1. Clinical benefits of granulocyte colony-stimulating factor therapy after hematopoietic stem cell transplant in children: Results of a prospective randomized trial
- Author
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Dallorso, S., Rodelli, R., Messina, C., Pession, A., Giorgiani, G., FRANCA FAGIOLI, Locatelli, F., Manzitti, C., Balduzzi, A., Prete, A., Cesaro, S., Vassallo, E., Lanino, E., Dini, G., Dallorso, S, Rondelli, R, Messina, C, Pession, A, Giorgiani, G, Fagioli, F, Locatelli, F, Manzitti, C, Balduzzi, A, Prete, A, Cesaro, S, Vassallo, E, Lanino, E, and Dini, G
- Subjects
Male ,Peripheral Blood Stem Cell Transplantation ,Neutropenia ,RHu G-CSF ,Adolescent ,Neutrophils ,Graft Survival ,Hematopoietic Stem Cell Transplantation ,Infant ,Bone Marrow Transplantation ,Child ,Child, Preschool ,Female ,Granulocyte Colony-Stimulating Factor ,Humans ,Prospective Studies ,Bone marrow transplantation ,Children ,Preschool - Abstract
Background and Objectives. Hematopoietic stem cell transplantation (HSCT) is associated with profound neutropenia and significant morbidity and mortality. To evaluate the safety and efficacy of non-glycosylated recombinant human granulocyte colony-stimulating factor (rHuG-CSF) in accelerating myeloid recovery and its influence on infections, supportive therapy, and transplant-related mortality we carried out a randomized study in pediatric patients receiving HSCT. Design and Methods. Two hundred and twenty-one consecutive children, recipients of an allogeneic or autologous bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplant, were randomized to either receive rHuG-CSF 10 ug/kg (n=110) or not (n=111) Results. Myeloid engraftment was faster in the treated arm (14 vs 20 days, p=0.0001). Neutrophil recovery was accelerated both in the BM subgroups (allogeneic and autologous, p=0.002) and in the PBPC group (p=0.0005). All the other evaluated variables showed an advantage in favor of rHuG-CSF treated patients that was significant for platelet transfusion independence and time to discharge (p=0.02 and p=0.04, respectively) only in the BM subgroup. Interpretation and Conclusions. We conclude that faster neutrophil recovery in BM recipients receiving rHuG-CSF led to clinical benefits, while, in the PBPC subgroup, it did not translate into clinical advantages.