Niraparib Maintenance Versus Surveillance in Recurrent Ovarian Cancer
Posted: Tuesday, October 1, 2019
Patients with recurrent ovarian cancer treated with the PARP inhibitor niraparib experience an increase in the estimated time without symptoms or toxicity compared with those followed with routine surveillance. Ursula A. Matulonis, MD, of the Dana-Farber Cancer Institute in Boston, published this analysis of the ENGOT-OV16/NOVA trial with colleagues in the Journal of Clinical Oncology.
“When patients with recurrent ovarian cancer enter remission following platinum-based treatment, they now have the option to extend their progression-free survival with a PARP inhibitor,” said Dr. Matulonis in an institutional press release. “It’s important to demonstrate that, if we’re adding a maintenance therapy, we’re not significantly altering women’s quality of life.”
The ENGOT-OV16/NOVA trial compares niraparib with a placebo in women who have platinum-sensitive ovarian cancer and have received a minimum of two courses of platinum-based chemotherapy. A total of 553 participants were enrolled in this study and were categorized according to the presence or absence of a BRCA mutation. Time with toxicity was defined as the number of days that a patient experienced an adverse event after random assignment but before disease progression. Time without symptoms or toxicity provides an estimate of how long a patient is free of progressive disease and treatment toxicity and is calculated using the difference between progression-free survival and the time with toxicity.
Treatment with niraparib resulted in a mean progression-free survival of 3.23 and 1.44 years in the germline BRCA mutation and wild type BRCA cohorts, respectively. The mean time with toxicity was 0.28 years in patients with the BRCA mutation and 0.10 years for patients without the mutation compared with surveillance. Niraparib treatment was calculated to result in a mean time without symptoms or toxicity benefit of 2.95 years in patients who carry germline BRCA mutations and 1.34 years in patients with wild-type BRCA compared with surveillance.
Disclosure: The study authors’ disclosure information may be found at ascopubs.org.