title: Darbepoetin alfa for the treatment of anemia associated with myelodysplastic syndromes: efficacy and quality of life.
abstract: To evaluate efficacy, safety, changes in biological features, and quality of life (QoL) in low-risk anemic patients with MDS treated with darbepoetin alfa (DPO), 41 patients received DPO 150 microg weekly for 24 weeks. The dose was increased to 300 microg weekly in non-responsive patients. During treatment, 10/17 (59%) transfusion-dependent (TD) and 13/23 (56%) transfusion-free (TF) patients responded. In TF patients, Hb increased from 9.2 +/- 0.9 g/dL to 10.3 +/- 1.4 g/dL by 24 weeks (p = 0.004). The mean response duration was 22 weeks (95% CI: 19.7-24.0) in TF patients compared with 15.1 weeks (95% CI: 13.3-17.5) in TD patients. Response to treatment was associated with increases in QoL. Decreases in the percentage of apoptotic progenitor cells (p = 0.007) and CD34+ cells (p = 0.005) were observed. These results confirm previous studies demonstrating the safety and efficacy of DPO in anemic patients with MDS. Biological changes and improvement in QoL were associated with response. Adequate dosing is to be determined.
authors.affiliation: Hematology Unit, Azienda Ospedaliera 'Bianchi-Melacrino-Morelli', Reggio Calabria, Italy. estheroliva@hotmail.com
authors.forename: Esther N
authors.initials: EN
authors.lastname: Oliva
authors.forename: Francesco
authors.initials: F
authors.lastname: Nobile
authors.forename: Giuliana
authors.initials: G
authors.lastname: Alimena
authors.forename: Giorgina
authors.initials: G
authors.lastname: Specchia
authors.forename: Marco
authors.initials: M
authors.lastname: Danova
authors.forename: Bianca
authors.initials: B
authors.lastname: Rovati
authors.forename: Francesca
authors.initials: F
authors.lastname: Ronco
authors.forename: Stefana
authors.initials: S
authors.lastname: Impera
authors.forename: Antonio
authors.initials: A
authors.lastname: Risitano
authors.forename: Caterina
authors.initials: C
authors.lastname: Alati
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.forename: Ida
authors.initials: I
authors.lastname: Carmosino
authors.forename: Iolanda
authors.initials: I
authors.lastname: Vincelli
authors.forename: Roberto
authors.initials: R
authors.lastname: Latagliata
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D001803:Blood Transfusion; D003131:Combined Modality Therapy / Q000706:statistics & numerical data; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000150:complications*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011788:Quality of Life; D012044:Regression Analysis; D016896:Treatment Outcome
chemical_list: D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa