ENGOT-OV16/NOVA Trial: Niraparib Maintenance for Recurrent Ovarian Cancer
Posted: Monday, July 29, 2019
In the double-blind phase III ENGOT-OV16/NOVA trial, Josep M. del Campo, MD, of the Grupo Español de investigación en Cáncer de Ovario and Vall d’Hebrón University Hospital, Barcelona, and colleagues found that patients with platinum-sensitive, recurrent ovarian cancer experienced significantly longer progression-free survival with niraparib versus placebo platinum-based chemotherapy. The aim of the study was to evaluate the efficacy and patient-reported outcomes of niraparib maintenance therapy in patients who had experienced either partial or complete response to their last platinum-based treatment. Their findings were reported in the Journal of Clinical Oncology.
This multicenter trial comprised 553 patients randomly assigned 2:1 within one of two independent cohorts depending on germline BRCA mutation (germline BRCA mutation: n = 203; nongermline BRCA mutation: n = 350). At the onset of the study, 49% of the patients in each cohort had a partial response to their last platinum-based .
In patients treated with niraparib versus placebo who had germline BRCA mutation, progression-free survival rates improved; the hazard ratio for those with a partial response was 0.24, and the hazard ratio for those with a complete response was 0.30. In addition, progression-free survival rates improved with niraparib versus placebo in those who did not have germline BRCA mutation; the hazard ratio for those with a partial response was 0.35, and the hazard ratio for those with a complete response was 0.58.
“Our analysis provides evidence to support the use of maintenance therapy with niraparib in patients with a [partial response] to their last platinum-based therapy,” the authors stated.
Disclosure: The study authors’ disclosure information can be found at ascopubs.org.