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

European Journal of Cancer

Volumn 41, Issue 8, 2005, Pages 1140-1149

  Glaspy, John ^a   Henry, David ^b   Patel, Ravi ^c   Tchekmedyian, Simon ^d   Applebaum, Steve ^a   Berdeaux, Donald ^e   Lloyd, Richard ^f   Berg, Russell ^g   Austin, Matt ^g   Rossi, Greg ^g  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Joan Karnell Cancer Center   (United States)

^c Comprehensive Blood and Cancer Center ^*  (United States)

^d Pacific Shores Medical Group   (United States)

^e Virginia K Crosson Cancer Center ^*

^f AMGEN INC   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Asynchronous; Chemotherapy; Darbepoetin alfa; Erythropoietin synchronous; Pharmacokinetics

Indexed keywords

ERYTHROPOIETIN; HEMOGLOBIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN;

ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CANCER CHEMOTHERAPY; CLINICAL TRIAL; COMPARATIVE STUDY; CONCENTRATION (PARAMETERS); CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DEEP VEIN THROMBOSIS; DISEASE COURSE; DOSE TIME EFFECT RELATION; FEMALE; HEMOGLOBINOPATHY; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SPINAL CORD COMPRESSION; THROMBOSIS;

ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; ENZYME-LINKED IMMUNOSORBENT ASSAY; ERYTHROPOIETIN; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; TREATMENT OUTCOME;

EID: 21144440131     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2005.01.021     Document Type: Article

References (44)

1. J.E. Groopman, and L.M. Itri Chemotherapy-induced anemia in adults: incidence and treatment J Natl Cancer Inst 91 1999 1616 1634
2. J.L. Gabrilove, C.S. Cleeland, and R.B. Livingston 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 2001 2875 2882
3. T.J. Littlewood, E. Bajetta, and J. Nortier 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 2001 2865 2874
4. B. Mirtsching, V. Charu, and S. Vadhan-Raj Every-2-week darbepoetin alfa is comparable to rHuEPO in treating chemotherapy-induced anemia Oncology 16 10 (Suppl 11) 2002 31 36
5. S. Vadhan-Raj, B. Mirtching, and V. Charu Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks J Support Oncol 1 2003 131 138
6. J. Glaspy, R. Bukowski, and D. Steinberg Impact on therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice J Clin Oncol 15 1997 1218 1234
7. J.A. Glaspy, J.S. Jadeja, and G. Justice Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy Brit J Cancer 87 2002 268 276
8. J. Vansteenkiste, R. Pirker, and B. Massuti Double-blind, placebo-controlled, randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy J Natl Cancer Inst 94 2002 1211 1220
9. M. Hedenus, S. Hansen, and K. Taylor Randomized, dose-finding study of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies Brit J Haematol 119 2002 79 86
10. M. Hedenus, M. Adriansson, and J. San Miguel Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study Brit J Haematol 122 2003 394 403
11. A. Osterborg, Y. Brandberg, and V. Molostova Randomized, double-blind, placebo-controlled trial of recombinant human erythropoietin, epoetin beta, in hematologic malignancies J Clin Oncol 20 2002 2486 2494
12. G.D. Demetri, M. Kris, and J. Wade 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 16 1998 3412 3425
13. J.C. Egrie, E. Dwyer, and J.K. Browne Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin Exp Hematol 31 2003 290 299
14. J.L. Spivak, and B.B. Hogans The in vivo metabolism of recombinant human erythropoietin in the rat Blood 73 1989 90 99
15. D.W. Briggs, J.W. Fisher, and W.J. George Hepatic clearance of intact and desialylated erythropoietin Am J Physiol 227 1974 1385 1388
16. M.N. Fukuda, H. Sasaki, and L. Lopez Survival of recombinant erythropoietin in the circulation: the role of carbohydrates Blood 73 1989 84 89
17. O.J. Nielsen, M. Egfjord, and P. Hirth The metabolism of recombinant erythropoietin in the isolated perfused rat liver Liver 10 1990 343 349
18. K.E. Achyuthan, and A.M. Achyuthan Comparative enzymology, biochemistry and pathophysiology of human exo-alpha-sialidases (neuraminidases) Comp Biochem Physiol B: Biochem Mol Biol 129 2001 29 64
19. J.A. Widness, P. Veng-Pedersen, and R.L. Schmidt In vivo 125I-erythropoietin pharmacokinetics are unchanged after anesthesia, nephrectomy and hepatectomy in sheep J Pharmacol Exp Ther 279 1996 1205 1210
20. A. Heatherington, R. Rovetti, and D. Kotasek Predictability of pharmacokinetic properties of NESP administered once every 3 weeks in patients with nonmyeloid malignancies receiving cyclic chemotherapy Proc ASCO 20 2001 119a [Abstract 471]
21. S.T. Sawyer, S.B. Krantz, and E. Goldwasser Binding and receptor-mediated endocytosis of erythropoietin in Friend virus-infected erythroid cells J Biol Chem 262 1987 5554 5562
22. H. Kinoshita, N. Ohishi, and M. Kato Distribution of recombinant human erythropoietin following multiple intravenous administration and effects of age on the distribution in rats Arzneimittel-Forschung 42 1992 579 584
23. M. Kato, H. Kamiyama, and A. Okazaki Mechanism for the nonlinear pharmacokinetics of erythropoietin on rats J Pharmacol Exp Ther 283 1997 520 527
24. S.H. Chapel, P. Veng-Pedersen, and R.J. Hohl Changes in erythropoietin pharmacokinetics following busulfan-induced bone marrow ablation in sheep: evidence for bone marrow as a major erythropoietin elimination pathway J Pharmacol Exp Ther 298 2001 820 824
25. S.H. Chapel, P. Veng-Pedersen, and R.L. Schmidt Receptor-based model accounts for phlebotomy-induced changes in erythropoietin pharmacokinetics Exp Hematol 29 2001 425 431
26. M. Kato, K. Okano, and Y. Sakamoto Pharmacokinetics and pharmacodynamics of recombinant human erythropoietin in rats Arzneimittel-Forschung 51 2001 91 95
27. Y. Sawabe, Y. Takiguchi, and K. Kikuno Changes in levels of serum erythropoietin, serum iron and unsaturated iron binding capacity during chemotherapy for lung cancer Jpn J Clin Oncol 28 1998 182 186
28. A.C. Heatherington, J. Schuller, and A.J. Mercer Pharmacokinetics of novel erythropoiesis stimulating protein (NESP) in cancer patients: preliminary report Brit J Cancer 84 2001 11 16
29. D. Kotasek, G. Steger, and W. Faught 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 39 2003 2026 2034
30. C. Hartley, S. Elliott, and G. Begley Kinetics of haematopoietic recovery after dose-intensive chemo/radiotherapy in mice: optimized erythroid support with darbepoetin alpha Brit J Haematol 122 2003 623 636
31. M. Allon, K. Kleinman, and M. Walczyk Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis Clin Pharmacol Ther 72 2002 546 555
32. S. Elliott, T. Lorenzini, and S. Asher Enhancement of therapeutic protein in vivo activities through glycoengineering Nat Biotechnol 21 2003 414 421
33. S. Elliott, T. Lorenzini, and D. Chang Fine-structure epitope mapping of antierythropoietin monoclonal antibodies reveals a model of recombinant human erythropoietin structure Blood 87 1996 2702 2713
34. R.I. Abels Use of recombinant human erythropoietin in the treatment of anemia in patients who have cancer Semin Oncol 19 1992 29 35
35. J.D. Kalbfleish, and R.L. Prentice The statistical analysis of failure time data 1st ed. 1980 John Wiley and Sons New York, NY
36. E.L. Lehmann Nonparametrics: statistical methods based on ranks 1975 Holden-Day Publications San Francisco, CA
37. E. Piroso, A.J. Erslev, and J. Caro Inappropriate increase in erythropoietin titers during chemotherapy Am J Hematol 32 1989 248 254
38. H. Ludwig, M. Pecherstorfer, and C. Leitgeb Recombinant human erythropoietin for the treatment of chronic anemia in multiple myeloma and squamous cell carcinoma Stem Cells 11 1993 348 355
39. P. Veng-Pedersen, S. Chapel, and N.H. Al-Hunitia Pharmacokinetic tracer kinetics analysis of changes in erythropoietin receptor population in phlebotomy-induced anemia and bone marrow ablation Biopharm Drug Dispos 25 2004 149 156
40. W. Jelkmann The enigma of the metabolic fate of circulating erythropoietin (Epo) in view of the pharmacokinetics of the recombinant drugs rhEpo and NESP Eur J Haematol 69 2002 265 274
41. F.R. Dunphy, B.R. Harrison, and T.L. Dunleavy Erythropoietin reduces anemia and transfusions: a randomized trial with or without erythropoietin during chemotherapy Cancer 86 1999 1362 1367
42. D. Bowen, B. Ehmer, and P. Neubert The clearance of a single i.v. bolus of recombinant human erythropoietin from the serum of patients with myelodysplastic syndromes and its effects on erythropoiesis Exp Hematol 19 1991 613 616
43. S. Vadhan-Raj, B. Mirtsching, and S.A. Gregory Baseline (BL) covariates of response to darbepoetin alfa (DA) every 2 weeks (Q2W) in patients (pts) with chemotherapy-induced anemia (CIA Proc ASCO 23 2004 8061a
44. A.C. Heatherington Clinical pharmacokinetic properties of rHuEPO: a review G. Molineux M.A. Foote S.G. Elliot Erythropoietins and erythropoiesis molecular, cellular, preclinical, and clinical biology 2003 Birkhauser Verlag Basel, Switzerland 87 112