Effects of regorafenib (REG) therapy on health-related quality of life (HRQoL) in patients with metastatic colorectal cancer (mCRC) in the phase III CONCUR trial

Abstract

Background: In the phase III CORRECT and CONCUR trials, REG significantly improved overall survival (OS) vs placebo (PBO) in patients with mCRC whose disease progressed on standard treatments. In CORRECT, overall HRQoL was similar between REG and PBO. This analysis reports the HRQoL effects of REG in CONCUR. Methods: CONCUR (NCT01584830 ) was an international, multicenter trial which enrolled patients in Asia (N = 204). Patients were randomized 2:1 to receive REG 160 mg (n = 136) or PBO (n = 68) once daily for weeks 1–3 of each 4-week cycle. Planned HRQoL analyses were conducted using the European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the EuroQol-five dimension (EQ-5D) questionnaires. EORTC QLQ-C30 global health status (GHS) and the EQ-5D index and visual analogue scale (VAS) scores were expressed as least squares mean (LSM) time-adjusted area under the curve (AUC) to allow comparison of change in HRQoL across the treatment period. An exploratory post-hoc analysis assessed time to deterioration (TTD) of HRQoL, defined as the earliest ? 10-point score decline in GHS or physical functioning (PF) domain score, progression or death. Results: Overall changes from baseline in HRQoL scores appeared similar in the REG and PBO groups. LSM time-adjusted AUC of the EORTC QLQ-C30 GHS domain, EQ-5D index and VAS scores did not differ significantly between groups (table). TTD of HRQoL was significantly longer with REG vs PBO in post-hoc analyses (table). Conclusions: REG provided additional clinical benefit while maintaining HRQoL vs PBO in Asian patients. Clinical trial information: NCT01584830.