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Randomized study of 13-cis retinoic acid v placebo in the myelodysplastic
disorders
HP Koeffler, D Heitjan, R Mertelsmann, JE Kolitz, P Schulman, L Itri, P Gunter and E Besa
Department of Medicine, UCLA Medical Center.
A double-blind, placebo-controlled randomized trial of 13-cis retinoic acid
was performed to determine if the drug has a therapeutic effect in patients
with myelodysplastic syndromes (MDS). Sixty-eight evaluable patients with
MDS were randomized to receive a single, daily oral dose of either 13-cis
retinoic acid (13-CRA, 100 mg/m2) or matching placebo. Treatment was
continued, when possible, for a period of 6 months. Determination of
response to treatment was based on clinical course, repeat bone marrow
biopsies, and aspirates and blood counts (CBC) with WBC differential,
platelet, and reticulocyte numbers at specified intervals. No significant
difference was noted between the two treatment groups in response to test
drug (P = .66). One patient (3%) in the 13-CRA group and two patients (6%)
in the placebo group had a minor response. Approximately 30% of patients in
both groups had progression of their disease, and progression-free survival
was nearly identical. Greater than 90% of the patients receiving 13-CRA
developed mild or moderate skin toxicity that was reversible with
decreasing or discontinuing the drug. Our study did not find that 13-CRA
exerts a beneficial therapeutic effect in patients with MDS.
Volume 71,
Issue 3,
pp. 703-708,
03/01/1988
Copyright © 1988 by The American Society of Hematology
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