Darbepoetin alfa in anemia of myelodysplastic syndromes: Present and beyond

Expert Opinion on Biological Therapy

Volumn 10, Issue 4, 2010, Pages 605-614

  Kelaidi, C ^a,b   Fenaux, P ^a  

^a UNIVERSITÉ PARIS 13   (France)

^b G PAPANICOLAOU HOSPITAL   (Greece)

Author keywords

Anemia; Darbepoetin alfa; Erythropoiesis stimulating agent; Myelodysplastic syndromes

Indexed keywords

DEFERASIROX; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN;

ANEMIA; CANCER PATIENT; CHRONIC KIDNEY DISEASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERANCE; HUMAN; IRON OVERLOAD; LONG TERM CARE; MYELODYSPLASTIC SYNDROME; NONHUMAN; OUTCOME ASSESSMENT; OXYGEN CONSUMPTION; PRACTICE GUIDELINE; PURE RED CELL ANEMIA; QUALITY OF LIFE; REVIEW; TREATMENT DURATION; TREATMENT RESPONSE; WORLD HEALTH ORGANIZATION;

ANEMIA; CLINICAL TRIALS AS TOPIC; ERYTHROPOIETIN; HEMATINICS; HUMANS; MYELODYSPLASTIC SYNDROMES;

EID: 77949451888     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712591003709713     Document Type: Review

References (50)

1. Bennett JM, Catovsky D, Daniel MT, et al. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol 1982;51:189-199
2. Aul C, Gattermann N, Schneider W. Age-related incidence and other epidemiological aspects of myelodysplastic syndromes. Br J Haematol 1992;82:358-367
3. Germing U, Gattermann N, Strupp C, et al. Validation of the WHO proposals for a new classification of primary myelodysplastic syndromes: a retrospective analysis of 1600 patients. Leuk Res 2000;24:983-992
4. Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: incidence and survival in the United States. Cancer 2007;109:1536-1542
5. Rollison DE, Howlader N, Smith MT, et al. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood 2008;112:45-52
6. Harris NL, Jaffe ES, Diebold J, et al. The World Health Organization classification of hematological malignancies report of the Clinical Advisory Committee Meeting, Airlie House, Virginia, November 1997. Mod Pathol 2000;13:193-207
7. Greenberg P, Cox C, LeBeau MM, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1997;89:2079-2088
8. Crawford J, Cella D, Cleeland CS, et al. Relationship between changes in hemoglobin level and quality of life during chemotherapy in anemic cancer patients receiving epoetin alfa therapy. Cancer 2002;95:888-895
9. Littlewood TJ, Cella D, Nortier JW, Epoetin Alfa Study Group. Erythropoietin improves quality of life. Lancet Oncol 2002;3:459-460
10. Greenberg PL. Myelodysplastic syndromes: iron overload consequences and current chelating therapies. J Natl Compr Canc Netw 2006;4:91-96
11. Kelaidi C, Stamatoullas A, Beyne-Rauzy O, et al. Myelodysplastic syndrome (MDS) in France: results of a one-week cross-sectional survey on daily practice management in 919 patients by the GFM. ASH Annual Meeting Abstracts. Blood 2008;112:2672
12. Italian Coopoerative Study Group for rHuEpo in Myelodysplastic Syndromes. A randomized double-blind placebo-controlled study with subcutaneous recombinant human erythropoietin in patients with low-risk myelodysplastic syndromes. Br J Haematol 1998;103:1070-1074
13. Thompson JA, Gilliland DG, Prchal JT, et al. Effect of recombinant human erythropoietin combined with granulocyte/ macrophage colony-stimulating factor in the treatment of patients with myelodysplastic syndrome. GM/EPO MDS Study Group. Blood 2000;95:1175-1179
14. Casadevall N, Durieux P, Dubois S, et al. Health, economic, and quality-of-life effects of erythropoietin and granulocyte colony-stimulating factor for the treatment of myelodysplastic syndromes: a randomized, controlled trial. Blood 2004;104:321-327
15. Cheson BD, Greenberg PL, Bennett JM, et al. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood 2006;108:419-425
16. Park S, Grabar S, Kelaidi C, et al. Predictive factors of response and survival in myelodysplastic syndrome treated with erythropoietin and G-CSF: the GFM experience. Blood 2008;111:574-582
17. Jädersten M, Malcovati L, Dybedal I, et al. Erythropoietin and granulocyte-colony stimulating factor treatment associated with improved survival in myelodysplastic syndrome. J Clin Oncol 2008;26:3607-3613
18. Greenberg PL, Sun Z, Miller KB, et al. Treatment of myelodysplastic syndromes patients with erythropoietin with or without granulocyte colony-stimulating factor: results of a prospective randomized Phase 3 trial by the Eastern Cooperative Oncology Group (E1996). Blood 2009;114(12):2393-2400
19. Hellstrom-Lindberg E, Negrin R, Stein R, et al. Erythroid response to treatment with G-CSF plus erythropoietin for the anaemia of patients with myelodysplastic syndromes: proposal for a predictive model. Br J Haematol 1997;99:344-351
20. 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;11:1-202, iii-iv
21. Lanthier M, Behrman R, Nardinelli C. Economic issues with follow-on protein products. Nat Rev Drug Discov 2008;7:733-737
22. Macdougall IC, Rossert J, Casadevall N, et al. A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med 2009;361:1848-1855
23. Egrie JC, Dwyer E, Browne JK, et al. Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin. Exp Hematol 2003;31:290-299
24. Elliott S, Lorenzini T, Asher S, et al. Enhancement of therapeutic protein in vivo activities through glycoengineering. Nat Biotechnol 2003;21:414-421
25. Macdougall IC, Gray SJ, Elston O, et al. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol 1999;10:2392-2395
26. Agoram B, Aoki K, Sameer Doshi, et al. Investigation of the effects of altered receptor binding activity on the clearance of erythropoiesis-stimulating proteins: Nonerythropoietin receptor-mediated pathways may play a major role. J Pharm Sci 2009;98:2198-2211
27. Macdougall IC, Padhi D, Jang G. Pharmacology of darbepoetin alfa. Nephrol Dial Transplant 2007;22(Suppl 4):iv2-iv9
28. Heatherington AC, Dittrich C, Sullivan JT, et al. Pharmacokinetics of darbepoetin alfa after intravenous or subcutaneous administration in patients with non-myeloid malignancies undergoing chemotherapy. Clin Pharmacokinet 2006;45:199-211
29. Hesketh PJ, Arena F, Patel D, et al. A randomized controlled trial of darbepoetin alfa administered as a fixed or weight-based dose using a front-loading schedule in patients with anemia who have nonmyeloid malignancies. Cancer 2004;100:859-868
30. Hedenus M, Hansen S, Taylor K, et al. Randomized, dose-finding study of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. Br J Haematol 2002;119:79-86
31. Musto P, Lanza F, Balleari E, et al. Darbepoetin alpha for the treatment of anaemia in low-intermediate risk myelodysplastic syndromes. Br J Haematol 2005;128:204-209
32. Stasi R, Abruzzese E, Lanzetta G, et al. Darbepoetin alfa for the treatment of anemic patients with low- and intermediate-1-risk myelodysplastic syndromes. Ann Oncol 2005;16:1921-1927
33. Mannone L, Gardin C, Quarre MC, et al. High-dose darbepoetin alpha in the treatment of anaemia of lower risk myelodysplastic syndrome results of a phase II study. Br J Haematol 2006;133:513-519
34. Giraldo P, Nomdedeu B, Loscertales J, et al.; Aranesp in Myelodysplastic Syndromes (ARM) Study Group. Darbepoetin alpha for the treatment of anemia in patients with myelodysplastic syndromes. Cancer 2006;107:2807-2816
35. Gabrilove J, Paquette R, Lyons RM, et al. Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anaemia in patients with myelodysplastic syndromes. Br J Haematol 2008;142:379-393
36. Gotlib J, Lavori P, Quesada S, et al. A Phase II intra-patient dose-escalation trial of weight-based darbepoetin alfa with or without granulocyte-colony stimulating factor in myelodysplastic syndromes. Am J Hematol 2009;84:15-20
37. Seidenfeld J, Piper M, Flamm C, et al. Epoetin treatment of anemia associated with cancer therapy: a systematic review and meta-analysis of controlled clinical trials. J Natl Cancer Inst 2001;93:1204-1214
38. Ross SD, Allen IE, Probst CA, et al. Efficacy and safety of erythropoiesis-stimulating proteins in myelodysplastic syndrome: a systematic review and meta-analysis. Oncologist 2007;12:1264-1273
39. Rizzo JD, Somerfield MR, Hagerty KL, 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 2008;26:132-149
40. Scrijvers D, Roila F, ESMO Guidelines Working Group. Erythropoiesis- stimulating agents in cancer patients: ESMO recommendations for use. Ann Oncol 2009;20:159-161
41. Myelodysplastic syndromes. NCCN Clinical Practice Guidelines in Oncology. Fort Washington, PA; National Comprehensive Cancer Network 2009. Available from: http://www.nccn. org/professionals/physician-gls/PDF/mds. pdf [Last accessed 18 February 2010]
42. 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;299:914-924
43. Casadevall N, Dupuy E, Molho-Sabatier P, et al. Autoantibodies against erythropoietin in a patient with pure red-cell aplasia. N Engl J Med 1996;334:630-633
44. Bennett CL, Luminari S, Nissenson AR, et al. Pure red-cell aplasia and epoetin therapy. N Engl J Med 2004;351:1403-1408
45. Roger SD, Suranyi MG, Walker RG, et al. A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease. Curr Med Res Opin 2008;24:2181-2187
46. 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;373:1532-1542
47. Ludwig H, Crawford J, Osterborg 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;27:2838-2847
48. Bastit L, Vandebroek A, Altintas S, et al. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. J Clin Oncol 2008;26:1611-1618
49. Pedrazzoli P, Farris A, Del Prete S, et al. Randomized trial of intravenous iron supplementation in patients with chemotherapy-related anemia without iron deficiency treated with darbepoetin alpha. J Clin Oncol 2008;26:1619-1625
50. Musto P, Modoni S, Alicino G, et al. Modifications of erythropoiesis in myelodysplastic syndromes treated with recombinant erythropoietin as evaluated by soluble transferrin receptor, high fluorescence reticulocytes and hypochromic erythrocytes. Haematologica 1994;79:493-499