The effect of the APPRISE mandate on use of erythropoiesis-stimulating agents and transfusion rates in ovarian cancer patients.

Abstract

5060 Background: Erythropoiesis-stimulating agents (ESAs) have long been used to support chemotherapy-induced anemia in patients with epithelial ovarian cancer (EOC). Recent studies have demonstrated that ESAs may lead to increased tumor growth and shorter survival. The FDA mandated new guidelines (APPRISE, for Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) for consenting patients before ESA administration. We sought to quantify the change in ESA use and RBC transfusion rates after the APPRISE mandate was instituted. Methods: A retrospective chart review identified patients with EOC undergoing chemotherapy after initiating the APPRISE mandate. A similar subset of patients treated prior to the APPRISE guidelines served as a control cohort. Abstracted data included patient demographics, primary or second line treatment status, chemotherapy regimen, number of patients requiring ESA or RBCs, or both, and a cost savings analysis. Results: 84 patients with EOC were identified as having undergone 367 cycles of first or second line chemotherapy after the APPRISE guidelines were instituted. A matched set of 88 patients receiving 613 cycles of chemotherapy within a year prior to institution of the APPRISE guidelines was analyzed for comparison. The two groups were statistically similar. Most patients in each group were initially diagnosed with advanced stage disease, were receiving primary chemotherapy, and were receiving taxane/platinum-based chemotherapy. 45 of 88 patients (51%) in the pre-APPRISE group received a total of 196 ESA injections compared to 0 of 84 patients (0%) in the post-APPRISE group. In spite of discontinuing the use of ESAs and no change in transfusion thresholds, RBC transfusion in the post-APPRISE group was similar to that in the pre-APPRRISE group (8.3% vs. 14.8%, p=.28). Omission of ESAs in the post-APPRISE group resulted in a cost-savings of an estimated $700,000 in billable charges. Conclusions: In our institution, the APPRISE guidelines resulted in complete cessation of ESA use in patients with EOC, resulting in considerable cost savings. Importantly, RBC transfusion rates did not increase after the guidelines were imposed.