Tolerability of maintenance olaparib in newly diagnosed patients with advanced ovarian cancer and a BRCA mutation in the randomized phase III SOLO1 trial.

This research evaluated the tolerability and safety of maintenance olaparib in patients recently diagnosed with advanced ovarian cancer and a BRCA mutation, using data from the randomized, double-blind, placebo-controlled phase III SOLO1 trial. Patients were assigned to receive either 300 mg of olaparib twice daily (260 patients) or a placebo (131 patients), with treatment lasting up to two years for most. The study focused on the timing, duration, and severity of common adverse events (AEs). Key findings showed that the most frequent hematologic AEs (anemia, neutropenia, thrombocytopenia) and non-hematologic AEs (nausea, fatigue/asthenia, vomiting) typically appeared within three months of starting olaparib. Most first events of hematologic AEs, nausea, and vomiting resolved within two months, while fatigue/asthenia lasted a median of 3.48 months. These AEs were largely manageable through supportive care or dose adjustments, with a minority of patients (11.5% in the olaparib group) discontinuing treatment due to AEs, compared to 2.3% in the placebo group. Importantly, 64.2% of patients still on olaparib at 24 months maintained the recommended starting dose. Although three cases of acute myeloid leukemia (AML) were reported in the olaparib group, no new safety concerns emerged, and the overall profile was predictable. The findings confirm that maintenance olaparib offers a manageable safety profile and no new risks, supporting its role as a standard of care for this patient population.