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The Effect of the APPRISE Mandate on Use of Erythropoiesis-Stimulating Agents and Transfusion Rates in Patients With Ovarian Cancer Receiving Chemotherapy

Boone, Jonathan D.; Fauci, Janelle M.; Walters, Christy L.; Whitworth, Jenny M.; Bevis, Kerri S.; Alvarez, Ronald D.

Obstetrical & Gynecological Survey: April 2013 - Volume 68 - Issue 4 - p 291–292
doi: 10.1097/01.ogx.0000429301.39964.9a
Gynecology: Gynecologic Oncology

Dyspnea and fatigue are common in patients with chemotherapy-induced anemia (CIA) and have an adverse effect on quality of life. Erythropoiesis-stimulating agents (ESAs) initially showed great promise as a safe alternative to transfusion in early studies. However, a number of studies raised concerns that use of ESA in a variety of tumors may be associated with disease progression, thromboembolic events, and decreased overall survival. In 2011, the Food and Drug Administration issued the new APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) guidelines, which advised patients of the risks associated with ESA use.

The aim of this study was to quantify the change in ESA use and red blood cell transfusion rates associated with the implementation of the APPRISE mandate at a single institution. A retrospective chart review identified 172 eligible patients with epithelial ovarian cancer who underwent chemotherapy before and after the APPRISE mandate. Transfusion rates were compared in the pre-APPRISE group (n = 88) and a post-APPRISE group (n = 84). Abstracted data included patient demographics, stage of disease and patient status, chemotherapy regimens, and number of patients receiving transfusion or ESA. A cost analysis was performed to calculate the total savings in the absence of ESA use.

Patients in the pre-APPRISE patients underwent 613 cycles of chemotherapy, whereas those in the post-APPRISE group had 367 cycles of chemotherapy. The data showed no statistically significant differences between groups. Most patients in both groups had advanced-stage disease and received taxane/platinum as primary chemotherapy. Of the 88 patients in the pre-APPRISE group, 45 (51%) received a total of 196 ESA; none of the patients in the post-APPRISE group received ESA. There was no significant difference in the number of red blood cell transfusions (pre-APPRISE group: 8.3% vs post-APPRISE group: 14.8%; P = 0.28). Omission of ESAs in the post-APPRISE group resulted in an estimated cost savings of $680,904.

Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL

© 2013 by Lippincott Williams & Wilkins.