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

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 [[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: Dennis A Revicki, Donald Stull, Margaret Vernon, Michael Rader, Dianne Tomita, Hema N Viswanathan
• Journal: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation (Qual Life Res) Vol. 21 Issue 2 Pg. 311-21 (Mar 2012) ISSN: 1573-2649 [Electronic] Netherlands
• PMID: 21644007 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Hematinics
• Hemoglobins
• Erythropoietin
• Darbepoetin alfa

Topics

• Aged
• Anemia (chemically induced, drug therapy)
• Darbepoetin alfa
• Erythropoietin (analogs & derivatives, therapeutic use)
• Fatigue (drug therapy, etiology)
• Female
• Hematinics (therapeutic use)
• Hemoglobins
• Humans
• Male
• Middle Aged
• Neoplasms (complications, drug therapy)
• Randomized Controlled Trials as Topic
• Treatment Outcome