Erythropoiesis-stimulating agents for anemic patients with cancer

Expert Review of Hematology

Volumn 3, Issue 6, 2010, Pages 697-704

  Sheikh, Semira ^a   Littlewood, Tim J ^a  

^a CHURCHILL HOSPITAL   (United Kingdom)

Author keywords

anemia; cancer; erythropoiesis stimulating agents; quality of life; survival

Indexed keywords

ANTIANEMIC AGENT; GRANULOCYTE COLONY STIMULATING FACTOR; HEMOGLOBIN; HEPCIDIN; IRON; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN;

ANEMIA; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER SURVIVAL; CLINICAL TRIAL; DISEASE ASSOCIATION; DRUG SAFETY; ERYTHROCYTE TRANSFUSION; FOOD AND DRUG ADMINISTRATION; HEMOGLOBIN BLOOD LEVEL; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; RISK BENEFIT ANALYSIS; SOLID TUMOR; THROMBOEMBOLISM; THROMBOSIS; TREATMENT RESPONSE; VENOUS THROMBOEMBOLISM;

ANEMIA; DISEASE PROGRESSION; ERYTHROPOIETIN, RECOMBINANT; HEMATINICS; HUMANS; IRON; NEOPLASMS; PROGNOSIS; QUALITY OF LIFE; VENOUS THROMBOEMBOLISM;

EID: 78649525838     PISSN: 17474086     EISSN: None     Source Type: Journal    
DOI: 10.1586/ehm.10.64     Document Type: Review

References (67)

1. Groopman JE. Chemotherapy-induced anemia in adults: Incidence and treatment. J. Natl Cancer Inst. 91, 1616-1634, (1999).
2. Ludwig H, Van Belle S, Barrett-Lee P et al. The European cancer anaemia survey (ECAS): A large, multinational, prospective survey defining the prevalence, incidence and treatment of anaemia in cancer patients. Eur. J. Cancer 40, 2293-2306, (2004). Reported the incidence and prevalence of anemia in a very large number of cancer patients across Europe.
3. Spivak JL, Gascon P, Ludwig H. Anemia management in oncology and hematology. Oncologist 14(Suppl. 1), 43-56 (2009).
4. Wood PA, Hrushesky WJM. Cisplatinassociated anemia: An erythropoietin deficiency syndrome. J. Clin. Invest. 95(4), 1650-1659 (1995).
5. Bohlius J, Schmidlin K, Brilliant C et al. Recombinant human erythropoiesisstimulating agents and mortality in patients with cancer: A meta-analysis of randomised trials. Lancet 373, 1532-1542 (2009). This meta-analysis is the largest and most up-to-date review of the safety and effectiveness of erythropoiesis-stimulating agents (ESAs) in patients with cancer.
6. Cella D, Kallich J, McDermott A, Xu X. The longitudinal relationship of hemoglobin, fatigue and quality of life in anemic cancer patients: Results from five randomized clinical trials. Ann. Oncol. 15(6), 979-986 (2004).
7. Lind M, Vernon C, Cruikshank D et al. The level of haemoglobin in anaemic cancer patients correlates positively with quality of life. Br. J. Cancer 86(8), 1243-1249 (2002).
8. Caro JJ, Salas M, Ward A, Goss G. Anemia as an independent prognostic factor for survival in patients with cancer. Cancer 91(12), 2214-2221 (2001).
9. Dubsky P, Sevelda P, Jakesz R et al. Anemia is a significant prognostic factor in local relapse-free survival of premenopausal primary breast cancer patients receiving adjuvant cyclophosphamide/methotrexate/ 5-fluorouracil chemotherapy. Clin. Cancer Res. 14(7), 2082-2087 (2008).
10. Vaupel P. Hypoxia and aggressive tumor phenotype: Implications for therapy and prognosis. Oncologist 12(Suppl. 3), 21-26 (2008).
11. Curt GA, Breitbart W, Cella D et al. Impact of cancer-related fatigue on the lives of patients: New findings from the Fatigue Coalition. Oncologist 5(5), 353-360 (2000).
12. Glaus A, Mueller S. Hemoglobin and fatigue in cancer patients: Inseparable twins? Schweiz. Med. Wochenschr. 130, 471-477 (2000).
13. Spano JP, Khayat D. Treatment options for anaemia, taking risks into consideration: Erythopoiesis-stimulating agents versus transfusions. Oncologist 12(Suppl. 3), 27-32 (2008).
14. Surgenor SD, Kramer RS, Olmstead EM et al. The association of per-operative red blood cell transfusions and decreased long-term survival after cardiac survival. Anesth. Anal. 108, 1741-1746 (2009).
15. Ludwig H, Fritz E, Kotzmann H, Hoecker P, Gisslinger H, Barnas U. Erythropoietin treatment of anemia associated with multiple myeloma. N. Engl. J. Med. 322(24), 1693-1699 (1990). (Pubitemid 20231526)
16. Bohlius J, Schmidlin K, Brilliant C et al. Erythropoietin or darbepoetin for patients with cancer - meta-analysis based on individual patient data. Cochrane Database Syst. Rev. 3, 1-289 (2009).
17. Macdougall IC. Novel erythropoiesisstimulating agents: A new era in anemia management. Clin. J. Am. Soc. Nephrol. 3(1), 200-207 (2008).
18. Macdougall IC, Rossert J, Casadevall N et al. A peptide-based erythropoietinreceptor agonist for pure red-cell aplasia. N. Engl. J. Med. 361(19), 1848-1855 (2009).
19. Littlewood TJ, Bajetta E, Nortier JWR 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(11), 2865-2874 (2001).
20. Wolson J, Yao GL, Raftery J et al. A systematic review and economic evaluation of epoetin alfa, epoetin beta and darbepoetin alfa in anaemia associated with cancer, especially that attributable to cancer treatment. Health Technol. Assess. 11(13) 1-202 (2007).
21. Jadersten M, Malcovati L, Dybedal I et al. Erythropoietin and granulocyte-colony stimulating factor treatment associated with improved survival in myelodysplastic syndrome. J. Clin. Oncol. 26, 3607-3613 (2008).
22. Baron F, Frere P, Beguin Y. Once weekly recombinant human erythropoietin therapy is very efficient after allogeneic peripheral blood stem cell transplantation when started soon after engraftment. Haematologica 88, 718-720 (2003). (Pubitemid 36781603)
23. Vanstraelen G, Baron F, Frere P, Hafraoui K, Fillet G, Beguin Y. Efficacy of recombinant human erythropoietin therapy started one month after autologous peripheral blood stem cell transplantation. Haematologica 90, 1269-1270 (2005).
24. Gabrilove JL, Cleeland CD, Livingston RB, Sarokhan B, Winer E, Einhorn LH. Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: Improvements in hemoglobin and quality of life are similar to three-times-weekly dosing. J. Clin. Oncol. 19(11), 2875-2882 (2001).
25. Cazzola M, Beguin Y, Kloczo J, Spicka I, Coiffier B. Once-weekly epoietin beta is highly effective in treating anaemic patients with lymphoproliferative malignancy and defective endogenous erythropoietin production. Br. J. Haematol. 122(3), 386-393 (2003).
26. Chang J, Couture F, Young S et al. Once weekly epoetin alfa maintains hemoglobin, improves quality of life and reduces transfusion in breast cancer patients receiving chemotherapy. J. Clin. Oncol. 23(12), 2597-2605 (2005).
27. Witzig TE, Silberstein PT, Loprinzi CL et al. Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy. J. Clin. Oncol. 23(12), 2606-2617 (2005).
28. Theurl I, Aigner E, Theurl M et al. Regulation of iron haemostasis in anemia of chronic disease and iron deficiency anemia: Diagnostic and therapeutic implications. Blood 113, 5277-5286 (2009).
29. Locatelli F, Gascon P. Is nephrology more at ease than oncology with erythropoiesisstimulating agents? Treatment guidelines and an update on benefits and risks. Oncologist 14(Suppl. 1), 57-62 (2009). The current situation regarding ESA use in renal medicine.
30. Auerbach M, Ballard H. Intravenous iron in oncology. J. Natl Compr. Canc. Netw. 6(6), 585-592 (2008). Overview of the role of intravenous iron in improving the response to ESAs in patients with cancer.
31. Auerbach M, Ballard H, Trout JR et al. Intravenous iron optimizes response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: A multicenter, open-label, randomized trial. J. Clin. Oncol. 22(7), 1301-1307 (2004).
32. Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist 12(2), 231-242 (2007).
33. Hedenus M, Birgegard G, Nasman P et al. Addition of intravenous iron to epoetin beta increases hemoglobin response and decreases epoetin dose requirement in anemic patients with lymphoproliferative malignancies. Leukemia 21(4), 627-632 (2007).
34. Bastit L, Vandebroek A, Altintas S et al. A randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alfa administration every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. J. Clin. Oncol. 25(10), 1611-1618 (2008).
35. 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 alfa. J. Clin. Oncol. 25(10), 1619-1625 (2008).
36. Steensma DP, Dakhil SR, Dalton R et al. A Phase III randomised study of the effects of parenteral iron, oral iron, or no iron supplementation on the erythropoietic response to darbepoetin alfa for patients with chemotherapy-associated anemia; a study of the Mayo Clinic Research Consortium (MCCRC). Presented at: 51st American Society of Haematology. New Orleans, LA, USA, 5-8 December 2009 (Abstract 630).
37. Auerbach M. Should intravenous iron be the standard of care in oncology? J. Clin. Oncol. 26(10), 1579-1581 (2008).
38. Littlewood TJ, Alikhan R. The use of intravenous iron in patients with cancer-related anaemia. Br. J. Haematol. 141(6), 751-756 (2008).
39. Bunn HF. End run around Epo. N. Engl. J. Med. 361(19), 1901-1903 (2009).
40. Littlewood TJ, Zagari M, Pallister C et al. Baseline and early treatment factors are not clinically useful for predicting individual response to erythropoietin in anemic cancer patients. Oncologist 8(1), 99-107 (2003).
41. Reinhardt U, Tulusan A, Angermund R et al. Increased hemoglobin levels and improved quality-of-life assessments during epoetin alfa treatment in anemic cancer patients: Results of a prospective, multicentre German trial. Oncologist 10(3), 225-237 (2005).
42. Rizzo JD, Seidenfeld J, Piper M, Aronson N, Lichtin A, Littlewood TJ. Erythropoietin: A paradigm for the development of practice guidelines. Hematology Am. Soc. Hematol. Educ. Program 1, 10-30 (2001).
43. Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: Results from a prospective community oncology study. Procrit Study Group. J. Clin. Oncol. 16(10), 3412-3425 (1998).
44. Glaspy J, Bukowski R, Steinberg D et al. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J. Clin. Oncol. 15(3), 1218-1234 (1997).
45. Fallowfield L, Gagnon D, Zagari M et al. Multivariate regression analyses of data from a randomized, double-blind, placebo-controlled study confirm quality of life benefit from epoetin alfa in patients receiving non-platinum chemotherapy. Br. J. Cancer 87(12), 1341-1353 (2002).
46. Vansteenkiste J, Pirker R, Massuti B et al. Double-blind, placebo-controlled, randomized Phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy. J. Natl Cancer Inst. 94, 1211-1220 (2002).
47. Glaser CM, Millesi W, Kornek GV et al. Impact of hemoglobin level and use of recombinant erythropoietin on efficacy of preoperative chemoradiation therapy for squamous cell carcinoma of the oral cavity and oropharynx. Int. J. Radiat. Oncol. Biol. Phys. 50(3), 705-715 (2001). (Pubitemid 32519598)
48. Henke M, Laszig R, Ruebe 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).
49. Leyland-Jones B, Semiglazov V, Pawlicki M 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. 23(25), 5960-5972 (2005).
50. Wright JR, Ung YC, Julian JA et al. Randomized, double-blind, placebocontrolled trial of erythropoietin in non-small-cell lung cancer with diseaserelated anemia. J. Clin. Oncol. 25(9), 1027-1032 (2007).
51. Bennett CL, Silver SM, Djulbegovic B et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoietin administration for the treatment of cancer-associated anemia. JAMA 299(8), 914-924 (2008).
52. Ross SD, Allen EA, Henry DH, Seaman C, Sercus B, Goodnough LT. Clinical benefits and risks associated with epoetin and darbepoietin in patients with chemotherapy-induced anemia: A systematic review of the literature. Clin. Ther. 28(6), 801-822 (2006).
53. Bohlius J, Wilson J, Seidenfeld J et al. Erythropoietin or darbepoetin for patients with cancer. Cochrane Database Syst. Rev. 1, 1-273 (2006).
54. Aapro M, Spivak JL. Update on erythropoiesis-stimulating agents and clinical trials in oncology. Oncologist 14(Suppl. 1), 6-15 (2009).
55. 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 anaemia. J. Clin. Oncol. 27, 1-10 (2009).
56. Fandrey J, Dicato M. Examining the involvement of erythropoiesis- stimulating agents in tumor proliferation (erythropoietin receptors, receptor binding, signal transduction), angiogenesis, and venous thromboembolic events. Oncologist 14 (Suppl. 1), 34-42 (2009).
57. Littlewood TJ. Is normalising haemoglobin in patients with CKD harmful and if so why? J. Renal Care 35, 25-28 (2009).
58. Henke M, Mattern D, Pepe M et al. Do erythropoietin receptors on cancer cells explain unexpected clinical findings? J. Clin. Oncol. 24(29), 4708-4713 (2006).
59. Arcasoy MO. Erythropoiesis-stimulating agent use in cancer: Preclinical and clinical perspectives. Clin. Cancer Res. 14(15), 4685-4690 (2008).
60. Sinclair AM, Todd MD, Forsythe K et al. Expression and function of erythropoietin receptors in tumors. Cancer 110(3), 477-488 (2007).
61. Sinclair AM, Coxon A, McCaffery I et al. Functional erythropoietin receptor is undetectable in endothelial, cardiac, neuronal and renal cells. Blood 115, 4264-4272 (2010). Casts considerable doubt on the presence of erythropoietin receptors on nonhematopoietic cells.
62. Swift S, Ellison AR, Kassner P et al. Absence of functional EpoR expression in human tumour cell lines. Blood 115, 4254-4263 (2010).
63. Khuri FR. Weighing the hazards of erythropoiesis stimulation in patients with cancer N. Engl. J. Med. 356(24), 2445-2448 (2007).
64. Steinbrook R. Erythropoietin, the FDA, and oncology. N. Engl. J. Med. 356(24), 2448-2451 (2007).
65. Erythropoietin analogues: An unnecessary class of drugs. Lancet Oncol. 9(2), 81 (2008).
66. Jelkmann W. Erythropoietin: Back to basics. Blood 115, 4151-4152 (2010) 67 Sasu BJ, Cooke KS, Arvedson TL et al. Antihepcidin antibody treatment modulates iron metabolism and is effective in a mouse model of inflammation-induced anemia. Blood 115, 3616-3624 (2010).
67. 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. 26, 132-149 (2008).