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Support Care Cancer. 2018 Jan;26(1):7-20. doi: 10.1007/s00520-017-3854-x. Epub 2017 Sep 22.

A systematic literature review of the efficacy, effectiveness, and safety of filgrastim.

Author information

1
Department of Medicine, University of Washington, 1959 NE Pacific St, Seattle, WA, 98195, USA. dcdale@uw.edu.
2
Duke Cancer Institute, Duke University Medical Center, 30 Duke Medicine Circle, Duke South 25177 Morris Bldg, Durham, NC, 27710, USA.
3
Clinical Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
4
Global Biostatistical Sciences, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
5
Pre-Pivotal Drug Product Technologies, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
6
Global Scientific Affairs, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
7
Oxford PharmaGenesis Ltd, Tubney Warren Barn, Tubney, Oxford, OX13 5QJ, UK.
8
Department of Medicine, University of Washington, 1959 NE Pacific St, Seattle, WA, 98195, USA.
9
Public Health Sciences Division and Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, 98109, USA.

Abstract

PURPOSE:

Filgrastim (NEUPOGEN®) is the originator recombinant human granulocyte colony-stimulating factor widely used for preventing neutropenia-related infections and mobilizing hematopoietic stem cells. This report presents findings of a systematic literature review and meta-analysis of efficacy and safety of originator filgrastim to update previous reports.

METHODS:

A literature search of electronic databases, congress abstracts, and bibliographies of recent reviews was conducted to identify English-language reports of clinical trials and observational studies evaluating filgrastim in its US-approved indications up to February 2015. Two independent reviewers assessed titles/abstracts and full texts of publications, and extracted data from studies that compared originator filgrastim vs placebo or no treatment. For outcomes with sufficient homogeneous data reported across studies, meta-analysis was performed and relative risk (RR) determined. Data were summarized descriptively for all other evaluated outcomes.

RESULTS:

A total of 1194 unique articles evaluating originator filgrastim were identified, with 25 meeting eligibility criteria for data extraction: 18 randomized controlled trials, 2 nonrandomized clinical trials, and 5 observational studies. In chemotherapy-induced neutropenia (CIN), filgrastim vs placebo or no treatment significantly reduced febrile neutropenia incidence (RR 0.63, 95% CI 0.53-0.75) and grade 3 or 4 neutropenia incidence (RR 0.50, 95% CI 0.37-0.68). The most commonly reported adverse event (AE) with filgrastim was bone pain (RR 2.61, 95% CI 1.29-5.27 in CIN). Additional efficacy and safety outcomes are described within indications.

CONCLUSIONS:

This systematic literature review and meta-analysis confirms and updates previous reports on the efficacy and safety of originator filgrastim. Bone pain was the commonly reported AE associated with filgrastim use.

KEYWORDS:

Absolute neutrophil count; Granulocyte colony-stimulating factor; Meta-analysis; NEUPOGEN®; Neutropenia; Systematic review

PMID:
28939926
PMCID:
PMC5827957
DOI:
10.1007/s00520-017-3854-x
[Indexed for MEDLINE]
Free PMC Article

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