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Darbepoetin α for the treatment of anemia in patients with myelodysplastic syndromes
Author(s) -
Giraldo Pilar,
Nomdedeu Benet,
Loscertales Javier,
Requena Carmen,
de Paz Raquel,
Tormo Mar,
Navarro Pilar,
Benedit Patricia,
Gasquet José Antonio
Publication year - 2006
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.22343
Subject(s) - medicine , anemia , myelodysplastic syndromes , darbepoetin alfa , erythropoietin , chronic myelomonocytic leukemia , gastroenterology , international prognostic scoring system , surgery , bone marrow
BACKGROUND. Anemia occurs as a comorbidity in from 80% to 85% of patients with myelodysplastic syndromes (MDS): It causes fatigue, increases transfusion needs, and reduces quality of life. Darbepoetin α (DA) is an erythropoiesis‐stimulating protein (ESP) that is more highly glycosylated and has a longer half‐life relative to recombinant human erythropoietin (rHuEPO), thus, allowing less frequent administration, increased convenience, and better compliance. METHODS. This retrospective analysis included 81 patients with MDS who were enrolled at 9 Spanish centers and who received once‐weekly, subcutaneous DA (75–300 μg) for 16 weeks. RESULTS. Fifty‐five percent of all patients (38 of 69 evaluable patients) achieved responses; 30.4% of were major responses, and 24.6% were minor responses; 64.7% of rHuEPO‐naive patients and 45.7% rHuEPO‐treated patients responded; and 43.2% had received previous rHuEPO. Most responses (65.8%) occurred at or before Week 8. The median age at diagnosis was 70 years (range, 38–87 years), the median age at the initiation of DA treatment was 75 years (range, 39–91 years), and 56.8% of patients were women. The median time from last ESP dose to DA initiation was 16.8 weeks (range, 0.0–159.0 weeks; <1 week in 53.1% of patients). According to the French‐American‐British classification system (n = 81 patients), 39.5% had refractory anemia (RA), 46.9% had RA with ringed sideroblasts, 9.9% had RA with excess blasts (RAEB), 1.2% had RAEB in transformation, and 2.5% had chronic myelomonocytic leukemia. According to the International Prognostic Scoring System (n = 47 patients), 55.3% of patients were in the low‐risk group, and 36.2% of patients were in the intermediate‐1‐risk group. The median baseline hemoglobin level was 8.9 g/dL (range, 8.4–9.1 g/dL). The Starting DA dose was 75 μg per week in 3.7% of patients, 150 μg per week in 65.4% of patients, and 300 μg per week in 29.6% of patients (the dose was increased in 18.5% of patients and reduced in 9.9% of patients; median time to dose adjustment, 8 weeks). Five patients received granulocyte colony‐stimulating factors. No DA‐related adverse reactions occurred. CONCLUSIONS. In the current study, 55% of evaluable patients with MDS safely achieved an erythroid response. Cancer 2006. © 2006 American Cancer Society.