Ovarian cancer: maintenance olaparib does not worsen health-related QoL

  • Friedlander M & et al.
  • Lancet Oncol
  • 16 Jul 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%).

Limitations

  • Patient preferences were not evaluated.

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