title: Neoadjuvant treatment of unresectable liver disease with irinotecan and 5-fluorouracil plus folinic acid in colorectal cancer patients.
abstract: BACKGROUND
  The aim of this study was to observe the effects of neoadjuvant therapy with irinotecan and 5-fluorouracil (5-FU)/folinic acid (FA) on the resection rate and survival of colorectal cancer patients with initially unresectable hepatic metastases.
  
  
  METHODS
  Forty patients received neoadjuvant chemotherapy comprising irinotecan 180 mg/m(2) administered intravenously (i.v.) on day 1, FA 200 mg/m(2) i.v. on days 1 and 2, 5-FU 400 mg/m(2) i.v. bolus on days 1 and 2, and 5-FU 1200 mg/m(2) as a continuous 48-h i.v. infusion on day 1. The treatment was repeated every 2 weeks and response was assessed every 12 weeks (six cycles).
  
  
  RESULTS
  The objective response rate to chemotherapy was 47.5% (n = 19), with two complete responses and disease stabilization in 11 (27.5.%) patients. Responses were unconfirmed for 11 patients undergoing surgery within 2 weeks. Treatment was well tolerated and adverse events were typical of the chemotherapy agents used. Twenty-seven (67.5%) patients reported hematological toxicity (35.0% grade 3/4) and 14 (35.0%) reported gastrointestinal toxicity (12.5% grade 3/4). Thirteen patients (32.5%) underwent potentially curative liver resection following chemotherapy. Chemotherapy was particularly effective in patients with large metastases on entry to the study. The median time to progression is 14.3 months and, at a median follow-up of 19 months, all patients are alive.
  
  
  CONCLUSIONS
  Neoadjuvant therapy with irinotecan combined with 5-FU/FA enabled a significant proportion of patients with initially unresectable liver metastases to undergo surgical resection. The effects of treatment on survival have yet to be determined.
authors.affiliation: Unit of Medical Oncology, Department of Internal Medicine, Catholic University of Sacred Heart, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Pozzo
authors.forename: M
authors.initials: M
authors.lastname: Basso
authors.forename: A
authors.initials: A
authors.lastname: Cassano
authors.forename: M
authors.initials: M
authors.lastname: Quirino
authors.forename: G
authors.initials: G
authors.lastname: Schinzari
authors.forename: N
authors.initials: N
authors.lastname: Trigila
authors.forename: M
authors.initials: M
authors.lastname: Vellone
authors.forename: F
authors.initials: F
authors.lastname: Giuliante
authors.forename: G
authors.initials: G
authors.lastname: Nuzzo
authors.forename: C
authors.initials: C
authors.lastname: Barone
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000031:analogs & derivatives / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006498:Hepatectomy / Q000379:methods; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009367:Neoplasm Staging; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin