title: Primary chemotherapy with epirubicin and vinorelbine in women with locally advanced breast cancer.
abstract: BACKGROUND
  To assess the activity and toxicity of primary chemotherapy with epirubicin (60 mg/m2 every other week) and vinorelbine (25 mg/m2, weekly) plus granulocyte colony-stimulating factor (G-CSF) for 12 weeks, in patients with locally advanced breast cancer in a multicenter setting.
  
  
  METHODS
  Patients with stage IIIA or IIIB breast cancer, not older than 70, were eligible. A two-stage phase II design was applied. Response was assessed clinically, instrumentally and pathologically.
  
  
  RESULTS
  Out of 48 enrolled patients, 87.5% received all planned cycles, with a median dose-intensity of 30 mg/m2/week for epirubicin and 23.8 mg/m2/week for vinorelbine. A clinical or instrumental objective response was reached in 42 patients (87.5%, exact 95% CI: 74.7-95.3); significant downstaging was reached in all but one patient; 6 cases had a pathological complete response in the breast, and 2 cases in the lymph nodes too (pathological complete response rate 4.2%, exact 95% CI: 0.5-14.2); a further 2 patients had only microscopic cancer foci at pathological examination of the breast. Radiological tests underestimated the treatment effect on the breast. Toxicity was mild, neutropenia being the most frequent (grade 3-4 in 47% of patients), but never complicated with fever or sepsis. Mild constipation (< or =grade 2) occurred in 35% of patients. Moderate to severe asthenia occurred in 12% of 6 patients. No cardiac toxicity was reported. At 3 years, disease-free survival was 68% and overall survival 81%.
  
  
  CONCLUSIONS
  Primary chemotherapy with epirubicin every other week, weekly vinorelbine and G-CSF support is highly active and well tolerated in patients with locally advanced breast cancer.
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy. cnistico@ifo.it
authors.forename: Cecilia
authors.initials: C
authors.lastname: Nisticò
authors.forename: Andrea
authors.initials: A
authors.lastname: De Matteis
authors.forename: Emanuela
authors.initials: E
authors.lastname: Rossi
authors.forename: Flavio
authors.initials: F
authors.lastname: Carnino
authors.forename: Roberto
authors.initials: R
authors.lastname: Valenza
authors.forename: Biagio
authors.initials: B
authors.lastname: Agostara
authors.forename: Emilio
authors.initials: E
authors.lastname: Bria
authors.forename: Antonio
authors.initials: A
authors.lastname: Farris
authors.forename: Marco
authors.initials: M
authors.lastname: Cremonesi
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: D'Ottavio
authors.forename: Angela
authors.initials: A
authors.lastname: Vaccaro
authors.forename: Carlo
authors.initials: C
authors.lastname: Garufi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Giunta
authors.forename: Claudio
authors.initials: C
authors.lastname: Botti
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Edmondo
authors.initials: E
authors.lastname: Terzoli
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine