Annals of Oncology Advance Access published online on December 8, 2006
Annals of Oncology, doi:10.1093/annonc/mdl427
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© 2006 European Society for Medical Oncology
FOLFIRI.3, a new regimen combining 5-fluorouracil, folinic acid and irinotecan, for advanced pancreatic cancer: results of an Association des Gastro-Entérologues Oncologues (Gastroenterologist Oncologist Association) multicenter phase II study
1 Service d'Hépato-gastro-entérologie, Groupe Hospitalier Pitié Salpétrière, Paris cedex 13, France
2 Service d'Hépato-gastro-entérologie, Hôpital Européen Georges Pompidou, Paris cedex 15, France
3 Service d'Hépato-gastro-entérologie, Hôpital Bichat, Paris cedex 18, France
4 Clinique Saint Jean, Lyon, France
5 Clinique Jeanne D'Arc, Gien, France
6 Service d'oncologie médicale, Groupe Hospitalier Pitié Salpétrière, Paris cedex 13, France
7 Service d'Hépato-gastro-entérologie, Hôpital du Val de Grâce, Paris cedex 5, France
*Correspondence to: Dr J. Taïeb, Service d'Hépatogastro-entérologie, Groupe Hospitalier Pitié Salpêtrière, 47-89, Bd de l'Hôpital, 75013 Paris, France. Tel: +33-1-421-61041; Fax: +33-1-421-61425; E-mail: jtaieb{at}club-internet.fr
Background: The purpose of the study was to prospectively evaluate the efficacy and tolerability of the FOLFIRI.3 regimen in patients with unresectable pancreatic adenocarcinoma.
Patients and methods: Chemotherapy-naive patients with histologically proven advanced pancreatic adenocarcinoma were treated with the FOLFIRI.3 regimen, consisting of irinotecan 90 mg/m2 as a 60-min infusion on day 1, leucovorin 400 mg/m2 as a 2-h infusion on day 1, followed by 5-fluorouracil (5-FU) 2000 mg/m2 as a 46-h infusion and irinotecan 90 mg/m2, repeated on day 3, at the end of the 5-FU infusion, every 2 weeks.
Results: Forty patients were enrolled, of whom 29 (73%) had metastatic disease. A total of 441 cycles were delivered (1–53). Grade 3–4 neutropenia occurred in 35% of the patients, accompanied by fever in two cases. Other relevant grade 3–4 toxic effects were nausea-vomiting (27%) and diarrhea (25%). Grade 2 alopecia occurred in 48% of the patients. There were no treatment-related deaths. The confirmed response rate was 37.5%. Stable disease was observed in 27.5% of the patients. The median progression-free and overall survivals were 5.6 months and 12.1 months, respectively. The 1-year survival rate was 51%.
Conclusion: The FOLFIRI.3 regimen seems to be active on advanced pancreatic cancer and to have a manageable toxicity profile. The lack of cross-resistance between FOLFIRI.3 and gemcitabine-based regimens allows efficient second-line therapies.
irinotecan, pancreatic cancer, systemic chemotherapy
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