Impact of Safety Concerns and Regulatory Changes on the Usage of Erythropoiesis-Stimulating Agents and RBC Transfusions

Purpose. Safety concerns raised in the recent oncology trials with erythropoiesis-stimulating agents (ESAs) have led to regulatory restrictions on their use. We wished to determine the impact of these changes on the use of ESAs and RBC transfusions. Methods. In a retrospective observational study of patients treated at a comprehensive cancer center in 2006-2008, data on all ESA doses dispensed, RBCs transfused, and hemoglobin levels on the days of transfusions and ESA initiations were analyzed. Results. Compared with 2006, the total patients treated was 14% higher (28,339 versus 24,806) in 2007 and 22% higher (30,254) in 2008. Patients receiving ESAs decreased by 26% and 61%, and ESA units dispensed decreased by 29% (from 30,206 units to 21,409 units) and 80% (6,102 units) in 2007 and 2008, respectively. However, RBC transfusions increased by only 2% (from 38,218 units to 38,948 units) in 2007 and by 8% (41,438) in 2008. The mean hemoglobin on the day of transfusion was the same for each year (8.4 g/dl); however, an increasing proportion of patients initiated ESAs at lower hemoglobin (<10 g/dl) levels. After adjusting for demographics and diagnostic variables for 3 years (n = 83,399), a multivariate logistic regression showed a significant decline in ESA use (p < .0001) without an increase in RBC transfusions. Conclusions. Recent ESA safety concerns and regulatory restrictions have significantly decreased ESA use. The lack of a significant impact on transfusions may be related to a lower hemoglobin threshold used to initiate ESAs or treatment of patients less likely to respond. The Oncologist 2010;15:1359-1369