Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population.
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.
Cella
David
D
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
Zagari
Martin J
MJ
Vandoros
Christina
C
Gagnon
Dennis D
DD
Hurtz
Hans-Jürgen
HJ
Nortier
Johan W R
JW
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
D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa