Quality-Adjusted Time Without Symptom Or Toxicity (Qa-Twist) And Quality-Adjusted Progression-Free Survival (Qa-Pfs) Of First-Line (1l) Maintenance Niraparib In Patients With Advanced Ovarian Cancer (Oc): Results From The Prima Trial

The PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) phase III trial showed niraparib significantly prolongs median PFS vs placebo in patients with advanced OC responsive to 1L platinum (Pt)-based chemotherapy (CT), regardless of biomarker status. This post hoc analysis of PRIMA examined the QA-TWiST and QA-PFS of patients on maintenance niraparib vs placebo. Patients with OC responsive to 1L Pt CT were randomised 2:1 to receive once-daily maintenance niraparib or placebo. QA-TWiST analyses were performed, defining TOX as the mean duration in which a patient experienced grade ≥2 adverse events (fatigue or asthenia, nausea, vomiting, abdominal pain, and abdominal bloating) from randomisation to disease progression/censoring. Mean QA-TWiST was calculated as UTOX x TOX + UTWiST x TWiST, where UTWiST and UTOX represent utilities applied to the time spent in TWiST and TOX health states, respectively. UTWiST was considered 1.00, i.e., the best possible quality of life for a patient. UTOX was calculated using EQ-5D index scores from the PRIMA trial. Restricted mean QA-PFS was calculated from the area under the quality-survival product function up to the last PFS of patients randomised to niraparib. Patient follow-up was 27.8 months. There were significant improvements in mean QA-TWiST for niraparib vs placebo in the intention-to-treat (ITT) and homologous recombination-deficient (HRd) cohorts, with mean gains of 3.5 and 5.9 months, respectively (Table). Similarly, QA-PFS was significantly longer with niraparib vs placebo in these cohorts. In patients with OC, 1L niraparib maintenance was associated with significant gains in QA-TWiST and QA-PFS vs placebo, confirming the benefit of niraparib in the overall ITT population and HRd cohorts.Table: 738PMean QA-TWiST and QA-PFS in ITT and HRd cohortsMean (95% CI) duration, monthsQA-TWiSTNiraparibPlaceboQA-TWiST GainITT population15.4 (14.1, 16.4)11.8 (10.1, 13.2)3.5 (1.7, 5.6)HRd population19.1 (17.4, 20.5)13.3 (10.9, 15)5.9 (3.5, 8.6)QA-PFSNiraparibPlaceboDifferenceITT14 (12.6, 15)9.9 (8.6, 11)4.1 (2.2, 5.8)HRd population17.7 (15.6, 19.1)11.2 (9.1, 12.6)6.5 (3.9, 8.9) Open table in a new tab .