GRANULOCYTE-COLONY-STIMULATING FACTOR ACCELERATES NEUTROPHIL ENGRAFTMENT FOLLOWING PERIPHERAL-BLOOD STEM-CELL TRANSPLANTATION - A PROSPECTIVE, RANDOMIZED TRIAL

Purpose: It is well-established that the infusion of hematopoietic gro wth factors (HGF) accelerates neutrophil recovery in patients undergoi ng high-dose therapy followed by autologous bone marrow infusion. In a ddition, there is evidence that the infusion of autologous peripheral- blood stem cells (PBSC) accelerates engraftment in comparison to patie nts who receive bone marrow alone. However, few data are available reg arding the ability of HGF to accelerate engraftment further in patient s who receive PBSC following high-dose therapy. Patients and Methods: Forty-one patients undergoing high-dose therapy followed by infusion o f autologous PBSC with or without bone marrow were randomized to recei ve granulocyte colony-stimulating factor (G-CSF) 5 mu g/kg/d beginning on day +1 following transplant or standard posttransplant supportive care without HGF. Results: The median time to a neutrophil count great er than or equal to 500/mu L 10.5 days in the G-CSF group versus 16 da ys in the control group (P=.0001). G-CSF was associated with statistic ally significant reductions in the time to neutrophil engraftment amon g patients who received PBSC alone (11 v 17 days, P=.0003) and in pati ents who received PBSC in conjunction with bone marrow (10 v 14 days, P=.02), The median duration of posttransplant hospitalization (18 v 24 days, P=.002) and the median number of days on nonprophylactic antibi otics (11 v 15, P=.03) were also significantly reduced. Conclusion: Ad ministration of G-CSF in the posttransplant period accelerates the rat e of neutrophil engraftment, shortens the duration of hospitalization, and reduces the number of days on nonprophylactic antibiotics in pati ents who receive autologous PBSC with or wiihout autologous bone marro w following high-dose therapy. (C) 1995 by American Society of Clinica l Oncology.