Quality of Life Research

, Volume 21, Issue 2, pp 311–321

Assessing the effect of darbepoetin alfa on patient-reported fatigue in chemotherapy-induced anemia in four randomized, placebo-controlled clinical trials

  • Dennis A. Revicki
  • Donald Stull
  • Margaret Vernon
  • Michael Rader
  • Dianne Tomita
  • Hema N. Viswanathan
Article

DOI: 10.1007/s11136-011-9946-z

Cite this article as:
Revicki, D.A., Stull, D., Vernon, M. et al. Qual Life Res (2012) 21: 311. doi:10.1007/s11136-011-9946-z

Abstract

Purpose

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 [\( \hat{\beta } \)] = 0.30 to 0.53, all P < 0.05) than placebo. Patients with greater rates of change in hemoglobin reported improvements in fatigue outcomes (\( \hat{\beta } \) = 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.

Keywords

Darbepoetin alfa Chemotherapy-induced anemia Clinical trials Fatigue Latent growth curve modeling 

Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  • Dennis A. Revicki
    • 1
  • Donald Stull
    • 1
  • Margaret Vernon
    • 1
  • Michael Rader
    • 2
  • Dianne Tomita
    • 3
  • Hema N. Viswanathan
    • 3
  1. 1.United BioSource CorporationBethesdaUSA
  2. 2.Union State Bank Cancer CenterNyack HospitalNyackUSA
  3. 3.Amgen Inc.Thousand OaksUSA

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