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Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis

SIMPLE SUMMARY: Febrile neutropenia is the serious side-effect associated with myelosuppressive chemotherapy. Filgrastim, the first granulocyte colony-stimulating factor (G-CSF) was approved by the Food and Drug Administration for the treatment of neutropenia. Subsequently, pegfilgrastim (long-actin...

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Autores principales: Rastogi, Shruti, Kalaiselvan, Vivekananda, Ali, Sher, Ahmad, Ajaz, Guru, Sameer Ahmad, Sarwat, Maryam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8533340/
https://www.ncbi.nlm.nih.gov/pubmed/34681169
http://dx.doi.org/10.3390/biology10101069
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author Rastogi, Shruti
Kalaiselvan, Vivekananda
Ali, Sher
Ahmad, Ajaz
Guru, Sameer Ahmad
Sarwat, Maryam
author_facet Rastogi, Shruti
Kalaiselvan, Vivekananda
Ali, Sher
Ahmad, Ajaz
Guru, Sameer Ahmad
Sarwat, Maryam
author_sort Rastogi, Shruti
collection PubMed
description SIMPLE SUMMARY: Febrile neutropenia is the serious side-effect associated with myelosuppressive chemotherapy. Filgrastim, the first granulocyte colony-stimulating factor (G-CSF) was approved by the Food and Drug Administration for the treatment of neutropenia. Subsequently, pegfilgrastim (long-acting G-CSF) and filgrastim biosimilars were developed to have comparable efficacy to filgrastim. Therefore, it is necessary to produce a systematic review and meta-analysis that provides evidence that filgrastim is more efficacious than placebo/no-treatment, as it provides evidence on the comparable efficacy of filgrastim versus pegfilgrastim and biosimilar filgrastim. ABSTRACT: Background: The aim of this review and meta-analysis was to identify, assess, meta-analyze and summarize the comparative effectiveness and safety of filgrastim in head-to-head trials with placebo/no treatment, pegfilgrastim (and biosimilar filgrastim to update advances in the field. Methods: The preferred reporting items for systematic reviews and meta-analyses PRISMA statement were applied, and a random-effect model was used. Primary endpoints were the rate and duration of grade 3 or 4 neutropenia, and an incidence rate of febrile neutropenia. Secondary endpoints were time to absolute neutrophil count ANC recovery, depth of ANC nadir (lowest ANC), neutropenia-related hospitalization and other neutropenia-related complications. For filgrastim versus biosimilar filgrastim comparison, the primary efficacy endpoint was the mean difference in duration of severe neutropenia DSN. Results: A total of 56 studies were considered that included data from 13,058 cancer patients. The risk of febrile neutropenia in filgrastim versus placebo/no treatment was not statistically different. The risk ratio for febrile neutropenia was 0.58, a 42% reduction in favor of filgrastim. The most reported adverse event with FIL was bone pain. For pegfilgrastim versus filgrastim, no statistically significant difference was noted. The risk ratio was 0.90 (95% CI 0.67 to 1.12). The overall difference in duration of severe neutropenia between filgrastim and biosimilar filgrastim was not statistically significant. The risk ratio was 1.03 (95% CI 0.93 to 1.13). Conclusions: Filgrastim was effective and safe in reducing febrile neutropenia and related complications, compared to placebo/no treatment. No notable differences were found between pegfilgrastim and filgrastim in terms of efficacy and safety. However, a similar efficacy profile was observed with FIL and its biosimilars.
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spelling pubmed-85333402021-10-23 Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis Rastogi, Shruti Kalaiselvan, Vivekananda Ali, Sher Ahmad, Ajaz Guru, Sameer Ahmad Sarwat, Maryam Biology (Basel) Article SIMPLE SUMMARY: Febrile neutropenia is the serious side-effect associated with myelosuppressive chemotherapy. Filgrastim, the first granulocyte colony-stimulating factor (G-CSF) was approved by the Food and Drug Administration for the treatment of neutropenia. Subsequently, pegfilgrastim (long-acting G-CSF) and filgrastim biosimilars were developed to have comparable efficacy to filgrastim. Therefore, it is necessary to produce a systematic review and meta-analysis that provides evidence that filgrastim is more efficacious than placebo/no-treatment, as it provides evidence on the comparable efficacy of filgrastim versus pegfilgrastim and biosimilar filgrastim. ABSTRACT: Background: The aim of this review and meta-analysis was to identify, assess, meta-analyze and summarize the comparative effectiveness and safety of filgrastim in head-to-head trials with placebo/no treatment, pegfilgrastim (and biosimilar filgrastim to update advances in the field. Methods: The preferred reporting items for systematic reviews and meta-analyses PRISMA statement were applied, and a random-effect model was used. Primary endpoints were the rate and duration of grade 3 or 4 neutropenia, and an incidence rate of febrile neutropenia. Secondary endpoints were time to absolute neutrophil count ANC recovery, depth of ANC nadir (lowest ANC), neutropenia-related hospitalization and other neutropenia-related complications. For filgrastim versus biosimilar filgrastim comparison, the primary efficacy endpoint was the mean difference in duration of severe neutropenia DSN. Results: A total of 56 studies were considered that included data from 13,058 cancer patients. The risk of febrile neutropenia in filgrastim versus placebo/no treatment was not statistically different. The risk ratio for febrile neutropenia was 0.58, a 42% reduction in favor of filgrastim. The most reported adverse event with FIL was bone pain. For pegfilgrastim versus filgrastim, no statistically significant difference was noted. The risk ratio was 0.90 (95% CI 0.67 to 1.12). The overall difference in duration of severe neutropenia between filgrastim and biosimilar filgrastim was not statistically significant. The risk ratio was 1.03 (95% CI 0.93 to 1.13). Conclusions: Filgrastim was effective and safe in reducing febrile neutropenia and related complications, compared to placebo/no treatment. No notable differences were found between pegfilgrastim and filgrastim in terms of efficacy and safety. However, a similar efficacy profile was observed with FIL and its biosimilars. MDPI 2021-10-19 /pmc/articles/PMC8533340/ /pubmed/34681169 http://dx.doi.org/10.3390/biology10101069 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Rastogi, Shruti
Kalaiselvan, Vivekananda
Ali, Sher
Ahmad, Ajaz
Guru, Sameer Ahmad
Sarwat, Maryam
Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis
title Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis
title_full Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis
title_fullStr Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis
title_full_unstemmed Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis
title_short Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis
title_sort efficacy and safety of filgrastim and its biosimilars to prevent febrile neutropenia in cancer patients: a prospective study and meta-analysis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8533340/
https://www.ncbi.nlm.nih.gov/pubmed/34681169
http://dx.doi.org/10.3390/biology10101069
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