Efficacy and safety of pembrolizumab in the treatment of advanced hepatocellular carcinoma: a systematic review and meta-analysis.

IF 2.4 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-04-02 DOI:10.1007/s00228-025-03829-3

Mingyang Tang, Tao Liu, Yukun Zhang, Jun Ding

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Abstract

Background: The efficacy and safety of pembrolizumab in treating advanced hepatocellular carcinoma (HCC) are inconsistent across studies. This study sheds light on the efficacy and safety of pembrolizumab in advanced HCC patients.

Methods: Several databases were comprehensively searched up to January 13, 2025, to identify studies assessing pembrolizumab for advanced HCC. Outcome indicators included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), rash, adverse events (AEs), and severe adverse events (SAEs). Pooled effects were estimated through hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CIs). R 4.4.1. was employed for statistical analyses.

Results: Twenty-two studies involving 2964 patients were encompassed. Meta-analysis indicated that pembrolizumab demonstrated an ORR of 28% in single-arm analyses. Pembrolizumab significantly improved ORR in comparison to placebo (OR = 2.57, 95% CI: 1.32-5.03) but showed no significant advantage over nivolumab. Pembrolizumab markedly enhanced PFS (HR = 0.76, 95% CI: 0.69-0.85) and OS (HR = 0.78, 95% CI: 0.70-0.88) compared to placebo, but no significant differences were observed when compared to nivolumab. Pembrolizumab significantly raised the risk of rash in comparison to placebo (OR = 2.27, 95% CI: 1.55-3.31) but showed no significant difference versus nivolumab. The pembrolizumab group showed a higher incidence of AEs (OR = 1.94, 95% CI: 1.42-2.64) and SAEs (OR = 2.10, 95% CI: 1.04-4.25) than the placebo group, with no significant difference between pembrolizumab and nivolumab.

Conclusions: This study proves that pembrolizumab may have promising therapeutic effects in patients with advanced HCC, although no clear advantage over nivolumab was observed. The occurrence of AEs warrants attention in clinical practice.

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派姆单抗治疗晚期肝细胞癌的疗效和安全性：系统回顾和荟萃分析。

背景：派姆单抗治疗晚期肝细胞癌（HCC）的疗效和安全性在研究中并不一致。这项研究揭示了派姆单抗在晚期HCC患者中的有效性和安全性。方法：全面检索截至2025年1月13日的几个数据库，以确定评估派姆单抗治疗晚期HCC的研究。结局指标包括总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、皮疹、不良事件（ae）和严重不良事件（sae）。通过95%置信区间（ci）的风险比（hr）和优势比（ORs）估计合并效应。4.4.1 R。进行统计分析。结果：纳入22项研究，涉及2964例患者。荟萃分析显示，在单组分析中，派姆单抗的ORR为28%。与安慰剂相比，派姆单抗显著改善了ORR (OR = 2.57, 95% CI: 1.32-5.03)，但与纳武单抗相比没有显著优势。与安慰剂相比，派姆单抗显著提高了PFS （HR = 0.76, 95% CI: 0.69-0.85）和OS (HR = 0.78, 95% CI: 0.70-0.88)，但与纳武单抗相比无显著差异。与安慰剂相比，派姆单抗显著增加了皮疹的风险（OR = 2.27, 95% CI: 1.55-3.31），但与纳武单抗没有显著差异。派姆单抗组ae （OR = 1.94, 95% CI: 1.42-2.64）和sae （OR = 2.10, 95% CI: 1.04-4.25）的发生率高于安慰剂组，派姆单抗和纳武单抗之间无显著差异。结论：本研究证明派姆单抗在晚期HCC患者中可能具有良好的治疗效果，尽管没有观察到比纳武单抗更明显的优势。ae的发生在临床实践中值得重视。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.