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Drugs
Erschienen in: Drugs 8/2002

01.06.2002 | Adis New Formulation Profile

Pegfilgrastim

verfasst von: Monique P. Curran, Karen L. Goa

Erschienen in: Drugs | Ausgabe 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.
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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
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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
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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
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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).
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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).
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Metadaten
Titel
Pegfilgrastim
verfasst von
Monique P. Curran
Karen L. Goa
Publikationsdatum
01.06.2002
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 8/2002
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.2165/00003495-200262080-00012

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