title: Assessing the effect of darbepoetin alfa on patient-reported fatigue in chemotherapy-induced anemia in four randomized, placebo-controlled clinical trials.
abstract: OBJECTIVE
  This analysis examined the effects of darbepoetin alfa on hemoglobin and fatigue outcomes in patients with cancer using latent growth curve modeling (LGM).
  
  
  METHODS
  Data from 4 clinical trials of darbepoetin alfa in lung cancer (2 studies; n = 547; n = 288), lymphoproliferative malignancies (n = 339), and non-myeloid malignancies (n = 320) were analyzed separately. Fatigue was assessed using the FACT-Fatigue (FACT-F) scale. Effects of darbepoetin alfa on changes in hemoglobin and FACT-F scores were evaluated using LGM, controlling for age, gender, Eastern Cooperative Oncology Group performance status, health status, and total transfusions.
  
  
  RESULTS
  Patients receiving darbepoetin alfa had higher rates of change in hemoglobin (standardized regression coefficient [[Formula: see text]] = 0.30 to 0.53, all P < 0.05) than placebo. Patients with greater rates of change in hemoglobin reported improvements in fatigue outcomes ([Formula: see text] = 0.28 to 0.59, all P < 0.05). The total standardized effect of darbepoetin alfa on fatigue outcomes corresponded to a mean change of 0.9 to 3.5 points in FACT-F scores, with one trial demonstrating changes exceeding the minimal important difference of 3 points.
  
  
  CONCLUSIONS
  Darbepoetin alfa improved hemoglobin which was associated with improved fatigue across the 4 trials. Clinically, meaningful improvement in fatigue was seen in 2 trials. More complex statistical analysis models of treatment may assist in understanding the effects of erythropoiesis-stimulating agents on patient-reported outcomes.
authors.affiliation: United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA. dennis.revicki@unitedbiosource.com
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: Donald
authors.initials: D
authors.lastname: Stull
authors.forename: Margaret
authors.initials: M
authors.lastname: Vernon
authors.forename: Michael
authors.initials: M
authors.lastname: Rader
authors.forename: Dianne
authors.initials: D
authors.lastname: Tomita
authors.forename: Hema N
authors.initials: HN
authors.lastname: Viswanathan
mesh_terms: D000368:Aged; D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa