Epoetin alfa for the treatment of cancer- and chemotherapy-related anaemia: Product review and update

Expert Opinion on Pharmacotherapy

Volumn 6, Issue 2, 2005, Pages 295-310

  Henry, David H ^a  

^a PENNSYLVANIA HOSPITAL   (United States)

Author keywords

Anaemia; Cancer; Epoetin alfa; Haemoglobin; Quality of life; Recombinant human erythropoietin

Indexed keywords

ANTHRACYCLINE; ANTINEOPLASTIC AGENT; CYCLOPHOSPHAMIDE; EPIRUBICIN; ERYTHROPOIETIN RECEPTOR; HEMOGLOBIN; IRON; PACLITAXEL; PLACEBO; RECOMBINANT ERYTHROPOIETIN;

ANEMIA; AREA UNDER THE CURVE; ASTHENIA; BLOOD TRANSFUSION; BREAST CANCER; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER SURVIVAL; CELL DIFFERENTIATION; CLINICAL TRIAL; COGNITIVE DEFECT; CONSTIPATION; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DISEASE ASSOCIATION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG COST; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG STRUCTURE; DRUG UTILIZATION; DYSPNEA; EDEMA; ERYTHROID PRECURSOR CELL; ERYTHROPOIESIS; FATIGUE; FEVER; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HEALTH CARE ORGANIZATION; HEMATOLOGIC MALIGNANCY; HUMAN; LUNG NON SMALL CELL CANCER; MALIGNANT NEOPLASTIC DISEASE; MEDICAL LITERATURE; META ANALYSIS; NAUSEA AND VOMITING; NEUROPROTECTION; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PREDICTION; QUALITY OF LIFE; RETICULOCYTE; REVIEW; SYSTEMATIC REVIEW; THROMBOSIS; TREATMENT OUTCOME;

ANEMIA; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS; EPOETIN ALFA; HUMANS; NEOPLASMS; PRACTICE GUIDELINES;

EID: 14544281948     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.6.2.295     Document Type: Review

References (79)

1. GROOPMAN JE, ITRI LM: Chemotherapy-induced anemia in adults: incidence and treatment. J. Natl. Cancer Inst. (1999) 91 1616-1634.
2. HARRISON L, SHASHA D, SHIAOVA L, WHITE C, RAMDEEN B, PORTENOY R: Prevalence of anemia in cancer patients undergoing radiation therapy. Semin. Oncol. (2001) 28(2 Suppl. 8):54-59.
3. 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 (2004) 40 2293-2306.
4. LUDWIG H, STRASSER K: Symptomatology of anemia. Semin. Oncol. (2001) 28(2 Suppl. 8):7-14.
5. CARO JJ, SALAS M, WARD A, GOSS G: Anemia as an independent prognostic factor for survival inpatients with cancer: a systemic, quantitative review. Cancer (2001) 91(12):2214-2221.
6. THOMAS GM: Raising hemoglobin level: an opportunity for increasing survival? Oncology (2002) 63(Suppl. 2):19-28.
7. VAN BELLE SJ, COCQUYT V: Impact of hemoglobin levels on the outcome of cancers treated with chemotherapy. Crit. Rev. Oncol. Hematol. (2003) 47:1-11.
8. CELLA D: The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin. Hematol. (1997) 34(Suppl. 2):13-19.
9. CELLA D: Factors influencing quality of life in cancer patients: anemia and fatigue. Semin. Oncol. (1998) 25(3 Suppl. 7):43-46.
10. VOGELZANG NJ, BREITBART W, CELLA D et al., for the FATIGUE COALITION: Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. Semin. Hematol. (1997) 34(3 Suppl. 2):4-12.
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 (2000) 5:353-360.
12. CURT G, JOHNSTON PG: Cancer fatigue: the way forward. Oncologist (2003) 8(Suppl. 1):27-30.
13. SPIVAK JL: Cancer-related anemia: its causes and characteristics. Semin. Oncol. (1994) 21(2 Suppl. 3):3-8.
14. MILLER CB, JONES RJ, PIANTADOSI S, ABELOFF MD, SPIVAK JL: Decreased erythropoietin response in patients with the anemia of cancer. N. Engl. J. Med. (1990) 322:1689-1692.
15. BRON D, MEULEMAN N, MASCAUX C: Biological basis of anemia. Semin. Oncol. (2001) 28(2 Suppl. 8):1-6.
16. RIZZO JD, LICHTIN AE, WOOLF SH et al.: Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the ASCO and the ASH. J. Clin. Oncol. (2002) 20:4083-4107.
17. BOKEMEYER C, AAPRO MS, COURDI A et al.: EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer. Eur. J. Cancer (2004) 40(15):2201-2216.
18. PRESCRIRE INTERNATIONAL: Epoetin alfa and epoetin beta: treatment of anaemia due to cytotoxic chemotherapy. Prescrire International (2002) 11(58):39-43.
19. EGRIE JC, BROWNE JK: Development and characterization of novel erythropoiesis stimulating protein (NESP). Br. J. Cancer (2001) 84(Suppl. 1):3-10.
20. SYED RS, REID SW, LI C et al.: Efficiency of signalling through cytokine receptors depends critically on receptor orientation. Nature (1998) 395(6701):511-516.
21. MULCAHY L: The erythropoietin receptor. Semin. Oncol. (2001) 28(2 Suppl. 8):19-23.
22. MORREALE A, PLOWMAN B, DELATTRE M, BOGGIE D, SCHAEFER M: Clinical and economic comparison of epoetin alfa and darbepoetin alfa. Curr. Med. Res. Opin. (2004) 20(3):381-395.
23. SCHWARTZBERG L, SHIFFMAN R, TOMITA D, STOLSHEK B, ROSSI G, ADAMSON RA: multicenter retrospective cohort study of practice patterns and clinical outcomes of the use of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia. Clin. Ther. (2003) 25 11):2781-2796.
24. CHEUNG W, MINTON N, GUNAWARDENA K: Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly. Eur. J. Clin. Pharmacol. (2001) 57:411-418.
25. ZAGARI M, WACHOLTZ M, XIU L: An open-label, controlled, randomized, dose comparison study of epoetin alfa for the treatment of anemia in cancer patients receiving platinum-containing chemotherapy. Proceedings of the European Hematological Association. Lyons, France (2003):Abstract 0177.
26. RAMAKRISHNAN R, CHEUNG WK, WACHOLTZ MC, MINTON N, JUSKO WJ: Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after single and multiple doses in healthy volunteers. J. Clin. Pharmacol. (2004) 44(9):991-1002.
27. CHEUNG WK, DANNEMANN B, WACHOLTZ M, LAU H, MILLER D: Pharmacokinetics (PK) and pharmacodynamics (PD) of epoetin alfa in anemic cancer patients receiving cyclic chemotherapy. Blood (2004) 104 11):Abstract 4101.
28. GROGAN M, THOMAS GM, MELAMED I et al.: The importance of hemoglobin levels during radiotherapy for carcinoma of the cervix. Cancer (1999) 86(8):1528-1536.
29. 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(4):888-895.
30. GRALOW JR, HUDIS CA, WILLIAMS D: Incremental improvements in QOL related to changes in Hb in breast cancer (BC) patients (pts) receiving adjuvant chemotherapy (ADJCT) and QW epoetin alfa therapy. Blood (2003) 102(11):Abstract 4392.
31. SHASHA D, CREMIEUX P, HARRISON L: Relationship between hemoglobin levels and quality of life during radiation therapy plus concomitant or sequential chemotherapy in patients with cancer and anemia treated with epoetin alfa. JNCCN (2004) 2(5):509-517.
32. O'SHAUGHNESSY J, VUKELJA S, SAVIN M et al:. Impact of epoetin alfa on cognitive function, asthenia, and quality of life in women with breast cancer receiving adjuvant or neoadjuvant chemotherapy. analysis of 6-month follow-up data. Breast Cancer Res. Treat. ( 2002) 76:S138 (Abstract 550).
33. CRAWFORD J, ROBERT F, PERRY MC, BELANI C, SAROKHAN B: Prevention of anemia with once weekly epoetin alfa in patients with non-small cell lung cancer (NSCLC). Lung Cancer (2003) 41 Suppl. 2):S74 (Abstract O-254).
34. HUDIS CA, WILLIAMS D: Early treatment of mild anemia with once-weekly epoetin alfa significantly improves hemoglobin and quality of life in early-stage breast cancer patients during conventional adjuvant chemotherapy. Breast Cancer Res. Treat. (2003) 82(Suppl. 1):S154 (Abstract 639).
35. STRAUS DJ, TESTA M, RIGGS SA, TULPULE A, SAROKHAN B: Early treatment with epoetin alfa improves anemia, quality of life, and productivity in patients with hematologic malignancies and mild anemia during chemotherapy. Blood (2003) 102(11):Abstract 1811.
36. SAVONIJE J, VAN GROENINGEN C, VAN BOCHOVE A, PINEDO H, GIACCONE G: Early intervention with epoetin alfa during platinum-based chemotherapy. Proceedings of the American Society of Clinical Oncology New Orleans, Louisiana, USA (2004) 22(14S):Abstract 8111.
37. FASTENAU J, LEFEBVRE P, DUH MS, BUTEAU S, MCKENZIE RS, PIECH CT: Evaluation of the relationship between early haemoglobin rise during epoetin alfa treatment and improved patient-reported quality of life. Proceedings of the American Society of Clinical Oncology. New Orleans, Louisiana, USA (2004) 22(14S):Abstract 8124.
38. GLASPY J, BUKOWSKI R, STEINBERG D, TAYLOR C, TCHEKMEDYIAN S, VADHAN-RAJ S, for the PROCRIT STUDY GROUP: Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. J. Clin. Oncol. (1997) 15(3):1218-1234.
39. DEMETRI GD, KRIS M, WADE J, DEGOS L, CELLA D, for the PROCRIT STUDY GROUP: 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. J. Clin. Oncol. (1998) 16(10):3412-3425.
40. LITTLEWOOD TJ, BAJETTA E, NORTIER JW, VERCAMMEN E, RAPOPORT B, for the EPOETIN ALFA STUDY GROUP: 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 11):2865-2874.
41. GABRILOVE JL, CLEELAND CS, 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. (2001) 19(11):2875-2882.
42. SHASHA D, GEORGE MJ, HARRISON LB: Once-weekly dosing of epoetin alfa increases hemoglobin and improves quality of life in anemic cancer patients receiving radiation therapy either concomitantly or sequentially with chemotherapy. Cancer (2003) 98 5):1072-1079.
43. WITZIG TE, SILBERSTEIN PT, LOPRINZI CL et al.: Phase III, randomized, double-blind study of epoetin alfa versus placebo in anemic patients with cancer undergoing chemotherapy. J. Clin. Oncol. (2004) (In Press).
44. FALLOWFIELD L, GAGNON D, ZAGARI M et al.: Multivariate regression analyses of data from a randomised, double-blind, placebo-controlled study confirm quality of life benefit of epoetin alfa in patients receiving nonplatinum chemotherapy. Br. J. Cancer (2002) 87(11):1341-1353.
45. FAIRCLOUGH DL, GAGNON DD, ZAGARI MJ, MARSCHNER N, DICATO M, for the EPOETIN ALFA STUDY GROUP: Evaluation of quality of life in a clinical trial with nonrandom dropout: the effect of epoetin alfa in anemic cancer patients. Qual. Life. Res. (2003) 12 8):1013-1027.
46. JONES M, SCHENKEL B, JUST J, FALLOWFIELD L: Epoetin alfa improves quality of life in patients with cancer: results of a meta-analysis. Cancer (2004) 101(8):1720-1732.
47. ABELS R: Erythropoietin for anaemia in cancer patients. Eur. J. Cancer (1993) 29A(Suppl. 2):S2-S8.
48. BOHLIUS J, LANGENSIEPEN S, SCHWARZER G et al.: Erythropoietin for patients with malignant disease. Cochrane Database Syst. Rev. (2004) (3):CD003407.
49. 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 (2003) 362(9392):1255-1260.
50. LEYLAND-JONES B; BEST INVESTIGATORS AND STUDY GROUP: Breast cancer trial with erythropoietin terminated unexpectedly. Lancet Oncol. (2003) 4(8):459-460.
51. AUERBACH M, BALLARD H, TROUT R et al.: Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. J. Clin. Oncol. (2004) 22(7):1301-1307.
52. HENRY DH, DAHL NV, AUERBACH M, TCHEKMEDYIAN S, LAUFMAN LR: Intravenous ferric gluconate (FG) for increasing response to epoetin (EPO) in patients with anemia of cancer chemotherapy: results of a multicenter, randomized trial. Blood (2004) 104(11 :Abstract 3696.
53. GILLESPIE TW: Anemia in cancer: therapeutic implications and interventions. Cancer Nurs. (2003) 26(2):119-130.
54. CRÉMIEUX PY, BARRETT B, ANDERSON K, SLAVIN MB: Cost of outpatient blood transfusion in cancer patients. J. Clin. Oncol. (2000) 18(14):2755-2761.
55. CRÉMIEUX PY, FINKELSTEIN SN, BERNDT ER, CRAWFORD J, SLAVIN MB: Cost-effectiveness, quality-adjusted life-years and supportive care. Pharmacoeconomics (1999) 16(5 Pt 1):459-472.
56. CRÉMIEUX PY, FASTENAU JM, KOSICKI G, PIECH CT, FENDRICK AM: Cost-minimization analysis of once-weekly vs. thrice-weekly epoetin alfa for chemotherapy-related anemia. J. Manag. Care. Pharm. (2004) 10(6):531-537.
57. HENRY DH, ABELS RI: Recombinant human erythropoietin in the treatment of cancer and chemotherapy-induced anemia: results of double-blind and open-label follow-up studies. Semin. Oncol. (1994) 21(2 Suppl. 3):21-28.
58. QUIRT I, ROBESON C, LAU CY et al.: Epoetin alfa therapy increases hemoglobin levels and improves quality of life in patients with cancer-related anemia who are not receiving chemotherapy and patients with anemia who are receiving chemotherapy. J. Clin. Oncol. (2001) 19(21):4126-4134.
59. SHASHA D, HENRY DH, WILLIAMS D: Epoetin alfa 40,000 U QW increases hemoglobin and is safe in anemic patients with cancer not receiving chemotherapy or radiation therapy. Blood (2004) 104 11):Abstract 4223.
60. LUDWIG H, FRITZ E, LEITGEB C, PECHERSTORFER M, SAMONIGG H, SCHUSTER J: Prediction of response to erythrpoietin treatment in chronic anemia of cancer. Blood (1994) 84(4):1056-1063.
61. LITTLEWOOD TJ, ZAGARI M, PALLISTER C, PERKINS A: Baseline and early treatment factors are not clinically useful for predicting individual response to erythropoietin in anemic cancer patients. Oncologist (2003) 8(99):99-107.
62. CAZZOLA M, BEGUIN Y, KLOCZKO J, SPICKA I, COIFFIER B: Once-weekly epoetin beta is highly effective in treating anaemic patients with lymphoproliferative malignancy and defective endogenous erythropoietin production. Br. J. Haematol. (2003) 122 386-393.
63. HEDENUS M, ADRIANSSON M, SAN MIGUEL J et al.: Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study. Br. J. Haematol. (2003) 122 394-403.
64. BANU E, LEVEE M, SCOTTE F et al.: Corrected area under serum hemoglobin curve (Hb-AUC) as a predictor of maximal hemoglobin response after erythropoietin (rHuEPO) treatment in chemotherapy-induced anemia patients. Proceedings of the American Society of Clinical Oncology. New Orleans, Louisiana, USA (2004) 22(14S):Abstract 9586.
65. MCKENZIE RS, LEFEBVRE P, ROSBERG J, DUH MS, FASTENAU J, PIECH CT: Comparison of anemia outcomes associated with early response to epoetin alfa (EPO) with QW and TIW dosing. Proceedings of the American Society of Clinical Oncology. New Orleans, Louisiana, USA (2004) 22 14S):Abstract 6141.
66. PATTON J, KUZUR M, LIGGETT W, MIRANDA F, VARSOS H, PORTER L: Epoetin alfa 60,000 U once weekly followed by 120,000 U every 3 weeks increases and maintains hemoglobin in anemic cancer patients undergoing chemotherapy. Oncologist (2004) 9(1):90-96.
67. LANGER CJ, WILLIAMS D: Anemia correction and hemoglobin maintenance with epoetin alfa 60,000 U QW followed by 80,000 U Q3W in anemic patients with cancer receiving chemotherapy. Blood (2003) 102(11):Abstract 4374.
68. GREGORY SA, BALTZ B, WILLIAMS D: Every-two-week (Q2W) maintenance dosing with epoetin alfa in anemic patients with cancer receiving chemotherapy: 60,000 U QW to target Hb 12 g/dL, followed by 60,000 U Q2W. Blood (2004) 104(11):Abstract 4233.5.
69. MOEBUS V, KURBACHER C, NITZ U et al.: Epoetin alfa prevents anemia and transfusions in patients receiving dose-dense sequential chemotherapy (ETC). Breast Cancer Res. Treat. (2003) 82(Suppl. 1):S153 (Abstract 638).
70. BARNIAS A, ARAVANTINOS G, KALOFONOS C et al.: Prevention of anemia in patients with solid tumors receiving platinum-based chemotherapy by recombinant human erythropoietin: a prospective open-label, randomized trial by the Hellenic Cooperative Oncology Group. Oncology (2003) 64:102-110.
71. BUEMI M, CAVALLARO E, FLOCCARI F et al.: Erythropoietin and the brain: from neurodevelopment to neuroprotection. Clin. Sci. (2002) 103(3):275-282.
72. OLSEN NV: Central nervous system frontiers for the use of erythropoietin. Clin. Infect. Dis. (2003) 37(Suppl. 4):S323-S330.
73. BRINES ML, GHEZZI P, KEENAN S et al.: Erythropoietin crosses the blood-brain barrier to protect against experimental injury. P.N.A.S. (2000) 97(19):10526-10531.
74. EHRENREICH H, DEGNER D, MELLER J et al.: Erythropoietin: a candidate compound for neuroprotection in schizophrenia. Mol. Psychiatry (2004) 9(1):42-54.
75. WESTPHAL G, NIEDERBERGER E, BLUM C et al.: Erythropoietin and G-CSF receptors in human tumor cells: expression and aspects regarding functionality. Tumori (2002) 88:150-159.
76. YASUDA Y, FUJITA Y, MATSUO T et al.: Erythropoietin regulates tumor growth of human malignancies. Carcinogenesis (2003)24(6):1021-1029.
77. GLASER CM, MILLESI W, KORNEK G 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. (2001) 50(3):705-715.
78. GROTE T, CASTILLO R, FISHKIN E, DELEO M: The effect of r-HuEPO in patients with small cell lung cancer (SCLC). Lung Cancer (2003) 41(Suppl. 2):S74 (Abstract O-252).
79. HENRY DH: Anemia in patients with cancer or undergoing cancer therapy: impact and current treatment practice. T.A.T.M. (2004) (In Press).