1.
"Filgrastim following HLA-identical allogeneic bone marrow transplantation: long-term outcomes of a randomized trial"
T, B. O., H, G., N, B. A., A, L., L, T., L, B. H., S, H., B, Z., S, L.
Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 2018
Abstract
Human recombinant G-CSF reduces the duration of neutropenia following HLA-identical allogeneic bone marrow transplantation. However, its use remains controversial due to the risk of increasing the incidence of acute graft-versus-host disease (aGvHD) and slower platelet recovery. To clarify these risks, we conducted a prospective randomised placebo-controlled trial of filgrastim 5 mcg/kg/day IV from day 7 post-transplant until neutrophil recovery in 145 consecutive adults undergoing HLA-identical allogeneic bone marrow transplantation, with cyclosporine and methotrexate as GvHD prophylaxis. The primary endpoint was the incidence of aGvHD; haematological recovery, non-relapse mortality and post-transplant complications were secondary endpoints. Filgrastim had no significant effect on the incidence of aGvHD, platelet recovery, platelet transfusion requirements, chronic GvHD or survival. Filgrastim accelerated granulocyte recovery significantly (with absolute neutrophil counts>0.5x10(9)/L achieved after a median of 16 days versus 23 days for placebo, p <10(-4)), and reduced both early non-relapse mortality (2.9% versus 10.5%; p=0.042) and the duration of IV antibiotic therapy (18 versus 26 days, p=0.001) and hospitalisation (27 versus 34 days, p=0.017). In conclusion, in this setting, filgrastim reduced significantly the duration of neutropenia, IV antibiotic therapy, hospitalization and early non-relapse mortality, without increasing the risk of acute and chronic GvHD, relapse or delaying platelet recovery.