Pegfilgrastim: An Investigational Sustained-Duration G-CSF With Once-Per-Cycle Dosing and Safety and Efficacy Equivalent to Those of Filgrastim

2.50
Hdl Handle:
http://hdl.handle.net/10755/165599
Category:
Abstract
Type:
Presentation
Title:
Pegfilgrastim: An Investigational Sustained-Duration G-CSF With Once-Per-Cycle Dosing and Safety and Efficacy Equivalent to Those of Filgrastim
Author(s):
Bedell, Cindi
Author Details:
Cindi Bedell, US Oncology, Houston, Texas, USA
Abstract:
Chemotherapy-induced neutropenia (CIN) is a serious consequence of cancer treatment that can substantially increase a patient's risk of infection and compromise treatment efficacy. Prophylactic G-CSF (Fligrastim [Neupogen]) administered after chemotherapy reduces neutropenia and related complications. It must be given by daily injection, however, possibly compromising adherence by necessitating extra office visits or administration by patients or caregivers who must master home administration without nursing support. Pegfilgrastim, a sustained-duration formulation of Filgrastim created by adding polyethylene glycol to the Filgrastim molecule, is given only once per chemotherapy cycle. Owing to a novel clearance mechanism, pegfilgrastim stays in the body through the absolute neutrophil count (ANC) nadir, leaving only as the ANC rises. Pegfilgrastim is not removed by the kidneys like Filgrastim, but is instead cleared from the circulation through binding to neutrophils and neutrophil precursors. When the ANC is low there are fewer neutrophils, so the blood levels of pegfilgrastim remain high. This unique self-regulating mechanism protects patients from neutropenia in a patient-specific manner according to their ANC kinetics after chemotherapy. Clinical trials in patients with solid tumors and hematologic malignancies including lung cancer, breast cancer, and non-Hodgkin's lymphoma have shown that pegfilgrastim given prophylactically once-per-cycle is at least as safe and effective as a course of daily Filgrastim. A single injection of pegfilgrastim per chemotherapy cycle was as effective as Filgrastim in reducing days of severe neutropenia and the incidence of febrile neutropenia (FN) in all cycles. In the largest phase III trial in breast cancer patients treated with AT (doxorubicin/docetaxel), pegfilgrastim compared to Filgrastim was associated with significantly less FN over all cycles (9% versus 18%, P = 0.029). A median of 10 daily injections of Filgrastim was administered per cycle compared to a single dose of pegfilgrastim. Pegfilgrastim is well tolerated with side effects similar to those with Filgrastim; bone pain did not differ between pegfilgrastim and Filgrastim in randomized blinded clinical trials. Pegfilgrastim is a novel colony-stimulating factor that can simplify how prophylactic growth factors are given after chemotherapy. Minimizing the number of injections given on successive days has positive implications for both patients and nurses.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2002
Conference Name:
27th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Washington, D.C., USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titlePegfilgrastim: An Investigational Sustained-Duration G-CSF With Once-Per-Cycle Dosing and Safety and Efficacy Equivalent to Those of Filgrastimen_GB
dc.contributor.authorBedell, Cindien_US
dc.author.detailsCindi Bedell, US Oncology, Houston, Texas, USAen_US
dc.identifier.urihttp://hdl.handle.net/10755/165599-
dc.description.abstractChemotherapy-induced neutropenia (CIN) is a serious consequence of cancer treatment that can substantially increase a patient's risk of infection and compromise treatment efficacy. Prophylactic G-CSF (Fligrastim [Neupogen]) administered after chemotherapy reduces neutropenia and related complications. It must be given by daily injection, however, possibly compromising adherence by necessitating extra office visits or administration by patients or caregivers who must master home administration without nursing support. Pegfilgrastim, a sustained-duration formulation of Filgrastim created by adding polyethylene glycol to the Filgrastim molecule, is given only once per chemotherapy cycle. Owing to a novel clearance mechanism, pegfilgrastim stays in the body through the absolute neutrophil count (ANC) nadir, leaving only as the ANC rises. Pegfilgrastim is not removed by the kidneys like Filgrastim, but is instead cleared from the circulation through binding to neutrophils and neutrophil precursors. When the ANC is low there are fewer neutrophils, so the blood levels of pegfilgrastim remain high. This unique self-regulating mechanism protects patients from neutropenia in a patient-specific manner according to their ANC kinetics after chemotherapy. Clinical trials in patients with solid tumors and hematologic malignancies including lung cancer, breast cancer, and non-Hodgkin's lymphoma have shown that pegfilgrastim given prophylactically once-per-cycle is at least as safe and effective as a course of daily Filgrastim. A single injection of pegfilgrastim per chemotherapy cycle was as effective as Filgrastim in reducing days of severe neutropenia and the incidence of febrile neutropenia (FN) in all cycles. In the largest phase III trial in breast cancer patients treated with AT (doxorubicin/docetaxel), pegfilgrastim compared to Filgrastim was associated with significantly less FN over all cycles (9% versus 18%, P = 0.029). A median of 10 daily injections of Filgrastim was administered per cycle compared to a single dose of pegfilgrastim. Pegfilgrastim is well tolerated with side effects similar to those with Filgrastim; bone pain did not differ between pegfilgrastim and Filgrastim in randomized blinded clinical trials. Pegfilgrastim is a novel colony-stimulating factor that can simplify how prophylactic growth factors are given after chemotherapy. Minimizing the number of injections given on successive days has positive implications for both patients and nurses.en_GB
dc.date.available2011-10-27T12:21:35Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:21:35Z-
dc.conference.date2002en_US
dc.conference.name27th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationWashington, D.C., USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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