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Title: Quality of life in patients with K-RAS wild-type colorectal cancer: the CO.20 phase 3 randomized trial.
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
Jeffrey, Mark
Alcindor, Thierry
Ng, Siobhan
Salim, Muhammad
Sabesan, Sabe
Easaw, Jay C.
Shannon, Jenny
El-Tahche, Fabyolla
Walters, Ian
Dongsheng, Tu
O'Callaghan, Christopher J.
Institutional Author: American Cancer Society
Australasian Gastrointestinal Trials Group
NCIC Clinical Trials Group
Issue Date: 2014
Publisher: Wiley Online Library
Place of publication: Hoboken, N.J.
Publication Title: Cancer
Volume: 120
Issue: 2
Start Page: 181
End Page: 189
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 (P5.02) 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;120:181–9. VC 2013 American Cancer Society. KEYWORDS: colorectal cancer, K-RAS, palliative chemotherapy, quality of life, questionnaires, patient-reported outcomes.
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ISSN: 0008-543X
Internal ID Number: 00546
Health Subject: CANCER
Type: Journal Article
Appears in Collections:Research Output

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