Pegfilgrastim administered in an abbreviated schedule, significantly improved neutrophil recovery after high-dose radiation-induced myelosuppression in rhesus macaques

Radiation Research

Volumn 178, Issue 5, 2012, Pages 403-413

  Farese, A M ^a   Cohen, M V ^b   Stead, R B ^c   Jackson III, W ^d   MacVittie, T J ^d  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b Intergrated Research Facility   (United States)

^c BioPharma Consulting Services   (United States)

^d Statistician   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENTAMICIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ANIMAL EXPERIMENT; ARTICLE; BONE MARROW SUPPRESSION; DRUG BLOOD LEVEL; DRUG HALF LIFE; IRRADIATION; MALE; NEUTROPHIL; NEUTROPHIL COUNT; NONHUMAN; PRIORITY JOURNAL; RADIATION DOSE; RADIATION EXPOSURE; RADIATION INJURY; RHESUS MONKEY; SINGLE DRUG DOSE;

ANIMALS; DRUG ADMINISTRATION SCHEDULE; GRANULOCYTE COLONY-STIMULATING FACTOR; LETHAL DOSE 50; MACACA MULATTA; MALE; NEUTROPENIA; NEUTROPHILS; RADIATION-PROTECTIVE AGENTS; RECOMBINANT PROTEINS; X-RAYS;

ANIMALIA; MACACA MULATTA;

EID: 84868618718     PISSN: 00337587     EISSN: 19385404     Source Type: Journal    
DOI: 10.1667/RR2900.1     Document Type: Article

References (79)

1. Morstyn G, Campbell L, Souza LM, Alton NK, Keech J, Green M, et al. Effect of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy. Lancet 1988; 1:668-72.
2. Sheridan WP, Morstyn G, Wolf M, Dodds A, Lusk J, Maher D, et al. Granulocyte colony-stimulating factor and neutrophil recovery after high-dose chemotherapy and autologous bone marrow transplantation. Lancet 1989; 2:891-5.
3. Monroy RL, Skelly RR, MacVittie TJ, Davis TA, Sauber JJ, Clark SC, et al. The effect of recombinant GM-CSF on the recovery of monkeys transplanted with autologous bone marrow. Blood 1987; 70:1696-9. (Pubitemid 18026191)
4. Crawford J, Ozer H, Stoller R, Johnson D, Lyman G, Tabbara I, et al. Reduction by granulocyte-colony stimulating factor of fever and neutropenia induced by chemotherapy in patients with smallcell lung cancer. New Eng J Med 1991; 325:164-70.
5. Nienhuis AW, Donahue RE, Karlsson S, Clark SC, Agricola B, Antinoff N, et al. Recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) shortens the period of neutropenia after autologous bone marrow transplantation in a primate model. J Clin Invest 1987; 80:573-7.
6. Welte K, Gabrilove J, Bronchud MH, Platzer E, Morstyn G. Filgrastim (r-metHuG-CSF): the first 10 years. Blood 1996; 88:1907-29. (Pubitemid 26307891)
7. Bishop MR, Tarantolo SR, Geller RB, Lynch JC, Bierman PJ, Pavletic ZS, et al. A randomized, double-blind trial of filgrastim (granulocyte colony-stimulating factor) versus placebo following allogeneic blood stem cell transplantation. Blood 2000; 96:80-5. (Pubitemid 30456454)
8. Armitage JO. Emerging applications of recombinant human granulocyte-macrophage colony-stimulating factor. Blood 1998; 92:4491-508. (Pubitemid 29005850)
9. Clark OAC, Lyman GH, Castro AA, Clark LGO, Djulbegovic B. Colony-stimulating factors for chemotherapy-induced febrile neutropenia: A meta-analysis of randomized controlled trials. J Clin Oncol 2005; 23:4198-214. (Pubitemid 46211326)
10. Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L, et al. 2006 update of recommendations for the use of white blood cell growth factors: An evidence-based clinical practice guideline. J Clin Oncol 2006; 24:3187-205. (Pubitemid 46638957)
11. Timmer-Bonte JN, de Boo TM, Smit HJ, Biesma B, Wilschut FA, Cheragwandi SA, et al. Prevention of chemotherapy-induced febrile neutropenia by prophylactic antibiotics plus or minus granulocyte colony-stimulating factor in small-cell lung cancer: A dutch randomized phase III study. J Clin Oncol 2005; 23(31): 7974-984. (Pubitemid 46657398)
12. Kuderer N, Dale DC, Crawford J, Lyman G. Impact of primary prophylaxis with granulosyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: A systematic review. J Clin Oncol 2007; 25: 3158-67. (Pubitemid 47218066)
13. Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim one per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 2002; 20:727-31. (Pubitemid 34111380)
14. Holmes FA, Jones SE, O'Shaughnessy J, Vukelja T, George T, Savin M, et al. Comparable efficacy and safety profiles of onceper-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 2002; 13:903-9. (Pubitemid 34752686)
15. Crawford J, Kreisman H, Garewal H, Jones SE, Shoemaker D, Pupa MR, et al. The impact of Filgrastim schedule variation on hematopoietic recovery post-chemotherapy. Ann Oncol 1997; 8:1117-24. (Pubitemid 27521219)
16. Vose JM, Crump M, Lazarus H, Emmanouilides C, Schenkein D, Moore J, et al. Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol 2003; 21(514):519.
17. Baranov AE. Allogenic bone marrow transplantation after severe, uniform total-body irradiation: experience from recent (Nyasvizh, Belarus) and previous radiation accidents. In: MacVittie TJ, Weiss JF, Browne D, editors. Advances in the Treatment of Radiation Injuries: Advances in the Biosciences, Vol. 94. First ed. Tarrytown (NY): Pergamon; Elsevier Science Ltd; 1996. P. 281-93.
18. Baranov AE, Guskova AK. Acute radiation disease in Chernobyl accident victims. In: Ricks RC, Fry SA, editors. The medical basis for radiation accident preparedness II; Clinical experience and follow-up since 1979. New York: Elsevier; 1990. P. 79-87.
19. Liu Q, Jiang B, Jiang L-P, Wu Y, Wang X-G, Zhao F-L, et al. Clinical report of three cases of acute radiation sickness from a 60Co radiation accident in Henan province in China. J Radiat Res 2008; 49:63-9. (Pubitemid 351214419)
20. Guskova AK, Nadezhina NM, Barabanova AV, Baranov AE, Gusev IA, Protasova TG, et al. Acute effects of radiation exposure following the Chernobyl acident: Immediate results of radiation sickness and outcome of treatment. In: Browne D, Weiss JF, MacVittie TJ, Pillai MV, editors. Treatment of Radiation Injuries. New York: Plenum Press; 1990. P. 195-209.
21. Hirama T, Tanosaki S, Kandatsu S, Kuroiwa N, Kamada T, Tsuji H, et al. Initial Medical Management of Patients Severely Irradiated in the Tokai-mura Criticality Accident. Br J of Radiol 2003; 76:246-53. (Pubitemid 36582069)
22. Biological effects of radiation injury. Miamisburg, OH: AlphaMed Press; 1997.
23. Ricks RC, Fry SA, editors. The medical basis for radiation accident preparedness II: Clinical experience and follow-up since 1979. New York, NY: Elsevier Science Inc.; 1990.
24. Browne D, Weiss JF, MacVittie TJ, Pillai MV, editors. Treatment of radiation injuries. Proceedings of the first consensus development conference on the treatment of radiation injuries. New York: Plenum Press; 1990.
25. MacVittie TJ, Weiss JF, Browne D, editors. Advances in the treatment of radiation injuries. Proceedings of 2nd consensus development conference on the treatment of radiation injuries. Tarrytown, NY: Pergamon, Elsevier Science Inc.; 1996.
26. Ricks RC, Berger ME, O'Hara F, editors. The medical basis for radiation accident preparedness IV: Clinical care of victims. Washington, DC: Parthenon Publishers; 2002.
27. MacVittie TJ, Weiss JF, Browne D. Consensus summary on the treatment of radiation injuries. In: MacVittie TJ, Weiss JF, Browne D, editors. Advances in the treatment of radiation injuries. 1st ed. Tarrytown(NY): Pergamon, Elsevier Sciences Inc.; 1996. P. 325-46.
28. Waselenko JK, MacVittie TJ, Blakely WF, Pesik N, Wiley AL, Dickerson WE, et al. Medical Management of the Acute Radiation Syndrome: Recommendations of the Strategic National Stockpile Radiation Working Group. Ann Int Med 2004; 140:1037-51.
29. Crawford LM. New drug and biological drug products; Evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Federal Register 67[105], 37988-37998. 5-31-2002. 21 CFR parts 314 and 601, FDA, HHS; ACTION: Final Rule.
30. FDA, CBER. Guidance for Industry: Animal Models-Essential Elements to Address Efficacy Under the Animal Rule: 1-19; 2009.
31. Washington, DC, National Institutes of Health. The Institute of Laboratory Animal Resources, National Research Council: Guide for the Care and Use of Laboratory Animals; 1996.
32. Eldred E, Trowbridge WV. Radiation sickness in the monkey. Radiology 1954; 62:65-73.
33. Armed Forces Radiobiology Research Institute. Stanley RE, Seigneur LJ, Strike TA. The acute mortality response of monkeys (Macacca mulatta) to mixed gamma-neutron radiations and 250 kVp X rays: SR66-23; 1966.
34. Henschke UK, Morton JL. Mortality of Rhesus monkeys after single total body irradiation. Am J Roentgenol 1957; 77(5): 889-909.
35. Haigh MV, Paterson E. Effects of a single session of whole body irradiation in the rhesus monkey. Brit J Radiol 1956; 29:148-57.
36. Schlumberger HG, Vazquez JJ. Pathology of total body irradiation in the monkey. Am J Pathol 1954; 30:1013-47.
37. Allen JR, Van Lancker JL, Wolf RC. The use of bone marrow transplants in the protection of rhesus monkeys against total body x-irradiation. Amer J Vet Res 1964; 25:1740-4.
38. Byron JW, Haigh MV, Lajtha LG. Effect of an antibiotic regime on monkeys exposed to total-body irradiation. Nature 1964; 202:977-9.
39. Welte K, Bonilla MA, Gillio AP, Boone TC, Potter GK, Gabrilove JL, et al. Recombinant human granuloctye colony-stimulating factor. Effects on hematopoiesis in normal and cyclophosphamidetreated primates. J Exper Med 1987; 165:941-8. (Pubitemid 17064496)
40. Farese AM, Roskos L, Cheung E, Stead RB, Yin SM, MacVittie TJ. A single administration of r-metHuG-SD/01 (SD01) significantly improves neutrophil recovery following autologous bone marrow transplantation. Blood 1998; 92:112.
41. Farese AM, Yang B-B, Roskos L, Stead RB, MacVittie TJ. Pegfilgrastim, a sustained-duration form of filgrastim, significantly improves neutrophil recovery after autologous marrow transplanation in rhesus macaques. Bone Mar Transplan 2003.
42. MacVittie TJ, Farese AM, Jackson WI. Defining the full therapeutic potential of recombinant growth factors in the post radiation-accident environment: the effect of supportive care plus administration of G-CSF. Health Phys 2005; 89(5):546-55. (Pubitemid 41463888)
43. Yang B-B, Hill RL, Hollifield AM, Green M, Holmes FA, Sheridan WP, et al. Pegfilgrastim Serum Concentrations on the Twelfth Day After Dosing Are Unlikely to Stimulate Granulopoiesis: A Retrospective Analysis of Six Clinical Trials in a Variety of Cancer Populations. J Support Oncol 2004; 2:48-9.
44. Johnston E, Crawford J, Blackwell S, Bjurstrom T, Lockbaum P, Roskos L, et al. Randomized dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 2000; 18:2522-8. (Pubitemid 30432517)
45. Tanaka H, Tanaka Y, Shinagawa K, Yamagishi Y, Ohtaki K, Asano K. Three types of recombinant human granulocyte-colony stimulating factor have equivalent biological activities in monkeys. Cytokine 1997; 5:360-9. (Pubitemid 27248246)
46. Borleffs JC, Bosschaert M, Vrehen HM, Scneider ME, et al. Effect of escalating doses of recombinant human granulocyte colonystimulating factor (filgrastim) on circulating neutrophils in healthy subjects. Clin Thera 1998; 20(4):722-36. (Pubitemid 28421493)
47. Zamboni WC. Pharmacokinetics of pegfilgrastim. Pharmacotherapy 2003; 23(8):9S-14S.
48. Curran MP, Goa KL. Pegfilgrastim. Drugs 2002; 62:1212-3.
49. Roskos LK, Lum P, Lockbaum P, Schwab G, Yang B-B. Pharmacokinetic/ pharmacodynamic modeling of pegfilgrastim in healthy subjects. J Clin Pharmacol 2006; 46:747-57. (Pubitemid 43882798)
50. Hughes WT. Use of antimicrobial agents for treatment of infection in the neutropenic immunocompromised patient. In: Ricks R, Berger ME, O'Hara FMJr, editors. The medical basis for radiationaccident preparedness. The clinical care of victims. Washington, DC: The Parthenon Publishing Group; 2002; 117-29.
51. Schimpff SC. Infections in radiation accidents. In: Browne D, Weiss JF, MacVittie TJ, Pillai MV, editors. Treatment of radiation injuries. New York: Plenum Press; 1990; 75-85.
52. Gafter-Gvili A, Fraser A, Mical P, Leibovici L. Meta-Analysis: Antibiotic Prophylaxis Reduces Mortality in Neutropenic Patients. Ann Int Med 2005; 142:979-95. (Pubitemid 40840313)
53. Hughes WT, Armstrong D, Bodey GP, Feld R, Mandell GL, Meyers JD, et al. Guidelines for the use of antimicrobial agents in neutropenic patients with unexplained fever. J Infect Dis 1990; 161:381-96. (Pubitemid 20107933)
54. Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis 2002; 34:730-51. (Pubitemid 34194843)
55. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology-v.1: Fever and neutropenia. Version 1. 2005; 8-31.
56. Hughes WT, Armstrong D, Bodey GP, Brown AE, Edwards JE, Feld R, et al. 1997 Guidelines for the Use of Antimicrobial Agents in Neutropenic Patients with Unexplained Fever. Clin Infect Dis 1997; 25(3):551-73. (Pubitemid 127774275)
57. Bodey GP, Buckley M, Sathe YS, Freireich EJ. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Int Med 1966; 64:328-40.
58. Timmer-Bonte JN, de Boo TM, Smit HJ, Biesma B, Wilschut FA, Cheragwandi SA, et al. Prevention of chemotherapy-induced febrile neutropenia by prophylatic antibiotics plus or minus granulocyte colony-stimulating factor in small cell lung cancer: a Dutch Randomized Phase III Study. J Clin Oncol 2005; 23:7974-84. (Pubitemid 46657398)
59. Aapro MS, Cameron DA, Pettengell R, Bohlius J, Crawford J, Ellis M, et al. EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidents of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. Eur J Cancer 2006; 42(15):2433-53. (Pubitemid 44442936)
60. Lyman GH. Guidelines of the National Comprehensive Cancer Network on the use of myeloid growth factors with cancer chemotherapy: a review of the evidence. J Natl Compr Canc Netw 2005; 3(4):557-71. (Pubitemid 44265429)
61. Schuening FG, Storb R, Goehle S, Graham TC, Appelbaum FR, Hackman R et al. Effect of recombinant human granulocyte colony-stimulating factor on hematopoiesis of normal dogs and on hematopoietic recovery after otherwise lethal total body irradiation. Blood 1989; 74:1308-13. (Pubitemid 19227440)
62. Patchen ML, MacVittie TJ, Solberg BD, Souza LM. Therapeutic administration of recombinant human granulocyte colony stimulating factor accelerated hemopoietic regeneration and enhances survival in a murine model of radiation-induced myelosuppression. Inter J Cell Clon 1990; 8:107-22. (Pubitemid 20123464)
63. MacVittie TJ, Monroy RL, Patchen ML, Souza LM. Therapeutic use of recombinant human G-CSF in a canine model of sublethal and lethal whole-body irradiation. Int J Radiat Biol 1990; 57:723-36. (Pubitemid 20115270)
64. Patchen ML, Fischer R, MacVittie TJ. Effects of combined administration of IL-6 and G-CSF on recovery from radiationinduced hemopoietic aplasia. Experi Hematol 1993; 21:338-44. (Pubitemid 24216777)
65. Tanikawa S, Nakao I, Tsuneska K, Nobio N. Effects of recombinant granuloctye colony-stimulating factor (rG-CSF) and recombinant granuloctye-macrophage colony-stimulating factor (rGM-CSF) on acute radiation hematopoietic injury in mice. Experi Hematol 1989; 17:883-8. (Pubitemid 19217183)
66. Tanikawa S, Nose M, Yoshiro A, Tsuneoka K, Shikita M, Nara N. Effects of recombinant human granuloctye colony-stimulating factor on the hematologic recovery and survival of irradiated mice. Blood 1990; 76:445-9. (Pubitemid 20251808)
67. Farese AM, Hunt P, Grab LB, MacVittie TJ. Combined administration of recombinant human megakaryocyte growth and development factor and granulocyte colony-stimulating factor enhances multilineage hematopoietic reconstitution in nonhuman primates after radiation-induced marrow aplasia. J Clin Invest 1996; 97:2145-51.
68. MacVittie TJ, Farese AM, Herodin F, Grab LB, Baum CM, McKearn JP. Combination therapy of radiation-induced bone marrow aplasia in nonhuman primates using synthokine SC-55494 and recombinant human granulocyte colony-stimulating factor. Blood 1996; 87(10):4129-35.
69. Cheung EN, Cosenza M, Lopez O, Hayashi M, Wariner G, Roskos IK. Modeling of r-metHuG-CSF-SD/01 (SD/01) mediated granulopoiesis in normal animals with mathematical extrapolation to neutropenic settings. Blood 1998; 92:379.
70. Roskos LK, Lum P, Schwab G, Yang B-B. Pharmacokinetic/pharmacodynamic modeling of pegfilgrastim in healthy subjects. J Clin Pharmacol 2006; 46:747-57. (Pubitemid 43882798)
71. Lord BI, Woolford LB, Molineux G. Kinetics of neutrophil production in normal and neutropenic animals during the response to filgrastim (r-metHu G-CSF) or filgrastim SD/01 (Peg-r-metHu G-CSF). Clin Cancer Res 2001; 7:2085-90. (Pubitemid 32994848)
72. Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, et al. A randomized double-blind multicenter phase III study of fixeddose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 2003; 14:29-35. (Pubitemid 36150255)
73. Molineux G, Kinstler O, Briddell B, Hartley C, McElroy P, Kerzic P, et al. A new form of Filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans. Experi Hematol 1999; 27:1724-34.
74. Lord BI, Bronchud MH, Owens S, Chang J, Howell A, Souza L, et al. The kinetics of human granulopoiesis following treatment with granulocyte colony-stimulating factor in vivo. Proc Natl Acad Sci USA 1989; 86:9499-503. (Pubitemid 20010454)
75. Engel C, Scholz M, Loeffler M. A computational model of human granulopoiesis to stimulate the hematotoxic effects of multicycle polychemotherapy. Blood 2004; 104(8):2323-31. (Pubitemid 39331829)
76. Mackey MC, Aprikyan AAG, Dale DC. The rate of apoptosis in post mitotic neutrophil precursors of normal and neutropenic humans. Cell Prolif 2003; 36:27-34. (Pubitemid 36237800)
77. Basu S, Hodgson G, Katz M, Dunn AR. Evaluation of role of GCSF in the production, survival, and release of neutrophils from bone marrow into circulation. Blood 2002; 100:854-61. (Pubitemid 34832610)
78. Meisenberg BR, Davis TA, Melaragno AJ, Stead R, Monroy RL. A comparison of therapeutic schedules for administering granulocyte colony-stimulating factor to nonhuman primates after highdose chemotherapy. Blood 1992; 79:2267-72.
79. Neelis KJ, Hartong SCC, Egeland T, Thomas GR, Eaton DL, Wagemaker G. The efficacy of single-dose administration of thrombopoietin with coadministration of either granulocyte/macrophage or granulocyte colony-stimulating factor in myelosuppressed rhesus monkeys. Blood 1997; 90:2565-73. (Pubitemid 27413465)