Women with ovarian cancer, in most cases, have a relapse within three years after the routine treatment with surgery and platinum-based chemotherapy. Even though the benefits of oral olaparib, a poly-polymerase inhibitor, in relapsed disease have been well studied, the efficacy of olaparib as maintenance therapy is unclear. This study aims to assess the benefits of olaparib as maintenance therapy in women with newly diagnosed advanced ovarian cancer.
This international, randomized, double-blind, phase 3 trial included a total of 391 patients with newly diagnosed advanced (stage III or IV) high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or endometrioid ovarian cancer. The patients were randomly assigned in a 2:1 ratio to receive oral olaparib (300 mg twice daily [n=262]) or placebo (n=131). The primary outcome was progression-free survival.
During the median follow-up of 41 months, the risk of disease progression and death was 70% lower in the olaparib group than in the placebo group. A few known toxic effects of olaparib occurred in the olaparib group.
The research concluded that olaparib as maintenance therapy offered substantial benefits in terms of progression-free and overall survival in women with newly diagnosed advanced ovarian cancer, as compared with placebo.