The development of erythropoietic agents in oncology

Expert Opinion on Emerging Drugs

Volumn 10, Issue 3, 2005, Pages 553-567

  Glaspy, John A ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Anaemia; Chemotherapy; Darbepoetin ; Epoetin ; Epoetin ; Erythropoietin

Indexed keywords

ANTIANEMIC AGENT; ANTINEOPLASTIC AGENT; CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; CYTOKINE RECEPTOR ANTAGONIST; ERYTHROPOIETIN; FG 2216; HEMATIDE; HEPCIDIN; IRON; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ANEMIA; CANCER; CANCER CHEMOTHERAPY; CLINICAL TRIAL; COST BENEFIT ANALYSIS; DIALYSIS; DRUG EFFICACY; DRUG SAFETY; HUMAN; KIDNEY FAILURE; META ANALYSIS; ONCOLOGY; PARENTERAL NUTRITION; QUALITY OF LIFE; REVIEW; SYSTEMATIC REVIEW; THROMBOSIS; TUMOR GROWTH;

ANIMALS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS; DRUG INDUSTRY; ERYTHROPOIETIN; HUMANS; NEOPLASMS;

EID: 23844452722     PISSN: 14728214     EISSN: None     Source Type: Journal    
DOI: 10.1517/14728214.10.3.553     Document Type: Review

References (83)

1. GROOPMAN JE, ITRI LM: Chemotherapy-induced anemia in adults: incidence and treatment. J. Natl. Cancer Inst. (1999) 91(19):1616-1634.
2. 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(24):1689-1692.
3. NOWROUSIAN: Rherythropoietin. In: Cancer Supportive Treatment. SE Al (Ed.), Marcel Dekker, Inc, New York, USA (1996):13-34.
4. ABELS RI: Use of recombinant human erythropoietin in the treatment of anemia in patients who have cancer. Semin. Oncol. (1992) 19(3 Suppl. 8):29-35.
5. 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.
6. OSTERBORG A, BRANDBERG Y, MOLOSTOVA V et al.: Randomized, double-blind, placebo-controlled trial of recombinant human erythropoietin, epoetin beta, in hematologic malignancies. J. Clin. Oncol. (2002) 20(10):2486-2494.
7. STORRING PL, TIPLADY RJ, GAINES DAS RE et al.: Epoetin alfa and beta differ in their erythropoietin isoform compositions and biological properties. Br. J. Haematol. (1998) 100(1):79-89.
8. VOGELZANG NJ, BREITBART W, CELLA D et al.: Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The fatigue coalition. Semin. Hematol. (1997) 34(3 Suppl. 2):4-12.
9. 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(5):353-360.
10. CELLA D, ZAGARI MJ, VANDOROS C, GAGNON DD, HURTZ HJ, NORTIER JW: Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. J. Clin. Oncol. (2003) 21(2):366-373.
11. GLASPY J: The impact of epoetin alfa on quality of life during cancer chemotherapy: a fresh look at an old problem. Semin. Hematol. (1997) 34(3 Suppl. 2):20-26.
12. 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. (1998) 16(10):34l2-3425.
13. 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.
14. LITTLEWOOD TJ, BAJETTA E, NORTIER JW, VERCAMMEN E, RAPOPORT B: 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.
15. 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 non-platinum chemotherapy. Br. J. Cancer (2002) 87(12):1341-1353.
16. BOOGAERTS M, COIFFIER B, KAINZ C: Impact of epoetin beta on quality of life in patients with malignant disease. Br. J. Cancer (2003) 88(7):988-995.
17. ROSS SD, FAHRBACH K, FRAME D, SCHEYE R, CONNELLY JE, GLASPY J: The effect of anemia treatment on selected health-related quality-of-life domains: a systematic review. Clin. Ther. (2003) 25(6):1786-1805.
18. 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.
19. EGRIE JC, BROWNE JK: Development and characterization of novel erythropoiesis stimulating protein (Nesp). Br. J. Cancer (2001) 1:3-10.
20. GLASPY JA, JADEJA JS, JUSTICE G et al.: Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy. Br. J. Cancer (2002) 87(3):268-276.
21. KOTASEK D, STEGER G, FAUCHT W et al.: Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. Eur. J. Cancer (2003) 39(14):2026-2034.
22. 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. (2002) 94(16):1211-1220.
23. 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(3):394-403.
24. GLASPY J: Phase III clinical trials with darbepoetin: implications for clinicians. Best Pract. Res. Clin. Haematol. (2005) 18(3):407-416.
25. BAROSI G, MARCHETTI M, LIBERATO NL: Cost-effectiveness of recombinant human erythropoietin in the prevention of chemotherapy-induced anaemia. Br. J. Cancer (1998) 78(6):781-787.
26. KAVANAGH BD, FISCHER BA, SEGRETI EM et al.: Cost analysis of erythropoietin versus blood transfusions for cervical cancer patients receiving chemoradiotherapy. Int. J. Radiat. Oncol. Biol. Phys. (2001) 51(2):435-441.
27. RIZZO JD, LICHTIN AE, WOOLF SH et al.: Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and The American Society of Hematology. Blood (2002) 100(7):2303-2320.
28. 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.
29. 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(15):2293-2306.
30. SCHWARTZBERG L, SHIFFMAN R, TOMITA D, STOLSHEK B, ROSSI G, ADAMSON R: A 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.
31. HERRINGTON JD, DAVIDSON SL, TOMITA DK, GREEN L, SMITH RE, BOCCIA RV: Utilization of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia. Am. J. Health Syst. Pharm. (2005) 62(1):54-62.
32. HENRY DH: Epoetin alfa for the treatment of cancer- and chemotherapy-related anaemia: product review and update. Expert Opin. Pharmacother. (2005) 6(2):295-310.
33. 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(4):859-868.
34. SCHWARTZBERG LS, YEE LK, SENEGAL FM et al.: A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer. Oncologist (2004) 9(6):696-707.
35. VADHAN-RAJ S, MIRTSCHING B, CHARU V et al.: Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. J. Support Oncol. (2003) 1(2):131-138.
36. WALTZMAN RJ, CROOT C, WILLIAMS D: Final hematologic results: epoetin alfa (Epo) 40,000 units qw versus darbepoetin alfa (Darb) 200 mcg q2w in anemic cancer patients (Pts) receiving chemotherapy (Ct). Proceedings Of The American Society Of Clinical Oncology (2005) 23(16s):736s.
37. GLASPY J, BERG R, TOMITA D, ROSSI G, VADHAN-RAJ S: Final results of a Phase III, randomized, open-label study of darbepoetin alfa 200 meg every 2 weeks (Q2w) versus epoetin alfa 40,000 U weekly (Qw) in patients with chemotherapy-induced anemia (Cia). Proceedings Of The American Society Of Clinical Oncology (2005) 23(16s):760s.
38. 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(3):386-393.
39. GLASPY J, HENRY D, PATEL R et al.: Effects of chemotherapy on endogenous erythropoietin levels, and the pharmacokinetics and erythropoietic response of darbepoetin alfa: a randomised clinical trial of synchronous versus asynchronous dosing of darbepoetin alfa. Eur. J. Cancer (2005) (In Press).
40. CANON JL, VANSTEENKISTE J, BODOKY G et al.: Final results of a randomized, double-blind, active-controlled trial of darbepoetin alfa administered once every 3 weeks (q3w) for the treatment of anemia in patients receiving multicycle chemotherapy. Proceedings Of The American Society Of Clinical Oncology (2005) 23(16s):799s.
41. PANESAR A, AGARWAL R: Safety and efficacy of sodium ferric gluconate complex in patients with chronic kidney disease. Am. J. Kidney Dis. (2002) 40(5):924-931.
42. GLASPY J, CAVILL I: Role of iron in optimizing responses of anemic cancer patients to erythropoietin. Oncology (1999) 13(4):461-473.
43. PONCHIO L, BEGUIN Y, FARINA G et al.: Evaluation of erythroid marrow response to recombinant human erythropoietin in patients with cancer anaemia. Haematologica (1992) 77(6):494-501.
44. AUERBACH M, BALLARD H, TROUT JR 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.
45. HENRY D, DAHL N, AUERBACH D, TCHEKMEDYIAN S, LAUFMAN L: Intravenous ferric gluconate (Fg) for increasing response to epoetin (Epo) in patients with anemia of cancer chemotherapy - results of a multi-center, randomized trial. Blood (2004) 104(11):3696a.
46. CASADEVALL N, NATAF J, VIRON B et al.: Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N. Engl. J. Med. (2002) 346(7):469-475.
47. BENNETT CL, LUMINARI S, NISSENSON AR et al.: Pure red-cell aplasia and epoetin therapy. N. Engl. J. Med. (2004) 351(14):1403-1408.
48. GANZ T: Hepcidin, a key regulator of iron metabolism and mediator of anemia of inflammation. Blood (2003) 102(3):783-788.
49. NEMETH E, VALORE EV, TERRITO M, SCHILLER G, LICHTENSTEIN A, GANZ T: Hepcidin, a putative mediator of anemia of inflammation, is a Type II acute-phase protein. Blood (2003) 101(7):2461-2463.
50. ANDREWS NC: Anemia of inflammation: the cytokine-hepcidin link. J. Clin. Invest. (2004) 113(9):1251-1253.
51. NEMETH E, RIVERA S, GABAYAN V et al.: IL-6 mediates hypoferremia of inflammation by inducing the synthesis of the iron regulatory hormone hepcidin. J. Clin. Invest. (2004) 113(9):1271-1276.
52. NEMETH E, TUTTLE MS, POWELSON J et al.: Hepcidin regulates cellular iron efflux by binding to ferroportin and inducing its internalization. Science (2004) 306(5704):2090-2093.
53. RIVERA S, LIU L, NEMETH E, GABAYAN V, SORENSEN OE, GANZ T: Hepcidin excess induces the sequestration of iron and exacerbates tumor-associated anemia. Blood (2005) 105(4):1797-1802.
54. BRUGNARA C: Iron deficiency and erythropoiesis: new diagnostic approaches. Clin. Chem. (2003) 49(10):1573-1578.
55. WUN T, LAW L, HARVEY D, SIERACKI B, SCUDDER SA, RYU JK: Increased incidence of symptomatic venous thrombosis in patients with cervical carcinoma treated with concurrent chemotherapy, radiation, and erythropoietin. Cancer (2003) 98(7):1514-1520.
56. BOHLIUS J, LANGENSIEPEN S, SCHWARZER G et al.: Recombinant human erythropoietin and overall survival in cancer patients: results of a comprehensive meta-analysis. J. Natl. Cancer Inst. (2005) 97(7):490-498.
57. STOHLAWETZ PJ, DZIRLO L, HERGOVICH N et al.: Effects of erythropoietin on platelet reactivity and thrombopoiesis in humans. Blood (2000) 95(9):2983-2989.
58. VALLES J, SANTOS MT, AZNAR J et al.: Erythrocytes metabolically enhance collagen-induced platelet responsiveness via increased thromboxane production, adenosine diphosphate release, and recruitment. Blood (1991) 78(1):154-162.
59. VALLES J, SANTOS MT, AZNAR J et al.: Platelet-erythrocyte interactions enhance alpha(Iib)beta(3) integrin receptor activation and P-selectin expression during platelet recruitment: down-regulation by aspirin ex vivo. Blood (2002) 99(11):3978-3984.
60. WUN T, PAGLIERONI T, HAMMOND WP, KAUSHANSKY K, FOSTER DC: Thrombopoietin is synergistic with other hematopoietic growth factors and physiologic platelet agonists for platelet activation in vitro. Am. J. Hematol. (1997) 54(3):225-232.
61. LEYLAND-JONES B: Breast cancer trial with erythropoietin terminated unexpectedly. Lancet Oncol. (2003) 4(8):459-460.
62. 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.
63. TEICHER BA, HOLDEN SA, AL-ACHI A, HERMAN TS: Classification of antineoplastic treatments by their differential toxicity toward putative oxygenated and hypoxic tumor subpopulations in vivo in the fsaiic murine fibrosarcoma. Cancer Res. (1990) 50(11):3339-3344.
64. KELLEHER DK, MATTHEINSEN U, THEWS O, VAUPEL P: Blood flow, oxygenation, and bioenergetic status of tumors after erythropoietin treatment in normal and anemic rats. Cancer Res. (1996) 56(20):4728-4734.
65. THEWS O, KOENIG R, KELLEHER DK, KUTZNER J, VAUPEL P: Enhanced radiosensitivity in experimental tumours following erythropoietin treatment of chemotherapy-induced anaemia. Br. J. Cancer (1998) 78(6):752-756.
66. THEWS O, KELLEHER DK, VAUPEL P: Erythropoietin restores the anemia-induced reduction in cyclophosphamide cytotoxicity in rat tumors. Cancer Res. (2001) 61(4):1358-1361.
67. ACS G, ACS P, BECKWITH SM et al.: Erythropoietin and erythropoietin receptor expression in human cancer. Cancer Res. (2001) 61(9):3561-3565.
68. ACS G, ZHANG PJ, REBBECK TR, ACS P, VERMA A: Immunohistochemical expression of erythropoietin and erythropoietin receptor in breast carcinoma. Cancer (2002) 95(5):969-981.
69. ARCASOY MO, AMIN K, KARAYAL AF et al.: Functional significance of erythropoietin receptor expression in breast cancer. Lab. Invest. (2002) 82(7):911-918.
70. ACS G, CHEN M, XU X, ACS P, VERMA A, KOCH CJ: Autocrine erythropoietin signaling inhibits hypoxia-induced apoptosis in human breast carcinoma cells. Cancer Lett. (2004) 214(2):243-251.
71. ARCASOY MO, AMIN K, CHOU SC, HAROON ZA, VARIA M, RALEIGH JA: Erythropoietin and erythropoietin receptor expression in head and neck cancer: relationship to tumor hypoxia. Clin. Cancer Res. (2005) 11(1):20-27.
72. CONSTANTINESCU SN, GHARRARI S, LODISH HF: The erythropoietin receptor: structure, activation, and intracellular signal transduction. Trends Endocrinol. Metab. (1999) 10(1):18-23.
73. BUSSE L, SINCLAIR A, ROGERS N, SAROSI I, VAN G, ELLIOT S: Is Epo receptor over-expressed in human tumor cells? Proc. Am. Assoc. Cancer Res. (2005) 46:1077.
74. SINCLAIR A, BUSSE L, ROGERS N et al.: Epo receptor transcription is not elevated nor predictive of surface expession in human tumor cells. Proc. Am. Assoc. Cancer Res. (2005) 46:1287.
75. RIZZO JD, LICHTIN AE, WOOLF SH et al.: Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. J. Clin. Oncol. (2002) 20(19):4083-4107.
76. BAMIAS A, ARAVANTINOS G, KALOFONOS C et al.: Prevention of anemia in patients with solid tumors receiving platinum- based chemotherapy by recombinant human erythropoietin (rHuEPO): a prospective, open label, randomized trial by the Hellenic Cooperative Oncology Group. Oncology (2003) 64(2):102-110.
77. VANSTEENKISTE J, TOMITA D, ROSSI G, PIRKER R: Darbepoetin alfa in lung cancer patients on chemotherapy: a retrospective comparison of outcomes in patients with mild versus moderate-to-severe anaemia at baseline. Support Care Cancer (2004) 12(4):253-262.
78. CHARU V, SAIDMAN B, BEN-JACOB A et al.: Improvements In fatigue are associated with early treatment with every-3-week (Q3w) darbepoetin alfa (Da) treatment in anemic patients (Pts) receiving chemotherapy (Ctx). Blood (2004) 104(11):233a.
79. SMITH RE, TCHEKMEDYIAN NS, CHAN D et al.: A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer. Br. J. Cancer (2003) 88(12):1851-1858.
80. SIKOLE A, SPASOVSKI G, ZAFIROV D, POLENAKOVIC M: Epoetin omega for treatment of anemia in maintenance hemodialysis patients. Clin. Nephrol. (2002) 57(3):237-245.
81. BREN A, KANDUS A, VARL J et al.: A comparison between epoetin omega and epoetin alfa in the correction of anemia in hemodialysis patients: a prospective, controlled crossover study. Artif. Organs (2002) 26(2):91-97.
82. MARXSEN JH, STENGEL P, DOEGE K et al.: Hypoxia-inducible factor-1 (Hif-1) promotes its degradation by induction of hif-alpha-prolyl-4-hydroxylases. Biochem. J. (2004) 381 (Pt 3):761-767.
83. NICOLAS G, CHAUVET C, VIATTE L et al.: The gene encoding the iron regulatory peptide hepcidin is regulated by anemia, hypoxia, and inflammation. J. Clin. Invest. (2002) 110(7):1037-1044.