title: FOLFIRI.3, a new regimen combining 5-fluorouracil, folinic acid and irinotecan, for advanced pancreatic cancer: results of an Association des Gastro-Enterologues Oncologues (Gastroenterologist Oncologist Association) multicenter phase II study.
abstract: 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.
  
  
  METHODS
  Chemotherapy-naive patients with histologically proven advanced pancreatic adenocarcinoma were treated with the FOLFIRI.3 regimen, consisting of irinotecan 90 mg/m(2) as a 60-min infusion on day 1, leucovorin 400 mg/m(2) as a 2-h infusion on day 1, followed by 5-fluorouracil (5-FU) 2000 mg/m(2) as a 46-h infusion and irinotecan 90 mg/m(2), 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%.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Service d'Hépato-Gastro-Entérologie, Groupe Hospitalier Pitié Salpétrière, Paris cedex 13. jtaieb@club-internet.fr
authors.forename: J
authors.initials: J
authors.lastname: Taïeb
authors.forename: T
authors.initials: T
authors.lastname: Lecomte
authors.forename: T
authors.initials: T
authors.lastname: Aparicio
authors.forename: A
authors.initials: A
authors.lastname: Asnacios
authors.forename: T
authors.initials: T
authors.lastname: Mansourbakht
authors.forename: P
authors.initials: P
authors.lastname: Artru
authors.forename: D
authors.initials: D
authors.lastname: Fallik
authors.forename: J P
authors.initials: JP
authors.lastname: Spano
authors.forename: B
authors.initials: B
authors.lastname: Landi
authors.forename: G
authors.initials: G
authors.lastname: Lledo
authors.forename: J
authors.initials: J
authors.lastname: Desrame
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010297:Paris / Q000453:epidemiology; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin