title: Continuous infusion fluorouracil in the management of advanced breast cancer: a phase II study.
abstract: OBJECTIVE
  The evaluation of unconventional schedules of well-known drugs represents a promising avenue in the search for new regimens with a better therapeutic index in metastatic breast cancer. In particular, protracted continuous infusion (PCI) of 5-fluorouracil (5-FU) has yielded interesting results in gastrointestinal malignancies and in breast cancer.
  
  
  METHODS
  From March 1996 30 consecutive patients with heavily pretreated breast cancer were treated with PCI 5-FU at a daily dose of 250 mg/m2 by means of disposable elastomeric pumps until progression or toxicity. The median age was 54 years (range, 28-71) and median performance status was 1 (range, 0-3). All patients but four were pretreated with anthracycline-containing regimens or taxanes; the median number of chemotherapy lines was 3 (range, 2-4). Metastatic sites were predominantly visceral in 60% of the patient population.
  
  
  RESULTS
  All 30 patients were evaluable for response and toxicity. The median duration of PCI was 20 weeks (range, 2-36 weeks). Two complete responses (7%) and eight partial remissions (26%) were observed, giving an overall response rate of 33%. The median duration of response was six months (range, 4-9 months). Stabilization was observed in seven patients (23%) with a median duration of seven months (range, 3-9 months). The main toxic effects were grade I-II mucositis and hematologic toxicity, while grade 3 hand-foot syndrome was observed in eight patients (27%).
  
  
  CONCLUSIONS
  This study confirms the efficacy and safety of 5-FU at this dosage and schedule in heavily pretreated women with advanced breast cancer. In order to improve on these results further studies are needed in a less advanced stage of the disease and together with other active drugs.
authors.affiliation: Division of Medical Oncology C, Centro di Riferimento Oncologico, National Cancer Institute, Aviano, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Crivellari
authors.forename: M D
authors.initials: MD
authors.lastname: Magri
authors.forename: A
authors.initials: A
authors.lastname: Buonadonna
authors.forename: D
authors.initials: D
authors.lastname: Lombardi
authors.forename: C
authors.initials: C
authors.lastname: Paolello
authors.forename: M
authors.initials: M
authors.lastname: De Cicco
authors.forename: D
authors.initials: D
authors.lastname: Fantin
authors.forename: A
authors.initials: A
authors.lastname: Veronesi
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged
chemical_list: D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil