title: Four-day infusion of fluorouracil plus vinorelbine as salvage treatment of heavily pretreated metastatic breast cancer.
abstract: OBJECTIVE
  Anthracyclines-taxanes containing regimens are widely used for breast cancer treatment both in neoadjuvant-adjuvant setting and in metastatic disease. Recently high-dose chemotherapy (HDC) with autologous stem cell support has been introduced as adjuvant treatment for high-risk primary breast cancer and for selected subsets of women with metastatic disease. Therefore, salvage treatment for previously treated patients with progressive disease becomes even more problematic. A regimen of continuous infusion of fluorouracil (FU) and vinorelbine (VNR) has been evaluated in heavily pretreated metastatic breast cancer patients.
  
  
  METHODS
  Forty-eight women, median age 52 years, with previously treated breast cancer entered the study. All but one received more than one line of prior systemic chemotherapy for metastatic disease. Furthermore 14 women had undergone HDC with peripheral blood progenitor cells transplantation in adjuvant setting (6 pts), or metastatic disease (8 pts). Treatment consisted of four-day infusion of FU (1000 mg/m2/day) plus VNR (20 mg/m2/i.v. day 1 and 5), recycled every 3 weeks for a total of six courses. Drugs administration was discontinued for G4 toxicity, tumor progression or patient's refusal.
  
  
  RESULTS
  Twenty PR and four CR for an overall response rate of 50% (95%C.I. 36-64%) were recorded. The therapeutic efficacy of the tested regimen was documented both in patients unresponsive to previous anthracyclines-taxanes combinations and in those relapsing after HDC. The median duration of response was 9 months and median survival 16 months. One third of patients experienced Grade-3 stomatitis-mucositis, hematological toxicity was mild and no cardiac toxicity was observed. Twenty-five women (52%) suffered from infusion-related phlebitis (in half of patients a central venous device was necessary at some point of the treatment program).
  
  
  CONCLUSIONS
  The combination of FU infusion and VNR i.v. is an effective salvage treatment for heavily pretreated metastatic breast cancer patients, and may represent a valid alternative when other cytotoxic regimens are not feasible.
authors.affiliation: Divisione di Oncologia Medica, Fondazione S. Maugeri, Clinica del Lavoro e della Riabilitazione (IRCCS), Istituto Scientifico di Pavia, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Zambelli
authors.forename: F S
authors.initials: FS
authors.lastname: Robustelli della Cuna
authors.forename: L
authors.initials: L
authors.lastname: Ponchio
authors.forename: G
authors.initials: G
authors.lastname: Ucci
authors.forename: G A
authors.initials: GA
authors.lastname: Da Prada
authors.forename: G
authors.initials: G
authors.lastname: Robustelli della Cuna
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D016879:Salvage Therapy; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D000077235:Vinorelbine; D005472:Fluorouracil