title: Second-line chemotherapy with fluorouracil, leucovorin, and irinotecan (FOLFIRI regimen) in patients with advanced small bowel adenocarcinoma after failure of first-line platinum-based chemotherapy: a multicenter AGEO study.
abstract: BACKGROUND
  Small bowel adenocarcinoma (SBA) is a rare tumor with poor prognosis. First-line platinum-based chemotherapy is active in patients with advanced SBA, but data regarding second-line chemotherapy are lacking. The aim of this study was to evaluate the efficacy and tolerability of fluorouracil, leucovorin, and irinotecan (FOLFIRI regimen) as second-line chemotherapy in patients with advanced SBA.
  
  
  METHODS
  We analyzed all consecutive patients who received second-line chemotherapy with FOLFIRI among 93 patients with advanced SBA included from 1996 to 2008 in a previous retrospective multicenter study. Progression-free survival (PFS) and overall survival (OS) were estimated from the start of second-line chemotherapy using the Kaplan-Meier method. Cox models were applied for multivariate analyses.
  
  
  RESULTS
  Among 51 patients who received second-line chemotherapy, 28 patients (male, 57%; median age, 54 years; metastatic disease, 96%) were treated with FOLFIRI after progression (n = 24) or limiting toxicity (n = 4) to first-line FOLFOX (n = 19) or LV5FU2-cisplatin (n = 9). Grade 3-4 toxicity was observed in 48% of patients (grade 3-4 neutropenia, 37%). After a median follow-up of 21.5 months, all patients had tumor progression, and 22 patients died. Objective response rate was 20%, and disease control rate was 52%. Median PFS and OS were 3.2 and 10.5 months, respectively. No clinical, biological, or tumor characteristics were associated with PFS or OS by multivariate analysis.
  
  
  CONCLUSIONS
  Second-line chemotherapy with FOLFIRI produced disease control in half of patients with advanced SBA after failure with first-line platinum-based chemotherapy. Nevertheless, the short median PFS warrants the evaluation of other treatments including targeted therapies.
authors.affiliation: Medical Oncology Service, Hospital Saint Antoine, AP-HP, University of Paris VI, Paris, France.
authors.forename: Aziz
authors.initials: A
authors.lastname: Zaanan
authors.forename: Mélanie
authors.initials: M
authors.lastname: Gauthier
authors.forename: David
authors.initials: D
authors.lastname: Malka
authors.forename: Christophe
authors.initials: C
authors.lastname: Locher
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Gornet
authors.forename: Anne
authors.initials: A
authors.lastname: Thirot-Bidault
authors.forename: David
authors.initials: D
authors.lastname: Tougeron
authors.forename: Julien
authors.initials: J
authors.lastname: Taïeb
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Thomas
authors.initials: T
authors.lastname: Aparicio
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007414:Intestinal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D007421:Intestine, Small; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D019233:Retreatment
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin