title: Epoetin delta: efficacy in the treatment of anaemia in cancer patients receiving chemotherapy.
abstract: OBJECTIVE
  To assess the effect of epoetin delta on anaemia in patients with cancer who were receiving chemotherapy.
  
  
  METHODS
  This report includes data from two 12-week studies of epoetin delta: a randomised, double-blind, placebo-controlled study of three times weekly epoetin delta (150 or 300IU/kg) and an open-label extension collecting further efficacy and safety information, in which patients initially received epoetin delta 150IU/kg. Co-primary end points for the double-blind study were an increase in haemoglobin levels and a reduction in the requirement for red blood cell transfusions compared with placebo.
  
  
  RESULTS
  Double-blind study: 313 cancer patients were randomised to epoetin delta or placebo. Epoetin delta was associated with a significantly greater increase in haemoglobin levels from baseline compared with placebo (epoetin delta 150 and 300IU/kg vs placebo: 2.5 and 2.5g/dl vs 0.6g/dl; P<0.0001 for both comparisons), meeting one co-primary end point. However, there were no significant differences between groups in the proportion of patients requiring red blood cell transfusions (epoetin delta 150 and 300IU/kg vs placebo: 26.0 and 21.9% vs 26.9%), the second co-primary end point. Open-label study: 149 patients entered the extension study. During the extension, haemoglobin levels were maintained and a higher proportion of patients who previously received placebo required transfusions than those who had previously received epoetin delta (previous epoetin delta 150 and 300IU/kg: 7.1 and 11.4% vs previous placebo: 15.9%). Adverse events were as expected for this population in both studies.
  
  
  CONCLUSIONS
  Epoetin delta shows potential as a treatment for anaemia in cancer patients receiving chemotherapy.
authors.affiliation: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warszawa, Poland. maciekk@coi.waw.pl
authors.forename: M
authors.initials: M
authors.lastname: Krzakowski
mesh_terms: D000740:Anemia / Q000150:complications* / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006454:Hemoglobins / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D011994:Recombinant Proteins; D012449:Safety
chemical_list: D000970:Antineoplastic Agents; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; C516023:epoetin delta