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Annals of Oncology 2005 16(Supplement 4):iv56-iv60; doi:10.1093/annonc/mdi909
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© 2005 European Society for Medical Oncology

Invited Paper

FOLFIRI regimen in advanced colorectal cancer: the experience of the Gruppo Oncologico dell'Italia Meridionale (GOIM)

E. Maiello1,2,*, V. Gebbia3, F. Giuliani1, G. Paoletti4, N. Gebbia5, N. Borsellino6, G. Cartenì7, G. Pezzella8, L. Manzione9, S. Romito10, M. Lopez4 and G. Colucci1,11

1 Oncology Institute, Bari; 2 Casa Sollievo della Sofferenza Hospital, S. Giovanni Rotondo; 3 La Maddalena Hospital, Palermo; 4 Regina Elena Institute, Rome; 5 University of Palermo; 6 University of Napoli; 7 Buccheri La Ferla Hospital, Palermo; 8 Cardarelli Hospital, Naples; 9 Ospedale Nord, Taranto; 10 S. Carlo Hospital, Potenza; 11 Cardarelli Hospital, Campobasso, Italy

* Correspondence to: Dr Evaristo Maiello, Medical Oncology Unit, Casa Sollievo della Sofferenza Hospital, Viale dei Cappuccini, 71013 San Giovanni Rotondo, Italy. Tel: +39-0882-410640; Fax: +39-0882-412792; Email: e.maiello{at}operapadrepio.it

Purpose:: To verify the experience of the GOIM in the treatment of advanced colorectal cancer patients with the FOLFIRI combination therapy.

Patients and methods:: Patients entered in three consecutive trials of the GOIM (protocols no. 9706, 9901, and 2301) were reported in this analysis. A total of 287 chemotherapy-naive patients were treated with FOLFIRI regimen: Irinotecan 180 mg/m2 on day 1 with LV5FU2 regimen (LV at 100 mg/m2 administered as a 2-hour infusion before FU at 400 mg/m2 as an intravenous bolus injection, and FU at 600 mg/m2 as a 22-hour infusion immediately after 5FU bolus injection on day 1 and 2); the treatment was repeated every 2 weeks.

Results:: 287 patients entered in these three trials, and 264 (92%) were evaluable for response. The overall response rate was 34.5% (95% confidence interval [CI]: 29% to 40%). When only assessable patients were analyzed, overall response rate was 37% (95% CI: 31% to 43%). Median time to progression, median duration of response and survival were 7 months, 10.5 months and 14 months, respectively. All but three patients were evaluable for toxicity which was globally mild; grade 3–4 toxicity was uncommon, and gastrointestinal disturbances were the most common.

Conclusions:: FOLFIRI regimen is effective and well-tolerated as first-line treatment in patients with advanced colorectal cancer. Further studies needed to evaluate the improvement in results with the addition of new drugs to this combination therapy.

Key words: colorectal cancer, combination therapy, folinic acid, fluorouracil, irinotecan


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