title: Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale.
abstract: OBJECTIVE
  We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer.
  
  
  METHODS
  A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m(2) on day 1 with LV 100 mg/m(2) administered as a 2-hour infusion before FU 400 mg/m(2) administered as an intravenous bolus injection, and FU 600 mg/m(2) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m(2) on day 1 with LV5FU2 regimen).
  
  
  RESULTS
  One hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31% in arm A (95% CI, 24.6% to 38.3%) and 34% in arm B (95% CI, 27.2% to 41.5%; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed.
  
  
  CONCLUSIONS
  There is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.
authors.affiliation: Medical and Experimental Oncology Unit, Oncology Institute, Via Amendola 209, 70126 Bari, Italy. colucci@goim.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Paoletti
authors.forename: Francesco
authors.initials: F
authors.lastname: Giuliani
authors.forename: Michele
authors.initials: M
authors.lastname: Caruso
authors.forename: Nicola
authors.initials: N
authors.lastname: Gebbia
authors.forename: Giacomo
authors.initials: G
authors.lastname: Cartenì
authors.forename: Biagio
authors.initials: B
authors.lastname: Agostara
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pezzella
authors.forename: Luigi
authors.initials: L
authors.lastname: Manzione
authors.forename: Nicola
authors.initials: N
authors.lastname: Borsellino
authors.forename: Andrea
authors.initials: A
authors.lastname: Misino
authors.forename: Sante
authors.initials: S
authors.lastname: Romito
authors.forename: Ernesto
authors.initials: E
authors.lastname: Durini
authors.forename: Stefano
authors.initials: S
authors.lastname: Cordio
authors.forename: Marisa
authors.initials: M
authors.lastname: Di Seri
authors.forename: Massimo
authors.initials: M
authors.lastname: Lopez
authors.forename: Evaristo
authors.initials: E
authors.lastname: Maiello
authors.forename: Severino
authors.initials: S
authors.lastname: Montemurro
authors.forename: Antonio
authors.initials: A
authors.lastname: Cramarossa
authors.forename: Vito
authors.initials: V
authors.lastname: Lorusso
authors.forename: Maurizio
authors.initials: M
authors.lastname: Di Bisceglie
authors.forename: Maurizio
authors.initials: M
authors.lastname: Chiarenza
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Valerio
authors.forename: Teresa
authors.initials: T
authors.lastname: Guida
authors.forename: Vita
authors.initials: V
authors.lastname: Leonardi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Pisconti
authors.forename: Gerardo
authors.initials: G
authors.lastname: Rosati
authors.forename: Francesco
authors.initials: F
authors.lastname: Carrozza
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Nettis
authors.forename: Matteo
authors.initials: M
authors.lastname: Valdesi
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Filippelli
authors.forename: Santo
authors.initials: S
authors.lastname: Fortunato
authors.forename: Sergio
authors.initials: S
authors.lastname: Mancarella
authors.forename: Cosimo
authors.initials: C
authors.lastname: Brunetti
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin