Originally published as JCO Early Release 10.1200/JCO.2008.19.6048 on March 9 2009

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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

From the Cross Cancer Institute, Edmonton, Alberta; National Cancer Institute of Canada Clinical Trials Group; and Departments of Oncology and Community Health and Epidemiology, Queen's University, Kingston; Princess Margaret Hospital, Toronto; Grand River Regional Cancer Centre, Kitchener; and Ottawa Health Research Institute, University of Ottawa, Ottawa, Ontario; British Columbia Cancer Agency, Vancouver Cancer Centre, Vancouver, British Columbia; Hôpital Notre-Dame, Université de Montréal, Montréal, Québec, Canada; Flinders Medical Centre, Adelaide; Peter MacCallum Cancer Centre and Department of Medicine, University of Melbourne; and Cabrini Hospital, Melbourne, Australia; Royal North Shore Hospital and Faculty of Medicine, University of Sydney, Sydney; and Royal Brisbane and Womens Hospital, Herston, Australia.

Corresponding author: Heather-Jane Au, MD, MPH, Cross Cancer Institute, 11560 University Ave, Edmonton, Alberta, T6G 1Z2, Canada; e-mail: heathera{at}cancerboard.ab.ca.

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 < .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.

Supported by the National Cancer Institute of Canada Clinical Trials Group, the Australasian Gastro-Intestinal Trials Group, Bristol-Myers Squibb, and ImClone Systems Inc.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

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