title: Combination chemotherapy with docetaxel plus vinorelbine in metastatic breast cancer patients with prior exposure to anthracyclines.
abstract: OBJECTIVE
  To evaluate the anti-tumor activity and tolerance of docetaxel plus vinorelbine in metastatic breast cancer (MBC) patients previously treated with anthracyclines.
  
  
  METHODS
  Fifty patients with MBC were treated with docetaxel 75 mg/m2 (subsequently reduced to 60 mg/m2) plus vinorelbine 30 mg/m2 (subsequently reduced to 24 mg/m2). both on day 1, every 3 weeks, for a maximum of six cycles. All patients had previously received anthracyclines as adjuvant treatment (< 12 months disease-free interval) or first-line therapy for MBC. Thirty-seven patients had received at least one prior regimen for MBC. Twenty-five patients had prior high-dose chemotherapy with stem-cell rescue. Thirty patients had multiple metastatic sites. Liver and lung disease were the predominant metastatic site in 31 patients.
  
  
  RESULTS
  Forty-nine patients were assessable for response. Nineteen patients achieved a partial response and four a complete response (overall response rate, 46%; 95% confidence interval (95% CI): 32%-60%). Fourteen patients (28%) had stable disease on treatment. Median Kaplan-Meier estimated progression-free and duration of response times are 21 and 29 weeks. Median survival time is 47 weeks. Hematological dose-limiting toxicity, prompted a 20% dose reduction for both drugs after the first thirteen patients were treated. Neutropenia > or = grade 3 occurred in nineteen (34%) patients, neutropenic fever in 15 (7) courses, and mucositis > or = grade 3 in 6 (3%) courses.
  
  
  CONCLUSIONS
  The combination of docetaxel plus vinorelbine on day 1 every 3 weeks is feasible and active in MBC patients with prior anthracycline exposure. This regimen is safe, well-tolerated and convenient for the patients.
authors.affiliation: Division of Medical Oncology, Hospital Clinico Universitario, Zaragoza, Spain.
authors.forename: J L
authors.initials: JL
authors.lastname: Martí
authors.forename: P
authors.initials: P
authors.lastname: Bueso
authors.forename: J I
authors.initials: JI
authors.lastname: Mayordomo
authors.forename: M D
authors.initials: MD
authors.lastname: Isla
authors.forename: A
authors.initials: A
authors.lastname: Saenz
authors.forename: P
authors.initials: P
authors.lastname: Escudero
authors.forename: L
authors.initials: L
authors.lastname: Murillo
authors.forename: E
authors.initials: E
authors.lastname: Filipovich
authors.forename: R
authors.initials: R
authors.lastname: Andres
authors.forename: A
authors.initials: A
authors.lastname: Tres
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016001:Confidence Intervals; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D043823:Taxoids; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000903:Antibiotics, Antineoplastic; D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine