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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
Hegg, Roberto; Mattar, André; Matos-Neto, João Nunes de; Pedrini, José Luiz; Aleixo, Sabina Bandeira; Rocha, Roberto Odebrecht; Cramer-Junior, Renato Peixoto; van-Eyll-Rocha, Sylvie.
Affiliation
  • Hegg, Roberto; Hospital Pérola Byington. Centro de Referência da Saúde da Mulher. São Paulo. BR
  • Mattar, André; Hospital Pérola Byington. Centro de Referência da Saúde da Mulher. São Paulo. BR
  • Matos-Neto, João Nunes de; Hospital Pérola Byington. Centro de Referência da Saúde da Mulher. São Paulo. BR
  • Pedrini, José Luiz; Hospital Pérola Byington. Centro de Referência da Saúde da Mulher. São Paulo. BR
  • Aleixo, Sabina Bandeira; Hospital Pérola Byington. Centro de Referência da Saúde da Mulher. São Paulo. BR
  • Rocha, Roberto Odebrecht; Hospital Pérola Byington. Centro de Referência da Saúde da Mulher. São Paulo. BR
  • Cramer-Junior, Renato Peixoto; Hospital Pérola Byington. Centro de Referência da Saúde da Mulher. São Paulo. BR
  • van-Eyll-Rocha, Sylvie; Hospital Pérola Byington. Centro de Referência da Saúde da Mulher. São Paulo. BR
Clinics ; Clinics;71(10): 586-592, Oct. 2016. tab, graf
Article de En | LILACS | ID: lil-796864
Bibliothèque responsable: BR1.1
ABSTRACT

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 11 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¯).
Sujet(s)
Mots clés

Texte intégral: 1 Indice: LILACS Sujet Principal: Tumeurs du sein / Produits pharmaceutiques biosimilaires / Filgrastim / Agents hématologiques / Neutropénie Type d'étude: Clinical_trials Limites du sujet: Adult / Female / Humans langue: En Texte intégral: Clinics Thème du journal: MEDICINA Année: 2016 Type: Article

Texte intégral: 1 Indice: LILACS Sujet Principal: Tumeurs du sein / Produits pharmaceutiques biosimilaires / Filgrastim / Agents hématologiques / Neutropénie Type d'étude: Clinical_trials Limites du sujet: Adult / Female / Humans langue: En Texte intégral: Clinics Thème du journal: MEDICINA Année: 2016 Type: Article