- 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.
- 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.
- 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.
- Post hoc analysis, lack of OS data.