Safety of Irinotecan in Patients with Digestive System Cancers:a Real-World Study from FAERS Database,2004-2024
10.11735/j.issn.1004-0242.2025.05.A010
- VernacularTitle:伊立替康在消化系统恶性肿瘤中的安全性:基于FAERS数据库的2004-2024年真实世界研究
- Author:
Yanlin WANG
1
;
Ji ZHU
1
Author Information
1. 浙江中医药大学第二临床医学院,浙江 杭州 310053;浙江省肿瘤医院,中国科学院杭州医学研究所,浙江 杭州 310022
- Publication Type:Journal Article
- Keywords:
irinotecan;
topoisomerase Ⅰ inhibitor;
digestive system cancer;
adverse events;
Food and Drug Administration Adverse Event Reporting System database
- From:
China Cancer
2025;34(5):397-407
- CountryChina
- Language:Chinese
-
Abstract:
[Purpose]To analyze irinotecan-related adverse events(AEs)signals,to provide references for clinically safe prescribing practices.[Methods]A retrospective pharmacovigilance analysis was con-ducted using Food and Drug Administration Adverse Event Reporting System(FAERS)database from the first quarter of 2004 to the last quarter of 2024.After duplicate removal,four disproportionality analysis methods were applied:reporting odds ratio(ROR),proportional reporting ratio(PRR),Bayesian confi-dence propagation neural network(BCPNN),and empirical Bayes geometric mean(EBGM),and subgroups were analyzed by age(≥65 years old vs＜65 years old)and outcome(death vs non-death).[Results]A total of 8 456 irinotecan-related reports comprising 27 177 AEs were identified.The most frequently reported AEs included diarrhea,nausea,neutropenia,vomiting,and fatigue.Additionally,several unexpected and significant AEs signals were detected,such as cell-mediated cytotoxicity,pyomyositis,neuropathic muscular atrophy,administration site recall reaction and ischemic neuropathy.Subgroup analysis indicated that elderly patients showed higher reported frequencies of diarrhea,neutropenia and leukopenia,while younger patients had more frequent reports of nausea,vomiting and peripheral neuropathy.The median time to AEs onset was 31 d,with 49.8％occurring within the first month of treatment.[Conclusion]The AEs related to irinotecan should be paid attention to.When using irinotecan for the treatment of digestive system cancer,symptoms such as diarrhea,nausea and neutropenia should be closely monitored to reduce the risk of drug use.
