仑伐替尼联合抗程序性死亡-1 抗体治疗肝细胞癌患者的有效性和安全性：一项真实世界队列研究。
Effectiveness and safety of lenvatinib plus anti-programmed death-1 antibodies in patients with hepatocellular carcinoma: A real-world cohort study.
机构信息
Department of Liver Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
出版信息
Cancer Med. 2023 Apr;12(8):9202-9212. doi: 10.1002/cam4.5661. Epub 2023 Feb 15.
OBJECTIVE
Lenvatinib plus anti-programmed death-1 (anti-PD-1) antibody combinations have shown potent anti-tumor effect in phase I/II trials in advanced or unresectable hepatocellular carcinoma (HCC), but real-world data are limited.
METHODS
To investigate the effectiveness and safety of lenvatinib plus anti-PD-1 antibodies in a real-world cohort, we retrospectively evaluated 210 patients with unresectable or advanced HCC treated with these regimens between October 2018 and February 2022.
RESULTS
The objective response rate and disease control rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 were 28.1% and 75.2%. Median overall survival (OS) and progression-free survival (PFS) in the overall cohort were 17.2 and 8.4 months, respectively. Median OS and PFS of patients receiving first-line treatment reached 18.9 and 9.6 months. Median OS was significantly longer in patients with Child-Pugh class A versus B (18.8 vs. 5.9 months, respectively), as was median PFS (9.1 vs. 4.4 months). Patients with albumin-bilirubin (ALBI) grade 1 versus grade 2/3 also had significantly greater median OS (23.5 vs. 13.4 months). Treatment-related adverse events (AEs) occurred in 79.5% of patients. Patients with ALBI grade 2/3 had a higher rate of grade 3/4 AEs than patients with ALBI grade 1 (57.5% vs. 38.5%).
CONCLUSION
Lenvatinib combined with anti-PD-1 antibody therapy was effective in patients with sufficient liver function reserve. Further study is needed to improve therapeutic efficacy and AE management in patients with Child-Pugh class B or ALBI grade 2/3.
目的
仑伐替尼联合抗程序性死亡-1（anti-PD-1）抗体在晚期或不可切除的肝细胞癌（HCC）的 I/II 期临床试验中显示出强大的抗肿瘤作用，但真实世界的数据有限。
方法
为了在真实世界队列中研究仑伐替尼联合抗 PD-1 抗体的有效性和安全性，我们回顾性评估了 2018 年 10 月至 2022 年 2 月期间接受这些方案治疗的 210 例不可切除或晚期 HCC 患者。
结果
根据实体瘤反应评估标准 1.1（RECIST）v1.1，客观缓解率和疾病控制率分别为 28.1%和 75.2%。总队列的中位总生存期（OS）和无进展生存期（PFS）分别为 17.2 和 8.4 个月。接受一线治疗的患者的中位 OS 和 PFS 分别达到 18.9 和 9.6 个月。Child-Pugh 分级 A 患者的中位 OS 明显长于 B 级患者（18.8 与 5.9 个月），中位 PFS 也更长（9.1 与 4.4 个月）。ALBI 分级 1 患者的中位 OS 也明显长于分级 2/3 患者（23.5 与 13.4 个月）。79.5%的患者发生治疗相关不良事件（AEs）。ALBI 分级 2/3 的患者发生 3/4 级 AEs 的比例高于 ALBI 分级 1 的患者（57.5% vs. 38.5%）。
结论
仑伐替尼联合抗 PD-1 抗体治疗在肝功能储备充足的患者中有效。需要进一步研究以提高 Child-Pugh 分级 B 或 ALBI 分级 2/3 患者的治疗疗效和 AE 管理。
Zotero 插件