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Blood, 1 March 2002, Vol. 99, No. 5, pp. 1578-1584
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Sustained response to recombinant human erythropoietin and
intermittent all-trans retinoic acid in patients with
myelodysplastic syndromes
Roberto Stasi,
Maurizio Brunetti,
Edmondo Terzoli, and
Sergio Amadori
From the Department of Medical Sciences, Regina
Apostolorum Hospital, Albano Laziale; the Department of Complementary
Oncology, Regina Elena Institute, Rome; and the Department of
Hematology, University of Rome Tor Vergata, S. Eugenio Hospital, Italy.
In vitro studies suggest that all-trans retinoic acid
(ATRA) synergizes with erythropoietin (EPO) for the stimulation of
hematopoiesis in patients with myelodysplastic syndrome (MDS). A
clinical trial was performed to evaluate whether a combination of these
agents was effective in relieving the cytopenias associated with MDS. Twenty-seven patients with low- or intermediate-risk MDS were enrolled
in a 12-week study. ATRA was administered orally at the dose of 80 mg/m2 per day in 2 divided doses for 7 consecutive days
every other week. Recombinant human EPO was given subcutaneously 3 times a week. The EPO dose was initiated at 150 U/kg and was increased to 300 U/kg if after 6 weeks there was no or there was suboptimal erythroid response. Patients who responded to therapy were continued on
ATRA and EPO at the same doses for 6 additional months (extension phase). Further treatment was given to patients with a continued response. Clinically significant erythroid responses with increases of
hemoglobin levels of at least 1 g/dL or reduction of
transfusion needs were seen in 13 (48%) patients, with 4 showing
improved responses after dose escalation of EPO. Ten (37%) patients
displayed continued responses during 6 months of extended treatment,
and 7 (26%) are still responsive after a follow-up period of 13 months. Neutrophil responses were observed in 5 of 12 patients with
neutropenia, and platelet responses were observed in 6 of 9 patients
with thrombocytopenia. Three patients displayed trilineage responses
that were sustained during continuation therapy. Side effects were
observed in all patients but were of mild entity and did not require
discontinuation of therapy. It is concluded that the combination
ATRA + EPO is an effective and well-tolerated treatment for
patients with low- and intermediate-risk MDS. The optimal ATRA and EPO
schedule and the role of maintenance treatment remain to be determined
and warrant further investigation.
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