A randomised study of 10 microg/kg/day (single dose) vs 2 x 5 microg/kg/day (split dose) G-CSF as stem cell mobilisation regimen in high-risk breast cancer patients.
A randomised trial in breast cancer patients was designed to compare the number of peripheral blood progenitor cells collected after mobilisation with a single dose of 10 microg/kg/day granulocyte colony-stimulating factor (G-CSF) (n=14) or a split dose of 5 microg/kg twice daily (n=14). Both groups were well balanced. No significant differences were observed between groups regarding aphereses parameters. The total number of CD34+ cells collected was higher in the split-dose group (mean of 7.1 and median of 7.4 x 10(6)/kg) than in the single-dose group (5.6 and 5.8 x 10(6)/kg, respectively) (P=0.26). The mean of CD34+ cells collected after the first apheresis procedure was 3.9 x 10(6)/kg for the split dose group and 3.1 x 10(6)/kg for the single-dose group (P=0.24). Circulating CD34+ cells before the first apheresis were higher for the split-dose group (mean 79.7 vs 59.2 x 10(6)/l) (P=0.14). All bone pain scores applied were significantly higher for the split-dose group. Our primary end point of improving the mean of total CD34+ cells collected to 2.5 x 10(6)/kg was not achieved with twice-daily G-CSF administration. Further studies evaluating different mobilisation schedules with G-CSF are needed to determine the optimal regimen.
Carrión
R
R
Unidad de Trasplante de Médula Osea, Departamento de Oncología, Hospital General Universitario Gregorio Marañón, Madrid, Spain. jose.carrion@madrid.org
Serrano
D
D
Gómez-Pineda
A
A
Díez-Martín
J L
JL
D000328:Adult; D018952:Antigens, CD34 / Q000032:analysis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000628:therapy*; D002452:Cell Count; D004305:Dose-Response Relationship, Drug; D005260:Female; D006085:Graft Survival; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D019650:Hematopoietic Stem Cell Mobilization / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007937:Leukapheresis; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced; D036102:Peripheral Blood Stem Cell Transplantation / Q000379:methods; D014182:Transplantation, Autologous
D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor