Impact of erythropoiesis-stimulating agents on red blood cell transfusion in Korea
- 185 Downloads
Background Erythropoiesis-stimulating agents (ESAs) have been shown to reduce the need for red blood cell (RBC) transfusions and to improve quality of life for cancer patients with anaemia. However, increased risks of mortality and disease progression have been reported when using ESAs with excessive target haemoglobin levels. In 2007, the United States Food and Drug Administration and Korea Food and Drug Administration issued regulatory alerts for using ESAs in cancer patients. Objective This retrospective study was performed to evaluate changes in ESA prescribing patterns between 2006 and 2010 and the impact on RBC transfusions in patients with solid tumours. Setting The Seoul National University Hospital (SNUH) in Korea. Methods This study includes adult patients with solid tumours who were diagnosed and treated in the SNUH from January 2006 to December 2010. The exclusion criterion was concomitant chronic renal failure. The patients’ Hb levels and prescription data for ESAs and RBC transfusions were statistically analysed. The number of inpatient and outpatient solid-tumour patients was also analysed as a baseline. Main outcome measure Prescription data on ESAs and RBC transfusion. Results After adjusting for the number of patient visits, the monthly mean ESA doses dispensed decreased by an average of 1,192 mcg per quarter over the last 5 years, and the number of RBC transfusions ordered increased by 3.77 instances per quarter. After correcting for the number of patients, the mean doses of ESA dispensed each month decreased by 3,190 mcg per quarter, and the number of RBC transfusions ordered increased by 9.51 instances per quarter. Conclusion During the last 5 years, the number of ESA doses dispensed at SNUH decreased and the number of RBC transfusions at SNUH increased, independent of the number of patients. The reduction in ESA use was thought to be due to the release of the safety alert letter in 2007. However, this study did not analyse other risk factors that may have influenced the number of RBC transfusions (e.g. metastatic cancer, comorbidities, surgery). Still, the results of this study suggest that the decreased ESA doses were relevant to the increased RBC transfusions.
KeywordsErythropoiesis-stimulating agents Prescribing patterns Red blood cell transfusions Solid tumour South Korea
Conflicts of interest
- 3.Littlewood TJ, Bajetta E, Nortier JW, Vercammen E, Rapoport B. Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: results of a randomized, double-blind, placebo-controlled trial. J Clin Oncol. 2001;19:2865–74.PubMedGoogle Scholar
- 5.FDA. Postmarket drug safety information for patients and providers: information on erythropoiesis-stimulating agents (ESA) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp); 16 Feb 2010. http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm109375.htm. Accessed 9 Feb 2012.
- 7.Leyland-Jones B, Semiglazov V, Pawlicki M, Pienkowski T, Tjulandin S, Manikhas G, et al. Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. J Clin Oncol. 2005;23:5960–72.PubMedCrossRefGoogle Scholar
- 9.Jenkins JK. FDA news and events: erythropoiesis-stimulating agents (ESA); 26 June 2007. Available at http://www.fda.gov/NewsEvents/Testimony/ucm110908.htm. Accessed 9 Feb 2012.
- 10.Korea Food and Drug Administration. ESA medicine safety letter distribution; 16 May 2007. Available at http://www.kfda.go.kr/index.kfda?mid=394&pageNo=11&seq=4178&cmd=v. Accessed 9 Feb 2012.
- 11.Korea National Statistics Office. Korea Standard Classification of Disease; 1 Jan 2011. Available at http://kostat.go.kr/kssc/stclass/StClassAction.do?method=searchDisName&classKind=5&catgrp=kssc&catid1=kssc03&catid2=kssc03b. Accessed 9 Feb 2012.
- 12.US Food and Drug Administration product label. Aranesp® (Darbepoetin alfa) For Injection; 16 Feb 2010.Google Scholar
- 14.Central Cancer Registration Office. 2008 National Cancer Statistics; 28 Dec 2010. Available at http://naver.nanet.go.kr/SearchDetailView.do?cn=MONO1201129381&sysid=nhn. Accessed 9 Feb 2012.
- 17.Rizzo JD, Somerfield MR, Hagerty KL, Seidenfeld J, Bohlius J, Bennett CL, Cella DF, et al. Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update. J Clin Oncol. 2007;26:132–49.PubMedCrossRefGoogle Scholar
- 18.Ludwig H, Crawford J, Osterborg A, Vansteenkiste J, Henry DH, Fleishman A, et al. Pooled analysis of individual patient-level data from all randomized, double-blind, placebo-controlled trials of darbepoetin alfa in the treatment of patients with chemotherapy-induced anemia. J Clin Oncol. 2009;27:2838–47.PubMedCrossRefGoogle Scholar
- 21.Ferrajoli A, Buzdar AU, Dejesus Y, Cheng L, Michaud LB, Rodriguez MA. Usage of erythropoiesis-stimulating agents in cancer patients at an academic cancer center and experience with specific care management tools for anemia. Cancer. 2011 [Epub 2011 Jan 24].Google Scholar