title: Second-line combination chemotherapy of oral S-1 with cisplatin and irinotecan for colorectal cancer resistant to 5-FU.
abstract: OBJECTIVE
  A phase I clinical trial has been planned to determine the recommended dose and to assess the safety and efficacy of combination chemotherapy of S-1 with cisplatin and irinotecan (SCI regimen) as a second-line treatment in 5-fluorouracil (5-FU) resistant colorectal cancer (CRC).
  
  
  METHODS
  Patients with unresectable recurrent or metastatic CRC were enrolled in this study for second-line treatment. On an outpatient basis, the patients received a treatment SCI regimen comprising S-1 oral administration for 28 days followed by withdrawal for 2 weeks, plus cisplatin and irinotecan were administered on days 1, 8, 15 and 22 by intravenous injection. These courses were repeated every 6 weeks. Starting doses were 70 mg/m2 S-1, 6 mg/m2 Cisplatin, and 60 mg/m2 Irinotecan.
  
  
  RESULTS
  A total of 29 patients was enrolled. Dose-limiting toxicities were fatigue, nausea, and leucopenia. Twenty-three patients at recommended dose were evaluable for treatment response. The response rate was 21.7% (5 partial responses, 13 stable diseases, and 5 progressive diseases). The median progression-free survival rate was 4.3 months; the median survival time was 9.6 months.
  
  
  CONCLUSIONS
  The SCI regimen is feasible in an outpatient setting and should be considered as second-line chemotherapy for patients with 5-FU resistant CRC.
authors.affiliation: Department of General Surgical Science (Surgery I), Gunma University Graduate School of Medicine Gunma, Japan. chuchumi@showa-gunma-u.ac.jp
authors.forename: Soichi
authors.initials: S
authors.lastname: Tsutsumi
authors.forename: Satoru
authors.initials: S
authors.lastname: Yamaguchi
authors.forename: Munenori
authors.initials: M
authors.lastname: Ide
authors.forename: Kaori
authors.initials: K
authors.lastname: Tsuboi
authors.forename: Takaharu
authors.initials: T
authors.lastname: Fukasawa
authors.forename: Sayaka
authors.initials: S
authors.lastname: Yamaki
authors.forename: Takayuki
authors.initials: T
authors.lastname: Asao
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kuwano
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000008:administration & dosage*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage*; D011725:Pyridines / Q000008:administration & dosage*; D005641:Tegafur / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D011725:Pyridines; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002945:Cisplatin; D005472:Fluorouracil; D002166:Camptothecin