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Hematopoietic growth factors for graft failure after bone marrow
transplantation: a randomized trial of granulocyte-macrophage colony-
stimulating factor (GM-CSF) versus sequential GM-CSF plus granulocyte- CSF
DJ Weisdorf, CM Verfaillie, SM Davies, AH Filipovich, JE Wagner , JS Miller, J Burroughs, NK Ramsay, JH Kersey and PB McGlave
Department of Medicine, University of Minnesota, Minneapolis, USA.
Delay in hematologic recovery after bone marrow transplantation (BMT) can
extend and amplify the risks of infection and hemorrhage, compromise
patients' survival, and increase the duration and cost of hospitalization.
Because current studies suggest that granulocyte- macrophage (GM)
colony-stimulating factor (CSF) may potentiate the sensitivity of
hematopoietic progenitor cells to G-CSF, we performed a prospective,
randomized trial comparing GM-CSF (250 micrograms/m2/d x 14 days) versus
sequential GM-CSF x 7 days followed by G-CSF (5 micrograms/kg/d x 7 days)
as treatment for primary or secondary graft failure after BMT. Eligibility
criteria included failure to achieve a white blood cell (WBC) count > or
= 100/microL by day +21 or > or = 300/microL by day +28, no absolute
neutrophil count (ANC) > or = 200/microL by day +28, or secondary
sustained neutropenia after initial engraftment. Forty-seven patients were
enrolled: 23 received GM-CSF (10 unrelated, 8 related allogeneic, and 5
autologous), and 24 received GM- CSF followed by G-CSF (12 unrelated, 7
related allogeneic, and 5 autologous). For patients receiving GM-CSF alone,
neutrophil recovery (ANC > or = 500/microL) occurred between 2 and 61
days (median, 8 days) after therapy, while those receiving GM-CSF+G-CSF
recovered at a similar rate of 1 to 36 days (median, 6 days; P = .39).
Recovery to red blood cell (RBC) transfusion independence was slow,
occurring 6 to 250 days (median, 35 days) after enrollment with no
significant difference between the two treatment groups (GM-CSF: median, 30
days; GM-CSF+G- CSF; median, 42 days; P = .24). Similarly, platelet
transfusion independence was delayed until 4 to 249 days (median, 32 days)
after enrollment, with no difference between the two treatment groups (GM-
CSF: median, 28 days; GM-CSF+G-CSF: median, 42 days; P = .38). Recovery
times were not different between patients with unrelated donors and those
with related donors or autologous transplant recipients. Survival at 100
days after enrollment was superior after treatment with GM-CSF alone. Only
1 of 23 patients treated with GM-CSF died versus 7 of 24 treated with
GM-CSF+G-CSF who died 16 to 84 days (median, 38 days) after enrollment,
yielding Kaplan-Meier 100-day survival estimates of 96% +/- 8% for GM-CSF
versus 71% +/- 18% for GM-CSF+G-CSF (P = .026). These data suggest that
sequential growth factor therapy with GM-CSF followed by G-CSF offers no
advantage over GM-CSF alone in accelerating trilineage hematopoiesis or
preventing lethal complications in patients with poor graft function after
BMT.(ABSTRACT TRUNCATED AT 400 WORDS)
Volume 85,
Issue 12,
pp. 3452-3456,
06/15/1995
Copyright © 1995 by The American Society of Hematology
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