Adverse events associated with targeted therapy and immunotherapy for ovarian cancer: a FAERS pharmacovigilance study

The addition of targeted therapy and immunotherapy has significantly improved survival in ovarian cancer patients. This analysis aimed to investigate the adverse events associated with targeted and immunotherapy drugs in patients with ovarian cancer.

Adverse event reports related to bevacizumab, poly (ADP-ribose) polymerase (PARP) inhibitors, and immune checkpoint inhibitors (ICI: PD-1, PD-L1, CTLA-4 inhibitors) in ovarian cancer were sourced from the FDA Adverse Event Reporting System (FAERS) database (Q3 2014 to Q3 2025). The disproportionality analysis, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN), was employed to detect safety signals associated with different drugs.

A total of 209,920 adverse event reports were included in the analysis, involving 33,538 ovarian cancer patients. Among adverse events associated with the target drug (n = 183,935), 157,470 (85.61%) reports were related to PARP inhibitors, followed by bevacizumab [21,001 (11.42%)], PD-1 inhibitors [3,702 (2.01%)], PD-L1 inhibitors [1,317 (0.72%)], and CTLA-4 inhibitors [425 (0.23%)]. Adverse events are most frequently reported within 30 days of taking the medication. The most frequently reported safety signals at the preferred term level associated with PARP inhibitors included Energy increased, Vitamin D decreased, Nocturia, Intentional underdose, Hunger, and Brain neoplasm. For bevacizumab, the most frequently reported safety signals were Gastrointestinal perforation, Proteinuria, Intestinal perforation, and Embolism. For ICI, the most frequently reported safety signals comprised Product use in unapproved indication, Off label use, Death, and Malignant neoplasm progression. The most frequently reported safety signals linked to combination therapy using different drugs vary. For the combination of bevacizumab and PARP inhibitors, the most frequently reported safety signals included Interstitial lung disease, Myelodysplastic syndrome, Myelosuppression, Acute myeloid leukaemia, and Proteinuria.

This study systematically analyzed the safety signals related to different drugs during the treatment of ovarian cancer, which may assist clinicians in identifying drug alert signals.