Adverse event profile following maintenance olaparib in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer in the phase III SOLO2 trial

OBJECTIVE: To characterize the occurrence, duration, and outcomes of the most common non-hematological (nausea, vomiting, fatigue/asthenia) and hematological (anemia, neutropenia) adverse events experienced by patients receiving olaparib in the phase III SOLO2 trial. METHODS: SOLO2 (NCT01874353) is a randomized, double-blind, placebo-controlled trial. Eligible patients had histologically confirmed relapsed high-grade serous ovarian cancer or high-grade endometrioid cancer with a BRCA mutation and were in response after platinum-based chemotherapy. Patients were randomized 2:1 to olaparib tablets 300 mg twice daily (N = 196) or placebo (N = 99). Safety outcomes were analyzed in all randomized patients who received ≥1 dose of study drug (olaparib, n = 195; placebo, n = 99). RESULTS: The most common adverse events of interest (nausea, vomiting, fatigue/asthenia, anemia, and neutropenia) were generally reported early, within the first 1 to 3 months of olaparib treatment, and were mostly grade 1/2. For all adverse events of interest, the risk of experiencing an event was statistically significantly higher with olaparib than with placebo (nausea hazard ratio [HR] 3.38, p