanced Hepatocellular Carcinoma: A Retrospective, Real-world Study Conducted in Japan.

机构信息

Department of Gastroenterology, Nara Medical University, Kashihara, Japan.

Department of Gastroenterology, Nara Medical University, Kashihara, Japan

出版信息

Anticancer Res. 2022 Jan;42(1):173-183. doi: 10.21873/anticanres.15471.

DOI:10.21873/anticanres.15471

PMID:34969723

Abstract

AIM

We evaluated real-world efficacy and toxicity of lenvatinib in 142 patients with advanced hepatocellular carcinoma (HCC) at six tertiary referral centres.

PATIENTS AND METHODS

The patients with advanced HCC treated with lenvatinib were grouped into two categories based on REFLECT criteria for analysis of efficacy and safety. The primary endpoint was progression-free survival (PFS).

RESULTS

The objective response rate (ORR) at week 12 of therapy was 41.5%, with a median PFS of 176 days. Child-Pugh score of 5 points, the presence of extrahepatic metastasis and adverse effects grade 2 or higher were considered independent factors associated with both better PFS and ORR. The ORR for patients who fulfilled the REFLECT inclusion criteria was significantly higher than that for those who did not. However, no significant differences in PFS were observed between the two groups. The incidence rate of adverse effects grade 3 or higher was 40.1%, which was similar for the two groups.

CONCLUSION

Lenvatinib is safe and effective for patients, whether or not they satisfy REFLECT criteria. The result warrants replication in a larger study.

摘要

目的

我们在六个三级转诊中心评估了 142 例晚期肝细胞癌（HCC）患者接受仑伐替尼治疗的真实世界疗效和毒性。

患者和方法

根据 REFLECT 标准对接受仑伐替尼治疗的晚期 HCC 患者进行疗效和安全性分析分组。主要终点是无进展生存期（PFS）。

结果

治疗 12 周时的客观缓解率（ORR）为 41.5%，中位 PFS 为 176 天。Child-Pugh 评分 5 分、存在肝外转移和不良事件 2 级或更高被认为是与更好的 PFS 和 ORR 相关的独立因素。符合 REFLECT 纳入标准的患者的 ORR 显著高于不符合的患者。然而，两组间 PFS 无显著差异。不良事件 3 级或更高的发生率为 40.1%，两组相似。