Advanced ovarian cancer: maintenance olaparib extends PFS in all subgroups

  • DiSilvestro P & et al.
  • J Clin Oncol
  • 4 Aug 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Maintenance olaparib significantly improves PFS in patients with newly diagnosed advanced ovarian cancer irrespective of surgery timing, residual disease status after surgery, response after platinum-based chemotherapy, or type of BRCA mutation.

Why this matters

  • The findings show that regardless of patient baseline outcomes from surgery and chemotherapy or BRCA mutation type, patients with newly diagnosed advanced ovarian cancer are at high risk for disease progression and benefit from maintenance olaparib treatment.

Study design

  • Prespecified subgroup analyses of phase 3, multicenter, randomized, double-blind SOLO1 study.
  • 391 patients after first-line platinum-based chemotherapy were randomly assigned 2:1 to maintenance olaparib or placebo.
  • Funding: AstraZeneca.

Key results

  • Median follow-up was approximately 41 months in the olaparib and placebo groups.
  • Maintenance olaparib significantly reduced the risk for progression or death vs placebo in patient subgroups:
    • Upfront (HR, 0.31; 95% CI, 0.21-0.46) and interval surgery (HR, 0.37; 95% CI, 0.24-0.58).
    • Residual (HR, 0.44; 95% CI, 0.25-0.77) and no residual (HR, 0.33; 95% CI, 0.23-0.46) disease after surgery and complete response (HR, 0.34; 95% CI, 0.24-0.47) and partial response (HR, 0.31; 95% CI, 0.18-0.52) at baseline.
    • BRCA1 (HR, 0.41; 95% CI, 0.30-0.56) and BRCA2 (HR 0.20; 95% CI, 0.10-0.37) mutation.

Limitations

  • Small patient numbers in some subgroups.