title: FOLFIRI with or without celecoxib in advanced colorectal cancer: a randomized phase II study of the Gruppo Oncologico dell'Italia Meridionale (GOIM).
abstract: BACKGROUND
  The aim of the study was to verify the efficacy and safety of the addition of celecoxib to FOLFIRI combination therapy in patients affected by advanced colorectal cancer.
  
  
  METHODS
  Eighty-one chemotherapy-naïve patients entered in this randomized phase II trial of the GOIM (protocol no. 2301). Patients were randomized to receive FOLFIRI regimen (arm A): irinotecan 180 mg/m(2) on day 1 with LV5FU2 regimen (LV at 100 mg/m(2) administered as a 2-h infusion before FU at 400 mg/m(2) as an intravenous bolus injection, and FU at 600 mg/m(2) as a 22-h infusion immediately after 5-FU bolus injection on day 1 and 2); or FOLFIRI plus celecoxib 400 mg twice daily for 14 days (arm B). Both treatments were repeated every 2 weeks.
  
  
  RESULTS
  Seventy-seven patients (38 in arm A and 39 in arm B) were evaluable for response. The overall response rate was 41% in arm A (95% CI 27% to 57%) and 35% in arm B (95% CI 20% to 50%). When only assessable patients were analyzed, overall response rate was 45% in arm A (95% CI 29% to 61%) and 36% in arm B (95% CI 21% to 51%). Median time to progression, median duration of response and survival were, respectively, 8 months, 9 months and 16 months in arm A, and 7 months, 9 months and 19 months in arm B. All patients were evaluable for toxicity, which was globally mild in both arms; grade 3-4 toxicity was uncommon, and gastrointestinal disturbances were the most common.
  
  
  CONCLUSIONS
  FOLFIRI regimen is effective and well-tolerated as a first-line treatment in patients with advanced colorectal cancer. The addition of celecoxib to FOLFIRI regimen does not improve results.
authors.affiliation: Oncology Institute, Bari, Italy. e.maiello@operapadrepio.it
authors.forename: E
authors.initials: E
authors.lastname: Maiello
authors.forename: F
authors.initials: F
authors.lastname: Giuliani
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.forename: N
authors.initials: N
authors.lastname: Di Renzo
authors.forename: G
authors.initials: G
authors.lastname: Pezzella
authors.forename: S
authors.initials: S
authors.lastname: Romito
authors.forename: R
authors.initials: R
authors.lastname: Mallamaci
authors.forename: M
authors.initials: M
authors.lastname: Lopez
authors.forename: G
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000068579:Celecoxib; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D011720:Pyrazoles; D013449:Sulfonamides; D000077150:Oxaliplatin; D000077146:Irinotecan; D000068579:Celecoxib; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin