ESMO Asia 2020: SOLO1 Update on Olaparib Maintenance for BRCA-Mutated Ovarian Cancer
Posted: Monday, November 30, 2020
Patients with newly diagnosed BRCA-mutated advanced ovarian cancer appeared to derive a significant progression-free survival benefit from maintenance therapy with the PARP inhibitor olaparib after platinum-based chemotherapy, according to Michael Friedlander, MBChB, of the Prince of Wales Hospital, Randwick, Australia, and colleagues. The 5-year follow-up data from the SOLO1 trial presented during the European Society for Medical Oncology (ESMO) Asia Virtual Congress 2020 (Abstract 234O) seems consistent with previous reports.
Patients who responded to first-line platinum-based chemotherapy were randomly assigned in a 2:1 ratio to receive either olaparib (n = 260) or a placebo (n = 131). Progression-free survival events occurred in 45% of the patients treated with olaparib and in 76% of those treated with the placebo. The median duration of progression-free survival was 56 months with olaparib and 13.8 months with the placebo. The progression-free survival rates at 1, 2, 3, 4, and 5 years were 87.7%, 73.6%, 60.1%, 52.3%, and 48.3% with olaparib and 51.4%, 34.6%, 26.9%, 21.5%, and 20.5% with the placebo, respectively.
Among patients in complete response at baseline, the median duration of recurrence-free survival was not reached with olaparib and was 15.3 months with the placebo; this translates to a 63% reduction in the risk of disease recurrence or death. At 1, 2, 3, 4, and 5 years, the recurrence-free survival rates were 91%, 77.2%, 64%, 55.2%, and 51.9% with olaparib and 58%, 39%, 28.9%, 23%, and 21.8% with the placebo, respectively.
The safety profile of olaparib appeared to be consistent with previous reports. No new cases of myelodysplastic syndrome or acute myeloid leukemia were observed in this study population. The incidence rates of new primary malignancies were similar with olaparib (3%) and with the placebo (4%).
Disclosure: For full disclosures of the study authors, visit nejm.org.