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Blood, Vol. 95 No. 4 (February 15), 2000:
pp. 1175-1179
Effect of recombinant human erythropoietin combined with
granulocyte/ macrophage colony-stimulating factor in the
treatment of patients with myelodysplastic syndrome
John A. Thompson,
D. Gary Gilliland,
Josef T. Prchal,
John M. Bennett,
Kay Larholt,
Richard A. Nelson,
Esther H. Rose,
Margaret H. Dugan, and
the GM/EPO MDS Study Group
From the Division of Oncology, University of Washington, Seattle,
WA; Hematology/Oncology Research, Howard Hughes Medical Institute,
Brigham and Women's Hospital, Harvard Medical School, Boston, MA;
Division of Hematology/Oncology, University of Alabama, Birmingham, AL;
Cancer Center, University of Rochester, Rochester, NY; RW Johnson
Pharmaceutical Research Institute, Raritan, NJ; and Schering Plough
Research Institute, Kenilworth, NJ.
This randomized, placebo-controlled trial was designed to assess the
efficacy and safety of therapy with granulocyte-macrophage colony-stimulating factor (GM-CSF) and erythropoietin (epoetin alfa) in
anemic, neutropenic patients with myelodysplastic syndrome. Sixty-six
patients were enrolled according to the following
French-American-British classification: refractory anemia (20),
refractory anemia with excess blasts (35), refractory anemia with
ringed sideroblasts (9), and refractory anemia with excess blasts in
transformation (2). Patients were stratified by their serum
erythropoietin levels (less than or equal to 500 mU/mL, n = 37;
greater than 500 mU/mL, n = 29) and randomized, in a 2:1 ratio, to
either GM-CSF (0.3-5.0 µg/kg·d) + epoetin alfa (150 IU/kg 3 times/wk) or GM-CSF (0.3-5.0 µg/kg·d) + placebo (3 times/wk). The
mean neutrophil count rose from 948 to 3831 during treatment with
GM-CSF ± epoetin alfa. Hemoglobin response (increase greater than or
equal to 2 g/dL, unrelated to transfusion) occurred in 4 of 45 (9%)
patients in the GM-CSF + epoetin alfa group compared with 1 of 21 (5%) patients with GM-CSF + placebo group
(P = NS). Percentages of patients in the
epoetin alfa and the placebo groups requiring transfusions of red blood
cells were 60% and 92%, respectively, for the low-endogenous erythropoietin patients and 95% and 89% for the high-endogenous erythropoietin patients (P = NS). Similarly,
the average numbers of units of red blood cells transfused during the
12-week study in the epoetin alfa and the placebo groups were 5.9 and
9.5, respectively, in the low-endogenous erythropoietin patients and
9.7 and 8.6 in the high-endogenous erythropoietin patients
(P = NS). GM-CSF ± epoetin alfa had no
effect on mean platelet count. Treatment was well tolerated in most
patients, though 10 withdrew from the study for reasons related
predominantly to GM-CSF toxicity.
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