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A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients

OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label...

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Autores principales: Hegg, Roberto, Mattar, André, de Matos, João Nunes, Pedrini, José Luiz, Aleixo, Sabina Bandeira, Rocha, Roberto Odebrecht, Cramer, Renato Peixoto, van-Eyll-Rocha, Sylvie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5054975/
https://www.ncbi.nlm.nih.gov/pubmed/27759847
http://dx.doi.org/10.6061/clinics/2016(10)06
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author Hegg, Roberto
Mattar, André
de Matos, João Nunes
Pedrini, José Luiz
Aleixo, Sabina Bandeira
Rocha, Roberto Odebrecht
Cramer, Renato Peixoto
van-Eyll-Rocha, Sylvie
author_facet Hegg, Roberto
Mattar, André
de Matos, João Nunes
Pedrini, José Luiz
Aleixo, Sabina Bandeira
Rocha, Roberto Odebrecht
Cramer, Renato Peixoto
van-Eyll-Rocha, Sylvie
author_sort Hegg, Roberto
collection PubMed
description OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa's approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima®).
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spelling pubmed-50549752016-10-11 A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients Hegg, Roberto Mattar, André de Matos, João Nunes Pedrini, José Luiz Aleixo, Sabina Bandeira Rocha, Roberto Odebrecht Cramer, Renato Peixoto van-Eyll-Rocha, Sylvie Clinics (Sao Paulo) Clinical Science OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa's approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima®). Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo 2016-10 2016-10 /pmc/articles/PMC5054975/ /pubmed/27759847 http://dx.doi.org/10.6061/clinics/2016(10)06 Text en Copyright © 2016 CLINICS http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium or format, provided the original work is properly cited.
spellingShingle Clinical Science
Hegg, Roberto
Mattar, André
de Matos, João Nunes
Pedrini, José Luiz
Aleixo, Sabina Bandeira
Rocha, Roberto Odebrecht
Cramer, Renato Peixoto
van-Eyll-Rocha, Sylvie
A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients
title A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients
title_full A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients
title_fullStr A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients
title_full_unstemmed A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients
title_short A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients
title_sort phase iii, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients
topic Clinical Science
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5054975/
https://www.ncbi.nlm.nih.gov/pubmed/27759847
http://dx.doi.org/10.6061/clinics/2016(10)06
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