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

• Published in: Supportive care in cancer Vol. 26; no. 1; pp. 7 - 20
• Main Authors: Dale, David C., Crawford, Jeffrey, Klippel, Zandra, Reiner, Maureen, Osslund, Timothy, Fan, Ellen, Morrow, Phuong Khanh, Allcott, Kim, Lyman, Gary H.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-01-2018; Springer; Springer Nature B.V
• Subjects: Chemotherapy; Clinical trials; Comparative analysis; Effectiveness; Evidence-based medicine; Filgrastim - administration & dosage; Filgrastim - pharmacology; Filgrastim - therapeutic use; Granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - pharmacology; Granulocyte Colony-Stimulating Factor - therapeutic use; Health aspects; Hematologic Agents - administration & dosage; Hematologic Agents - pharmacology; Hematologic Agents - therapeutic use; Hematopoietic stem cells; Humans; Infection; Literature reviews; Medical research; Medicine; Medicine & Public Health; Meta-analysis; Neutropenia; Nursing; Nursing Research; Oncology; Pain Medicine; Patient safety; Pegfilgrastim; Political aspects; Prevention; Rehabilitation Medicine; Respiratory system agents; Review; Review Article; Safety regulations; Systematic review; NEUPOGEN; Granulocyte colony-stimulating factor; Absolute neutrophil count; Meta-analysis; Neutropenia
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-017-3854-x

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.