BACKGROUND: In the phase II, randomized, double-blind FIGHT trial (NCT03694522), treatment with bemarituzumab plus mFOLFOX6 resulted in improvements in progression-free survival and overall survival relative to mFOLFOX6 alone in previously untreated locally advanced or metastatic gastric or gastroesophageal junction cancer with fibroblast growth factor receptor 2b overexpression. Using data from the final analysis, we analyzed patient-reported outcomes (PROs) to evaluate the impact of adding bemarituzumab to mFOLFOX6 on health-related quality of life (HRQoL).
MATERIALS AND METHODS: Patients were randomized 1 : 1 to bemarituzumab plus mFOLFOX6 (n = 77) or placebo plus mFOLFOX (n = 78). European Organisation for Research and Treatment of Cancer Core 30-item Quality of Life (EORTC QLQ-C30) and the EuroQol EQ-5D-5L questionnaires were administered at baseline, week 6, every 8 weeks thereafter, and at end-of-treatment visit. Least-squares mean changes from baseline in PRO scale scores were estimated using mixed models for repeated measures; time to deterioration and improvement were assessed using Cox proportional hazards models. Analyses were exploratory post hoc.
RESULTS: PRO scale scores at baseline and compliance rates across PRO assessments over time were similar between the bemarituzumab and placebo arms. Least-squares mean changes from baseline on key EORTC QLQ-C30 scales (global health status/QoL, physical functioning, fatigue, nausea and vomiting, and appetite loss) and the EQ-5D-5L visual analog scale were similar over time between treatment arms. Analyses of time to deterioration, sustained deterioration, and improvement suggested similar HRQoL between treatment arms.
CONCLUSIONS: Treatment with bemarituzumab plus mFOLFOX6 was associated with sustained HRQoL relative to mFOLFOX6 alone.
