DURHAM, North Carolina—Improving quality of life for cancer patients is the driving force behind clinical patterns of use of erythropoietin(Drug information on erythropoietin) (EPO) therapy, at least in this country, according to Jeffrey Crawford, MD. Although the Food and Drug Administration approved epoetin alfa(Drug information on 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?
