Introduction The drug 5-fluorouracil (5-FU) has been the main agent for the treatment of metastatic colorectal cancer (mCRC) for over 40 years. Conventional bolus schedules of 5-FU are associat- ed with gastrointestinal toxicity (eg, diarrhea, stomatitis) and myelosuppression. 1 Although infused 5-FU–based regimens offer some efficacy benefits and a better tolerability profile to bolus regimens, 2,3 they carry the added cost of the unwanted complications, discomforts, and inconveniences associated with central venous access. 4 Capecitabine is an oral fluoropyrimidine that is replacing 5-FU as single-agent therapy for mCRC because of its good efficacy, favorable tolerability profile, and convenience in this patient group. 1,5 Pooled results from 2 pivotal randomized phase III clinical trials in which capecitabine (1250 mg/m 2 twice daily on days 1-14 every 3 weeks) was compared with 5-FU/leucovorin (LV; Mayo Clinic regimen) in > 1200 patients showed that capecitabine achieved a higher overall response rate (26% vs. 17%, P < .0002), while the median time to disease progression (4.5 months) and overall survival (13 months; OS) were similar in both groups. 5 In addition, efficacy data from the X-ACT adjuvant trial in stage III colon cancer shows that capecitabine single-agent therapy results in at least equivalent disease-free survival, superior Abstract Submitted: Aug 20, 2007; Revised: Jan 3, 2008; Accepted: Jan 17, 2008 Address for correspondence: José G.M Segalla, MD, Rua das Palmeiras, 122 Jaú, São Paulo, Brazil, CEP: 17210-120 Fax: 55-14-3624-9422; e-mail: segalla@amaralcarvalho.org.br 1 Hospital Amaral Carvalho, Jaú, São Paulo, Brazil 2 Instituto do Câncer Arnaldo Vieira de Carvalho (ICAVC), São Paulo, Brazil 3 Hospital das Clínicas de São Paulo, São Paulo, Brazil 4 Hospital Erasto Gaertner, Curitiba, Paraná, Brazil 5 Associação Hospital de Caridade de Ijuí, Ijuí, Rio Grande du Sul, Brazil 6 Hospital Beneficência Portuguesa de Santos, Santo, São Paulo, Brazil 7 Hospital São Joaquim - Real e Benemérita Sociedade Portuguesa de Beneficiência de São Paulo, SP, Brazil 8 Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo, Brazil 9 Centro de Quimioterapia e Imunoterapia Ltda., Belo Horizonte, Minas Gerais, Brazil 10 Instituto do Câncer do Ceará, Fortaleza, Ceará, Brazil José G.M. Segalla, 1 Brigitte Van Eyll, 2 Mirian Hatsue Honda Federico, 3 Nills G. Skare, 4 Fábio A. Franke, 5 Martha R. Perdicaris, 6 Urias de Paula Filho, 7 Otávio Gampel, 8 Sebastião Cabral, 9 Ronaldo de Albuquerque Ribeiro 10 Purpose:This study evaluated the effects of oral capecitabine on the quality of life (QOL) of Brazilian patients with metastatic colorectal cancer who received capecitabine (1000 or 1250 mg/m 2 twice a day on days 1-14, every 3 weeks) in a prospective, multicenter, open-label, noncomparative study. Patients and Methods: Patients completed the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR38 questionnaires before cycle 1, at weeks 7 and 13, and at the end of treatment. In total, 1437 patients (mean age, 59.6 years [± 13.5 years]) were enrolled. Results: In women, statistically significant improvements were observed in 6 QLQ-C30 and 6 QLQ-CR38 domains (QLQ-C30: emotional function, nausea/ vomiting, pain, constipation, financial problems, and body image; QLQ-CR38: future perspective, micturition problems, defeca- tion problems, stoma-related problems, weight loss and global health status). In men, statistically significant improvements were observed in 8 QLQ-C30 and 5 QLQ-CR38 domains (QLQ-C30: emotional function, social function, pain, insomnia, appetite loss, constipation, financial problems, and future perspective; QLQ-CR38: micturition problems, defecation problems, stoma- related problems, weight loss, and global health status). Statistically significant worsening of sexual function/enjoyment occurred in both sexes. Conclusion: Overall, 59%-86% of patients maintained or improved QOL during capecitabine therapy. Clinical Colorectal Cancer, Vol. 7, No. 2, 126-133, 2008 Key words: 5-Fluorouracil, Least square mean value, Leucovorin, Uracil-tegafur Contribution Original Evaluation of Quality of Life in Patients with Metastatic Colorectal Cancer Treated with Capecitabine Electronic forwarding or copying is a violation of US and International Copyright Laws. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by CIG Media Group, LP, ISSN #1533-0028, provided the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA 978-750-8400. 126 • Clinical Colorectal Cancer March 2008