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Annals of Oncology Advance Access originally published online on August 20, 2008
Annals of Oncology 2009 20(2):251-257; doi:10.1093/annonc/mdn557
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© The Author 2008. 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

Randomized study of weekly irinotecan plus high-dose 5-fluorouracil (FUIRI) versus biweekly irinotecan plus 5-fluorouracil/leucovorin (FOLFIRI) as first-line chemotherapy for patients with metastatic colorectal cancer: a Spanish Cooperative Group for the Treatment of Digestive Tumors Study

E. Aranda1,*, M. Valladares2, M. Martinez-Villacampa3, M. Benavides4, A. Gomez1, B. Massutti5, E. Marcuello6, M. Constenla7, J. C. Cámara8, A. Carrato9, R. Dueñas10, M. Reboredo2, M. Navarro3 and E. Díaz-Rubio11

1 Medical Oncology Service, Hospital Universitario Reina Sofía, Córdoba
2 Department of Medical Oncology, Complejo Hospitalario Juan Canalejo Marítimo de Oza, La Coruña
3 Department of Medical Oncology, Instituto Catalán de Oncología, Hospital Duran i Reinals, Barcelona
4 Department of Medical Oncology, Hospital Regional Universitario Carlos Haya, Málaga
5 Department of Medical Oncology, Hospital General Universitario de Alicante, Alicante
6 Department of Medical Oncology, Hospital Santa Creu i Sant Pau, Barcelona
7 Department of Medical Oncology, Complejo Hospitalario de Pontevedra, Pontevedra
8 Department of Medical Oncology, Fundación Hospital Alcorcón, Madrid
9 Department of Medical Oncology, Hospital General Universitario de Elche, Alicante
10 Department of Medical Oncology, Hospital Ciudad de Jaén, Jaén
11 Medical Oncology Service, Hospital Universitario Clínico San Carlos, Madrid, Spain

* Correspondence to: Dr E. Aranda, Medical Oncology Service, Hospital Universitario Reina Sofía, Avda Menéndez Pidal s.n., 14004 Córdoba, Spain. Tel: +34-957-011-582; Fax: +34-957-011-626; E-mail: earandaa{at}seom.org

Background: Irinotecan plus infusional 5-fluorouracil/leucovorin (FOLFIRI) is accepted as a reference treatment for the first-line treatment of patients with metastatic colorectal cancer (MCRC). The aim of this study was to demonstrate that a regimen without leucovorin (LV) (FUIRI) is not inferior to the standard FOLFIRI (response rate).

Patients and methods: Chemotherapy-naive patients with MCRC were randomized to receive either irinotecan (180 mg/m2 on day 1) + 5-fluorouracil (5-FU) (400 mg/m2 bolus and 600 mg/m2 22-h infusion) + LV (200 mg/m2 on days 1–2) (FOLFIRI) every 2 weeks or irinotecan (80 mg/m2) + 5-FU (2.250 mg/m2 48-h infusion) (FUIRI) weekly.

Results: In all, 346 patients were included, 173 in each arm. In the intention-to-treat analysis, the response rates for FOLFIRI and FUIRI were 57% [95% confidence interval (CI) 49% to 64%] and 51% (95% CI 43% to 59%), respectively (P = 0.2809). No statistically significant differences were observed between FOLFIRI and FUIRI regarding median progression-free survival (8.3 versus 8.4 months; P = 0.4339) nor median overall survival (21.6 versus 19.2 months; log-rank test P = 0.2941). Grade 3/4 neutropenia was significantly more frequent on FOLFIRI arm (27% versus 9%), while the proportion of diarrhea was higher on FUIRI arm (21% versus 42%).

Conclusion: FUIRI represents a valid alternative without LV to the FOLFIRI regimen as MCRC first-line treatment.

Key words: colorectal cancer, 5-fluorouracil, irinotecan

Received for publication May 7, 2008. Revision received July 11, 2008. Accepted for publication July 14, 2008.


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