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Annals of Oncology Advance Access originally published online on June 30, 2009
Annals of Oncology 2009 20(12):1964-1970; doi:10.1093/annonc/mdp236
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

A randomized phase III study comparing adjuvant 5-fluorouracil/folinic acid with FOLFIRI in patients following complete resection of liver metastases from colorectal cancer

M. Ychou1,*, W. Hohenberger2, S. Thezenas1, M. Navarro3, J. Maurel4, C. Bokemeyer5, E. Shacham-Shmueli6, F. Rivera7, C. Kwok-Keung Choi8 and A. Santoro9

1 CRLC Val d'Aurelle, Montpellier, France
2 Department of Surgery, University Hospital, Erlangen, Germany
3 Instituto Catalán de Oncologia, Hospital Duran I Reinals, Barcelona, Spain
4 Hospital Clinic de Barcelona, Ciberehd, Spain
5 University Medical Center Hamburg-Eppendorf, Hamburg, Germany
6 Department of Oncology, Tel Aviv Sourasky Medical Centre, Tel-Aviv, Israel
7 Hospital Universitario Marques de Valdecilla, Santander, Spain
8 Department of Clinical Oncology, 1/F Professorial Block, Queen Mary Hospital, Hong Kong
9 Department of Oncology and Hematology, Istituto Clinico Humanitas IRCCS, Rozzano, Milan, Italy

* Correspondence to: Prof. M. Ychou, CRLC Val d'Aurelle, 208 rue des Apothicaires, 34298 Montpellier Cedex, France. Tel: +33-4-67-61-30-66; Fax: +33-4-67-61-30-22; E-mail: marc.ychou{at}valdorel.fnclcc.fr

Background: Studies indicate that adjuvant 5-fluorouracil (5-FU) with folinic acid (FA) in colorectal cancer patients with completely resectable liver-limited metastases (LMCRC) offers clinical benefit over surgery alone. This phase III trial compared FOLFIRI with simplified 5-FU/FA in this setting.

Patients and methods: LMCRC patients were randomized to receive every 14 days, FA, 400 mg/m2 infused over 2 h, followed by 5-FU as a 400 mg/m2 i.v. bolus, followed by continuous 5-FU infusion, 2400 mg/m2 over 46 h (LV5FUs) with or without irinotecan: 180 mg/m2 infusion (FOLFIRI). The primary end point was disease-free survival (DFS); secondary end points included overall survival (OS) and safety.

Results: Treated patients (n = 306) were balanced for critical prognostic factors in each arm. Median DFS in patients receiving LV5FUs was 21.6 versus 24.7 months for FOLFIRI [hazard ratio (HR) 0.89, log-rank P = 0.44]. No significant differences were found in OS. A trend was observed for improved DFS in patients receiving FOLFIRI within 42 days of surgery (HR 0.75, P = 0.17). Grade 3/4 toxic effects were more common in patients treated with FOLFIRI versus LV5FUs (47% versus 30%) with neutropenia being most common (23% versus 7%).

Conclusion: FOLFIRI in the adjuvant treatment of LMCRC showed no significant improvement in DFS compared with LV5FUs.

Key words: adjuvant treatment, colorectal cancer, FOLFIRI, 5-fluorouracil, resection of liver metastases

Received for publication February 2, 2009. Revision received March 9, 2009. Accepted for publication March 20, 2009.


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