title: Safety of irinotecan and infusional fluorouracil/leucovorin (FOLFIRI) in Japan: a retrospective review of 48 patients with metastatic colorectal cancer.
abstract: BACKGROUND
  A combination of irinotecan and infusional fluorouracil/leucovorin (FOLFIRI) has become one of the global standard chemotherapy regimens for metastatic colorectal cancer. The aim of this study was to evaluate the feasibility of FOLFIRI in a Japanese population with metastatic colorectal cancer.
  
  
  METHODS
  This retrospective analysis included 48 patients with unresectable metastatic colorectal cancer who received FOLFIRI between May 2004 and June 2005. Evaluation points included adverse events, dose intensity, response rate, progression-free survival, and overall survival.
  
  
  RESULTS
  Thirty-eight (79%) patients received FOLFIRI as first-line chemotherapy. Eighteen patients received original full-dose FOLFIRI and 30 patients received reduced FOLFIRI with irinotecan at 150 mg/m(2). Eighteen (38%) of the 48 patients experienced grade 3 or 4 neutropenia, 5 (10%) had grade 3 vomiting and 5 (10%) had grade 3 diarrhea. Toxicity was tolerable, with appropriate dose reduction if necessary. There were no treatment-related deaths or early deaths within the first 60 days of treatment. Median dose intensities (with relative dose intensities in parentheses) in all patients and in patients who received full-dose FOLFIRI were 129 mg/m(2) per 2 weeks (71%) and 144 mg/m(2) per 2 weeks (80%) for irinotecan and 2349 mg/m(2) per 2 weeks (84%) and 2376 mg/m(2) per 2 weeks (85%) for fluorouracil, respectively. The response rate in patients with measurable lesions was 37% (13/35; 95% confidence interval [CI], 21.1%-53.2%), and median progression-free survival was 8.4 months (95% CI, 6.4-10.3).
  
  
  CONCLUSIONS
  The dose intensity of irinotecan was relatively low, and toxicity was tolerable with appropriate dose reduction; efficacy was comparable to that previously reported. FOLFIRI is feasible and can be one of the standard treatment options for Japanese patients with metastatic colorectal cancer.
authors.affiliation: Division of Gastrointestinal Oncology and Digestive Endoscopy, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. nofuse@east.ncc.go.jp
authors.forename: Nozomu
authors.initials: N
authors.lastname: Fuse
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Doi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
authors.forename: Tomonori
authors.initials: T
authors.lastname: Yano
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hamamoto
authors.forename: Keiko
authors.initials: K
authors.lastname: Minashi
authors.forename: Makoto
authors.initials: M
authors.lastname: Tahara
authors.forename: Manabu
authors.initials: M
authors.lastname: Muto
authors.forename: Masahiro
authors.initials: M
authors.lastname: Asaka
authors.forename: Shigeaki
authors.initials: S
authors.lastname: Yoshida
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* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D007564:Japan; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin