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DOI: 10.1055/s-0032-1328884
A Review of Safety, Efficacy, and Utilization of Erythropoietin, Darbepoetin, and Peginesatide for Patients with Cancer or Chronic Kidney Disease: A Report from the Southern Network on Adverse Reactions (SONAR)
Publikationsverlauf
Publikationsdatum:
30. Oktober 2012 (online)
Abstract
The erythropoiesis-stimulating agents (ESAs) erythropoietin and darbepoetin prevent transfusions among chemotherapy-associated anemia patients. Clinical trials, meta-analyses, and guidelines identify mortality, tumor progression, and venous thromboembolism (VTE) risks with ESA administration in this setting. Product labels advise against administering ESAs with potentially curative chemotherapy (United States) or to conduct risk–benefit assessments (Europe/Canada). Since 2007, fewer chemotherapy-associated anemia patients in the United States and Europe receive ESAs. ESAs and the erythropoietin receptor agonist peginesatide prevent transfusions among chronic kidney disease (CKD) patients; clinical trials, guidelines, and meta-analyses demonstrate myocardial infarction, stroke, VTE, or mortality risks with ESAs targeting high hemoglobin levels. U.S. labels recommend administering ESAs or peginesatide at doses sufficient to prevent transfusions among dialysis CKD patients. For dialysis CKD patients, Canadian and European labels recommend targeting hemoglobin levels of 10 to 12 g/dL and 11 to 12 g/dL, respectively, with ESAs. ESA utilization for dialysis CKD patients has decreased in the United States.
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References
- 1 Besarab A, Bolton WK, Browne JK , et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 1998; 339 (9) 584-590
- 2 Pfeffer M, Burdmann EA, Cooper DE , et al. A trial of darbepoetin-alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009; 361: 1-14
- 3 FDA. Briefing Document on Peginesatide for the Oncologic Drug Advisory Committee (ODAC) December 7, 2011. Available at: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/oncologicdrugsadvisorycommittee/ucm282292.pdf . Accessed April 4, 2012
- 4 Leyland-Jones B. BEST Investigators and Study Group. Breast cancer trial with erythropoietin terminated unexpectedly. Lancet Oncol 2003; 4 (8) 459-460
- 5 Henke M, Laszig R, Rübe C , et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet 2003; 362 (9392) 1255-1260
- 6 Bennett CL, Silver SM, Djulbegovic B , et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia. JAMA 2008; 299 (8) 914-924
- 7 Wilson J, Yao GL, Raftery J , et al. A systematic review and economic evaluation of epoetin alpha, epoetin beta and darbepoetin alpha in anaemia associated with cancer, especially that attributable to cancer treatment. Health Technol Assess 2007; 11 (13) 1-202 , iii–iv
- 8 Bohlius J, Schmidlin K, Brillant C , et al. Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials. Lancet 2009; 373 (9674) 1532-1542
- 9 Glaspy J, Crawford J, Vansteenkiste J , et al. Erythropoiesis-stimulating agents in oncology: a study-level meta-analysis of survival and other safety outcomes. Br J Cancer 2010; 102 (2) 301-315
- 10 Tonelli M, Hemmelgarn B, Reiman T , et al. Benefits and harms of erythropoiesis-stimulating agents for anemia related to cancer: a meta-analysis. CMAJ 2009; 180 (11) E62 –E71
- 11 Epogen package insert. Amgen, Inc. 2007. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103234s5158ppi.pdf . Accessed May 2, 2012
- 12 FDA Advisory Committee Briefing Document. Reassessment of the risks of erythropoiesis-stimulating agents (ESAs) administered for the treatment of anemia associated with chronic renal failure. Joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee. September 11, 2007. Available at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4315b1-01-FDA.pdf . Accessed May 2, 2012
- 13 Rizzo JD, Somerfield MR, Hagerty KL , et al; American Society of Clinical Oncology; American Society of Hematology. 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 2008; 26 (1) 132-149
- 14 Meeting Briefing Document ODAC. Epoetin alfa and darbepoetin. 2008. Available at: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4345b2-05-amgen.pdf . Accessed May 2, 2012
- 15 Epogen FDA. (Epoetin alfa) For injection package insert. 2008. Available at: http://www.fda.gov/cder/foi/label/2008/103234s5195sPI.pdf . Accessed May 2, 2012
- 16 Patient Medication Guide FDA. Epogen (Epoetin alfa). 2008. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5195Medguide.pdf . Accessed May 2, 2012
- 17 National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: cancer and chemotherapy–induced anemia. V.1.2009. Available at: http://www.nccn.org/professionals/physician_gls/PDF/anemia.pdf . Accessed May 2, 2012
- 18 US FDA. FDA approves a risk evaluation and mitigation strategy (REMS) to ensure the safe use of erythropoiesis-stimulating agents (ESAs). 2010. Available at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm200847.htm . Accessed May 2, 2012
- 19 Rizzo JD, Brouwers M, Hurley P , et al; American Society of Clinical Oncology; American Society of Hematology. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. J Clin Oncol 2010; 28 (33) 4996-5010
- 20 European Medicines Agency. Public Statement. Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease. October 2007. Available at: http://www.emea.europa.eu/pdfs/human/press/pus/49618807en.pdf . Accessed May 2, 2012
- 21 Aapro M, Spivak JL. Update on erythropoiesis-stimulating agents and clinical trials in oncology. Oncologist 2009; 14 (Suppl. 01) 6-15
- 22 Medicines and Healthcare products Regulatory Agency (MHRA). Conclusions from the Committee for Medicinal Products for Human Use (CHMP) – Review of safety of erythropoiesis stimulating agents (ESAs) in patients with anaemia resulting from renal insufficiency or chemotherapy in cancer patients. 2008. Available at: http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con023076.pdf . Accessed May 2, 2012
- 23 National Institute for Health and Clinical Excellence (NICE). Technology Appraisal Guidance-Epoetin Alfa, Epoetin Beta, and Darboepoetin Alfa for Cancer Treatment Induced Anaemia. London, UK: National Institute for Health and Clinical Excellence (NICE); 2008. . Available at: http://www.nice.org.uk/nicemedia/pdf/TA142Guidance.pdf . Accessed
- 24 Health Canada. Important safety information and new prescribing information for the erythropoiesis-stimulating agents, aranesp (darbepoetin alfa) and EPREX (epoetin alfa). 2007. . Available at: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-avis/public/2007/aranesp_eprex_pc-cp-eng.pdf . Accessed May 2, 2012
- 25 Tonelli M, Lloyd A, Lee H , et al. Overview of systematic review and economic evaluation of erythropoiesis stimulating agents for anemia of cancer or of chemotherapy (technology overview number 51). Ottawa: Canadian Agency for Drugs and Technologies in Health; 2009
- 26 Singh AK, Szczech L, Tang KL , et al; CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006; 355 (20) 2085-2098
- 27 Drüeke TB, Locatelli F, Clyne N , et al; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006; 355 (20) 2071-2084
- 28 Cotter DJ, Stefanik K, Zhang Y, Thamer M, Scharfstein D, Kaufman J. Hematocrit was not validated as a surrogate end point for survival among epoetin-treated hemodialysis patients. J Clin Epidemiol 2004; 57 (10) 1086-1095
- 29 KDOQI. KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 Update of Hemoglobin Target. Am J Kidney Dis 2007; 50 (3) 471-530
- 30 Phrommintikul A, Haas SJ, Elsik M, Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. Lancet 2007; 369 (9559) 381-388
- 31 Zhang Y, Thamer M, Kaufman JS, Cotter DJ, Hernán MA. High doses of epoetin do not lower mortality and cardiovascular risk among elderly hemodialysis patients with diabetes. Kidney Int 2011; 80 (6) 663-669
- 32 KDOQI. KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis 2007; 50 (3) 471-530
- 33 US FDA. Center for Drug Evaluation and Research. Cardiovascular and Renal Drugs Advisory Committee meeting. 2008. Available at: http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4390t1-part1.PDF . Accessed May 2, 2012
- 34 Epogen FDA. (Epoetin alfa) For injection package insert. November 19, 2008. Available at: http://www.fda.gov/cder/foi/label/2008/103234s5195sPI.pdf . Accessed May 2, 2012
- 35 US FDA. Center for Drug Evaluation and Research. Cardiovascular and Renal Drugs Advisory Committee meeting. 2010. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM238530.pdf . Accessed May 2, 2012
- 36 US FDA. Center for Drug Evaluation and Research. Cardiovascular and Renal Drugs Advisory Committee meeting. 2011. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM256586.pdf . Accessed May 2, 2012
- 37 Epogen package insert FDA. 2010. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103234s5199lbl.pdf . Accessed May 2, 2012
- 38 Epogen/Procrit label. June 24, 2011. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103234Orig1s5166_103234Orig1s5266lbl.pdf . Accessed May 2, 2012
- 39 EMA summary of product characteristics. Abseamed (Epoetin alfa). October 12, 2009. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/000726/WC500028289.pdf . Accessed April 4, 2012
- 40 Locatelli F, Aljama P, Canaud B , et al. Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study. Nephrol Dial Transplant 2010; 25 (9) 2846-2850
- 41 National Institute for Health and Clinical Excellence (NICE). Appraisal Consultation Document – Erythropoietin for anaemia induced by cancer treatment. 2011. http://www.nice.org.uk/guidance/index.jsp?action=article&r=true&o=34940 . Accessed May 2, 2012
- 42 Manns BJ, White CT, Madore F , et al. Introduction to the Canadian Society of Nephrology clinical practice guidelines for the management of anemia associated with chronic kidney disease. Kidney Int Suppl 2008; (110) S1-S3
- 43 Report T. Canadian Agency for Drugs and Technology in Health. Erythropoiesis-stimulating agents for anemia of chronic kidney disease: systematic review and economic evaluation. 2009. Available at: http://www.cadth.ca/media/pdf/H0468_Erythropoiesis-stimulating_agents_tr_e.pdf . Accessed May 2, 2012
- 44 Bennett CL, McKoy JM, Henke M , et al. Reassessments of ESAs for cancer treatment in the US and Europe. Oncology (Williston Park) 2010; 24 (3) 260-268
- 45 McFarlane PA, Pisoni RL, Eichleay MA, Wald R, Port FK, Mendelssohn D. International trends in erythropoietin use and hemoglobin levels in hemodialysis patients. Kidney Int 2010; 78 (2) 215-223
- 46 Regidor D, McClellan WM, Kewalramani R, Sharma A, Bradbury BD. Changes in erythropoiesis-stimulating agent (ESA) dosing and haemoglobin levels in US non-dialysis chronic kidney disease patients between 2005 and 2009. Nephrol Dial Transplant 2011; 26 (5) 1583-1591
- 47 Goldsmith DJ, Covic AC. Significant further evidence to bolster the link between epoetin and strokes in chronic kidney disease and cancer. Kidney Int 2011; 80 (3) 237-239
- 48 Palmer SC, Navaneethan SD, Craig JC , et al. Meta-analysis: erythropoiesis-stimulating agents in patients with chronic kidney disease. Ann Intern Med 2010; 153 (1) 23-33
- 49 Medical Technology and Practice Patterns Institute (MTPPI). Citizen's petition. 2009. Available at: http://www.mtppi.org/new/FDA-2009-P-0426-0001.pdf . Accessed May 2, 2012
- 50 Cancer Care Ontario. Epoetin alfa (Eprex) Janseen Ortho Formulary. Available at: http://www.cancercare.on.ca/search/default.aspx?q=formulary%20erythropoietin&type=0,6-76,6-40484|-1,1377-78 . Accessed May 2, 2012
- 51 EMA. Manufacturer's label. Annex II. 2007. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000726/WC500028282.pdf . Accessed May 2, 2012
- 52 Medical Technology and Practice Patterns Institute (MTPPI). Citizen's petition. 2009. Available at: http://www.mtppi.org/new/FDA-2009-P-0426-0001.pdf . Accessed May 2, 2012