First-line olaparib maintenance improves long-term progression-free survival (PFS) versus placebo for patients with newly diagnosed, advanced BRCA-mutated ovarian cancer, according to 5-year follow-up data from the SOLO-1 trial presented at the virtual 2020 ESMO Annual Meeting.
“Newly diagnosed advanced ovarian cancer patients are at high risk of relapse and 5-year survival is 30–50%. Delay of recurrence, prolonged survival and, for some patients, increased chance of cure are goals of treatment in this setting,” explained Susana Banerjee, Royal Marsden Hospital NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom and colleagues.
The SOLO-1 trial previously demonstrated a PFS benefit for patients with ovarian cancer and a BRCA mutation who were in response after first-line platinum-based chemotherapy.
This analysis reports 5-year follow-up results from the SOLO-1 trial.
A total of 260 patients were randomized to receive olaparib (n = 260) or placebo (n = 131). Median treatment duration were 24.6 months and 13.9 months, respectively.
After a median follow-up of 5 years, median PFS for olaparib was 56 months compared with 13.8 months for placebo. Overall, 48.3% of patients treated with olaparib remained free from disease progression versus 20.5% on placebo.
Additionally, olaparib reduced the risk of disease progression or death by 67%.
The safety profile of olaparib was consistent with previous observations. The most common adverse events (AEs; ≥20%) were nausea (77%), fatigue/asthenia (63%), vomiting (40%), anemia (39%) and diarrhea (34%). The most common grade ≥3 AEs were anemia (22%) and neutropenia (9%). Treatment discontinuation was reported for 12% of patients receiving olaparib
“For patients with a BRCA-mutated and newly diagnosed advanced ovarian cancer, the benefit derived from 2 years of maintenance olaparib was sustained beyond the end of treatment,” concluded Dr Banerjee and colleagues, noting that this 5-year follow-up is the longest for any PARP inhibitor in this setting.—Janelle Bradley
Banerjee S, Moore KN, Colombo N, et al. Maintenance olaparib for patients (pts) with newly diagnosed, advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): 5-year (y) follow-up (f/u) from SOLO1. Presented at: 2020 Virtual ESMO Congress. September 14, 2020. Abstract 811MO.