Health-related quality of life in patients with advanced colorectal cancer treated with cetuximab: Overall and KRAS-specific results of the NCIC CTG and AGITG CO.17 Trial

Abstract

Purpose National Cancer Institute of Canada Clinical Trials Group CO.17 demonstrated the antiepidermal growth factor receptor (anti-EGFR) monoclonal antibody cetuximab improves overall and progression-free survival in patients with advanced, chemotherapy-refractory colorectal cancer (CRC), particularly in patients with wild-type KRAS tumors. This article reports the health-related quality-of-life (HRQL) outcomes from CO.17. Patients and Methods Patients (N = 572) with pretreated EGFR-detectable advanced CRC were randomly assigned to cetuximab and best supportive care (BSC) or to BSC alone. HRQL primary end points assessed by the EORTC QLQ-C30 were physical function (PF) and global health status (GHS); mean changes from baseline to 8 and 16 weeks were assessed. Post hoc analysis by KRAS mutation status was performed. Results Questionnaire compliance was 94% at baseline, but it declined differentially (67% v 47% for cetuximab v BSC at 16 weeks). PF change scores were -3.9 for cetuximab and -8.6 for BSC (P =.046) at 8 weeks and were -5.9 and -12.5 for cetuximab and BSC, respectively, (P =.027) at 16 weeks. GHS change scores were -0.5 and -7.1 (P =.008) at 8 weeks and were -3.6 and -15.2 (P =.008) at 16 weeks for cetuximab and BSC, respectively. In patients who had tumors with wild-type KRAS status, cetuximab resulted in less PF deterioration at 8 weeks (-0.7 v-7.2; P =.11) and 16 weeks (-3.4 v -13.8; P =.008) compared with BSC. Patients with wild-type status who received cetuximab experienced improved GHS at 8 weeks, whereas patients who received BSC alone deteriorated (3.2 v -7.7; P =.002). Cetuximab preserved GHS at 16 weeks (-0.2 v -18.1; P