title: Sequential docetaxel followed by epirubicin-vinorelbine as first-line chemotherapy in advanced breast cancer.
abstract: BACKGROUND
  This phase II study evaluated the efficacy and the tolerability of a sequential regimen of docetaxel followed by epirubicin-vinorelbine combination as first-line chemotherapy in advanced breast cancer.
  
  
  METHODS
  Twenty-seven patients received docetaxel 100 mg/m2 (4 cycles) followed by 4 cycles of epirubicin 90 mg/m2 (day 1) combined with vinorelbine 25 mg/m2 (days 1 and 5), with cycles repeated every 3 weeks. G-CSF was administered during epirubicin-vinorelbine treatment.
  
  
  RESULTS
  There were 1 (3.7%) CR and 14 (51.9%) PR, for an overall response rate of 55.6% (95% CI, 36.9%-74.3%). Median time to response, time to progression and overall survival were 2, 9 and 25 months, respectively. The dose-limiting toxicity was neutropenia (grade 3 to 4 in 85% of the patients). There was one toxic death due to neutropenic fever. Gastrointestinal side-effects were generally mild According to the Simon two-stage design the response rate was considered unsatisfactory and patient accrual was terminated.
  
  
  CONCLUSIONS
  This sequential regimen appears to be moderately effective; possibly, a modulation of the treatment based on objective responses instead of a fixed number of cycles may be more appropriate in order to obtain better results.
authors.affiliation: Regina Elena Institute for Cancer Research, Via Elio Chianesi 53, 00144 Rome, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Vici
authors.forename: Paolo
authors.initials: P
authors.lastname: Foggi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Capomolla
authors.forename: Mario
authors.initials: M
authors.lastname: Brandi
authors.forename: Francesco
authors.initials: F
authors.lastname: Giotta
authors.forename: Nicola
authors.initials: N
authors.lastname: Gebbia
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Lauro
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Valerio
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Paoletti
authors.forename: Franca
authors.initials: F
authors.lastname: Belli
authors.forename: Carmine
authors.initials: C
authors.lastname: Pizza
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Massimo
authors.initials: M
authors.lastname: Lopez
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage*; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine