A phase II study of FOLFIRI-3 (double infusion of irinotecan combined with LV5FU) after FOLFOX in advanced colorectal cancer patients

M Mabro, P Artru, T André, M Flesch, F Maindrault-Goebel, B Landi, G Lledo, A Plantade, C Louvet, A de Gramont, M Mabro, P Artru, T André, M Flesch, F Maindrault-Goebel, B Landi, G Lledo, A Plantade, C Louvet, A de Gramont

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.

Figures

Figure 1
Figure 1
Design of FOLFIRI (André et al, 1999), FOLFIRI-2 (Mabro et al, 2003) and FOLFIRI-3 regimens; cycles are repeated every 2 weeks.
Figure 2
Figure 2
Progression-free survival and overall survival in the FOLFIRI-3 study (65 patients).

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