Quality of life in patients with K‐RAS wild‐type colorectal cancer. Issue 2 (11th October 2013)

• Record Type: Journal Article
• 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.
• Is Part Of: Cancer. Volume 120:Issue 2(2014)
• Page Start: 181
• Page End: 189
• Publication Date: 2013-10-11
• Subjects: Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.28410
• Languages: English
• ISSNs: 0008-543X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncr28410-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>The CO.20 trial randomized patients with K‐<italic>RAS</italic> wild‐type, chemotherapy‐refractory, metastatic colorectal cancer to receive cetuximab (CET) plus brivanib alaninate (BRIV) or CET plus placebo (CET/placebo).</p> </sec> <sec id="cncr28410-sec-0002" sec-type="section"> <title>METHODS</title> <p>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.</p> </sec> <sec id="cncr28410-sec-0003" sec-type="section"> <title>RESULTS</title> <p>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 (<italic>P</italic> = .02) and 5.6 months versus 1.7 months for PF (<italic>P</italic> < .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.</p> </sec> <sec id="cncr28410-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>Compared with CET/placebo, the combination of CET/BRIV worsened time to QoL deterioration for patients with K‐<italic>RAS</italic> 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. <bold><italic>Cancer</italic> 2014;120:181–189</bold>. © <italic>2013 American Cancer Society</italic>.</p> </sec> </abstract>