title: A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer.
abstract: BACKGROUND
  To assess activity and safety of an experimental combination of irinotecan and oxaliplatin (IRINOX) as first-line treatment in advanced colorectal cancer.
  
  
  METHODS
  In this randomized phase II trial, 80 patients were treated: arm A (IRINOX) in 40 patients received at day 1 oxaliplatin 85 mg/m(2) and irinotecan 180 mg/m(2) biweekly, standard arm B received a biweekly simplified folinic acid (FA) and fluorouracil (FU), FA 200 mg/m(2) in a 2-h infusion and bolus injection of 5FU 400 mg/m(2) on day 1, then a two 400 mg/m(2) continuous infusion of FU on days 1 and 2 with either oxaliplatin 85 mg/m(2) (20 patients) or irinotecan 180 mg/m(2) (20 patients).
  
  
  RESULTS
  Twenty-one partial responses (52.5%, median duration 7.2 months) were observed with the IRINOX arm and two complete and 20 partial responses (55%, median duration 6.4 months) with arm B. Median progression-free and overall survival times were 8.4 and 19 months, respectively, in the IRINOX arm and 8.1 and 20.4 months in arm B. Main grade 3/4 toxic effects were, respectively, neutropenia 42.5% and 32.5%; febrile neutropenia 10% and 5%; diarrhea 32.5% and 7.5%; vomiting 10.0% and 5%; neurosensory toxicity 17.5% and 7.5%.
  
  
  CONCLUSIONS
  The IRINOX arm has a manageable toxicity and is active.
authors.affiliation: Department of Digestive Oncology, Institut Bergonié, Regional Cancer Center, Bordeaux, France. becouarn@bergonie.org
authors.forename: Y
authors.initials: Y
authors.lastname: Bécouarn
authors.forename: P
authors.initials: P
authors.lastname: Senesse
authors.forename: S
authors.initials: S
authors.lastname: Thézenas
authors.forename: E
authors.initials: E
authors.lastname: Boucher
authors.forename: A
authors.initials: A
authors.lastname: Adenis
authors.forename: L
authors.initials: L
authors.lastname: Cany
authors.forename: J H
authors.initials: JH
authors.lastname: Jacob
authors.forename: F
authors.initials: F
authors.lastname: Cvitkovic
authors.forename: C
authors.initials: C
authors.lastname: Montoto-Grillot
authors.forename: M
authors.initials: M
authors.lastname: Ychou
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin