Clinical Study

British Journal of Cancer (2007) 97, 297–301. doi:10.1038/sj.bjc.6603889 www.bjcancer.com
Published online 17 July 2007

Phase II study of UFT with leucovorin and irinotecan (TEGAFIRI): first-line therapy for metastatic colorectal cancer

J-P Delord1, J Bennouna2, P Artru3, H Perrier4, F Husseini5, F Desseigne6, E François7, R Faroux8, D Smith9, P Piedbois10, H Naman11, J Y Douillard2 and R Bugat1

  1. 1Institut Claudius Regaud, 20-24 rue du Pont saint Pierre, Toulouse 31052, France
  2. 2Centre René Gauducheau, Boulevard Jacques Monod, Nantes 44805, France
  3. 3Clinique St Jean, 30 rue Bataille, Lyon 69008, France
  4. 4Hôpital Saint Joseph, 26 Boulevard Louvain, Marseille 13008, France
  5. 5Hôpital Civil, Le Parc, 46 rue du Stauffen, Colmar 68024, France
  6. 6Centre Léon Bérard, 28 rue Laënnec, Lyon 69373, France
  7. 7Centre Antoine Lacassagne, 33 avenue de Valombrose, Nice 06189, France
  8. 8Centre Hospitalier Départemental, rue des Oudairies, La Roche sur Yon 85925, France
  9. 9Centre Hospitalier Universitaire Saint André, 1 rue Jean Burguet, Bordeaux 33075, France
  10. 10Centre Hospitalier Universitaire Henri Mondor, 51 avenue du Maréchal de Lattre de Tassigny, Créteil 94000, France
  11. 11Centre Azuréen Cancérologie, 112 avenue du Docteur-Donat, Mougins 06250, France

Correspondence: Dr J-P Delord, E-mail: delord.jean-pierre@claudiusregaud.fr

Received 30 April 2007; Revised 13 June 2007; Accepted 22 June 2007; Published online 17 July 2007.

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Abstract

This phase II trial was performed to evaluate the efficacy and tolerability of oral tegafur–uracil (UFT®) with leucovorin (LV) combined with intravenous (i.v.) irinotecan every 3 weeks (TEGAFIRI) as first-line treatment for patients with metastatic colorectal cancer (mCRC). Patients received oral UFT 250 mg m-2 day-1 and LV 90 mg day-1 in three divided daily doses for 14 days followed by a 1-week rest and i.v. irinotecan 250 mg m-2 as a 90-min infusion every 3 weeks. Tumour responses, assessed every two cycles using RECIST criteria, were reviewed by an independent review committee. In 52 evaluable patients, the best overall response rate was 33% (95% confidence intervals (CI) 20–47%; 1 complete and 16 partial responses). The median time to progression was 5.4 months (95% CI 3.02–7.52 months) and median overall survival was 14.9 months (11.73–17.97 months). A total of 307 cycles were administered, with a median number of five cycles per patient (range: 1–10). The most common grade 3/4 toxicities were neutropenia (25% of patients), diarrhoea (22%), vomiting (11%) and anaemia (11%). The TEGAFIRI regimen is a feasible, well-tolerated and convenient treatment option for patients with non-resectable mCRC.

Keywords:

UFT, colorectal cancer, leucovorin, irinotecan, first-line treatment