Reassessments of ESAs for cancer treatment in the US and Europe

ONCOLOGY

Volumn 24, Issue 3, 2010, Pages

  Bennett, Charles L ^a   McKoy, June M ^b   Henke, Michael ^c   Silver, Samuel M ^d   MacDougall, Iain C ^e   Birgegard, Gunnar ^f   Luminari, Stefano ^g   Casadevall, Nicole ^h   Schellekens, Huub ⁱ   Sartor, Oliver ^j   Lai, Stephen Y ^k   Armitage, James O ^l  

^a JESSE BROWN VA MEDICAL CENTER   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c UNIVERSITY OF FREIBURG   (Germany)

^d UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^e KING'S COLLEGE LONDON   (United Kingdom)

^f UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^g UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^h HÔTEL DIEU   (France)

ⁱ UTRECHT UNIVERSITY   (Netherlands)

^j TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k UNIVERSITY OF TEXAS   (United States)

^l UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANEMIC AGENT; HEMOGLOBIN;

ANEMIA; ARTICLE; CANADA; CANCER PATIENT; CANCER THERAPY; CHRONIC KIDNEY DISEASE; EUROPE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE UTILIZATION; HUMAN; MORTALITY; PRACTICE GUIDELINE; REIMBURSEMENT; RISK ASSESSMENT; UNITED STATES;

EID: 77950788570     PISSN: 08909091     EISSN: 08909091     Source Type: Journal    
DOI: None     Document Type: Article

References (38)

1. Ludwig H, Sundal E, Pecherstorfer M, et al.: Recombinant human erythropoietin for the correction of cancer associated anemia with and without concomitant cytotoxic chemotherapy. Cancer 76:2319-2329, 1995.
2. Ludwig H, Fritz E: Anemia of cancer patients: Patient selection and patient stratification for epoetin treatment. Semin Oncol 25(suppl 7):35-38, 1998.
3. Nissenson AR: Epoetin and cognitive function. Am J Kidney Dis 20:21-24, 1992.
4. Nowrousian MR: Pathophysiology of cancer-related anemia, in Nowrousian MR (ed): Recombinant Human Erythropoietin (rhEPO) in Clinical Oncology, pp 39-62. WienNew York, Springer, 2002.
5. Hockel M, Knoop C, Schlenger K, et al.: Intratumoral pO2 predicts survival in advanced cancer of the uterine cervix. Radiother Oncol 26:45-50, 1993.
6. Knocke TH, Weitmann HD, Feldmann HJ, et al.: Intratumoral pO2-measurements as predictive assay in the treatment of carcinoma of the uterine cervix. Radiother Oncol 53(2):99-104, 1999.
7. Koury ST, Bondurant MC, Koury MJ: Localization of erythropoietin synthesizing cells in murine kidneys by in situ hybridization. Blood 71:524-527, 1988.
8. Spivak JL: Cancer-related anemia: Its causes and characteristics. Semin Oncol 21(suppl 3):3-8, 1994.
9. Koury MJ, Bondurant MC: Control of red cell production: The roles of programmed cell death (apoptosis) and erythropoietin. Transfusion 30:673-674, 1990.
10. Abels R: Erythropoietin for anemia in cancer patients. Eur J Cancer 29A(suppl 2):2-8, 1993.
11. Littlewood TJ, Bajetta E, Nortier JW, et al.: 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 19:2865-2874, 2001.
12. Bohlius J, Wilson J, Seidenfeld J, et al.: Recombinant human erythropoietins and cancer patients: Updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 98:708-714, 2006.
13. Leyland-Jones B: Breast cancer trial with erythropoietin terminated unexpectedly. Lancet Oncol 4:459-460, 2003. (Pubitemid 37009952)
14. Henke M, Laszig R, Rube C, et al.: Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: Randomised, double-blind, placebo-controlled trial. Lancet 362:1255-1260, 2003.
15. Arcasoy MO, Jiang X, Haroon ZA: Expression of erythropoietin receptor splice variants in human cancer. Biochem Biophys Res Commun 307:999-1007, 2003.
16. Henke M, Mattern D, Pepe M, et al.: Do erythropoietin receptors on cancer cells explain unexpected clinical findings? J Clin Oncol 24:4708-4713, 2006 (see erratum in J Clin Oncol 25:1457, 2007).
17. Um M, Gross AW, Lodish HF: A "classical" homodimeric erythropoietin receptor is essential for the antiapoptotic effects of erythropoietin on differentiated neuroblastoma SH-SY5Y and pheochromocytoma PC-12 cells. Cell Signal 19:634-645, 2007.
18. Hardee ME, Cao Y, Fu P, et al.: Erythropoietin blockade inhibits the induction of tumor angiogenesis and progression. PLoS One 2:e549, 2007.
19. Levine MN, Lee AY, Kakkar AK: From Trousseau to targeted therapy: New insights and innovations in thrombosis and cancer. J Thromb Haemost 1:1456-1463, 2003.
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 February 11, 2010.
21. Smith RE Jr, Aapro MS, Ludwig H, et al.: Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: Results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol 26:1040-1050, 2008.
22. 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 299:914-924, 2008.
23. 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 373:1532-1542, 2009 (see erratum in Lancet 374: 28, 2009).
24. US Food and Drug Administration: Erythropoeisis-stimulating agents (ESAs) [Changes to Procrit prescribing information], March 9, 2007. Available at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm129253.htm. Accessed February 16, 2010.
25. US Food and Drug Administration Center for Drug Evaluation and Research: 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. Presented at the 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 February 11, 2010.
26. Epogen [package insert]. Amgen, Inc. Thousand Oaks, CA, November 2007. Approved by the US Food and Drug Administration November 8, 2007. Available at http://www.accessdata.fda.gov/drugsatfda-docs/label/2007/103234s5158lbl.pdf. Accessed February 12, 2010.
27. Epogen [package insert labeling changes]. Amgen, Inc. Thousand Oaks, CA, August 2008. Approved by the US Food and Drug Administration November 19, 2008. Available at http://www.accessdata.fda.gov/drugsatfda-docs/label/2008/ 103234s5195sPI.pdf. Accessed February 12, 2010.
28. Amgen: Patient Medication Guide: Epogen (epoetin alfa). August 2008. Approved by the US Food and Drug Administration November 19, 2008. Available at http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088591.pdf. Accessed February 12, 2010.
29. European Medicines Agency: Assessment Report for Abseamed. London, October 23, 2008. Doc. ref. no. EMEA/672835/2008. Available at http://www.ema.europa.eu/humandocs/PDFs/EPAR/abseamed/Abseamed-H-727-II-06-AR. pdf. Accessed February 12, 2010.
30. National Comprehensive Cancer Network: NCCN clinical practice guidelines in oncology: Cancer and Chemotherapyinduced Anemia. V.1.2009. Available at http://www.nccn.org/professionals/physician-gls/PDF/anemia.pdf. Accessed February 11, 2010.
31. Bokemeyer C, Aapro MS, Courdi A, et al.: EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer 43:258-270, 2007.
32. Amgen 2007 Annual Report and Financial Summary. Available at http://phx.corporate-ir.net/External.File?item= UGFyZW50SUQ9MjAxMTJ8Q2hpbGRJRD0tMXxUeXBl. Accessed February 12, 2010. Amgen, Inc., Thousand Oaks, CA.
33. Naeim A, Glaspy J: Changes in RBC supportive medications and transfusions in cancer patients undergoing chemotherapy before and after FDA and Medicare actions in 2007 (abstract 20595). J Clin Oncol 26(May 20 suppl), 2008.
34. Vadhan-Raj S HV, Zhou X, Sizer K, et al.: Impact of safety concerns of erythropoiesis-stimulating agents (ESAs) and regulatory changes on the use of ESAs and red blood cell (RBC) transfusions at a comprehensive cancer center (abstract 1300). Presented at the 50th American Society of Hematology Annual Meeting and Exposition; December 6, 2008; San Francisco, CA.
35. Hess G, Nordyke RJ, Pirolli M, et al.: Effect of changes in labeling and reimbursement on use of ESAs and transfusions (abstract 20589). J Clin Oncol 26(suppl 15S), 2008.
36. Ludwig H, Aapro M, Bokemeyer C, et al.: Treatment patterns and outcomes in management of anaemia in cancer patients in Europe: Findings from the Anaemia Cancer Treatment Act (ACT) study. Eur J Cancer 45:1603-1615, 2009.
37. US Food and Drug Adminstration Amendments Act of 2007. Available at http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=110-cong-public- laws&docid=f:publ085.110 . Accessed on March 2, 2010.
38. US Food and Drug Administration: Safety Announcement: Information on Erythropoiesis-Stimulating Agents (ESA) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp). February 16, 2010. Available at http://www.fda.gov/drugs/drugsafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm1093 . Accessed on March 2, 2010.