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(Drug information on 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.