Risk of Gastrointestinal Adverse Events in Cancer Patients on Immune Checkpoint Inhibitors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

IF 1.1 4区医学 Q3 PHARMACOLOGY & PHARMACY

Journal of Clinical Pharmacy and Therapeutics Pub Date : 2026-04-07 DOI:10.1155/jcpt/7614368

Zhongli Liao, Xiaogang Hu, Shishi Yu, Jiong Wang, Bowen Deng, Fei Ao, Jian Yang

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Abstract

Background

Immune checkpoint inhibitors (ICIs) have improved the survival rates of cancer patients. However, ICIs often cause gastrointestinal adverse events (AEs). This study aims to assess the risk of gastrointestinal AEs associated with ICIs.

Methods

A comprehensive search was conducted in PubMed, Embase, Web of Science, and the Cochrane Library databases to identify eligible phase III or phase IV, double-blind randomized controlled trials (RCTs) investigating gastrointestinal AEs (nausea, vomiting, colitis, abdominal pain, constipation, and diarrhea) in cancer patients treated with ICIs, published before December 3, 2024. References were managed using EndNote X21, and all statistical analyses were performed in R (Version 4.3.3). The pooled incidence of gastrointestinal AEs was estimated using a random-effects model. Subgroup analyses were performed according to predefined study designs.

Results

After excluding studies that did not meet the criteria, 10 RCTs were eligible for the meta-analysis. Diarrhea was the most common low-grade gastrointestinal AE, with an incidence of 18.862% (95% confidence interval [CI] = 14.920%–23.845%), followed by nausea (10.798% [95% CI = 7.781%–14.983%]) and vomiting (6.454% [95% CI = 3.945%–9.527%]). Among high-grade gastrointestinal AEs, diarrhea and colitis were the most common, with incidences of 3.719% (95% CI = 1.788%–6.314%) and 2.668% (95% CI = 1.590%–4.479%), respectively. Additionally, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors, either alone or in combination with PD-1 inhibitors, were associated with a significantly higher risk of diarrhea and colitis compared to programmed cell death protein 1 (PD-1) inhibitors alone.

Conclusion

Gastrointestinal AEs are relatively common during ICI therapy. Monitoring and managing these events, especially diarrhea and colitis, are crucial to improving treatment efficacy in cancer patients, especially those receiving CTLA-4 inhibitors.

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使用免疫检查点抑制剂的癌症患者胃肠道不良事件的风险：随机对照试验的系统回顾和荟萃分析

免疫检查点抑制剂（ICIs）提高了癌症患者的生存率。然而，ICIs经常引起胃肠道不良事件（ae）。本研究旨在评估胃肠道不良事件与ici相关的风险。方法全面检索PubMed、Embase、Web of Science和Cochrane Library数据库，以确定2024年12月3日前发表的符合条件的III期或IV期双盲随机对照试验（rct），研究接受ICIs治疗的癌症患者的胃肠道ae（恶心、呕吐、结肠炎、腹痛、便秘和腹泻）。使用EndNote X21管理文献，所有统计分析均在R （Version 4.3.3）中进行。使用随机效应模型估计胃肠道不良事件的合并发生率。根据预先设定的研究设计进行亚组分析。在排除了不符合标准的研究后，有10项rct符合meta分析的条件。腹泻是最常见的低级别胃肠道AE，发生率为18.862%(95%可信区间[CI] = 14.920% ~ 23.845%)，其次是恶心（10.798% [95% CI = 7.781% ~ 14.983%]）和呕吐（6.454% [95% CI = 3.945% ~ 9.527%]）。在高级别胃肠道ae中，腹泻和结肠炎最为常见，发生率分别为3.719% （95% CI = 1.7888 ~ 6.314%）和2.668% （95% CI = 1.590% ~ 4.479%）。此外，与单独使用程序性细胞死亡蛋白1 （PD-1）抑制剂相比，细胞毒性t淋巴细胞相关抗原4 （CTLA-4）抑制剂单独使用或与PD-1抑制剂联合使用与腹泻和结肠炎的风险显著升高相关。结论胃肠道不良反应在ICI治疗中较为常见。监测和管理这些事件，特别是腹泻和结肠炎，对于提高癌症患者的治疗效果至关重要，特别是那些接受CTLA-4抑制剂的患者。

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

Journal of Clinical Pharmacy and Therapeutics 医学-药学

CiteScore

4.10

自引率

5.00%

发文量

226

审稿时长

6 months

期刊介绍： The Journal of Clinical Pharmacy and Therapeutics provides a forum for clinicians, pharmacists and pharmacologists to explore and report on issues of common interest. Reports and commentaries on current issues in medical and pharmaceutical practice are encouraged. Papers on evidence-based clinical practice and multidisciplinary collaborative work are particularly welcome. Regular sections in the journal include: editorials, commentaries, reviews (including systematic overviews and meta-analyses), original research and reports, and book reviews. Its scope embraces all aspects of clinical drug development and therapeutics, including: Rational therapeutics Evidence-based practice Safety, cost-effectiveness and clinical efficacy of drugs Drug interactions Clinical impact of drug formulations Pharmacogenetics Personalised, stratified and translational medicine Clinical pharmacokinetics.