真实世界中帕博利珠单抗与纳武利尤单抗治疗晚期肝细胞癌的对比。
Real-world comparison of pembrolizumab and nivolumab in advanced hepatocellular carcinoma.
机构信息
Division of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, No.123, Dapi Rd., Niaosong Dist, 833, Kaohsiung, Taiwan.
School of Medicine, College of Medicine, Chang Gung University, 333, Taoyuan, Taiwan.
出版信息
BMC Cancer. 2023 Aug 29;23(1):810. doi: 10.1186/s12885-023-11298-z.
BACKGROUND
Nivolumab and pembrolizumab have not been directly compared in clinical trials, and the aim of this study is to investigate the efficacy and safety of nivolumab versus pembrolizumab in patients with advanced hepatocellular carcinoma (HCC) in real-world practice.
METHODS
We retrospectively reviewed patients with HCC who received intravenous nivolumab or pembrolizumab alone as second-line and later therapy. The objective response was determined according to the Response Evaluation Criteria in Solid Tumors criteria version 1.1. Adverse events (AEs) were graded based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. The Kaplan-Meier method was used to analyze progression-free survival (PFS) and overall survival (OS). Prognostic values were estimated using hazard ratios with 95% confidence intervals (CIs).
RESULTS
In total, 120 patients were enrolled, including 95 who received nivolumab and 25 who received pembrolizumab. All patients were staged as Barcelona Clinic Liver Cancer stage C, and 29 patients were classified as Child-Pugh classification B (7). The response rate of the pembrolizumab and nivolumab groups were 8.0% and 7.4%, respectively. There was no significant difference in the median PFS between the pembrolizumab and nivolumab groups (2.7 months versus 2.9 months). The median OS in the nivolumab group was longer than that in the pembrolizumab group (10.8 months versus 8.1 months); however, the difference was not statistically significant. The effects of pembrolizumab and nivolumab on the median PFS and OS were consistent across the subgroups based on baseline characteristics. The severity of all AEs was grades 1-2 without treatment interruption or dose adjustment; there was no statistically significant difference in the incidence of treatment-related AEs between these two groups. Additionally, the percentage of patients receiving subsequent therapy was consistent between the two groups.
CONCLUSION
The efficacy and safety of pembrolizumab and nivolumab were comparable in the management of patients with pretreated HCC in real-world practice.
背景
nivolumab 和 pembrolizumab 在临床试验中并未直接进行比较，本研究旨在探究真实世界中晚期肝细胞癌（HCC）患者接受 nivolumab 对比 pembrolizumab 治疗的疗效和安全性。
方法
我们回顾性分析了接受二线及以上静脉 nivolumab 或 pembrolizumab 单药治疗的 HCC 患者。根据实体瘤疗效评价标准 1.1 版评估客观缓解率。根据美国国立癌症研究所不良事件通用术语标准 5.0 版对不良事件（AE）进行分级。采用 Kaplan-Meier 法分析无进展生存期（PFS）和总生存期（OS）。采用风险比（HR）及其 95%置信区间（CI）估计预后价值。
结果
共纳入 120 例患者，其中接受 nivolumab 治疗 95 例，接受 pembrolizumab 治疗 25 例。所有患者巴塞罗那临床肝癌分期为 C 期，29 例为 Child-Pugh 分级 B（7）。pembrolizumab 组和 nivolumab 组的客观缓解率分别为 8.0%和 7.4%。两组中位 PFS 无显著差异（2.7 个月比 2.9 个月）。nivolumab 组中位 OS 长于 pembrolizumab 组（10.8 个月比 8.1 个月），但差异无统计学意义。基于基线特征的亚组分析显示，pembrolizumab 和 nivolumab 对中位 PFS 和 OS 的影响一致。所有 AE 严重程度均为 1-2 级，未中断治疗或调整剂量；两组治疗相关 AE 发生率无统计学差异。此外，两组患者接受后续治疗的比例一致。
结论
在真实世界中，pembrolizumab 和 nivolumab 治疗经治 HCC 的疗效和安全性相当。
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