Does granulocyte colony-stimulating factor worsen anemia in early breast cancer patients treated with epirubicin and cyclophosphamide?
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.
Papaldo
Paola
P
Department of Medical Oncology, Regina Elena Cancer Institute, Italy.
Ferretti
Gianluigi
G
Di Cosimo
Serena
S
Giannarelli
Diana
D
Marolla
Paolo
P
Lopez
Massimo
M
Cortesi
Enrico
E
Antimi
Mauro
M
Terzoli
Edmondo
E
Carlini
Paolo
P
Vici
Patrizia
P
Botti
Claudio
C
Di Lauro
Luigi
L
Naso
Giuseppe
G
Nisticò
Cecilia
C
Mottolese
Marcella
M
Di Filippo
Franco
F
Ruggeri
Enzo Maria
EM
Ceribelli
Anna
A
Cognetti
Francesco
F
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
D007191:Indazoles; D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D003520:Cyclophosphamide; C016371:lonidamine