title: A prospective observational study of the effectiveness, safety, and effect on fatigue of darbepoetin alfa for the treatment of chemotherapy-induced anaemia.
abstract: OBJECTIVE
  Anaemia is common in cancer patients treated with chemotherapy. Darbepoetin alfa (DA) is the only erythropoiesis-stimulating protein approved for administration at weekly and every-three-week intervals in cancer patients receiving chemotherapy. This article investigates the effectiveness, tolerability and effect on fatigue of DA.
  
  
  METHODS
  Prospective, observational study performed in 30 Spanish centres. Eligible patients were > or = 18 years of age, anaemic (haemoglobin [Hb] < or = 11 g/dL), with non-myeloid malignancies, receiving chemotherapy. DA (150 mug) was administered weekly for a maximum of 16 weeks (dosage doubled if Hb increased < 1 g/dL after 4 weeks).
  
  
  METHODS
  Haematopoietic response (Hb increase > or = 2 g/dL or Hb > or = 12 g/dL in the absence of transfusions in the previous 28 days), transfusion required between Weeks 5 and 16 and fatigue measured by the Fatigue subscale of the Functional Assessment of Cancer Therapy.
  
  
  RESULTS
  293 adults were recruited (56.4% women), with lymphoproliferative malignancies (44.3%) or solid tumours (55.7%). Baseline Hb was 9-11 g/dL in 83.7% of patients. Sixty-four per cent (95% CI: 58.1-69.4%) had a haematopoietic response and 12% required transfusions. After adjusting for performance status, concomitant diseases and chemotherapy type, an increase in Hb level was significantly associated with an improvement in Fatigue subscale (+1.9 points per 1 g/dL). Only 2% of patients had treatment-related adverse events: thromboembolic pulmonary disease (0.3%); hypersensitivity reaction (0.3%); local pain following DA administration (0.3%); insomnia (0.3%); thrombocytosis (0.3%) and deep vein thrombosis (0.3%).
  
  
  CONCLUSIONS
  Fixed-dose DA administered once weekly seems to be an effective, well-tolerated treatment for chemotherapy-induced anaemia in patients with non-myeloid malignancies, and there is an indication of a possible benefit on fatigue in the clinical practice.
authors.affiliation: Complexo Hospitalario Xeral-Calde, Severo Ochoa, s/n, 27004 Lugo, Spain.
authors.forename: J R
authors.initials: JR
authors.lastname: Mel
authors.forename: A
authors.initials: A
authors.lastname: Salar
authors.forename: C A
authors.initials: CA
authors.lastname: Rodríguez
authors.forename: A
authors.initials: A
authors.lastname: Alegre
authors.forename: A
authors.initials: A
authors.lastname: González
authors.forename: J
authors.initials: J
authors.lastname: Cassinello
authors.forename: J
authors.initials: J
authors.lastname: Montesinos
authors.forename: J A
authors.initials: JA
authors.lastname: Gasquet
authors.forename: J
authors.initials: J
authors.lastname: Sánchez
authors.forename: E
authors.initials: E
authors.lastname: Saigí
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000139:chemically induced* / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000068256:Darbepoetin alfa; D004920:Erythropoiesis / Q000187:drug effects*; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005221:Fatigue / Q000097:blood / Q000139:chemically induced* / Q000188:drug therapy*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000188:drug therapy; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa