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Originally published as JCO Early Release 10.1200/JCO.2006.09.8467 on June 4 2007 © 2007 American Society of Clinical Oncology. Phase III Study of Capecitabine Plus Oxaliplatin Compared With Continuous-Infusion Fluorouracil Plus Oxaliplatin As First-Line Therapy in Metastatic Colorectal Cancer: Final Report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial
From the Department of Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid; Hospital Vall dHebrón, University Barcelona; Hospital Clinic; Hospital Hospitalet, Barcelona; Hospital Reina Sofia, Córdoba; Hospital General, Alicante; Hospital Virgen Rocio, Sevilla; Hospital Germans Trias i Pujol, Badalona; Hospital Universitario Elche, Alicante; ICO, Girona; Hospital J. Ramón Jimenez, Huelva; Hospital Virgen de las Nieves, Granada; Hospital la Fe, Valencia; and the Hospital Marqués Valdecilla, Santander, Spain Address reprint requests to Eduardo Díaz-Rubio, PhD, Servicio de Oncologia Medica, Hospital Clínico San Carlos, 28040 Madrid, Spain; e-mail: ediazrubio.hcsc{at}salud.madrid.org Purpose: The aim of this phase III trial was to compare the efficacy and safety of capecitabine plus oxaliplatin (XELOX) versus Spanish-based continuous-infusion high-dose fluorouracil (FU) plus oxaliplatin (FUOX) regimens as first-line therapy for metastatic colorectal cancer (MCRC). Patients and Methods: A total of 348 patients were randomly assigned to receive XELOX (oral capecitabine 1,000 mg/m2 bid for 14 days plus oxaliplatin 130 mg/m2 on day 1 every 3 weeks) or FUOX (continuous-infusion FU 2,250 mg/m2 during 48 hours on days 1, 8, 15, 22, 29, and 36 plus oxaliplatin 85 mg/m2 on days 1, 15, and 29 every 6 weeks). Results: There were no significant differences in efficacy between XELOX and FUOX arms, which showed, respectively, median time to tumor progression (TTP; 8.9 v 9.5 months; P = .153); median overall survival (18.1 v 20.8 months; P = .145); and confirmed response rate (RR; 37% v 46%; P = .539). The safety profile of the two regimens was similar, although there were lower rates of grade 3/4 diarrhea (14% v 24%) and grade 1/2 stomatitis (28% v 43%), and higher rates of grade 1/2 hyperbilirubinemia (37% v 21%) and grade 1/2 hand-foot syndrome (14% v 5%) with XELOX versus FUOX, respectively. Conclusion: This randomized study shows a similar TTP of XELOX compared with FUOX in the first-line treatment of MCRC, although there was a trend for slightly lower RR and survival. XELOX can be considered as an alternative to FUOX. published online ahead of print at www.jco.org on June 4, 2007. Supported by the Treatment of Digestive Tumors (TTD), Madrid, Spain, and by Roche and Sanofi-Aventis. Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL; the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2005, Atlanta, GA; and the Annual Meeting of the European Society for Medical Oncology, Istanbul, Turkey, September 29-October 3, 2006. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. Related Editorial
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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