Maintenance Olaparib in Advanced Ovarian Cancer: PAOLA-1 Trial
Posted: Wednesday, February 12, 2020
According to the results of the PAOLA-1 trial, published in The New England Journal of Medicine, addition of maintenance olaparib resulted in significantly improved progression-free survival in patients with newly diagnosed, advanced, high-grade ovarian cancer who responded to a combination first-line therapy of chemotherapy plus bevacizumab.
“In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenance olaparib provided a significant progression-free survival benefit, which was substantial in patients with [homologous-recombination deficiency]-positive tumors, including those without a BRCA mutation,” concluded Isabelle Ray-Coquard, MD, PhD, of the Centre Léon Bérard in Lyon, France, and colleagues.
The international phase III trial included 806 patients who were randomly assigned 2:1 to receive either 300 mg of oral olaparib twice daily (n = 537) or placebo for up to 24 months (n = 269). Following that period, all patients received 15 mg/kg of bevacizumab every 3 weeks for up to 15 months. At a median follow-up of 22.9 months, the olaparib group saw a superior progression-free survival of 22.1 months, versus 16.6 months in the placebo group. Adverse events were as expected due to the established safety profiles of both medications.
For patients with tumors that tested positive for homologous-recombination deficiency and for BRCA mutations, the hazard ratio for disease progression or death was 0.33. For that group, the median progression-free survival with olaparib compared with placebo was 37.2 versus 17.7 months. For patients whose homologous-recombination deficiency–positive tumors did not have BRCA mutations, the hazard ratio was 0.43, and the median progression-free survival was 28.1 months with olaparib versus 16.6 months with placebo.
Disclosure: For full disclosures of the study authors, please visit nejm.org.