Efficacy and Safety of Pegfilgrastim for Hemopoietic Stem Cell Mobilization in Healthy Donors: A Systematic Review and Meta-Analysis.

Our study aims to determine the efficacy and the safety of pegfilgrastim for hematopoietic stem cell mobilization in healthy donors undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). PubMed, Scopus and CENTRAL (Cochrane Central Register of Controlled Trials) databases were systematically searched for eligible studies. Meta-analysis of proportions (for dichotomous outcomes) and meta-analysis of single means (for continuous data) were performed using a random-effects model. Heterogeneity was assessed using I2 statistics. A subgroup and leave-one-out sensitivity analyses were also conducted. The ROBINS-I tool was used for risk of bias assessment. R software (version 4.4.2) was used for all statistical analyses. PROSPERO registry number CRD420251015182. Seven studies were included. Following a single pegfilgrastim administration, 67% of donors achieved the target mobilization threshold of ≥4 × 10⁶ CD34⁺ cells/kg in one apheresis session (95% CI: 47%-85%). In the 12 mg subgroup, mobilization success increased to 76% (95% CI: 70%-81%). Circulating CD34+ progenitors reached a mean peak of 72.04/µL (95% CI: 50.69-102.37), increasing to 83.30/µL (95% CI: 73.11-94.91) with 12 mg dosing. The grafts yielded a mean of 6.75 × 10^6 CD34+ cells/kg recipient weight (95% CI: 5.12-8.89), rising to 7.95 × 10^6 CD34+ cells/kg (95% CI: 6.10-10.36) in the 12 mg dosing. Bone pain (76%; 95% CI: 51%-97%) and headaches (37%; 95% CI: 23%-53%) were the most reported side effects. Pegfilgrastim demonstrates favorable efficacy and tolerability for stem cell mobilization in healthy donors undergoing allo-HSCT. The 12 mg dose appears to be the most appropriate dose for achieving optimal mobilization outcomes.