The adverse reactions of bevacizumab in combination with the FOLFOX chemotherapy regimen in metastatic colorectal cancer.

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-04-07 DOI:10.1080/14740338.2025.2490274

DongQiang Luo, Jiyuan Zheng, Bingshuo Liu, Bohui Zheng, JiaZhen Jiang, Shulan Huang, Zilan Zhong, Wenling Zeng

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引用次数: 0

Abstract

Background: Bevacizumab combined with FOLFOX improves outcomes in metastatic colorectal cancer (mCRC), but comprehensive safety evaluations remain limited.

Research design and methods: We analyzed adverse drug reactions (ADRs) in the FDA Adverse Event Reporting System (FAERS), comparing FOLFOX monotherapy (366 reports), combination therapy (517 reports), and bevacizumab monotherapy (1,604 reports). Disproportionality analysis using ROR, PRR, BCPNN, and EBGM identified significant ADRs.

Results: Twenty-one ADRs were significantly associated with FOLFOX-bevacizumab combination therapy, predominantly infections (e.g. febrile infection) and gastrointestinal disorders (e.g. anastomotic leak, ulcerative gastritis). The combination exhibited comparable but fewer ADRs than monotherapies, excluding pneumothorax and hypertension. Certain ADRs showed higher incidence and shorter median onset time (3 days post-treatment).

Conclusions: Combination therapy demonstrates manageable safety with early monitoring, though stricter criteria for ADR detection may overlook rare events. Key risks align with monotherapy profiles, emphasizing vigilance for infection-related and gastrointestinal complications. Further studies are warranted to validate these pharmacovigilance findings.

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贝伐单抗联合 FOLFOX 化疗方案治疗转移性结直肠癌的不良反应。

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

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.