title: FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study.
abstract: OBJECTIVE
  The purpose of the present study was to evaluate the activity and the tolerability of the FOLFIRI regimen, administered as second-line chemotherapy in patients with locally advanced or metastatic pancreatic cancer after the failure of a gemcitabine-based regimen.
  
  
  METHODS
  Patients with locally advanced/metastatic disease who received a first-line chemotherapy (one line only) with gemcitabine ± platinoid (cisplatin, oxaliplatin) and who had measurable disease conform with the RECIST criteria were eligible for the study. FOLFIRI consists of irinotecan 180 mg/m(2) i.v. on day 1, leucovorin (l-form) 200 mg/m(2) i.v. on day 1 and 2, 5-FU 400 mg/m(2) i.v. bolus on days 1 and 2, and 5-FU 600 mg/m(2) i.v. by ci for 22 h on days 1 and 2, repeated every 2 weeks. The primary end point was the response rate.
  
  
  RESULTS
  Among the 50 enrolled patients, 4 partial responses (PR) (8%) and 14 stable diseases were observed, for a disease control rate of 18/50 (36%). Forty-one patients (82%) have been pretreated with cisplatin/oxaliplatin+gemcitabine as first-line chemotherapy. The median progression-free and overall survivals were 3.2 and 5 months, respectively. The 6-month survival rate was 32%. Grade 3-4 neutropenia and diarrhea occurred in 10 (20%) and 6 (12%) patients, respectively.
  
  
  CONCLUSIONS
  The FOLFIRI regimen showed a modest clinical activity in this quite heavily pretreated patients' population with locally advanced or metastatic pancreatic cancer with a manageable toxicity profile.
authors.affiliation: Medical Oncology Unit, Fondazione Poliambulanza, Via Bissolati 57, 25124, Brescia, Italy. zanib@numerica.it
authors.forename: Alberto
authors.initials: A
authors.lastname: Zaniboni
authors.forename: Enrico
authors.initials: E
authors.lastname: Aitini
authors.forename: Sandro
authors.initials: S
authors.lastname: Barni
authors.forename: Daris
authors.initials: D
authors.lastname: Ferrari
authors.forename: Stefano
authors.initials: S
authors.lastname: Cascinu
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Catalano
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Valmadre
authors.forename: Domenica
authors.initials: D
authors.lastname: Ferrara
authors.forename: Enzo
authors.initials: E
authors.lastname: Veltri
authors.forename: Claudio
authors.initials: C
authors.lastname: Codignola
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
chemical_list: D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin