메뉴 건너뛰기




Volumn 30, Issue 12, 2014, Pages 2523-2533

Lipegfilgrastim: Pharmacodynamics and pharmacokinetics for body-weight-adjusted and 6 mg fixed doses in two randomized studies in healthy volunteers

Author keywords

Granulocyte colony stimulating factor; Human volunteers; Safety; Sustained release preparations

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; PEGFILGRASTIM; RECOMBINANT PROTEIN;

EID: 84914169226     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2014.962131     Document Type: Article
Times cited : (21)

References (30)
  • 1
    • 0036467835 scopus 로고    scopus 로고
    • Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with highrisk stage ii or stage iii/iv breast cancer
    • Holmes FA, O'Shaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with highrisk stage II or stage III/IV breast cancer. J Clin Oncol 2002;20:727-31
    • (2002) J Clin Oncol , vol.20 , pp. 727-731
    • Holmes, F.A.1    O'Shaughnessy, J.A.2    Vukelja, S.3
  • 2
    • 84875167475 scopus 로고    scopus 로고
    • Colony-stimulating factors for febrile neutropenia during cancer therapy
    • Bennett CL, Djulbegovic B, Norris LB, Armitage JO. Colony-stimulating factors for febrile neutropenia during cancer therapy. N Engl J Med 2013;368:1131-9
    • (2013) N Engl J Med , vol.368 , pp. 1131-1139
    • Bennett, C.L.1    Djulbegovic, B.2    Norris, L.B.3    Armitage, J.O.4
  • 3
    • 0013877409 scopus 로고
    • Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia
    • Bodey GP, Buckley M, Sathe YS, Freireich EJ. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med 1966;64:328-40
    • (1966) Ann Intern Med , vol.64 , pp. 328-340
    • Bodey, G.P.1    Buckley, M.2    Sathe, Y.S.3    Freireich, E.J.4
  • 4
    • 79951816939 scopus 로고    scopus 로고
    • Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america
    • Freifeld AG, Bow EJ, Sepkowitz KA, et al. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis 2011;52:e56-93
    • (2011) Clin Infect Dis , vol.52 , pp. e56-93
    • Freifeld, A.G.1    Bow, E.J.2    Sepkowitz, K.A.3
  • 5
    • 0035990090 scopus 로고    scopus 로고
    • Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: A multicenter dose-finding study in women with breast cancer
    • Holmes FA, Jones SE, O'Shaughnessy J, et al. Comparable efficacy and safety profiles of once-per-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
    • (2002) Ann Oncol , vol.13 , pp. 903-909
    • Holmes, F.A.1    Jones, S.E.2    O'Shaughnessy, J.3
  • 6
    • 0025800331 scopus 로고
    • Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer
    • Crawford J, Ozer H, Stoller R, et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 1991;325:164-70
    • (1991) N Engl J Med , vol.325 , pp. 164-170
    • Crawford, J.1    Ozer, H.2    Stoller, R.3
  • 7
    • 0026428605 scopus 로고
    • Recombinant granulocyte- macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer
    • Nemunaitis J, Rabinowe SN, Singer JW, et al. Recombinant granulocyte- macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. N Engl J Med 1991;324:1773-8
    • (1991) N Engl J Med , vol.324 , pp. 1773-1778
    • Nemunaitis, J.1    Rabinowe, S.N.2    Singer, J.W.3
  • 8
    • 0026533982 scopus 로고
    • Granulocyte-macrophage colony-stimulating factor (gm-csf) as adjunct therapy in relapsed hodgkin disease
    • Gulati SC, Bennett CL. Granulocyte-macrophage colony-stimulating factor (GM-CSF) as adjunct therapy in relapsed Hodgkin disease. Ann Intern Med 1992;116:177-82
    • (1992) Ann Intern Med , vol.116 , pp. 177-182
    • Gulati, S.C.1    Bennett, C.L.2
  • 9
    • 0027390482 scopus 로고
    • Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy
    • Trillet-Lenoir V, Green J, Manegold C, et al. Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur J Cancer 1993;29A:319-24
    • (1993) Eur J Cancer , vol.29 A , pp. 319-324
    • Trillet-Lenoir, V.1    Green, J.2    Manegold, C.3
  • 10
    • 77954335295 scopus 로고    scopus 로고
    • Hematopoietic growth factors: Esmo clinical practice guidelines for the applications
    • Crawford J, Caserta C, Roila F. Hematopoietic growth factors: ESMO Clinical Practice Guidelines for the applications. Ann Oncol 2010;21(Suppl 5):v248- 51
    • (2010) Ann Oncol , vol.21 , pp. v248-v251
    • Crawford, J.1    Caserta, C.2    Roila, F.3
  • 11
    • 33745989223 scopus 로고    scopus 로고
    • 2006 update of recommendations for the use of white blood cell growth factors: An evidence-based clinical practice guideline
    • Smith TJ, Khatcheressian J, Lyman GH, 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
    • (2006) J Clin Oncol , vol.24 , pp. 3187-3205
    • Smith, T.J.1    Khatcheressian, J.2    Lyman, G.H.3
  • 12
    • 84914179447 scopus 로고    scopus 로고
    • Thousand Oaks, CA: Amgen Inc
    • Neulasta [package insert]. Thousand Oaks, CA: Amgen Inc., 2014
    • (2014) Neulasta [Package Insert]
  • 13
    • 79953303640 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of pegfilgrastim
    • Yang BB, Kido A. Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet 2011;50:295-306
    • (2011) Clin Pharmacokinet , vol.50 , pp. 295-306
    • Yang, B.B.1    Kido, A.2
  • 15
    • 84914117235 scopus 로고    scopus 로고
    • Assessment report: Lonquex
    • [Last accessed 14 May 2014]
    • Assessment report: lonquex. European Medicines Agency. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public- assessment-report/human/002556/WC500148382.pdf [Last accessed 14 May 2014]
    • European Medicines Agency
  • 16
    • 84983390911 scopus 로고    scopus 로고
    • A randomized, double-blind, active control, multicenter, dose-finding study of xm22, glycopegfilgrastim, in patients with breast cancer receiving myelosuppressive therapy [abstract 9080]
    • Buchner A, Bias P, Kaufmann M. A randomized, double-blind, active control, multicenter, dose-finding study of XM22, glycopegfilgrastim, in patients with breast cancer receiving myelosuppressive therapy [abstract 9080]. J Clin Oncol 2011;29:9080
    • (2011) J Clin Oncol , vol.29 , pp. 9080
    • Buchner, A.1    Bias, P.2    Kaufmann, M.3
  • 17
    • 84883507672 scopus 로고    scopus 로고
    • Efficacy and safety of lipegfilgrastim versus pegfilgrastim: A randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy
    • Bondarenko I, Gladkov OA, Elaesser R, et al. Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy. BMC Cancer 2013;13:386-98
    • (2013) BMC Cancer , vol.13 , pp. 386-398
    • Bondarenko, I.1    Gladkov, O.A.2    Elaesser, R.3
  • 18
    • 84914179495 scopus 로고    scopus 로고
    • Efficacy and safety of lipegfilgrastim in patients with lung cancer who are receiving chemotherapy [abstract 1014]
    • Gladkov OA, Volovat C, Bondarenko IM, et al. Efficacy and safety of lipegfilgrastim in patients with lung cancer who are receiving chemotherapy [abstract 1014]. Support Care Cancer 2012;20:S243
    • (2012) Support Care Cancer , vol.20 , pp. S243
    • Gladkov, O.A.1    Volovat, C.2    Bondarenko, I.M.3
  • 19
    • 1842535270 scopus 로고    scopus 로고
    • The design and development of pegfilgrastim (peg-rmethugcsf, neulasta)
    • Molineux G. The design and development of pegfilgrastim (PEG-rmetHuGCSF, Neulasta). Curr Pharm Des 2004;10:1235-44
    • (2004) Curr Pharm des , vol.10 , pp. 1235-1244
    • Molineux, G.1
  • 20
    • 84914101370 scopus 로고    scopus 로고
    • Glyco-pegylated r-methug-csf (xm22/ lipegfilgrastim) - A novel long-acting once-per-cycle filgrastim: Pharmacokinetics and pharmacodynamics for body weight adjusted doses and a 6mg fixed dose in health volunteers [abstract 1215]
    • Mueller U, Kohler E, Bias P, et al. Glyco-PEGylated R-metHuG-CSF (XM22/ lipegfilgrastim) - a novel long-acting once-per-cycle filgrastim: pharmacokinetics and pharmacodynamics for body weight adjusted doses and a 6mg fixed dose in health volunteers [abstract 1215]. Eur J Cancer 2011;47(Suppl 1):S149
    • (2011) Eur J Cancer , vol.47 , pp. S149
    • Mueller, U.1    Kohler, E.2    Bias, P.3
  • 21
    • 0037250159 scopus 로고    scopus 로고
    • A randomized double-blind multicenter phase iii study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy
    • Green MD, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 2003;14:29-35
    • (2003) Ann Oncol , vol.14 , pp. 29-35
    • Green, M.D.1    Koelbl, H.2    Baselga, J.3
  • 22
    • 0029760436 scopus 로고    scopus 로고
    • The ishage guidelines for cd34+ cell determination by flow cytometry. International society of hematotherapy and graft engineering
    • Sutherland DR, Anderson L, Keeney M, et al. The ISHAGE guidelines for CD34+ cell determination by flow cytometry. International Society of Hematotherapy and Graft Engineering. J Hematother 1996;5:213-26
    • (1996) J Hematother , vol.5 , pp. 213-226
    • Sutherland, D.R.1    Anderson, L.2    Keeney, M.3
  • 23
    • 84914152219 scopus 로고    scopus 로고
    • Guideline on clinical trials with haematopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy (emea/ cpmp/555/95 rev. 1)
    • [Last accessed 15 October 2013]
    • Guideline on clinical trials with haematopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy (EMEA/ CPMP/555/95 Rev. 1). European Medicine Agency. Available at: www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/12/ WC500017738.pdf [Last accessed 15 October 2013]
    • European Medicine Agency
  • 24
    • 29144453285 scopus 로고    scopus 로고
    • Single-dose pegfilgrastim for the mobilization of allogeneic cd34+ peripheral blood progenitor cells in healthy family and unrelated donors
    • Kroschinsky F, Holig K, Poppe-Thiede K, et al. Single-dose pegfilgrastim for the mobilization of allogeneic CD34+ peripheral blood progenitor cells in healthy family and unrelated donors. Haematologica 2005;90:1665-71
    • (2005) Haematologica , vol.90 , pp. 1665-1671
    • Kroschinsky, F.1    Holig, K.2    Poppe-Thiede, K.3
  • 25
    • 0032745325 scopus 로고    scopus 로고
    • A new form of filgrastim with sustained duration in vivo and enhanced ability to mobilize pbpc in both mice and humans
    • Molineux G, Kinstler O, Briddell B, et al. A new form of filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans. Exp Hematol 1999;27:1724-34
    • (1999) Exp Hematol , vol.27 , pp. 1724-1734
    • Molineux, G.1    Kinstler, O.2    Briddell, B.3
  • 26
    • 0242662216 scopus 로고    scopus 로고
    • Clonal dominance of chronic myelogenous leukemia is associated with diminished sensitivity to the antiproliferative effects of neutrophil elastase
    • El-Ouriaghli F, Sloand E, Mainwaring L, et al. Clonal dominance of chronic myelogenous leukemia is associated with diminished sensitivity to the antiproliferative effects of neutrophil elastase. Blood 2003;102: 3786-92
    • (2003) Blood , vol.102 , pp. 3786-3792
    • El-Ouriaghli, F.1    Sloand, E.2    Mainwaring, L.3
  • 27
    • 84914117234 scopus 로고    scopus 로고
    • Pegylated versus glycopegylated g-csfs and their biochemical and physiological properties [abstract]
    • Abdolzade-Bavil A, Cooksey BA, Scheckermann C, et al. Pegylated versus glycopegylated G-CSFs and their biochemical and physiological properties [abstract]. Blood 2013;122:4851
    • (2013) Blood , vol.122 , pp. 4851
    • Abdolzade-Bavil, A.1    Cooksey, B.A.2    Scheckermann, C.3
  • 28
    • 84914117233 scopus 로고    scopus 로고
    • Efficacy and safety of lipegfilgrastim compared with placebo in elderly patients with non-small cell lung cancer receiving cisplatin/etoposide chemotherapy [poster]
    • Presented at, Manchester, UK, 25-27 October
    • Volovat C, Bondarenko IM, Gladkov OA, et al. Efficacy and safety of lipegfilgrastim compared with placebo in elderly patients with non-small cell lung cancer receiving cisplatin/etoposide chemotherapy [poster]. Presented at the Annual Meeting of the International Society of Geriatric Oncology, Manchester, UK, 25-27 October 2012
    • (2012) The Annual Meeting of the International Society of Geriatric Oncology
    • Volovat, C.1    Bondarenko, I.M.2    Gladkov, O.A.3
  • 29
    • 33750547396 scopus 로고    scopus 로고
    • Haematological malignancies developing in previously healthy individuals who received haematopoietic growth factors: Report from the research on adverse drug events and reports (radar) project
    • Bennett CL, Evens AM, Andritsos LA, et al. Haematological malignancies developing in previously healthy individuals who received haematopoietic growth factors: report from the Research on Adverse Drug Events and Reports (RADAR) project. Br J Haematol 2006;135:642-50
    • (2006) Br J Haematol , vol.135 , pp. 642-650
    • Bennett, C.L.1    Evens, A.M.2    Andritsos, L.A.3
  • 30
    • 9644265310 scopus 로고    scopus 로고
    • Splenic rupture in a parental donor undergoing peripheral blood progenitor cell mobilization
    • Dincer AP, Gottschall J, Margolis DA. Splenic rupture in a parental donor undergoing peripheral blood progenitor cell mobilization. J Pediatr Hematol Oncol 2004;26:761-3
    • (2004) J Pediatr Hematol Oncol , vol.26 , pp. 761-763
    • Dincer, A.P.1    Gottschall, J.2    Margolis, D.A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.