Journal
BRITISH JOURNAL OF HAEMATOLOGY
Volume 142, Issue 3, Pages 379-393Publisher
WILEY
DOI: 10.1111/j.1365-2141.2008.07181.x
Keywords
myelodysplastic syndromes; erythropoiesis-stimulating agent; erythroid response; haemoglobin; transfusion
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Patients with myelodysplastic syndromes (MDS) often develop anaemia resulting in frequent transfusions and fatigue. Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anaemia. This single-arm, phase 2 study examined the efficacy of darbepoetin alfa 500 mu g every 3 weeks (Q3W) for treating anaemia in low-risk MDS patients (after 6 weeks, poor responders received darbepoetin alfa 500 mu g every 2 weeks). The primary end-point was the incidence of erythroid responses (International Working Group criteria) after 13 weeks of therapy. Secondary end-points included the incidence of erythroid responses at weeks 28 and 55, [or weeks 27 and 53 for dose escalations to every two weeks (Q2W)], and safety parameters. Analyses were stratified by the patient's previous ESA therapy status [ESA-naive (n = 144) vs. prior ESA-treated (n = 62)]. After 13 weeks of therapy, 49% of ESA-naive patients and 26% of prior ESA-treated patients achieved a major erythroid response. After 53/55 weeks, 59% of ESA-naive patients and 34% of prior ESA-treated patients achieved a major erythroid response; 82% of ESA-naive patients and 55% of prior ESA-treated patients achieved target haemoglobin of 110 g/l. Thromboembolic or related adverse events occurred in 2% of patients; no pulmonary embolisms were reported. In conclusion, darbepoetin alfa, 500 mu g Q3W appeared well tolerated and increased haemoglobin levels in low-risk MDS patients.
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