• Miquel Nogué, Antonieta Salud, Eduard Batiste-Alentorn, Eugeni Saigí, Ferran Losa, Lluís Cirera, Miguel Méndez, Juan Manuel Campos, Antonio Galan, Pilar Escudero, Angels Arcusa, Hermini Manzano, Edelmira Vélez de Mendizábal, Joaquim Pérez de Olaguer, Montserrat Boleda, Immaculada Guasch, and Pilar Vicente.
• Consorci Hospitalari Parc Taulí, Parc Taulí, Servei d'Oncologia Médica, s/n 08208 Sabadell, Barcelona, Spain. mnogue@hgv.es
• Eur. J. Cancer. 2005 Oct 1; 41 (15): 2241-9.

AbstractThis randomised, open-label trial compared oral tegafur (FT)/leucovorin (LV) with the intravenous bolus 5-fluorouracil (5-FU)/LV as first-line chemotherapy for advanced colorectal cancer (CRC). Patients were randomised to receive oral FT 750 mg/m2/day for 21 days and LV 15 mg/m2 every 8 h in cycles repeated every 28 days (n=114), or intravenous LV 20 mg/m2 followed by 5-FU 425 mg/m2 daily for 5 days every 4 weeks for 2 cycles, and later every 5 weeks (n=123). Response rate was significantly higher in the FT/LV arm (27%, 95% CI 19-35) than in the 5-FU/LV arm (13%, 95% CI 7-19) (p<0.004). The median time to progression was 5.9 months (95% CI, 5.3-6.5; FT/LV arm) and 6.2 months (95% CI, 5.4-6.9; 5-FU/LV arm). Median overall survival was 12.4 months (95% CI, 10.3-14.5 months; FT/LV arm) and 12.2 months (95% CI, 8.9-15.7 months; 5-FU/LV arm) (p=n.s.; hazard ratio FT/LV:5-FU/LV=1.02). 5-FU/LV showed a higher incidence of grade 3/4 neutropenia (4.1 vs. 0%). Non-hematological toxicities showed similar incidences in the two treatment arms. Oral FT/LV was more active than IV 5-FU/LV in terms of objective response rate with similar overall survival, and with a favorable toxicity profile. This makes FT/LV a valid alternative to the IV 5-FU schedule in CRC patients.

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