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Improving Quality of Life, Not Transfusion Avoidance, Drives Clinical Use of Erythropoietin

Improving Quality of Life, Not Transfusion Avoidance, Drives Clinical Use of Erythropoietin

DURHAM, North Carolina—Improving quality of life for cancer patients is
the driving force behind clinical patterns of use of erythropoietin (EPO)
therapy, at least in this country, according to Jeffrey Crawford, MD.
Although the Food and Drug Administration approved epoetin alfa (Epogen,
Procrit) based on evidence that it reduced the need for transfusions in
cancer patients with chemotherapy-related anemia, most current clinical use
of epoetin alfa is not to decrease transfusion needs. "I think we’re
convinced now that there is a quality-of-life benefit," Dr. Crawford
said (Figure 1), and epoetin alfa is now primarily directed at helping
cancer patients realize that benefit.

Dr. Crawford is professor of medicine in the divisions of oncology and
hematology at Duke University in Durham, North Carolina, and director of
clinical research at the Comprehensive Cancer Center at Duke University
Medical Center.

Community-Based Trials

Three community-based studies—the Glaspy, Demetri, and Gabrilove trials—have
consistently demonstrated the relationship between improving hemoglobin
levels and overall quality of life in cancer patients receiving
chemotherapy. Although the trials were not randomized and had no control
arms, the large number of patients—more than 7,000 total—make the
database very robust, Dr. Crawford said. Together these studies represent
one of the largest prospective, open-label, nonrandomized databases of any
therapeutic agent in cancer research.

The studies all used linear analogue self-assessment (LASA) scores to
measure quality of life (Table 1) and the Demetri and Gabrilove trials also
included the Functional Assessment of Cancer Therapy-Anemia (FACT-An).

Across the trials, hemoglobin improved by 1.8 to 2.0 g/dL. The
improvement in levels was not only associated with a significant reduction
in the need for transfusions. The trials also "demonstrated the
profound relationship between hemoglobin level and quality of life,"
Dr. Crawford stated. Quality of life measurements improved in a stepwise
fashion and in direct relation to increases in hemoglobin levels, and were
particularly significant among patients who achieved an improvement of 2 g/dL
in hemoglobin levels.

Target Hemoglobin Level?

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