Autores
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
Fecha de publicación
2005/6/30
Revista
New England Journal of Medicine
Volumen
352
Número
26
Páginas
2696-2704
Editor
Massachusetts Medical Society
Descripción

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 …
Citas totales
2005200620072008200920102011201220132014201520162017201820192020202123858911910010494110899589976580628945
Artículos de Google Académico
C Twelves, A Wong, MP Nowacki, M Abt, H Burris III… - New England Journal of Medicine, 2005