Safety of niraparib-based regimens in patients with ovarian cancer: A systematic review and meta-analysis

Background: Niraparib is approved as a maintenance treatment for ovarian cancer due to its potential to prolong progression-free survival. However, its widespread use is challenged by concerns about its safety profile. This systematic review and meta-analysis assesses the safety profile of niraparib in ovarian cancer treatment. Methods: A thorough literature search was done from inception to August 2024 using Embase, Cochrane Central Library, MEDLINE, and ClinicalTrials.gov. Randomized controlled trials (RCTs) and cohorts assessing the safety of niraparib in ovarian cancer were included. The primary outcome was adverse events. Review Manager was used to pool risk ratios (RR) with 95% confidence intervals (CIs) using the Mantel-Haenszel method for a random-effects analysis. Results: Eight studies were included in this meta-analysis, consisting of 4 Phase III RCTs and 4 observational studies with 2344 patients. Niraparib was associated with a higher risk of adverse events (RR = 1.05; 95 % CI: 1.02–1.09). Although subgroup analyses for the primary outcome did not show significant variations, secondary outcomes revealed notable findings. It also increases the risk of hematological toxicities, including thrombocytopenia (RR 2.75, 95 % CI 0.62–12.20), anemia (RR 1.74, 95 % CI: 1.06–2.86), and neutropenia (RR 1.63, 95 % CI: 1.04–2.54) with increased rates of treatment interruptions (RR 2.05, 95 % CI: 0.85–4.96) and dose reductions (RR = 2.35, 95 % CI: 0.89–6.17). Conclusion: Our meta-analysis suggests that niraparib is associated with a tolerable safety profile in ovarian cancer maintenance treatment, with hematological toxicities being the primary concern. Further large-scale RCTs are essential to validate these findings and develop standardized safety protocols.