Despite mostly increased awareness about CRC and screening, about half of the patients still present with, or subsequently develop, metastatic disease. Traditionally, 5-fluorouracil (5-FU) with or without leucovorin (LV) was the only drug used in the palliative treatment of patients with metastatic colorectal carcinoma (mCRC), but this treatment was reported to have a limited impact on survival. Recently, encouraging results have been obtained with capecitabine (Xeloda; F Hoffmann-La Roche Ltd, Basel, Switzerland), an oral fluoropyrimidine (Miwa et al, 1998; Sch��ller et al, 2000; Reigner et al, 2001). In the first-line treatment of mCRC, capecitabine as single-agent treatment was found to be at least equivalent to bolus 5-FU/LV in terms of time to disease progression and overall survival (OS), with higher response rates (Hoff et al, 2001; Van Cutsem et al, 2001; Cassidy et al, 2002).
A series of phase-III studies were subsequently performed, which showed the non-inferiority of a combination of oxaliplatin with capecitabine compared with different 5-FU-based regimens plus oxaliplatin in patients with mCRC (D��az-Rubio et al, 2007; Porschen et al, 2007; Cassidy et al, 2008; Rothenberg et al, 2008). On the basis of these results, capecitabine seemed to be an alternative to intravenous 5-FU. In addition to efficacy data, patient quality of life (QoL), convenience and satisfaction are assuming increasing importance in the assessment of cancer therapies. Quality of life considerations are crucial to understanding the impact of cancer on the patient, especially when treatments are palliative rather than curative (Payne, 1992).
On the basis of the American Society of Clinical Oncology, European Medicines Agency and Food and Drug Administration recommendations, health-related Quality-of-Life (HRQoL) questionnaires should be incorporated as secondary assessment criteria in controlled clinical trials conducted GSK-3 in patients with advanced cancers (ASCO, 1996; Beitz et al, 1996; EMEA, 2005). Among the available QoL questionnaires, the Cancer Quality of Life Questionnaire-C30 (QLQ-C30) was developed and validated by the European Organisation for Research and Treatment of Cancer (Fayers and Bottomley, 2002). It has already been used in more than 3000 studies worldwide and is translated and validated in 81 languages (EORTC, 2008). Acceptability of QLQ-C30 is excellent in patients suffering from CRC (Conroy et al, 2002). The module ��Chemotherapy Convenience and Satisfaction Questionnaire’ (CCSQ) of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, a collection of HRQoL questionnaires related to the management of chronic illnesses, measures the health-care satisfaction of patients (Webster et al, 2003; Yost et al, 2005a).