title: Quality of life, physical function and MRI T2* in elderly low-risk MDS patients treated to a haemoglobin level of ≥120 g/L with darbepoetin alfa ± filgrastim or erythrocyte transfusions.
abstract: OBJECTIVE
  Anaemia in low-risk myelodysplastic syndromes (MDS) is associated with reduced quality of life (QoL). Response to treatment with erythropoietin ± granulocyte colony-stimulating factor (G-CSF) is associated with improved QoL, but whether transfusion therapy with higher haemoglobin (Hb) target levels has similar effects is unknown. The objective for this prospective phase II Nordic multicentre trial was to assess QoL, response rate and physical function in elderly anaemic MDS patients treated to a target Hb level of >120 g/L.
  
  
  METHODS
  Thirty-six elderly patients with low- and intermediate-1 risk MDS received darbepoetin (DA) 300 μg/wk, with the addition of G-CSF if no response. If the Hb target was reached at 16 wk, treatment was maintained until week 26. Remaining patients were transfused to reach the target level for at least 8 wk.
  
  
  RESULTS
  Twenty-seven patients completed the study. Response rate to DA ± G-CSF was 67% in evaluable patients and 56% according to intention to treat. Eighteen patients reached the target Hb level according to protocol. QoL scores for fatigue, dyspnoea, constipation, and physical, role and social functioning improved significantly during study, with similar results for transfused and untransfused patients. Maintaining Hb >120 g/L did not confer a higher transfusion rate, once the target was reached. In two of fourteen patients, magnetic resonance imaging T2* indicated cardiac iron overload, however, without association with ferritin levels.
  
  
  CONCLUSIONS
  In elderly anaemic MDS patients, an increment in haemoglobin is associated with improved QoL, whether induced by growth factor treatment or transfusion therapy.
authors.affiliation: Section of Hematology and Coagulation, Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden. herman.n-ehle@vgregion.se
authors.forename: Herman
authors.initials: H
authors.lastname: Nilsson-Ehle
authors.forename: Gunnar
authors.initials: G
authors.lastname: Birgegård
authors.forename: Jan
authors.initials: J
authors.lastname: Samuelsson
authors.forename: Petar
authors.initials: P
authors.lastname: Antunovic
authors.forename: Jan
authors.initials: J
authors.lastname: Astermark
authors.forename: Hege
authors.initials: H
authors.lastname: Garelius
authors.forename: Lena M
authors.initials: LM
authors.lastname: Engström
authors.forename: Lars
authors.initials: L
authors.lastname: Kjeldsen
authors.forename: Lars
authors.initials: L
authors.lastname: Nilsson
authors.forename: Anna
authors.initials: A
authors.lastname: Olsson
authors.forename: Mette
authors.initials: M
authors.lastname: Skov-Holm
authors.forename: Jonas
authors.initials: J
authors.lastname: Wallvik
authors.forename: Nina
authors.initials: N
authors.lastname: Gulbrandsen
authors.forename: Eva
authors.initials: E
authors.lastname: Hellström-Lindberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000068256:Darbepoetin alfa; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005293:Ferritins / Q000097:blood; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D009190:Myelodysplastic Syndromes / Q000188:drug therapy / Q000628:therapy*; D011788:Quality of Life; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor; D000068256:Darbepoetin alfa; D005293:Ferritins; D000069585:Filgrastim