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Blood, 17 September 2009, Vol. 114, No. 12, pp. 2393-2400. Prepublished online as a Blood First Edition Paper on June 29, 2009; DOI 10.1182/blood-2009-03-211797.
CLINICAL TRIALS AND OBSERVATIONS Treatment of myelodysplastic syndrome patients with erythropoietin with or without granulocyte colony-stimulating factor: results of a prospective randomized phase 3 trial by the Eastern Cooperative Oncology Group (E1996)1 Stanford University Cancer Center, CA; 2 Dana-Farber Cancer Institute, Boston, MA; 3 Tufts-New England Medical Center, Boston, MA; 4 Wilmot Cancer Center, University of Rochester Medical Center, NY; 5 Northwestern University Feinberg School of Medicine, Chicago, IL; 6 Mayo Clinic, Rochester, MN; 7 Montefiore Medical Center, Bronx, NY; 8 Ottawa Hospital, Ottawa, ON; 9 Carle Clinic Association, Urbana, IL; 10 Veterans Administration Palo Alto Health Care System, CA; and 11 Rambam Medical Center and Technion, Haifa, Israel
This phase 3 prospective randomized trial evaluated the efficacy and long-term safety of erythropoietin (EPO) with or without granulocyte colony-stimulating factor plus supportive care (SC; n = 53) versus SC alone (n = 57) for the treatment of anemic patients with lower-risk myelodysplastic syndromes. The response rates in the EPO versus SC alone arms were 36% versus 9.6%, respectively, at the initial treatment step, 47% in the EPO arm, including subsequent steps. Responding patients had significantly lower serum EPO levels (45% vs 5% responses for levels < 200 mU/mL vs
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| Copyright © 2009 by American Society of Hematology Online ISSN: 1528-0020 | |||||||||
200 mU/mL) and improvement in multiple quality-of-life domains. With prolonged follow-up (median, 5.8 years), no differences were found in overall survival of patients in the EPO versus SC arms (median, 3.1 vs 2.6 years) or in the incidence of transformation to acute myeloid leukemia (7.5% and 10.5% patients, respectively). Increased survival was demonstrated for erythroid responders versus nonresponders (median, 5.5 vs 2.3 years). Flow cytometric analysis showed that the percentage of P-glycoprotein+ CD34+ marrow blasts was positively correlated with longer overall survival. In comparison with SC alone, patients receiving EPO with or without granulocyte colony-stimulating factor plus SC had improved erythroid responses, similar survival, and incidence of acute myeloid leukemia transformation. 
