Health-related quality of life in women with recurrentovarian cancer receiving paclitaxel plus trebananib orplacebo (TRINOVA-1)

Background: To evaluate the influence of treatment on health-related quality of life (HRQoL) in 919 women withrecurrent ovarian cancer enrolled in the TRINOVA-1 study, a randomized, placebo-controlled phase III study that demonstratedthat trebananib 15 mg/kg QW plus weekly paclitaxel significantly improved progression-free survival (PFS) comparedwith placebo plus weekly paclitaxel (7.2 versus 5.4 months; hazard ratio, 0.66; 95% confidence interval 0.57-0.77;P <0.001).Patients and methods: HRQoL was assessed with the Functional Assessment of Cancer Therapy-Ovary [FACT-O;comprising FACT-G and the ovarian cancer-specific subscale (OCS)] and EuroQOL EQ-5D instruments before treatmenton day 1 of weeks 1, 5, 9, 13, 17, and every 8 weeks thereafter and at the safety follow-up visit. A pattern-mixture modelwas used to evaluate the influence of patient dropout on FACT-O and OCS scores over time.Results: Of 919 randomized patients, 834 (91%) had a baseline and ≥1 post-baseline HRQoL assessment. At baseline,scores for all instruments were similar for both arms. At 25 weeks, mean ± SD changes from baseline were negligible,with mean ± SD changes typically