GM-CSF ACCELERATES NEUTROPHIL RECOVERY AFTER AUTOLOGOUS HEMATOPOIETICSTEM-CELL TRANSPLANTATION

Patients with non-myeloid hematologic malignancies (including Hodgkin' s and non-Hodgkin's lymphomas, myeloma and acute lymphoid leukemia) or solid tumors underwent cytoreductive conditioning regimens followed b y either autologous bone marrow transplantation (ABMT) (n = 343) or tr ansplantation of peripheral blood stem cells (PBSC) with (n = 44) or w ithout bone marrow (BM) (n = 16), In a randomized double-blind phase I II multi-center trial, patients received either granulocyte-macrophage colony-stimulating factor (GM-CSF, 10 mu g/kg/day) or placebo by dail y i.v. infusion beginning 24 h after bone marrow infusion and continui ng until the absolute neutrophil count (ANC) had recovered to greater than or equal to 1000/mm(3), or for a maximum of 30 days, Median time to neutrophil recovery was significantly shorter in the GM-CSF group ( 18 vs 27 days, P < 0.001), and more GM-CSF patients had neutrophil rec overy by day 30 (70 vs 48%), Median duration of hospitalization was si gnificantly shorter in the GM-CSF group (29 vs 32 days, P = 0.02), GM- CSF significantly reduced the median time to neutrophil recovery in pa tients receiving bone marrow only (19 vs 27 days, P < 0.001) or PBSC w ith or without bone marrow (14 vs 21 days, P < 0.001), The overall inc idence of adverse events was comparable in the two groups, although mo re patients in the GM-CSF group discontinued treatment due to adverse events (17 vs 9%, P < 0.001), No difference was noted in infection inc idence or time to platelet independence, GM-CSF had no negative impact on time to relapse or long-term survival These data indicate the posi tive influence of GM-CSF on neutrophil recovery and hospital stay in p atients receiving ABMT for a variety of clinical indications.