title: First-line treatment with epirubicin and vinorelbine in metastatic breast cancer.
abstract: OBJECTIVE
  This phase II multicenter trial was aimed at investigating the activity of epirubicin-vinorelbine combination as first-line chemotherapy in metastatic breast cancer patients.
  
  
  METHODS
  Ninety-seven patients with metastatic breast cancer and no prior exposure to anthracyclines received the following regimen: epirubicin 100 mg/m(2) by intravenous (IV) bolus infusion on day 1 plus vinorelbine 25 mg/m(2) by 30-minute IV infusion on days 1 and 5, every 3 weeks for up to eight cycles. All patients also received granulocyte colony-stimulating factor (G- CSF) on days 7 to 12 of every cycle.
  
  
  RESULTS
  Objective responses, confirmed at least 4 weeks after the first documentation, were observed in 65 out of 92 assessable patients (70.6%; 95% CI, 62% to 80%). Disease remained stable in 17 patients (18.5%). Responses were observed in all disease sites, being 94% in soft tissue, 60% in bone, and 66% in visceral disease. Median time to response, median duration of response, median time to progression, and median overall survival were 2, 9, 10, and 26 months, respectively. The dose-limiting toxicity was neutropenia, which was grade 4 in 36% of the patients, and was accompanied by fever in 26% of the cases. Grade 3 to 4 mucositis was encountered in 28% of the patients. Other toxicities were mild to moderate. No cardiotoxicity was observed.
  
  
  CONCLUSIONS
  The epirubicin-vinorelbine combination with G-CSF support has been shown in this study to be highly active as first-line treatment of metastatic breast cancer patients, with significant although transient toxicity. This justifies further evaluation in the neoadjuvant setting and in early-stage breast cancer.
authors.affiliation: Division of Medical Oncology B, Biostatistic Unit, Regina Elena Institute for Cancer Research, Rome, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Vici
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Antonella
authors.initials: A
authors.lastname: Amodio
authors.forename: Francesco
authors.initials: F
authors.lastname: Giotta
authors.forename: Franca
authors.initials: F
authors.lastname: Belli
authors.forename: Francesca
authors.initials: F
authors.lastname: Conti
authors.forename: Nicola
authors.initials: N
authors.lastname: Gebbia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pezzella
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Valerio
authors.forename: Mario
authors.initials: M
authors.lastname: Brandi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Pisconti
authors.forename: Ernesto
authors.initials: E
authors.lastname: Durini
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* / Q000401:mortality; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine