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

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