title: Second line chemotherapy with 5 fluorouracil and vinorelbine in anthracycline and taxane pretreated patients with metastatic breast cancer.
abstract: OBJECTIVE
  5-Fluorouracil (5-FU) and Vinorelbine (Vin) are active in the second line therapy of metastatic breast cancer (MBC). We conducted a multi-institutional phase II study to assess the activity of the combination of 5-FU and Vin in anthracycline and taxane pretreated patients with MBC.
  
  
  METHODS
  Patients with MBC previously treated with anthracyclines and taxanes, who had measurable or evaluable disease, were treated with folinic acid 200 mg/m2 IV, 5-FU 400 mg/m2 IV bolus, and 5-FU 600 mg/m2 continuous infusion over 24 hours on days 1, 2, 15, and 16 and Vin 25 mg/m2 on days 1 and 15 of a 28-day cycle, for six cycles. Response rate, time to disease progression, overall survival, and toxicity were evaluated.
  
  
  RESULTS
  Thirty-eight patients were enrolled and 35 were evaluable for response. Grade III and IV neutropenia was seen in four and three patients, respectively. At a median follow-up of 19.5 months, 33 patients have progressed, 14 during treatment and 19 during the follow-up period, and 23 have died for an overall survival of 12.3 months. The time to progression was six months. Eight patients had a partial response and 14 had stable disease for a clinical benefit rate of 63%.
  
  
  CONCLUSIONS
  The combination of 5-FU and Vin is well tolerated and is a good option for the palliative care of patients with MBC.
authors.affiliation: 1st Department of Medical Oncology, Hygeia Hospital, 4 Erithrou Stavrou & Kifissias Av., 151 23 Athens, Greece. edrazis@hol.gr
authors.forename: Evangelia
authors.initials: E
authors.lastname: Razis
authors.forename: Paris
authors.initials: P
authors.lastname: Kosmidis
authors.forename: Gerassimos
authors.initials: G
authors.lastname: Aravantinos
authors.forename: Charalambos
authors.initials: C
authors.lastname: Bakoyiannis
authors.forename: Jim
authors.initials: J
authors.lastname: Janinis
authors.forename: Helen
authors.initials: H
authors.lastname: Timotheadou
authors.forename: Christos
authors.initials: C
authors.lastname: Christodoulou
authors.forename: George
authors.initials: G
authors.lastname: Fountzilas
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D019008:Drug Resistance, Neoplasm; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016879:Salvage Therapy; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D000077235:Vinorelbine; D005472:Fluorouracil