1. ¹Department of Medical Oncology, Hôpital Foch, 40 rue Worth, 92151 Suresnes Cedex, France
2. ²Department of Medical Oncology, Clinique Saint-Jean, Lyon, France
3. ³Department of Medical Oncology, Hôpital Tenon, Paris, France
4. ⁴Department of Medicine, Hôpital de Dijon, Dijon, France
5. ⁵Department of Medical Oncology, Hôpital Saint-Antoine, Paris, France
6. ⁶Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France

Correspondence: Dr M Mabro, E-mail: m.mabro@hopital-foch.org

Received 9 November 2005; Revised 13 March 2006; Accepted 13 March 2006; Published online 11 April 2006.

Abstract

In advanced colorectal cancer previously treated with oxaliplatin, efficacy of irinotecan-based chemotherapy is poor and the best regimen is not defined. We designed FOLFIRI-3 and conducted a phase II study to establish its efficacy and safety in advanced colorectal cancer patients previously treated with FOLFOX. FOLFIRI-3 consisted of irinotecan 100 mg m^-2 as a 60-min infusion on day 1, running concurrently with leucovorin 200 mg m^-2 as a 2-h infusion on day 1, followed by 46-h continuous infusion of 5-fluorouracil (5FU) 2000 mg m^-2, and irinotecan 100 mg m^-2 repeated on day 3, at the end of the 5FU infusion, every 2 weeks. Sixty-five patients entered the study. The intent-to-treat objective response rate was 23% (95% CI 13–33%). Disease was stable in 37% of patients, progressed in 26% and was not assessable in 14%. From the start of FOLFIRI-3, median progression-free survival was 4.7 months and median survival 10.5 months. Main toxicities (% of patients) were grade 3–4 diarrhoea 23% and grade 4 neutropenia 11%. FOLFIRI-3 is a promising regimen achieving high response rate and progression-free survival in patients previously treated with FOLFOX with a moderate toxicity.