title: Relationship between changes in hemoglobin level and quality of life during chemotherapy in anemic cancer patients receiving epoetin alfa therapy.
abstract: BACKGROUND
  Hemoglobin increases have been associated with quality of life (QOL) improvements in anemic cancer patients treated with epoetin alfa, but intervention generally has been reserved for symptomatic anemia or hemoglobin < 10 g/dL. Relationships among hemoglobin, functional status, and patient reported QOL have not been well characterized.
  
  
  METHODS
  Data from two open-label, community-based trials of epoetin alfa therapy that enrolled 4382 anemic cancer patients undergoing chemotherapy were used to evaluate the relationship between hemoglobin changes and QOL changes. The authors measured QOL using the Linear Analog Scale Assessment (LASA) and the more detailed, disease-specific Functional Assessment of Cancer Therapy-Anemia (FACT-An) instrument. Analyses were performed to determine the incremental change in QOL associated with hemoglobin increases (1 g/dL increments).
  
  
  RESULTS
  Cross-sectional analyses showed a nonlinear relationship and significant positive correlation between high hemoglobin levels and high LASA and FACT-An scores (r = 0.25 and 0.29, respectively, P < 0.01). Patients with hemoglobin increases of > or = 2 g/dL reported statistically significant improvements in five FACT-An items selected a priori specifically to reflect functional capacity. An incremental analysis used regression methods to identify the longitudinal relationship between incremental changes in hemoglobin and QOL scores. This relationship was found to be nonlinear, with the maximum QOL gain occurring at a hemoglobin level of 12 g/dL (range, 11-13 g/dL). Patients with low baseline QOL scores and longer time periods between baseline and final QOL assessments experienced significantly (P < 0.05) greater increases in overall QOL. Progressive disease at baseline, change in disease status from baseline to end of study, and increase in self-reported pain or nausea all had significant (P < 0.05) negative effects on QOL scores.
  
  
  CONCLUSIONS
  A direct relationship exists between hemoglobin increases during epoetin alfa therapy and corresponding QOL improvements in cancer patients receiving chemotherapy across the clinically relevant hemoglobin range of 8-14 g/dL. These data suggest that the maximal incremental gain in QOL occurs when hemoglobin is in the range of 11-13 g/dL.
authors.affiliation: Duke Comprehensive Cancer Center, Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Crawford
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Charles S
authors.initials: CS
authors.lastname: Cleeland
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Cremieux
authors.forename: George D
authors.initials: GD
authors.lastname: Demetri
authors.forename: Brenda J
authors.initials: BJ
authors.lastname: Sarokhan
authors.forename: Mitchell B
authors.initials: MB
authors.lastname: Slavin
authors.forename: John A
authors.initials: JA
authors.lastname: Glaspy
mesh_terms: D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins
chemical_list: D000970:Antineoplastic Agents; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa