Efficacy of niraparib in patients with advanced ovarian cancer: A meta-analysis of randomized controlled trials.

5587 Background: Niraparib is a poly-adenosine diphosphate-ribose polymerase (PARP) inhibitor that has shown clinical benefits as a maintenance therapy for patients with advanced ovarian cancer. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy of niraparib as maintenance therapy after platinum-based chemotherapy for patients with advanced ovarian cancer. PubMed, Embase, and Cochrane Central Register of Controlled Trials databases were searched for RCTs published up to January 17, 2024. Hazard ratios (HR) and Odds ratio (OR) with 95% confidence intervals (CI) were pooled using a random-effects model. The endpoints of interest were time to first subsequent therapy (TFST) and progression-free survival (PFS). We performed subgroup analyses for BRCA-mutation, HRD-positive, HRD-negative, response to platinum therapy, and newly diagnosed disease. Results: Four RCTs were included, comprising a total of 1,935 patients of whom 1,291 received niraparib and 644 received placebo. Niraparib significantly improved PFS in the overall population (HR 0.45; 95% CI 0.31-0.66; p < 0.0001; I2= 82%), in patients with BRCA mutation (HR 0.32; 95% CI 0.25-0.43; p < 0.00001; I2= 21%), HRD positivity (HR 0.39; 95% CI 0.30-0.51; p < 0.00001; I2= 40%), HRD negativity (HR 0.45; 95% CI 0.36-0,57; p < 0.00001; I2= 0%), and newly diagnosed cancer (HR 0.59; 95% CI 0.39-0.73; p < 0.0001; I2= 68%). The TFST was longer in the niraparib group (HR 0.48; 95% CI 0.33-0.68; p < 0.0001; I2= 80%). There was no statistical difference between complete and partial response to platinum therapy (OR 1.00; 95% CI 0.87-0.1.16; p = 0.98; I2= 0%). Conclusions: Niraparib improves PFS and lowers the time to first subsequent therapy in patients with advanced ovarian cancer. Outcomes and results by studies. [Table: see text]