title: Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population.
abstract: OBJECTIVE
  Anemia, highly common among cancer patients, is often an underlying cause of cancer-related fatigue and other quality-of-life (QOL) deficits. Although randomized clinical trials have shown that treatment with epoetin alfa increases hemoglobin levels, reduces fatigue, lessens transfusion requirements, and improves overall QOL, cancer-related anemia and fatigue remain undertreated. This is, in part, because scales and measures of QOL are still relatively unfamiliar to most clinicians and because population-based reference ranges are lacking, thus making clinical trial results difficult to interpret.
  
  
  METHODS
  To aid in the interpretation of QOL results from clinical trials, we administered the Functional Assessment of Cancer Therapy-Anemia (FACT-An) QOL instrument to a nationally representative sample of 1,400 people using an Internet survey panel in the United States. We then compared the FACT-An data from the Internet survey with the QOL data of a 375-patient randomized, double-blind clinical trial evaluating epoetin alfa versus placebo in anemic cancer patients.
  
  
  RESULTS
  FACT-An, as administered to the survey population, displayed good psychometric properties and was able to discriminate between respondents with histories of specified illnesses, including anemia and cancer, and those without. Comparison of the population norm and clinical trial data showed that treatment with epoetin alfa resulted in clinically meaningful as well as statistically significant improvements in QOL (P <.01).
  
  
  CONCLUSIONS
  Reliable population norm data are now available to aid in the interpretation of clinical trial results where the FACT-An questionnaire is administered. In the clinical trial, treatment with epoetin alfa overcame much of the QOL deficit seen in anemic cancer patients compared with the norm population sample.
authors.affiliation: Center on Outcomes, Research and Education, Evanston Northwestern Healthcare and Institute for Health Sciences Research and Policy Studies, Northwestern University, IL 60201, USA. d-cella@northwestern.edu
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Zagari
authors.forename: Christina
authors.initials: C
authors.lastname: Vandoros
authors.forename: Dennis D
authors.initials: DD
authors.lastname: Gagnon
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Hurtz
authors.forename: Johan W R
authors.initials: JW
authors.lastname: Nortier
mesh_terms: D000293:Adolescent; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D001803:Blood Transfusion; D004311:Double-Blind Method; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005221:Fatigue / Q000209:etiology / Q000517:prevention & control; D006305:Health Status Indicators; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D009369:Neoplasms / Q000150:complications; D011788:Quality of Life; D011994:Recombinant Proteins; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa