title: Multicenter Phase II Study of a New Effective S-1 and Irinotecan Combination Schedule in Patients with Unresectable Metastatic or Recurrent Colorectal Cancer.
abstract: BACKGROUND
  This multicenter phase II study determined the efficacy and safety of new daily oral S-1 and weekly irinotecan (CPT-11) combination schedule in patients with previously untreated advanced or recurrent colorectal cancer.
  
  
  METHODS
  Patients received first-line chemotherapy comprising S-1 80 mg/m(2)/day given on days 3 to 7, 10 to 14, and 17 to 21 and 60 mg/m(2) CPT-11 administered intravenously on days 1, 8, and 15 of a 28-day cycle.
  
  
  RESULTS
  A total of 45 eligible patients were enrolled in this study. The overall response rate was 48.9%. Median progression-free survival and median overall survival was 8.1 months and 20.9 months, respectively. The rates of grade 3 or 4 toxicity were as follows: neutropenia, 8.9%; anemia, 4.4%; anorexia, 6.7%; and diarrhea, 6.7%.
  
  
  CONCLUSIONS
  This new S-1 and irinotecan combination schedule appeared to be an effective, well-tolerated, and convenient regimen in patients with advanced colorectal cancer as compared with conventional regimens such as FOLFIRI and IRIS.
authors: Yutaka
authors: Y
authors: Ogata
authors: Takaho
authors: T
authors: Tanaka
authors: Yoshito
authors: Y
authors: Akagi
authors: Nobuya
authors: N
authors: Ishibashi
authors: Yoshiaki
authors: Y
authors: Tsuji
authors: Keiko
authors: K
authors: Matono
authors: Makoto
authors: M
authors: Isobe
authors: Susumu
authors: S
authors: Sueyoshi
authors: Atsushi
authors: A
authors: Kaibara
authors: Kazuo
authors: K
authors: Shirouzu
keywords: S-1; advanced colorectal carcinoma; first-line chemotherapy; irinotecan; metronomic chemotherapy; multicenter phase II study