1. ¹Department of Medical Oncology, University General Hospital of Heraklion, PO Box 1352, Heraklion, Crete 71110, Greece
2. ²Third Department of Internal Medicine, School of Medicine, University of Athens, 'Sotiria' General Hospital of Athens, Greece
3. ³Department of Propedeutic Medicine, Medical Oncology Unit, School of Medicine, University of Athens, 'Laikon' General Hospital of Athens, Greece
4. ⁴First Department of Medical Oncology, 'METAXA'S' Anticancer Hospital of Athens, Greece
5. ⁵Department of Medical Oncology, General Hospital of Larissa, Greece
6. ⁶Department of Medical Oncology, University General Hospital of Alexandroupoli, Greece
7. ⁷Department of Medical Oncology, 'Venizelion' General Hospital of Heraklion, Greece
8. ⁸First Department of Medical Oncology, 'Theagenion' Anticancer Hospital of Thessaloniki, Greece

Correspondence: Dr J Souglakos, E-mail: georgsec@med.uoc.gr

Received 5 October 2005; Revised 19 January 2006; Accepted 23 January 2006; Published online 28 February 2006.

Abstract

To compare the efficacy and toxicity of oxaliplatin (L-OHP) in combination with irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOXIRI) vs irinotecan and 5-FU/LV (FOLFIRI) as first-line treatment of patients with metastatic colorectal cancer (MCC). A total of 283 chemotherapy-naïve patients with MCC were enrolled (FOLFIRI arm: n=146; FOLFOXIRI arm: n=137). In the FOLFOXIRI arm, CPT-11 (150 mg m^-2) was given on d₁, L-OHP (65 mg m^-2) on d₂, LV (200 mg m^-2) on days 2 and 3 and 5-FU (400 mg m^-2 as i.v. bolus and 600 mg m^-2 as 22 h i.v. continuous infusion) on days 2 and 3. In the FOLFIRI arm, CPT-11 (180 mg m^-2) was given on d₁ whereas LV and 5-FU were administered in the same way as in the FOLFOXIRI regimen. Both regimens were administered every 2 weeks. There was no difference in terms of overall survival (median OS: 19.5 and 21.5 months, for FOLFIRI and FOLFOXIRI, respectively; P=0.337), median time to disease progression (FOLFIRI: 6.9 and FOLFOXIRI: 8.4 months; P=0.17), response rates (33.6 and 43% for FOLFIRI and FOLFOXIRI, respectively; P=0.168). Patients treated with FOLFOXIRI had a significantly higher incidence of alopecia (P=0.0001), diarrhoea (P=0.0001) and neurosensory toxicity (P=0.001) compared with patients treated with FOLFIRI. The present study failed to demonstrate any superiority of the FOLFOXIRI combination compared with the FOLFIRI regimen, although the observed median OS is one of the best ever reported in the literature.