title: Efficacy and safety of an irinotecan plus bolus 5-fluorouracil and L-leucovorin regimen for metastatic colorectal cancer in Japanese patients: experience in a single institution in Japan.
abstract: BACKGROUND
  Short-term infusion of 5-fluorouracil with leucovorin in combination with irinotecan or oxaliplatin has been considered as standard treatment for metastatic colorectal cancer. However, until infusion of 5-fluorouracil regimens and oxaliplatin was approved for the treatment of metastatic colorectal cancer in Japan early in 2005, combination of irinotecan with bolus 5-fluorouracil/leucovorin had been the standard treatment. This retrospective study evaluates the efficacy and safety of a modified irinotecan with bolus 5-fluorouracil/leucovorin regimen in Japanese colorectal cancer patients.
  
  
  METHODS
  Forty-six patients untreated with chemotherapy for metastatic colorectal cancer received a modified form of the irinotecan with bolus 5-fluorouracil/leucovorin regimen, consisting of intravenous irinotecan (100 mg/m2) and l-leucovorin (10 mg/m2), and then 5-fluorouracil 500 mg/m2 as an intravenous bolus infusion, weekly for 4 weeks, repeated every 6 weeks until progression or unacceptable toxicity.
  
  
  RESULTS
  The overall response rate was 48% (95% confidence interval, 34-62%), and 48% of patients had stable disease. Median progression-free survival was 8.3 months and overall survival was 20.3 months. The incidence of grade 3 or 4 toxicity was as follows: neutropenia, 50%; diarrhea, 4%; fatigue, 13%; nausea, 7%; and vomiting, 7%. Neither treatment-related nor all-cause mortality occurred within 60 days of chemotherapy initiation. Despite the limited availability of oxaliplatin, 29 patients received an oxaliplatin-based regimen after progression.
  
  
  CONCLUSIONS
  A modified irinotecan plus bolus 5-fluorouracil/l-leucovorin regimen was an active and well-tolerated regimen in Japanese patients with advanced colorectal cancer, showing a different toxicity profile from Western patients.
authors.affiliation: Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan. t.yoshino@scchr.jp
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yoshino
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Onozawa
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hironaka
authors.forename: Akira
authors.initials: A
authors.lastname: Fukutomi
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Yamaguchi
authors.forename: Noriaki
authors.initials: N
authors.lastname: Hasuike
authors.forename: Kentaro
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Nozomu
authors.initials: N
authors.lastname: Machida
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ono
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 / Q000009:adverse effects / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007275:Injections, Intravenous; D007564:Japan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin