Moore K, et al. - Experts evaluated the benefit of olaparib as maintenance therapy in newly diagnosed advanced ovarian cancer. A substantial benefit was seen with olaparib use for maintenance therapy with regard to progression-free survival in women with newly diagnosed advanced ovarian cancer and a BRCA1/2 mutation; with olaparib vs placebo, there was also a 70% lower risk of disease progression or death.

Methods

• Authors conducted an international, randomized, double-blind, phase 3 trial to assess the effectiveness of olaparib as maintenance therapy in patients with newly diagnosed advanced (International Federation of Gynecology and Obstetrics stage III or IV) high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer (or a combination thereof) with a mutation in BRCA1, BRCA2, or both (BRCA1/2) who had a complete or partial clinical response after platinum-based chemotherapy.
• They randomly assigned the patients in a 2:1 ratio, to receive olaparib tablets (300 mg twice daily) or placebo.
• Progression-free survival was the primary end point.

Results

• As per data, out of the 391 patients who underwent randomization, 260 were assigned to receive olaparib and 131 to receive placebo.
• A centrally confirmed germline BRCA1/2 mutation was seen in a total of 388 patients, and a centrally confirmed somatic BRCA1/2 mutation was seen in 2 patients.
• Findings suggested that after a median follow-up of 41 months, the risk of disease progression or death was 70% lower with olaparib vs placebo (Kaplan-Meier estimate of the rate of freedom from disease progression and from death at 3 years, 60% vs 27%; hazard ratio for disease progression or death, 0.30; 95% confidence interval, 0.23 to 0.41; P < 0.001).
• The adverse events reported in this study were reported to be consistent with the known toxic effects of olaparib.