title: A phase II study evaluating the feasibility of a 5-week cycle of S-1 plus irinotecan (IRIS) in patients with advanced and recurrent colorectal cancer.
abstract: OBJECTIVE
  A number of clinical trials, including the FIRIS study, have shown that S-1 plus irinotecan (IRIS) is safe and effective in patients with colorectal cancer. Several different treatment protocols for IRIS are commonly used in Japan, besides the one used in the FIRIS study. This study was designed to evaluate the feasibility of a 5-week cycle of IRIS.
  
  
  METHODS
  Between January 2005 and February 2008, a total of 55 patients with metastatic colorectal cancer were enrolled at nine centers in Japan. All patients received irinotecan intravenously (80 mg/m(2)) on days 1 and 15 and S-1 orally (40-60 mg twice daily, according to body surface area) on days 1-21 of a 5-week repeated cycle.
  
  
  RESULTS
  The overall response rate was 29.1 %. The response rate was 43.8 % in patients who received IRIS as first-line therapy and 23.1 % in those who received IRIS as second-line or subsequent therapy. The median survival time was 678 days (22.6 months). Adverse events of Grade 3 or higher that occurred at an incidence of ≥10 % were neutropenia (12.7 %) and diarrhea (10.9 %).
  
  
  CONCLUSIONS
  Our efficacy and safety data suggest that a 5-week cycle of IRIS is an effective alternative to used currently regimens.
authors.affiliation: Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka 565-0871, Japan. thata@gesurg.med.osaka-u.ac.jp
authors.forename: Taishi
authors.initials: T
authors.lastname: Hata
authors.forename: Mutsumi
authors.initials: M
authors.lastname: Fukunaga
authors.forename: Kohei
authors.initials: K
authors.lastname: Murata
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Uemura
authors.forename: Takayuki
authors.initials: T
authors.lastname: Fukuzaki
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Ota
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ohue
authors.forename: Tadashi
authors.initials: T
authors.lastname: Ohnishi
authors.forename: Nobuo
authors.initials: N
authors.lastname: Tanaka
authors.forename: Ichiro
authors.initials: I
authors.lastname: Takemasa
authors.forename: Tsunekazu
authors.initials: T
authors.lastname: Mizushima
authors.forename: Masataka
authors.initials: M
authors.lastname: Ikeda
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Mitsugu
authors.initials: M
authors.lastname: Sekimoto
authors.forename: Riichiro
authors.initials: R
authors.lastname: Nezu
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D000077146:Irinotecan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin