title: Phase II study of combined treatment with irinotecan and S-1 (IRIS) in patients with inoperable or recurrent advanced colorectal cancer (HGCSG0302).
abstract: OBJECTIVE
  This phase II study was designed to evaluate the efficacy and safety of oral fluoropyrimidine S-1 plus irinotecan (IRIS regimen) in patients with previously untreated metastatic colorectal cancer.
  
  
  METHODS
  The response rate was the primary endpoint. Safety, progression-free survival time, and median survival time were secondary endpoints. The subjects were untreated patients with inoperable advanced colorectal cancer. Irinotecan was administered at a dose of 100 mg/m² (on days 1 and 15). S-1 (40 mg/m²) was administered for 2 weeks (on days 1 to 14) and followed by a 2-week rest.
  
  
  RESULTS
  Forty patients were enrolled. Four patients had grade 4 neutropenia, and six patients had grade 3 diarrhea. No other serious hematologic or nonhematologic adverse reactions occurred, and all patients received IRIS safely on an outpatient basis. The response rate was 52.5% (95% confidence interval [CI], 36.1-68.5%). Median progression-free survival was 8.6 months (95% CI, 5.3-11.9), and median survival time was 23.4 months (95% CI, 15.9-30.8).
  
  
  CONCLUSIONS
  IRIS produced a high response rate and could be given safely. IRIS may become a first-line treatment for inoperable or recurrent advanced colorectal cancer.
authors.affiliation: Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan. ykomatsu@med.hokudai.ac.jp
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yuki
authors.forename: Susumu
authors.initials: S
authors.lastname: Sogabe
authors.forename: Hiraku
authors.initials: H
authors.lastname: Fukushima
authors.forename: Ichiro
authors.initials: I
authors.lastname: Iwanaga
authors.forename: Mineo
authors.initials: M
authors.lastname: Kudo
authors.forename: Miki
authors.initials: M
authors.lastname: Tateyama
authors.forename: Takashi
authors.initials: T
authors.lastname: Meguro
authors.forename: Minoru
authors.initials: M
authors.lastname: Uebayashi
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Saga
authors.forename: Yuh
authors.initials: Y
authors.lastname: Sakata
authors.forename: Masahiro
authors.initials: M
authors.lastname: Asaka
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; 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; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin