ESA use in women with cancer: Consequences of the 2008 FDA clinical alert.
5040 Background: Erythropoietin stimulating agents (ESA) are used clinically as an alternative to blood transfusions in cancer patients suffering from symptoms of anemia. However, more recent randomized controlled trials of ESA usage concluded that its use is associated with an increased risk of tumor progression and death. As a result, in July 2008 the FDA issued a clinical alert restricting the use of ESA. A reduction in the prescribing of ESA was immediately seen but changes in blood transfusion rates have not been examined. Methods: A retrospective chart review was conducted drawing from patients under treatment in the Program in Women’s Oncology at Women and Infant’s Hospital from one year before the clinical alert (August 2007-July 2008) to one year afterward (August 2008-July 2009). The primary outcomes were blood transfusion and ESA administration rates compared across the two time periods. Results: The study population (n=776) included patients with a cancer diagnosis who received chemotherapy during one or both time periods. 165 (21.3%) patients received ESA treatment. The total number of ESA treatments administered in the study period of interest was 1,277, with the majority (60%) given prior to the FDA alert. The mean number of ESA treatments in the first time period was 6.39 per person as compared to 0.61 per person in the second time period. Of the study population, 186 (23.8%) patients received at least one blood transfusion. A total of 463 blood transfusions were administered during the entire study period but a significant difference was not observed in the proportion of those delivered prior to the FDA alert (52%) versus after the FDA alert (48%). The average number of transfusions given in the first time period was 2.34 per person, as compared to 2.17 per person in the second period. Conclusions: Our results indicate that despite a steep decline in the use of ESA for chemotherapy-induced anemia, blood transfusion rates were not significantly different between the two periods. Interestingly, a slight downward trend was observed from before the FDA alert to after the alert. While more work is needed to understand the implications of these findings, it suggests that resource utilization did not increase despite the reduction in ESA use.