索拉非尼对比乐伐替尼治疗阿特珠单抗/贝伐珠单抗治疗后进展的肝细胞癌：一项真实世界研究。

Sorafenib vs. Lenvatinib in advanced hepatocellular carcinoma after atezolizumab/bevacizumab failure: A real-world study.

机构信息

Department of Gastroenterology, CHA Bundang Medical Center, CHA University, Seongnam, Korea.

Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

出版信息

Clin Mol Hepatol. 2024 Jul;30(3):345-359. doi: 10.3350/cmh.2023.0553. Epub 2024 Mar 12.

BACKGROUND/AIMS: Atezolizumab plus bevacizumab (ATE+BEV) therapy has become the recommended first-line therapy for patients with unresectable hepatocellular carcinoma (HCC) because of favorable treatment responses. However, there is a lack of data on sequential regimens after ATE+BEV treatment failure. We aimed to investigate the clinical outcomes of patients with advanced HCC who received subsequent systemic therapy for disease progression after ATE+BEV.

METHODS

This multicenter, retrospective study included patients who started second-line systemic treatment with sorafenib or lenvatinib after HCC progressed on ATE+BEV between August 2019 and December 2022. Treatment response was assessed using the Response Evaluation Criteria in Solid Tumors (version 1.1.). Clinical features of the two groups were balanced through propensity score (PS) matching.

RESULTS

This study enrolled 126 patients, 40 (31.7%) in the lenvatinib group, and 86 (68.3%) in the sorafenib group. The median age was 63 years, and males were predominant (88.1%). In PS-matched cohorts (36 patients in each group), the objective response rate was similar between the lenvatinib- and sorafenib-treated groups (5.6% vs. 8.3%; P=0.643), but the disease control rate was superior in the lenvatinib group (66.7% vs. 22.2%; P<0.001). Despite the superior progression- free survival (PFS) in the lenvatinib group (3.5 vs. 1.8 months, P=0.001), the overall survival (OS, 10.3 vs. 7.5 months, P=0.353) did not differ between the two PS-matched treatment groups.

CONCLUSION

In second-line therapy for unresectable HCC after ATE+BEV failure, lenvatinib showed better PFS and comparable OS to sorafenib in a real-world setting. Future studies with larger sample sizes and longer follow-ups are needed to optimize second-line treatment.

背景/目的：阿替利珠单抗联合贝伐珠单抗（ATE+BEV）治疗已成为不可切除肝细胞癌（HCC）患者的推荐一线治疗方法，因为其治疗反应良好。然而，在 ATE+BEV 治疗失败后，关于序贯治疗方案的数据还很缺乏。我们旨在研究在 ATE+BEV 治疗后疾病进展的晚期 HCC 患者接受后续系统治疗的临床结果。

方法

这项多中心回顾性研究纳入了 2019 年 8 月至 2022 年 12 月期间在 ATE+BEV 治疗后 HCC 进展后开始二线系统治疗索拉非尼或仑伐替尼的患者。采用实体瘤反应评价标准（版本 1.1）评估治疗反应。通过倾向评分（PS）匹配平衡两组的临床特征。

结果

本研究共纳入 126 例患者，仑伐替尼组 40 例（31.7%），索拉非尼组 86 例（68.3%）。中位年龄为 63 岁，男性居多（88.1%）。在 PS 匹配队列（每组 36 例）中，仑伐替尼组和索拉非尼组的客观缓解率相似（5.6% vs. 8.3%；P=0.643），但仑伐替尼组的疾病控制率更高（66.7% vs. 22.2%；P<0.001）。尽管仑伐替尼组的无进展生存期（PFS）更优（3.5 个月 vs. 1.8 个月，P=0.001），但两组 PS 匹配治疗后的总生存期（OS，10.3 个月 vs. 7.5 个月，P=0.353）并无差异。