- Maintenance olaparib did not worsen health-related QoL (HRQoL) in patients with platinum-sensitive, relapsed ovarian cancer and BRCA1/2 mutation vs placebo.
- Olaparib was associated with prolonged Quality-adjusted PFS (QAPFS) and time without significant symptoms of toxicity (TWiST).
- Olaparib increased nonhematological grade ≥2 toxicities.
Why this matters
- Olaparib showed clinically significant improvement in PFS in preliminary analysis.
- Findings highlight the importance of including patient-centered outcomes besides HRQoL in maintenance therapy trials and are in line with Fifth Ovarian Cancer Consensus Conference recommendations.
- Phase 3, SOLO2 trial (ENGOT Ov-21) of 295 patients with platinum-sensitive, relapsed ovarian cancer and BRCA1/2 mutation, randomly assigned 2:1 to receive olaparib or placebo.
- Funding: AstraZeneca.
- At 12 months, the adjusted average mean change in Functional Assessment of Cancer Therapy-Ovarian Cancer Trial Outcome Index score with olaparib was not statistically different vs placebo (–2.90 vs –2.87; P=.98).
- Olaparib significantly improved mean QAPFS (13.96 vs 7.28 months; P<.0001 and mean twist vs months p placebo.>
- Nonhematological grade ≥2 adverse events with olaparib vs placebo were nausea (19% vs 3%), fatigue (13% vs 6%), abdominal pain (10% vs 6%), diarrhea (8% vs 5%), and vomiting (8% vs 4%).
- Patient preferences were not evaluated.