The following is a summary of “Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial,” published in the January 2023 issue of Oncology by DiSilvestro, et al.

Patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation benefited from maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib in SOLO1/GOG 3004. For a study, researchers presented overall survival (OS) data after a 7-year follow-up, the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line scenario, and a clinically important time point.

Patients in the double-blind phase III trial were randomized to receive maintenance olaparib (n = 260) or placebo (n = 131) for up to two years if they had just been diagnosed with advanced ovarian cancer and a BRCA mutation and were responding clinically to platinum-based chemotherapy. After a 7-year follow-up, a predetermined descriptive analysis of OS, a secondary endpoint, was performed.

The median follow-up was 88.9 months for olaparib and 87.4 months for placebo. The median treatment duration was 24.6 months for olaparib and 13.9 months for placebo. The risk ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P =.0004 [P< .0001 necessary to establish statistical significance]). At 7 years, olaparib patients were more likely to be alive than placebo patients, with a survival rate of 67.0% to 46.5% and a survival rate of 45.3% to 20.6%, respectively (Kaplan-Meier estimates). In addition, myelodysplastic syndrome and acute myeloid leukemia incidence remained low, while new primary malignancies remained evenly distributed among therapy groups.

The results supported the use of maintenance olaparib to achieve long-term remission in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation; the likelihood of cure may also be improved. It was true even though the improvement in OS with maintenance olaparib was not statistically significant by the predetermined criteria. During long-term follow-up, no fresh safety indicators were noticed.

Reference: ascopubs.org/doi/full/10.1200/JCO.22.01549