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A controlled trial of recombinant human erythropoietin after bone marrow
transplantation
H Link, MA Boogaerts, AA Fauser, S Slavin, J Reiffers, NC Gorin, AM Carella, F Mandelli, S Burdach and A Ferrant
Department of Hematology and Oncology, Medizinische Hochschule Hannover,
Germany.
Recombinant human erythropoietin (rHuEPO) stimulates erythropoietic bone
marrow cells and increases erythrocyte production. This prospective study
was designed to evaluate the effects of rHuEPO on regeneration of
erythropoiesis after allogeneic or autologous bone marrow transplantation
(BMT). Seventeen centers participated in this randomized, double-blind,
placebo-controlled multicenter trial. The randomization was performed
centrally for each center and stratified according to allogeneic or
autologous BMT and major ABO-blood group incompatibility. One hundred and
six patients received rHuEPO after allogeneic BMT and 109 patients received
placebo. After autologous BMT, 57 patients were treated with rHuEPO and 57
with placebo. Patients received either 150 IU/kg/day C127
mouse-cell-derived rHuEPO or placebo as continuous intravenous infusion.
Therapy started after bone marrow infusion and lasted until independence
from erythrocyte transfusions for 7 consecutive days with stable hemoglobin
levels > or = 9 g/100 mL or until day 41. After allogeneic BMT, the
reticulocyte counts were significantly higher with rHuEPO from day 21 to
day 42 after BMT. The median time (95% confidence intervals) to erythrocyte
transfusion independence was 19 days (range, 16.3 to 21.6) with rHuEPO and
27 days (range, 22.3 to > 42) with placebo (P < .003). The mean (+/-
SD) numbers of erythrocyte transfusions until day 20 after BMT were 6.6 +/-
4.8 with rHuEPO and 6.0 +/- 3.8 with placebo. However, from day 21 to day
41, the rHuEPO-treated patients received 1.4 +/- 2.5 (median, 0)
transfusions and the control group received 2.7 +/- 4.0 (median, 2)
transfusions (P = .004). In the follow-up period from day 42 up to day 100,
2.4 +/- 5.6 transfusions were required with rHuEPO and 4.5 +/- 9.6 were
required with placebo (P = .075). A multivariate analysis (ANOVA) showed
that acute graft-versus-host disease (GVHD), major ABO-blood group
incompatibility, age greater than 35 years, and hemorrhage significantly
increased the number of transfusions. However, after day 20, rHuEPO
significantly reduced the number of erythrocyte transfusions in these
patient groups, as well as reducing incompatibility in the major ABO-blood
group. For the whole study period, rHuEPO reduced the transfusion
requirements in GVHD III and IV from 18.4 +/- 8.6 to 8.5 +/- 6.8 U (P =
.05). After autologous BMT, there was no difference in the time to
independence from erythrocyte transfusions and in the regeneration of
reticulocytes. Marrow purging strongly increased the requirement for
transfusions as well as the time to transfusion independence.
Volume 84,
Issue 10,
pp. 3327-3335,
11/15/1994
Copyright © 1994 by The American Society of Hematology
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