Background: Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP), continues to be connected with considerably elevated progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, whatever the presence or lack of BRCA mutations. The effectiveness of niraparib in patients with recently diagnosed advanced ovarian cancer following a reaction to first-line platinum-based chemotherapy is unknown.
Methods: Within this randomized, double-blind, phase 3 trial, we at random assigned patients with recently diagnosed advanced ovarian cancer inside a 2:1 ratio to get niraparib or placebo once daily following a reaction to platinum-based chemotherapy. The main finish point was progression-free survival in patients who’d tumors with homologous-recombination deficiency as well as in individuals within the overall population, as determined on hierarchical testing. A prespecified interim analysis for overall survival was conducted during the time of the main analysis of progression-free survival.
Results: From the 733 patients who went through randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. One of the patients within this category, the median progression-free survival was considerably longer within the niraparib group compared to the placebo group (21.9 several weeks versus. 10.4 several weeks hazard ratio for disease progression or dying, .43 95% confidence interval [CI], .31 to .59 P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62 95% CI, 0.50 to 0.76 P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred.
Conclusions: Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency.