title: Adjuvant chemotherapy with high-dose cyclophosphamide, etoposide and cisplatin intensification without progenitor cell support in breast cancer patients with ten or more involved nodes: 5-year results of a pilot trial.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the clinical efficacy and tolerability of high-dose (HD) chemotherapy with growth factor support in primary breast cancer with extensive nodal involvement.
  
  
  METHODS
  Fifty-three patients with ten or more involved nodes were recruited and were given three cycles of standard-dose fluorouracil, epidoxorubicin and cyclophosphamide followed by one single course of high-dose CEP (cyclophosphamide, etoposide and cisplatin). No autologous progenitor support was used.
  
  
  RESULTS
  Five-year actuarial disease-free and overall survival were 40 and 60%, respectively. High-dose CEP required a median of 22 days of hospitalization and was associated with grade G3--4 nausea and vomiting in two thirds of the cases. Hematological toxicity was comparable to that of high-dose therapies delivered with autologous progenitor support. No therapy-related mortality was observed. CONCLUSIONS The efficacy of treatment was comparable to the best results of conventional therapy, with only a trend for improved survival. High-dose CEP was feasible with acceptable toxicity. Although this regimen does not require stem cell harvesting and storage, it requires clinical support comparable to autotransplantation procedures and side effects are not so manageable to recommend its use outside specialized units.
authors.affiliation: Department of Internal Medicine, Intensive Chemo-Immunotherapy Unit, University of Genoa, Genoa, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Ballestrero
authors.forename: A
authors.initials: A
authors.lastname: Rubagotti
authors.forename: P
authors.initials: P
authors.lastname: Stura
authors.forename: F
authors.initials: F
authors.lastname: Ferrando
authors.forename: D
authors.initials: D
authors.lastname: Amoroso
authors.forename: M
authors.initials: M
authors.lastname: Rinaldini
authors.forename: P
authors.initials: P
authors.lastname: Sismondi
authors.forename: F
authors.initials: F
authors.lastname: Genta
authors.forename: M
authors.initials: M
authors.lastname: Mesiti
authors.forename: F
authors.initials: F
authors.lastname: Brema
authors.forename: F
authors.initials: F
authors.lastname: Patrone
authors.forename: F
authors.initials: F
authors.lastname: Boccardo
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D010865:Pilot Projects
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D002945:Cisplatin