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As Hemoglobin Levels Rise, So Do Patients’ Assessments of Well-Being

As Hemoglobin Levels Rise, So Do Patients’ Assessments of Well-Being

THOUSAND OAKS, California—Increases in hemoglobin levels appear to
improve the physical, functional, emotional, and psychological well-being of
cancer patients with anemia. Based on the combined results of two
randomized, controlled clinical trials, data supporting this statement were
presented by Joel D. Kallich, PhD, associate director, health economics and
epidemiology, at Amgen, Thousand Oaks, California.

Participants in the trials, conducted in the United States, Canada,
Europe, and Australia, received concomitant chemotherapy and darbepoetin
alfa (Aranesp) or placebo over a 12-week period. Patients were then asked to
complete a questionnaire including items from three survey instruments.

  • The Functional Assessment of Cancer Therapy-Anemia (FACT-An) which
    contains measures of the domains of fatigue, anemia symptoms, and physical,
    functional, emotional, and social well-being was administered in these
    studies.
  • The Brief Symptom Inventory (BSI) includes a checklist of
    psychological symptoms, although only two—anxiety and depression—were
    included in this study.
  • Numerical rating scales were used to assess energy, ability to
    perform activities, and patients’ perceptions of their overall health or
    quality of life.

Physical Scores Improve

All domains measured by the FACT-An scales rose as hemoglobin increased,
particularly the physical and functional scores, Dr. Kallich reported.
"The FACT-Fatigue scale is the domain that is hypothesized to be the
most sensitive to hemoglobin change," Dr. Kallich said. "As
hemoglobin increases, by 2 or more grams per deciliter, we observe an
improvement in the FACT-Fatigue Scale score of approximately 4 points. This
is in contrast to those patients whose hemoglobin decreases, and whose
fatigue scale score shows a decrease of about 1.5 points." (see Figure
1).

The results of the analysis are sensitive to methods of estimating
missing data (such as information on people who dropped out or died during
the trial) as well as variability in the patient population. When one sets a
threshold for measuring patient improvement, for example, a 10% or more
improvement in FACT-Fatigue Scale scores, 13% more patients receiving
darbepoetin alfa had a 10% or more improvement in their scale scores than
those patients receiving placebo, Dr. Kallich reported. "Patients in
the placebo group received transfusions at the discretion of physicians,
therefore the effect that is shown here is the benefit above those receiving
transfusions. So what you are seeing here is an independent effect," he
said.

Psychological Outcomes

Measured by the BSI scale, depressive symptoms and anxiety decreased from
baseline to the end of trial. "As hemoglobin increases, approximately
45% of patients reported a 10% or more improvement in their feelings of
depression, anxiety, and overall health. This is an increase of
approximately 15% from those patients whose hemoglobin did not
improve," Dr. Kallich said.

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