title: The effect of the APPRISE mandate on use of erythropoiesis-stimulating agents and transfusion rates in patients with ovarian cancer receiving chemotherapy.
abstract: OBJECTIVE
  Erythropoiesis-stimulating agents (ESAs) support chemotherapy-induced anemia in patients with epithelial ovarian cancer (EOC). In response to research demonstrating that ESAs increase tumor growth and shorten survival, the Food and Drug Administration mandated the new APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) guidelines for consenting patients before ESAs administration. We sought to quantify the change in ESA and red blood cell (RBC) transfusion use after the APPRISE mandate was instituted.
  
  
  METHODS
  After institutional review board approval, a retrospective chart review compared patients with EOC undergoing chemotherapy before and after the APPRISE mandate. Abstracted data included patient demographics, chemotherapy treatment status and regimen, and number of patients requiring ESAs or RBCs. A cost savings analysis was also performed.
  
  
  RESULTS
  Eighty-four patients who underwent 367 cycles of chemotherapy after the APPRISE guidelines were compared with a matched set of 88 patients receiving 613 cycles of chemotherapy before the APPRISE guidelines. There were no statistically significant differences between the groups. Most patients had advanced stage disease and received primary taxane-/platinum-based chemotherapy. Of 88 patients, 45 (51%) in the pre-APPRISE group received a total of 196 ESA injections compared with 0 patients in the post-APPRISE group. Red blood cell transfusion in the post-APPRISE group was similar to that in the pre-APPRISE group (8.3% vs 14.8%, P = 0.28). Omission of ESAs in the post-APPRISE group resulted in a roughly $700,000 savings in billable charges.
  
  
  CONCLUSIONS
  In our institution, the APPRISE guidelines have resulted in complete cessation of the use of ESAs in patients with primary or recurrent EOC, resulting in considerable cost savings. Importantly, RBC transfusion rates did not significantly increase after the guidelines were imposed.
authors.affiliation: Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL 35233, USA. utjboone@gmail.com
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Boone
authors.forename: Janelle M
authors.initials: JM
authors.lastname: Fauci
authors.forename: Christy L
authors.initials: CL
authors.lastname: Walters
authors.forename: Jenny M
authors.initials: JM
authors.lastname: Whitworth
authors.forename: Kerri S
authors.initials: KS
authors.lastname: Bevis
authors.forename: Ronald D
authors.initials: RD
authors.lastname: Alvarez
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001803:Blood Transfusion / Q000331:legislation & jurisprudence / Q000379:methods / Q000706:statistics & numerical data*; D000077216:Carcinoma, Ovarian Epithelial; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D037141:Mandatory Programs / Q000331:legislation & jurisprudence; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000453:epidemiology / Q000628:therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000628:therapy; D061214:Patient Safety / Q000331:legislation & jurisprudence*; D012189:Retrospective Studies; D065227:Transfusion Reaction; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D000970:Antineoplastic Agents; D006397:Hematinics