Impact of Safety Concerns of Erythropoiesis-Stimulating Agents (ESAs) and Regulatory Changes on the Use of ESAs and Red Blood Cell (RBC) Transfusions at a Comprehensive Cancer Center

Abstract

Safety signals raised in the recent oncology clinical trials have led to various regulatory restrictions including FDA black-box warning, National Coverage Determination (NCD), and updated ASCO/ASH guidelines in 2007. The purpose of this study was to determine the impact of these changes on the utilization of ESAs and on transfusion (Tx) of RBCs in 2006 (prior to changes) and 2007. We identified the total number of unique patients that received any treatment including chemotherapy, radiation, transfusions, or any treatment in the out-patient and in-patient settings during this 2 year time period. All the data on the ESA doses dispensed by the hospital pharmacy and all the RBC transfusions dispensed by the Blood bank were also analyzed. The ESA units were calculated by converting 40,000 units of epoetin alfa or 100 mcg of darbepoetin alfa to one unit of ESA. When comparing 2007 to 2006, the number of patients that received ESAs decreased by 26% and the total ESA units decreased by 30%. The overall usage of ESAs decreased by 55%, from 2398 units in 1/2006 to 1080 units in 12/2007. However, the number of pts that received RBC transfusions increased only by 6% and the total number of RBC units transfused by 2% (from 38,218 units in 2006 to 38,948 units in 2007). The median Hgb on the day of transfusion was same for each year (Hgb 8.2 g/dL for both 2006 and 2007), suggesting that the lack of impact on RBC Tx may not be due to a change in Tx threshold. The total number of unique patients referred and treated at MDACC during 2007 (24,356) increased by 13% from 2006 (21,619), not accounting for a lack of impact on transfusions. We therefore examined Hgb at the initiation of ESAs in a subset of pts (n=212) that had not received ESA for at least 3 months. The median Hgb/HCT values at the initiation of ESAs were 9.5 g/dL/27.4. The most frequent utilization of ESAs and transfusions was in patients with hematological malignancies. Conclusion: These findings indicate that the recent ESA safety concerns and related regulatory changes have significantly affected the ESA utilization. The lack of significant impact of reduced ESA usage on RBC transfusions may be related to a lower Hgb threshold used at initiation of ESAs and/or the targeted patient population (less likely to respond) treated with ESAs. Further research is needed to establish the factors contributing to the lack of correlation and to optimize the use of ESAs.

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

“…Nevertheless, the reduction in ESA use at our center is in line with trends in the country. Furthermore, subsequent to the presentation of our findings [38], data reported in abstract form by another cancer center [39] support our finding that, despite a decline in ESA use, there is no significant impact on transfusions.…”