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- Title
Quality of life in patients with K- RAS wild-type colorectal cancer.
- Authors
Ringash, Jolie; Au, Heather‐Jane; Siu, Lillian L.; Shapiro, Jeremy D.; Jonker, Derek J.; Zalcberg, John R.; Moore, Malcolm J.; Strickland, Andrew; Kotb, Rami; Jeffery, Mark; Alcindor, Thierry; Ng, Siobhan; Salim, Muhammad; Sabesan, Sabe; Easaw, Jay C.; Shannon, Jenny; El‐Tahche, Fabyolla; Walters, Ian; Tu, Dongsheng; O'Callaghan, Christopher J.
- Abstract
BACKGROUND The CO.20 trial randomized patients with K- RAS wild-type, chemotherapy-refractory, metastatic colorectal cancer to receive cetuximab (CET) plus brivanib alaninate (BRIV) or CET plus placebo (CET/placebo). METHODS Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 at baseline and at 2, 4, 6, 8, 12, 16, and 24 weeks until disease progression. Predefined coprimary QoL endpoints were time to deterioration (first worsening from baseline of ≥ 10 points) on the Physical Function (PF) and Global (GHS) scales. RESULTS Of 750 randomized patients, 721 (358 of whom received CET/BRIV) were assessable for QoL. QoL compliance and baseline PF and GHS scores did not differ by treatment arm. The median time to deterioration was 1.6 months versus 1.1 months for GHS ( P = .02) and 5.6 months versus 1.7 months for PF ( P < .0001) favoring CET/placebo. Secondary analysis favored CET/placebo for QOL response on the PF, Cognitive Function, Fatigue, Nausea, Appetite, and Diarrhea scales. A greater percentage of patients on the CET/BRIV arm had PF worsening at 6 weeks (31% vs 17%). Clinical adverse events of ≥ grade 3 were more common with CET/BRIV than with CET/placebo, including fatigue (25% vs 11%), hypertension, rash, diarrhea, abdominal pain, dehydration, and anorexia. CONCLUSIONS Compared with CET/placebo, the combination of CET/BRIV worsened time to QoL deterioration for patients with K- RAS wild-type, chemotherapy-refractory, metastatic colorectal cancer on the PF and GHS scales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. This result may be due to higher rates of fatigue and gastrointestinal adverse events. Cancer 2014;120:181-189. © 2013 American Cancer Society.
- Subjects
COLON cancer patients; QUALITY of life; RANDOMIZED controlled trials; GTPASE-activating protein; CANCER chemotherapy; CETUXIMAB; PLACEBOS; THERAPEUTICS
- Publication
Cancer (0008543X), 2014, Vol 120, Issue 2, p181
- ISSN
0008-543X
- Publication type
Article
- DOI
10.1002/cncr.28410