Summary:
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 μg/kg/day granulocyte colony-stimulating factor (G-CSF) (n=14) or a split dose of 5 μg/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 × 106/kg) than in the single-dose group (5.6 and 5.8 × 106/kg, respectively) (P=0.26). The mean of CD34+ cells collected after the first apheresis procedure was 3.9 × 106/kg for the split dose group and 3.1 × 106/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 × 106/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 × 106/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.
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Acknowledgements
We thank Dr Ismael Buño, Joseph Holland and Louise Holland for reviewing the manuscript. Dr Filella (Hospital Clínico, Barcelona) performed the pharmacokinetic assays.
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Carrión, R., Serrano, D., Gómez-Pineda, A. et al. A randomised study of 10 μg/kg/day (single dose) vs 2 × 5 μg/kg/day (split dose) G-CSF as stem cell mobilisation regimen in high-risk breast cancer patients. Bone Marrow Transplant 32, 563–567 (2003). https://doi.org/10.1038/sj.bmt.1704202
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DOI: https://doi.org/10.1038/sj.bmt.1704202
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