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

    loading  Checking for direct PDF access through Ovid



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.


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%.


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.

Related Topics

    loading  Loading Related Articles