• Chris Twelves, Alfred Wong, Marek P Nowacki, Markus Abt, Howard Burris, Alfredo Carrato, Jim Cassidy, Andrés Cervantes, Jan Fagerberg, Vassilis Georgoulias, Fares Husseini, Duncan Jodrell, Piotr Koralewski, Hendrik Kröning, Jean Maroun, Norbert Marschner, Joseph McKendrick, Marek Pawlicki, Riccardo Rosso, Johannes Schüller, Jean-François Seitz, Borut Stabuc, Jerzy Tujakowski, Guy Van Hazel, Jerzy Zaluski, and Werner Scheithauer.
• University of Leeds and Bradford NHS Hospitals' Trust, Leeds, United Kingdom. c.twelves@bradford.ac.uk
• N. Engl. J. Med. 2005 Jun 30; 352 (26): 2696-704.

BackgroundIntravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an established alternative to bolus fluorouracil plus leucovorin as first-line treatment for metastatic colorectal cancer. We evaluated capecitabine in the adjuvant setting.MethodsWe randomly assigned a total of 1987 patients with resected stage III colon cancer to receive either oral capecitabine (1004 patients) or bolus fluorouracil plus leucovorin (Mayo Clinic regimen; 983 patients) over a period of 24 weeks. The primary efficacy end point was at least equivalence in disease-free survival; the primary safety end point was the incidence of grade 3 or 4 toxic effects due to fluoropyrimidines.ResultsDisease-free survival in the capecitabine group was at least equivalent to that in the fluorouracil-plus-leucovorin group (in the intention-to-treat analysis, P<0.001 for the comparison of the upper limit of the hazard ratio with the noninferiority margin of 1.20). Capecitabine improved relapse-free survival (hazard ratio, 0.86; 95 percent confidence interval, 0.74 to 0.99; P=0.04) and was associated with significantly fewer adverse events than fluorouracil plus leucovorin (P<0.001).ConclusionsOral capecitabine is an effective alternative to intravenous fluorouracil plus leucovorin in the adjuvant treatment of colon cancer.Copyright 2005 Massachusetts Medical Society.

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