In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 11 ( 2009-04-10), p. 1822-1828
Abstract:
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 〈 .001). No significant differences were noted between study arms for patients with mutated KRAS tumors. Conclusion Cetuximab offers important HRQL and survival benefits for pretreated patients with advanced, wild-type KRAS CRC.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2008.19.6048
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2009
detail.hit.zdb_id:
2005181-5
