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Pharmacologic doses of recombinant human erythropoietin in the treatment of
myelodysplastic syndromes [see comments]
RS Stein, RI Abels and SB Krantz
Department of Medicine, Vanderbilt University School of Medicine,
Nashville, TN.
Twenty patients with myelodysplastic syndromes (MDS) entered a randomized,
placebo-controlled, double-blind trial designed to evaluate the efficacy
and toxicity of high doses of recombinant human erythropoietin (rhEPO).
Patients completing the trial were eligible to receive rhEPO as part of an
open-label study. Eighteen patients were transfusion dependent; 10 had
refractory anemia (RA), and 10 had refractory anemia with ringed
sideroblasts (RARS). A response to rhEPO was defined as an increase in
hematocrit of 4 percentage points or more over baseline, or the elimination
of all transfusions with the hematocrit stable at the baseline level. In
the double-blind trial, 1 patient (12.5%) receiving rhEPO responded, as
compared with no responses in the placebo group. Overall, responses
occurred in 4 of 17 patients (24%) receiving rhEPO at a dose of 1,200 to
1,600 U/kg intravenously (IV) twice weekly. Changes in granulocyte or
platelet counts were not observed. Despite the administration of high doses
of rhEPO, toxicity attributable to rhEPO was not observed in either the
double-blind or open-label study. Response to rhEPO was not significantly
related to age, gender, type of MDS, time since diagnosis, time since
initiation of transfusion therapy, or baseline serum EPO. These studies
indicate that rhEPO can be administered safely in very high doses to
patients with MDS and that 24% of these patients will respond with
increased erythropoiesis.
Volume 78,
Issue 7,
pp. 1658-1663,
10/01/1991
Copyright © 1991 by The American Society of Hematology
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