PCN295 PATIENT-CENTERED OUTCOMES IN ARIEL3, A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF RUCAPARIB MAINTENANCE TREATMENT IN PATIENTS WITH RECURRENT OVARIAN CARCINOMA

Abstract

In ARIEL3, rucaparib (600 mg BID) maintenance treatment significantly improved progression-free survival (PFS) vs placebo in all predefined cohorts. This post hoc exploratory analysis investigated quality-adjusted PFS (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST). QA-PFS was calculated as PFS function × EQ-5D index score function. Q-TWiST was calculated as (μTOX × TOX) + TWiST. TOX represents the mean duration with grade ≥3 adverse events (AEs) or grade ≥2 AEs of nausea, vomiting, fatigue, and asthenia only. TWiST represents the mean duration without AEs or symptoms of progression. μTOX represents the standardized mean EQ-5D index score. This analysis utilized the primary efficacy data after unblinding (April 15, 2017, visit cutoff). In the intent-to-treat population, for rucaparib (n=375) vs placebo (n=189): mean (95% confidence interval [CI]) QA-PFS was 12.02 (10.96–13.03) months vs 5.74 (4.98–6.42) months (difference, 6.28 [4.85–7.47] months); mean (95% CI) Q-TWiST adjusting for grade ≥3 AEs was 13.32 (12.11–14.46) months vs 6.44 (5.78–7.18) months (difference, 6.88 [5.71–8.23] months); and mean (95% CI) Q-TWiST adjusting for common grade ≥2 AEs was 13.16 (12.01–14.33) months vs 6.40 (5.75–7.15) months (difference, 6.77 [5.64–8.14] months). In patients with a BRCA mutation (germline, somatic, or origin unknown), for rucaparib (n=130) vs placebo (n=66): mean (95% CI) QA-PFS was 15.28 (13.22–17.45) months vs 5.92 (4.71–7.23) months (difference, 9.37 [6.65–11.85] months); mean (95% CI) Q-TWiST adjusting for grade ≥3 AEs was 16.42 (14.29–18.18) months vs 6.70 (5.49–8.02) months (difference, 9.73 [7.10–11.94] months); and mean (95% CI) Q-TWiST adjusting for common grade ≥2 AEs was 16.24 (14.11–17.95) months vs 6.68 (5.45–8.00) months (difference, 9.56 [6.99–11.81] months). The significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib vs placebo in all predefined cohorts.