Quality of life in patients with K-RAS wild-type colorectal cancer: the CO.20 phase 3 randomized trial.

摘要: 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 placebo (CET/placebo). METHODS Quality of life (QoL) was assessed using the European Organization for Research and Treatment Cancer Quality Life Questionnaire C30 at baseline 2, 4, 6, 8, 12, 16, 24 weeks until disease progression. Predefined coprimary QoL endpoints were time deterioration (first worsening from ≥ 10 points) on Physical Function (PF) Global (GHS) scales. RESULTS Of 750 patients, 721 (358 whom received CET/BRIV) assessable QoL. compliance PF GHS scores did not differ by treatment arm. The median 1.6 months versus 1.1 (P = .02) 5.6 1.7 (P < .0001) favoring CET/placebo. Secondary analysis favored CET/placebo QOL response PF, Cognitive Function, Fatigue, Nausea, Appetite, Diarrhea scales. A greater percentage CET/BRIV arm had 6 (31% vs 17%). Clinical adverse events ≥ grade 3 more common than CET/placebo, including fatigue (25% 11%), hypertension, rash, diarrhea, abdominal pain, dehydration, anorexia. CONCLUSIONS Compared combination worsened scales C30. This result may be due higher rates gastrointestinal events. 2014;120:181–189. © 2013 American Society.