Recurrent ovarian cancer: rucaparib prolongs quality-adjusted survival

  • Oza AM & al.
  • J Clin Oncol
  • 24 Aug 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Maintenance rucaparib improves quality-adjusted PFS (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in previously treated patients with high-grade ovarian cancer irrespective of BRCA mutation status.

Why this matters

  • Findings show PFS benefit with maintenance rucaparib without detrimental effects on health status.
  • This is the first report of quality-adjusted outcomes for a poly(ADP-ribose) polymerase inhibitor in ovarian cancer.

Study design

  • In this double-blind, phase 3 ARIEL3 trial, 564 patients with platinum-sensitive, high-grade ovarian cancer with ≥2 prior chemotherapies were randomly assigned to receive rucaparib (n=375) or placebo (n=189).
  • Outcomes: QA-PFS and Q-TWiST.
  • Funding: Clovis Oncology.

Key results

  • Mean QA-PFS was significantly longer with rucaparib vs placebo (95% CIs) in:
    • Intent-to-treat population: difference, 6.28 (4.85-7.47) months.
    • BRCA-mutant cohort: difference, 9.37 (6.65-11.85) months.
    • Homologous recombination deficient (HRD) cohort: difference, 7.93 (5.93-9.53) months.
    • BRCA wild-type/loss of heterozygosity low patient subgroup: difference, 2.71 (0.31-4.44) months.
  • Mean difference in mean Q-TWiST (95% CIs) using grade ≥3 toxicities:
    • Intent-to treat population: 6.88 (5.71-8.23) months.
    • BRCA-mutant cohort: 9.73 (7.10-11.94) months.
    • HRD cohorts: 8.11 (6.36-9.49) months.

Limitations

  • Post hoc analysis, lack of OS data.