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Subcutaneous erythropoietin for treatment of refractory anemia in
hematologic disorders. Results of a phase I/II clinical trial [see
comments]
M Cazzola, L Ponchio, Y Beguin, V Rosti, G Bergamaschi, NL Liberato, V Fregoni, G Nalli, G Barosi and E Ascari
Department of Internal Medicine and Medical Therapy, University of Pavia,
Italy.
We have used recombinant human erythropoietin (rHuEPO) in a phase I/II
clinical trial to evaluate its ability to reverse refractory anemia in
hematologic disorders. rHuEPO was administered subcutaneously 5 days per
week at escalating doses (50 to 150 U/kg per day). The aim of treatment was
a hemoglobin (Hb) level greater than or equal to 10 g/dL without blood
transfusion. Of 25 patients treated, 17 were evaluable, most of them with a
regular need for transfusion. Eight of these had lymphoproliferative
disorders (three cases of malignant lymphoma and five of monoclonal
gammopathy) and were exposed to cytotoxic therapy. The other nine patients
had hematopoietic stem cell disorders (four cases of myelodysplastic
syndrome, three of idiopathic myelofibrosis, and two of chronic myelogenous
leukemia). All patients with lymphoproliferative disorder had serum EPO
levels inappropriately low for the degree of anemia, while patients with
stem cell disorder showed variable values. Erythroid marrow activity was
inadequate in all cases. Seven of eight patients with lymphoproliferative
disorder responded to treatment maintaining Hb above 10 g/dL without
transfusion. The median dose of rHuEPO required for correction of anemia
was 75 U/kg. In four cases response was maintained with 50 U/kg, three
times per week. There was no complete response among patients with
hematopoietic stem cell disorder, although transfusion requirement was
eliminated or reduced in four cases. Four patients developed functional
iron deficiency during rHuEPO treatment and required iron supplementation
to obtain response. Aggravation of splenomegaly was observed in two cases
of myeloproliferative disorder. We conclude that: (1) subcutaneous
administration of rHuEPO can be effective and safe in patients with
lymphoproliferative disorder exposed to chemotherapy and showing
inappropriate EPO response to anemia; (2) this is less likely in
hematopoietic stem cell disorders, although favorable responses may be
observed in occasional patients; and (3) functional iron deficiency as a
cause of nonresponse to rHuEPO is frequent also in nonrenal anemia.
Volume 79,
Issue 1,
pp. 29-37,
01/01/1992
Copyright © 1992 by The American Society of Hematology
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