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

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, and O'Callaghan, Christopher J. (2014) Quality of life in patients with K-RAS wild-type colorectal cancer: the CO.20 Phase 3 randomized trial. Cancer, 120 (2). pp. 181-189.

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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.

Item ID: 33946
Item Type: Article (Research - C1)
ISSN: 1097-0142
Keywords: colorectal cancer, K-RAS, palliative chemotherapy, quality of life, questionnaires, patient-reported outcomes.
Funders: Canadian Cancer Society Research Institute (CCSRI), Bristol-Myers Squibb
Projects and Grants: CCSRI grant number 021039
Date Deposited: 16 Jul 2014 00:42
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111799 Public Health and Health Services not elsewhere classified @ 100%
SEO Codes: 92 HEALTH > 9202 Health and Support Services > 920299 Health and Support Services not elsewhere classified @ 100%
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