| アブストラクト | BACKGROUND: Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment but are frequently linked to gastrointestinal immune-related adverse events, which can severely affect patient outcomes. RESEARCH DESIGN AND METHODS: We conducted a retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (2011-2024). Disproportionality analyses (ROR, PRR, BCPNN, MGPS) identified gastrointestinal adverse events (AEs) associated with ICIs across pan-cancer populations, while multivariable logistic regression and Bayesian network modeling were used to examine influencing factors. RESULTS: A total of 85 distinct gastrointestinal toxicities were identified and categorized as ICI-related gastrointestinal AEs (GI AEs). Substantial variation in ICI-related GI AE profiles was observed across different ICI regimens, with anti-CTLA-4 demonstrating the highest toxicity (ROR = 17.76 [16.88-18.68]). Logistic regression and Bayesian network analyses indicated that disease stage, concurrent targeted therapies, and ICI type significantly influenced the risk of developing ICI-related GI AEs. Patients with gastric variceal hemorrhage exhibited the highest mortality rate (63.64%). CONCLUSIONS: Our pharmacovigilance analysis reveals a high risk of gastrointestinal adverse events with ICI therapy, especially anti-CTLA-4. Stage IV disease, concurrent targeted therapies, and anti-CTLA-4 therapy or combination therapy further increase this risk, highlighting the need for personalized treatment strategies. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/10/13 |
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| 投稿者 | Gao, Yuye; Pei, Junpeng; Ji, Dengbo; Chen, Yongjiu; Huang, Yonglin; Wu, Aiwen |
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| 組織名 | State Key Laboratory of Holistic Integrative Management of Gastrointestinal;Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research,;Unit III, Gastrointestinal Cancer Center, Peking University Cancer Hospital &;Institute, Beijing, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41082243/ |
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