Niraparib in Newly Diagnosed Advanced Ovarian Cancer
Posted: Tuesday, December 10, 2019
Treatment with the PARP inhibitor niraparib resulted in “significantly increased” durations of progression-free survival in newly diagnosed patients with advanced ovarian cancer who responded to platinum-based chemotherapy, according to the PRIMA/ENGOT-OV26/GOG-3012 trial. This finding was reported regardless of the presence or absence of homologous-recombination deficiency. Antonio González-Martín, MD, PhD, of the Clínica Universidad de Navarra, Pamplona, Spain, and colleagues published their results in The New England Journal of Medicine.
The randomized, double-blind, phase III trial included 733 patients; all had high-grade serous or endometrioid tumors classified as stage III or IV and had already responded to first-line platinum-based chemotherapy. Patients were randomly assigned daily to oral doses of either niraparib or a placebo in a 2:1 ratio in 28-day cycles for either 36 months or until disease progression.
The median progression-free survival for patients who received niraparib was 13.8 months, compared with 8.2 months for the placebo group (hazard ratio = 0.62). Among the 50.9% of patients who had tumors with homologous-recombination deficiency, the median progression-free survival was longer with niraparib (21.9 months vs. 10.4 months; hazard ratio = 0.43).
Most of the patients experienced adverse effects during the trial, and they occurred more often among the niraparib group. The most common adverse events of grade 3 or higher were anemia (31% of patients), thrombocytopenia (28.7%), and neutropenia (12.8%).
The investigators noted that most patients with advanced ovarian cancer currently “do not have an effective treatment option to substantially reduce the risk of death or progressive disease after first-line chemotherapy.” Niraparib may now offer those patients an option beyond active surveillance.
Disclosure: The study authors’ disclosure information may be found at nejm.org.