ASCO20 Preview: Survival Benefit Reported With Maintenance Olaparib in Advanced Ovarian Cancer
Posted: Friday, May 15, 2020
Maintenance treatment of patients with platinum-sensitive, relapsed ovarian cancer associated with BRCA1/2 mutations using the PARP inhibitor olaparib led to an extended overall survival by an “unprecedented 12.9 months” compared with placebo, based on the final analysis of the phase III SOLO2/ENGOT-ov211 trial. Andres Poveda, MD, of Initia Oncology, Hospital Quirónsalud, Valencia, Spain, presented these findings on behalf of colleagues at a press briefing prior to the ASCO20 Virtual Scientific Program (Abstract 6002).
The randomized, double-blind clinical trial recruited 295 patients who had platinum-sensitive recurrent ovarian cancer and a BRCA mutation. These patients had received at least two prior lines of chemotherapy; they were either in response to their most recent chemotherapy regimen or had no evidence of disease nor a rising CA-125 level. Patients were stratified into two groups based on their response to previous chemotherapy as well as length of platinum-free interval. Patients were administered 300-mg tablets of olaparib or placebo twice daily as maintenance therapy within 8 weeks of their last dose of chemotherapy.
At the time of final data cutoff, the median follow-up for both treatment groups was 65 months. There was a long-term treatment benefit seen with olaparib versus placebo, with overall survival times of 51.7 months compared with 38.8 months, respectively (hazard ratio = 0.74, P = .0537). A similar effect was seen patients with germline BRCA mutations. For this subset, the median overall survival was 52.4 months with olaparib compared with 37.4 months with placebo (hazard ratio = 0.71, P = .0306).
At 5 years, Kaplan-Meier estimates suggest that 28.3% of patients in the olaparib arm and 12.8% of patients in the placebo arm were alive and had not received subsequent treatment. In total, 42.1% of patients receiving olaparib and 33.2% of patients receiving the placebo were alive. The long-term tolerability of olaparib was consistent with previous reports.
Disclosure: For full authors’ disclosures, visit coi.asco.org.