title: Combination chemotherapy of biweekly irinotecan (CPT-11) plus tegafur/uracil (UFT) and leucovorin (LV) for patients with metastatic colorectal cancer: phase I/II study in Japanese patients.
abstract: OBJECTIVE
  We aimed to evaluate the safety and efficacy of combination chemotherapy with biweekly irinotecan (CPT-11) plus oral tegafur/uracil (UFT) and leucovorin (LV) in patients with previously untreated metastatic colorectal adenocarcinoma in phase I/II setting.
  
  
  METHODS
  We recruited 37 patients with histologically proven metastatic colorectal adenocarcinoma. UFT (300 mg/m(2) per day) and LV (75 mg/day) were administered orally on days 1-21. CPT-11 was administered intravenously on day 1 and 15, at an initial dose of 60 mg/m(2), stepping up to 150 mg/m(2) in a traditional phase I fashion. The treatment was repeated every 4 weeks. After patients enrolled into a phase II portion, the efficacy and toxicity of this regimen were also assessed.
  
  
  RESULTS
  The recommended dose of CPT-11 was determined to be 150 mg/m(2). Although one patient had a pulmonary embolism after 60 mg/m(2) of CPT-11, the treatment was well tolerated in general. The overall objective response rate was 37.8% (14/37; 95% CI, 22.5-55.2) in all patients. Median progression-free survival was 226 days (95% CI, 133-276).
  
  
  CONCLUSIONS
  Biweekly CPT-11 plus UFT and LV had a reasonable safety profile with manageable toxicity, and had a promising activity in patients with metastatic colorectal cancer. Further trials are indicated based on the promising results observed in this study.
authors.affiliation: Department of Surgery, School of Medicine, Keio University, Shinanomachi, Shinjyuku-ku, Tokyo, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Okabayashi
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Hasegawa
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Ishii
authors.forename: Takashi
authors.initials: T
authors.lastname: Endo
authors.forename: Hiroki
authors.initials: H
authors.lastname: Ochiai
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Kubota
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kitagawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D000077146:Irinotecan; D007564:Japan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D014498:Uracil / Q000008:administration & dosage
chemical_list: D005641:Tegafur; D014498:Uracil; D000077146:Irinotecan; D002955:Leucovorin; D002166:Camptothecin