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Published in: Drugs 8/2002

01-06-2002 | Adis New Formulation Profile

Pegfilgrastim

Authors: Monique P. Curran, Karen L. Goa

Published in: Drugs | Issue 8/2002

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Abstract

  • ▴ Pegfilgrastim is a covalent conjugant of filgrastim (a recombinant human granulocyte colony-stimulating factor) and monomethoxypolyethylene glycol. It is administered as a single dose per myelosuppressive chemotherapy cycle to decrease the incidence of infection, as manifest by febrile neutropenia, in patients with nonmyeloid cancer.
  • ▴ Pegfilgrastim increases the terminal elimination half-life and decreases the apparent serum clearance of the drug in patients with nonmyeloid cancer. Serum concentrations of pegfilgrastim remain elevated during neutropenia but decline when the neutrophil count increases.
  • ▴ In phase III trials in patients with breast cancer and in a phase II trial in patients with non-Hodgkin’s lymphoma or Hodgkin’s disease, the mean duration of grade 4 neutropenia and the time to absolute neutrophil recovery during cycle 1 of chemotherapy was similar in recipients of single-dose pegfilgrastim or daily filgrastim.
  • ▴ In the larger of two phase III trials in patients with breast cancer, the incidence of febrile neutropenia over four cycles of chemotherapy was significantly lower in recipients of single-dose pegfilgrastim than that in recipients of daily injections of filgrastim. Moreover, the mean duration of grade 4 neutropenia in cycles 2 to 4 of chemotherapy was significantly lower in recipients of pegfilgrastim than that in recipients of daily filgrastim.
  • ▴ In comparative trials, there were no differences in the incidence and severity of adverse events, including skeletal pain, between single-dose pegfilgrastim and daily filgrastim in patients with nonmyeloid cancer receiving myelosuppressive chemotherapy.
Literature
1.
go back to reference NCCN practice guidelines for fever and neutropenia. Oncology 1999 May; 13 (Suppl.): 197–257 NCCN practice guidelines for fever and neutropenia. Oncology 1999 May; 13 (Suppl.): 197–257
2.
go back to reference Pizzo PA. Management of fever in patients with cancer and treatment-induced neutropenia. NEJM 1993 May 6; 328(18): 1323–32PubMedCrossRef Pizzo PA. Management of fever in patients with cancer and treatment-induced neutropenia. NEJM 1993 May 6; 328(18): 1323–32PubMedCrossRef
3.
go back to reference Frampton JE, Faulds D. Filgrastim. A reappraisal of pharmacoeconomic considerations in the prophylaxis and treatment of chemotherapy-induced neutropenia. Pharmacoeconomics 1996 Jan; 9(1): 76–96PubMedCrossRef Frampton JE, Faulds D. Filgrastim. A reappraisal of pharmacoeconomic considerations in the prophylaxis and treatment of chemotherapy-induced neutropenia. Pharmacoeconomics 1996 Jan; 9(1): 76–96PubMedCrossRef
4.
go back to reference Frampton JE, Lee CR, Faulds D. Filgrastim. A review of its pharmacological properties and therapeutic efficacy in neutropenia. Drugs 1994 Nov; 48(5): 731–60PubMedCrossRef Frampton JE, Lee CR, Faulds D. Filgrastim. A review of its pharmacological properties and therapeutic efficacy in neutropenia. Drugs 1994 Nov; 48(5): 731–60PubMedCrossRef
5.
go back to reference Delgardo C, Francis GE, Fisher D. The uses and properties of PEG-linked proteins. Crit Rev Ther Drug Carrier System 1992, 249–304 Delgardo C, Francis GE, Fisher D. The uses and properties of PEG-linked proteins. Crit Rev Ther Drug Carrier System 1992, 249–304
6.
go back to reference 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 Dec; 27(12): 1724–34PubMedCrossRef 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 Dec; 27(12): 1724–34PubMedCrossRef
7.
go back to reference 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 Jul; 7: 2085–90PubMed 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 Jul; 7: 2085–90PubMed
8.
go back to reference Farese AM, Roskos L, Stead RB, et al. r-metHuG-CSF-SD/01 significantly improves neutrophil recovery in myelosuppressed nonhuman primates [abstract no. 204]. Blood 1999 Nov 15; 94 (Suppl. 1. Part 1): 49 Farese AM, Roskos L, Stead RB, et al. r-metHuG-CSF-SD/01 significantly improves neutrophil recovery in myelosuppressed nonhuman primates [abstract no. 204]. Blood 1999 Nov 15; 94 (Suppl. 1. Part 1): 49
9.
go back to reference de Haan G, Ausema A, Wilkens M, et al. Efficient mobilization of haematopoietic progenitors after a single injection of pegylated recombinant human granulocyte colony-stimulating factor in mouse strains with distinct marrow-cell pool sizes. Br J Haematol 2000 Sep; 110(3): 638–46PubMedCrossRef de Haan G, Ausema A, Wilkens M, et al. Efficient mobilization of haematopoietic progenitors after a single injection of pegylated recombinant human granulocyte colony-stimulating factor in mouse strains with distinct marrow-cell pool sizes. Br J Haematol 2000 Sep; 110(3): 638–46PubMedCrossRef
10.
go back to reference Johnston E, Crawford J, Blackwell S, et al. Randomized, doseescalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 2000 Jul; 18(13): 2522–8PubMed Johnston E, Crawford J, Blackwell S, et al. Randomized, doseescalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 2000 Jul; 18(13): 2522–8PubMed
11.
go back to reference Allen RC, Mireles MA, Welch W, et al. Phase I study comparing daily filgrastim and single dose sustained-duration filgrastim in normal volunteers: effects on neutrophil respiratory burst activities [abstract no. 3944]. Blood 1999 Nov 15; 94 (Suppl. 1. Part 2): 172 Allen RC, Mireles MA, Welch W, et al. Phase I study comparing daily filgrastim and single dose sustained-duration filgrastim in normal volunteers: effects on neutrophil respiratory burst activities [abstract no. 3944]. Blood 1999 Nov 15; 94 (Suppl. 1. Part 2): 172
12.
go back to reference 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 high-risk stage II or stage III/IV breast cancer. J Clin Oncol 2002 Feb 1; 20(3): 727–31PubMedCrossRef 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 high-risk stage II or stage III/IV breast cancer. J Clin Oncol 2002 Feb 1; 20(3): 727–31PubMedCrossRef
13.
go back to reference Yowell SL, Crawford J, Holmes FA, et al. Sustained-duration, once-per-chemotherapy-cycle pegfilgrastim demonstrates highly efficient, self-regulating, neutrophil-dependent elimination [abstract no. 170]. Pharmacotherapy 2001 Oct; 21: 1281 Yowell SL, Crawford J, Holmes FA, et al. Sustained-duration, once-per-chemotherapy-cycle pegfilgrastim demonstrates highly efficient, self-regulating, neutrophil-dependent elimination [abstract no. 170]. Pharmacotherapy 2001 Oct; 21: 1281
14.
go back to reference Roskos LK, Yang B, Schwab G, et al. A cytokinetic model describes the granulopoietic effects of r-metHuG-CSF-SD/01 (SD/01) and the homeostatic regulation of SD/01 clearance in normal volunteers [abstract no. PIII-81]. Clin Pharmacol Ther 1999 Feb; 65: 196CrossRef Roskos LK, Yang B, Schwab G, et al. A cytokinetic model describes the granulopoietic effects of r-metHuG-CSF-SD/01 (SD/01) and the homeostatic regulation of SD/01 clearance in normal volunteers [abstract no. PIII-81]. Clin Pharmacol Ther 1999 Feb; 65: 196CrossRef
15.
go back to reference Green M, Koelble H, Baselga E, et al. A randomized, double-blind, phase 3 study evaluating fixed-dose, once-per-cycle pegylated filgrastim (SD/01) vs daily filgrastim to support chemotherapy for breast cancer [abstract no. 90]. 37th Annual Meeting of Clinical Oncology; 2001 May 12–15; San Francisco (CA). Green M, Koelble H, Baselga E, et al. A randomized, double-blind, phase 3 study evaluating fixed-dose, once-per-cycle pegylated filgrastim (SD/01) vs daily filgrastim to support chemotherapy for breast cancer [abstract no. 90]. 37th Annual Meeting of Clinical Oncology; 2001 May 12–15; San Francisco (CA).
16.
go back to reference Vose JM, Crump M, Lazarus H, et al. Single dose pegfilgrastim (SD/01) is as effective as daily filgrastim following ESHAP chemotherapy for subjects with Non-Hodgkin’s lymphoma or Hodgkin’s disease: results of a randomized, open-label study [abstract no. 3322]. Proceedings of the 43rd Annual Meeting of the American Society of Hematology; 2001 Dec 10–13; Chicago (IL). Vose JM, Crump M, Lazarus H, et al. Single dose pegfilgrastim (SD/01) is as effective as daily filgrastim following ESHAP chemotherapy for subjects with Non-Hodgkin’s lymphoma or Hodgkin’s disease: results of a randomized, open-label study [abstract no. 3322]. Proceedings of the 43rd Annual Meeting of the American Society of Hematology; 2001 Dec 10–13; Chicago (IL).
17.
go back to reference Amgen Inc, Thousand Oaks, California. Physician Package Insert Neulasta™ (Pegfilgrastim). 2002 Amgen Inc, Thousand Oaks, California. Physician Package Insert Neulasta™ (Pegfilgrastim). 2002
Metadata
Title
Pegfilgrastim
Authors
Monique P. Curran
Karen L. Goa
Publication date
01-06-2002
Publisher
Springer International Publishing
Published in
Drugs / Issue 8/2002
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.2165/00003495-200262080-00012

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