A randomised phase III intergroup trial comparing high-dose infusional 5-fluorouracil with or without folinic acid with standard bolus 5-fluorouracil/folinic acid in the adjuvant treatment of stage III colon cancer: the Pan-European Trial in Adjuvant Colon Cancer 2 study.

Abstract

PURPOSE:

To investigate whether infusional high-dose 5-flurouracil (HD-FU) provides a significant improvement in recurrence-free survival (RFS) and overall survival (OS) compared with a standard bolus 5-FU regimen (Mayo Clinic) in patients with curatively resectable stage III colon cancer.

METHODS:

Patients (n=1601) were randomised to receive either the Mayo Clinic regimen or one of the three HD-FU regimens; LV5FU2, the Arbeitsgemeinschaft Internistische Onkologie (AIO) or the Grupo Espaňol para el Tratamiento Digestivos (TTD), the data from which were combined to provide the HD-FU arm for final analysis.

RESULTS:

Patients were evenly balanced for age, TMN, tumor grade and vascular and lymphatic invasion. Median follow-up was approximately 42months, RFS (hazard ratio [HR]=0.997) and OS (HR=0.96) (primary end-point) were not statistically different between the two treatment arms. Infusional HD-FU was generally better tolerated than bolus 5-FU regimen.

CONCLUSIONS:

Infusional HD-FU does not improve RFS and OS in curatively resected stage III colon cancer patients compared to the Mayo Clinic regimen, but is less toxic.

• Authors: Claus-Henning Köhne, Laurent Bedenne, Alfredo Carrato, Olivier Bouché, Ivan Popov, Losa Gaspà, Manuel Valladares, Phillipe Rougier, Christiane Gog, Peter Reichardt, Jacques Wils, Francesco Pignatti, Frank Biertz
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 49 Issue 8 Pg. 1868-75 (May 2013) ISSN: 1879-0852 [Electronic] England
• PMID: 23571150 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2013 Elsevier Ltd. All rights reserved.

Chemical References

• Leucovorin
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, pathology)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Chemotherapy, Adjuvant
• Colonic Neoplasms (drug therapy, pathology)
• Diarrhea (chemically induced)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Europe
• Female
• Fluorouracil (administration & dosage, adverse effects, therapeutic use)
• Humans
• Infusions, Intravenous
• Kaplan-Meier Estimate
• Leucovorin (administration & dosage, adverse effects)
• Leukopenia (chemically induced)
• Male
• Middle Aged
• Neoplasm Staging
• Treatment Outcome
• Young Adult