Darbepoetin alpha for the treatment of anaemia in low-intermediate risk myelodysplasic syndromes.

Thirty-seven anaemic subjects with low-to -intermediate risk myelodysplastic syndrome (NIDS) received the highly glycosylated, long-acting erythropoiesis-stimulating molecule clarbepoetin-alpha (DPO) at the single, weekly dose of 150 mug s.c. for at least 12 weeks. Fifteen patients (40-5%) achieved an erythroid response (13 major and two minor improvements, respectively, according to International Working Group criteria). Such results are currently maintained after 7-22 months in 13 of the responders, one of whom required iron substitutive therapy during the treatment. One patient relapsed after 4 months. Another responder died after 5 months because of causes unrelated to the treatment. No relevant side-effects were recorded. At multivariate analysis, significant predictive factors of response were baseline serum levels of endogenous ery-thropoietin <100 IU/1, absent or limited transfusional needs, no excess of blasts and hypoplastic bone marrow. This study suggests that DPO, at the dose and schedule used, can be safely given in low-intermediate risk MDS and may be effective in a significant proportion of these patients.