title: Does granulocyte colony-stimulating factor worsen anemia in early breast cancer patients treated with epirubicin and cyclophosphamide?
abstract: OBJECTIVE
  We report on the effects of granulocyte colony-stimulating factor (G-CSF) on hemoglobin (Hb) value in early breast cancer patients receiving high-dose epirubicin and cyclophosphamide (EC) adjuvant treatment.
  
  
  METHODS
  Five hundred and six stage I or stage II female breast cancer patients were treated with E 120 mg/m2 and C 600 mg/m2 with or without G-CSF and randomly assigned to receive in a factorial 2 x 2 design: EC; EC + lonidamine; EC + G-CSF; EC + lonidamine + G-CSF. Five consecutive G-CSF schedules tested 100 randomly assigned patients each: (1) 480 microg subcutaneously on days 8 to 14; (2) 480 microg on days 8, 10, 12, 14; (3) 300 microg on days 8 to 14; (4) 300 microg on days 8, 10, 12, and 14; and (5) 300 microg on days 8 and 12. The mean Hb level of 246 patients receiving EC plus G-CSF was compared with that of 240 patients receiving EC alone. The data presented are derived from an exploratory hypothesis-generating analysis.
  
  
  RESULTS
  The EC dose intensity did not statistically differ between the G-CSF and the control arm. From the third cycle onward, the mean Hb value resulted significantly lower in G-CSF arm compared with control at each time point of each cycle (P < .0001). No statistically significant difference in the mean Hb level was observed between schedule 5 and control. Of interest, from the second course onward, the mean Hb level tended to be lower in patients receiving seven or four G-CSF injections compared with those patients who received only two injections.
  
  
  CONCLUSIONS
  Our data suggest that a G-CSF dose-related effect may play a role in worsening anemia in patients receiving adjuvant EC.
authors.affiliation: Department of Medical Oncology, Regina Elena Cancer Institute, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Papaldo
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Ferretti
authors.forename: Serena
authors.initials: S
authors.lastname: Di Cosimo
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Paolo
authors.initials: P
authors.lastname: Marolla
authors.forename: Massimo
authors.initials: M
authors.lastname: Lopez
authors.forename: Enrico
authors.initials: E
authors.lastname: Cortesi
authors.forename: Mauro
authors.initials: M
authors.lastname: Antimi
authors.forename: Edmondo
authors.initials: E
authors.lastname: Terzoli
authors.forename: Paolo
authors.initials: P
authors.lastname: Carlini
authors.forename: Patrizia
authors.initials: P
authors.lastname: Vici
authors.forename: Claudio
authors.initials: C
authors.lastname: Botti
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Lauro
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Naso
authors.forename: Cecilia
authors.initials: C
authors.lastname: Nisticò
authors.forename: Marcella
authors.initials: M
authors.lastname: Mottolese
authors.forename: Franco
authors.initials: F
authors.lastname: Di Filippo
authors.forename: Enzo Maria
authors.initials: EM
authors.lastname: Ruggeri
authors.forename: Anna
authors.initials: A
authors.lastname: Ceribelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
mesh_terms: D000740:Anemia / Q000139:chemically induced*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D004920:Erythropoiesis / Q000187:drug effects; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007191:Indazoles / Q000008:administration & dosage
chemical_list: D007191:Indazoles; D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D003520:Cyclophosphamide; C016371:lonidamine