title: Modified irinotecan plus bolus 5-fluorouracil/L-leucovorin for metastatic colorectal cancer at a single institution in Japan.
abstract: BACKGROUND
  The modified irinotecan plus bolus 5-fluorouracil/L-leucovorin (IFL) regimen (irinotecan plus bolus 5-fluorouracil/L-leucovorin) used to be one of the standard treatments for metastatic colorectal cancer until approval of oxaliplatin in Japan. We evaluated the efficacy of modified IFL therapy for Japanese patients.
  
  
  METHODS
  Forty-seven patients with metastatic colorectal cancer received irinotecan (100 mg/m(2)) and bolus 5-fluorouracil (500 mg/m(2)) plus L-leucovorin (10 mg/m(2)) on days 1 and 8 every 3 weeks until progression or unmanageable toxicity occurred. The data on toxicity and tumor response were analyzed retrospectively.
  
  
  RESULTS
  All patients discontinued modified IFL therapy due to cancer progression, except for one patient who developed severe liver dysfunction. The overall response rate was 25%. The median progression-free survival time (PFS) was 8.6 [corrected] months. The median overall survival time (OS) was 27.8 [corrected] months for all patients, 30.9 [corrected] months for patients receiving subsequent oxaliplatin therapy, and 14.5 [corrected] months for patients without oxaliplatin (P = 0.0031). According to multivariate analysis results, good performance status, a normal white cell count, and absence of local recurrence were associated with a better PFS. Tumor response was a good prognostic factor for both PFS and OS. Gastrointestinal symptoms were the most common toxicities, including grade 3 diarrhea (8%) and grade 3 anorexia (10%). Grade 4 neutropenia occurred in 6% of patients. No other drug-related severe adverse events or deaths were observed.
  
  
  CONCLUSIONS
  Modified IFL therapy is an effective and well-tolerated regimen for Japanese patients with metastatic colorectal cancer. Modified IFL therapy combined with biological agents might remain an option for some patients who refuse a central venous catheter.
authors.affiliation: Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo 135-8550, Japan.
authors.forename: Mitsukuni
authors.initials: M
authors.lastname: Suenaga
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Mizunuma
authors.forename: Daigo
authors.initials: D
authors.lastname: Shouji
authors.forename: Eiji
authors.initials: E
authors.lastname: Shinozaki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Matsusaka
authors.forename: Keisho
authors.initials: K
authors.lastname: Chin
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Oya
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Tetsuichiro
authors.initials: T
authors.lastname: Muto
authors.forename: Kiyohiko
authors.initials: K
authors.lastname: Hatake
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007262:Infusions, Intravenous; D000077146:Irinotecan; D007564:Japan / Q000453:epidemiology; D002955:Leucovorin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011355:Prodrugs; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007166:Immunosuppressive Agents; D011355:Prodrugs; D014803:Vitamin B Complex; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin