Abstract
Background: Granulocyte colony-stimulating factor (G-CSF) has been established for mobilizing allogeneic hematopoietic stem cells from healthy donors as the standard regimen. It has a short elimination half-life and daily subcutaneous injection. The pegylated form of filgrastim (pegfilgrastim) has a longer elimination half-life because of decreased serum clearance and might be a convenient alternative for allogeneic hematopoietic stem cell mobilization. Aims: To observe the efficacy and safety of pegfilgrastim in mobilization of donor stem cells compared with rhG-CSF. Methods: This study was a prospective randomize control single-center trial. 47 normal related donors received pegfilgrastim 12 mg subcutaneously to mobilize peripheral blood stem cells (PBSC) for allogeneic stem cell transplantation. 36 donors received 10 ug/kg granulocyte colony-stimulating factor (G-CSF) for mobilization in conventional filgrastim group. Pegfilgrastim group with inadequate mobilization (blood CD34+ cells 20/uL on day 4) were given additional daily doses of 10 ug/kg conventional filgrastim. Leukapheresis was planned to start 5 days after injection. Results: There were 40/47 donors in pegfilgrastim group who only required single leukapheresis, 29/36 in conventional filgrastim group. These indicated no statistical difference. The maximum concentration of white blood cells (WBC) and circulating CD34 cells occurred 5 days after egfilgrastim injection in two groups had significant statistical difference(P = 0.039,P = 0.02,respectively), median WBC in case group is 511836/ul vs.42.6884/ul in control group; CD34:median 128.33/ul vs.73.68/ul). In 44 out of 47 achieved neutrophil and platelet engraftment in pegfilgrastim group after transplantation,34/36 in conventional filgrastim group, respectively. Median neutrophil and platelet engraftments in the recipients in pegfilgrastim group occurred on day 14 and day 16, day 15 and day 17 in conventional filgrastim group. Pegfilgrastim group was associated with lower incidences of acute graft-versus-host disease(GVHD) (14.9% vs. 30.5%, p < 0.05) compared with conventional filgrastim. The main adverse events were bone pain and headache, the incidence ratio is 14.9% in pegfilgrastim group, 22.2% in conventional filgrastim group. Summary/Conclusion: PBSC mobilization in normal donor with single injection of pegfilgrastim is feasible. Further comparisons to standard G-CSF for allogeneic stem cell mobilization should be conducted in future.
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