Health-related Quality of Life in Women With Recurrent Ovarian Cancer Receiving Paclitaxel Plus Trebananib or Placebo (TRINOVA-1)
Menée aux Etats-Unis auprès de 919 patientes atteintes d'un cancer de l'ovaire récidivant et incluses dans un essai de phase III évaluant l'efficacité d'un traitement combinant paclitaxel et trébananib, cette étude analyse l'évolution de leur qualité de vie
Background : To evaluate the influence of treatment on health-related quality of life (HRQoL) in 919 women with recurrent ovarian cancer enrolled in the TRINOVA-1 study, a randomized, placebo-controlled phase 3 study that demonstrated that trebananib 15 mg/kg QW plus weekly paclitaxel significantly improved PFS compared with placebo plus weekly paclitaxel (7.2 versus 5.4 months; hazard ratio, 0.66; 95% CI, 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 treatment on day 1 of weeks 1, 5, 9, 13, 17, and every 8 weeks thereafter and at the safety follow-up visit. A pattern-mixture model was used to evaluate influence of patient dropout on FACT-O and OCS scores over time. Results : 834 of 919 randomized patients (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 <1 unit from baseline: −2.4±16.6 in the trebananib arm and −1.6±15.2 in the placebo arm for FACT-O, −0.71±5.5 in the trebananib arm and −0.86±4.9 in the placebo arm for OCS, and −0.02±0.22 in the trebananib arm and 0.02±0.19 in the placebo arm for EQ-5D. Distribution of scores was similar between treatment arms at baseline and over the course of the study. In pattern-mixture models, there was no evidence that patient dropout affected differences in mean FACT-O or OCS scores. Edema had limited effect on either FACT-O or OCS scores in patients with grade ≥2 edema or those with grade 1 or no edema. Conclusions : Our results demonstrate that the improvement in PFS among patients in the trebananib arm in the TRINOVA-1 study was achieved without compromising HRQoL.