title: A phase II study of irinotecan, 5-fluorouracil and leucovorin for treatment in patients with previously untreated advanced colorectal cancer.
abstract: OBJECTIVE
  We prospectively conducted a non-randomized phase II trial to evaluate the efficacy and safety of combination irinotecan, leucovorin (LV) and 5-fluorouracil (FU) as a first-line regimen for treating patients with previously untreated advanced colorectal cancer (CRC).
  
  
  METHODS
  Twenty-six previously untreated patients with advanced, recurrent or metastatic CRC were enrolled in this study. The patients received either irinotecan 180 mg/m(2) on day 1 with LV bolus of 200 mg/m(2) and FU bolus of 400 mg/m(2), and this was followed by FU continuous infusion of 600 mg/m(2) on day 1 and day 2 (the FOLFIRI regimen), or they were treated with LV bolus of 400 mg/m(2) and FU bolus of 400 mg/m(2) followed by FU continuous infusion of 2,400 mg/m(2) for 46 hours (the simplified FOLFIRI regimen), and these treatments were repeated every 2 weeks until disease progression.
  
  
  RESULTS
  The objective response rate was 23.1% (6/26) respectively, for both treatments. The median time to progression was 5.3 months (range: 0.4 approximately 19.9), and the overall survival was 11.2 months (range: 0.5 approximately 52.3). The prognostic factor for longer survival was the Eastern Cooperative Oncology Group (ECOG) performance status (PS). The non-hematological toxicities were similar for both treatment groups, with more frequent grade >or=3 neutropenia being noted for the simplified FOLFIRI regimen.
  
  
  CONCLUSIONS
  The biweekly irinotecan based regimen was demonstrated to have a moderate antitumor activity with acceptable toxicity profiles, and the ECOG PS was the independent prognostic factor.
authors.affiliation: Division of Hematology & Oncology, Department of Internal Medicine, Soon Chun Hyang University College of Medicine, Seoul, Korea.
authors.forename: Sang-Byung
authors.initials: SB
authors.lastname: Bae
authors.forename: Nam-Su
authors.initials: NS
authors.lastname: Lee
authors.forename: Han-Jo
authors.initials: HJ
authors.lastname: Kim
authors.forename: Kyoung-Ha
authors.initials: KH
authors.lastname: Kim
authors.forename: Hyun-Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Chan-Kyu
authors.initials: CK
authors.lastname: Kim
authors.forename: Kyu-Taeg
authors.initials: KT
authors.lastname: Lee
authors.forename: Sung-Kyu
authors.initials: SK
authors.lastname: Park
authors.forename: Jong-Ho
authors.initials: JH
authors.lastname: Won
authors.forename: Dae-Sik
authors.initials: DS
authors.lastname: Hong
authors.forename: Hee-Sook
authors.initials: HS
authors.lastname: Park