Abstract
The efficacy of pegfilgrastim±chemotherapy for mobilizing stem cells in patients with solid tumours was assessed. In cycle 0, a 14-day prechemotherapy cycle, patients (N=61) were randomized open-label to single doses of pegfilgrastim (6, 12 or 18 mg) on day 1, or daily filgrastim (10 μg/kg) for ⩽7 days. Mean peak peripheral CD34+ cell counts increased with pegfilgrastim dose, but were significantly higher than filgrastim only at the 18 mg dose (10.17 vs 4.96 × 104/ml; P=0.014). In the clinically relevant period of days 3–7, both 12 and 18 mg pegfilgrastim doses produced significantly higher peak CD34+ counts (8.18 and 9.96 vs 4.51 × 104/ml for filgrastim; P=0.034 and 0.006). In cycle 1, patients received carboplatin/paclitaxel on day 1, followed from day 2 by pegfilgrastim 6–18 mg or daily filgrastim (5 μg/kg/day for ⩽14 days) as per randomization in cycle 0. There were no significant differences in mean peak CD34+ count between pegfilgrastim and filgrastim, but there was an advantage for pegfilgrastim 18 mg in the relevant period of days 7–12 (3.14 vs 1.19 × 104/ml; P=0.043). A single pegfilgrastim dose (⩾6 mg) could be substituted for daily filgrastim in cytokine-only peripheral CD34+ cell mobilization.
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Acknowledgements
This study was supported by Amgen Ltd. We thank DW Fyfe, SD Pledge, WP Steward, C Gallagher and N Davidson (investigators at the study sites) for supporting this study, Phillippa Brown (Clinical Study Manager, Amgen Ltd, Uxbridge, UK), and Peter Royce, PhD, who provided assistance with the writing of this paper.
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Willis, F., Woll, P., Theti, D. et al. Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours. Bone Marrow Transplant 43, 927–934 (2009). https://doi.org/10.1038/bmt.2008.411
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DOI: https://doi.org/10.1038/bmt.2008.411
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