Authors
Chris Twelves, Alfred Wong, Marek P Nowacki, Markus Abt, Howard Burris III, 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, Werner Scheithauer
Publication date
2005/6/30
Journal
New England Journal of Medicine
Volume
352
Issue
26
Pages
2696-2704
Publisher
Massachusetts Medical Society
Description
Background
Intravenous 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.
Methods
We 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.
Results
Disease-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 …
Total citations
Scholar articles
C Twelves, A Wong, MP Nowacki, M Abt, H Burris III… - New England Journal of Medicine, 2005