Produção Nacional
Revisado por pares
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
2016; Elsevier BV; Volume: 71; Issue: 10 Linguagem: Inglês
10.6061/clinics/2016(10)06
ISSN1980-5322
AutoresRoberto Hegg, André Mattar, João Nunes de Matos, José Luiz Pedrini, Sabina B. Aleixo, Roberto Odebrecht Rocha, Renato Peixoto Cramer, Sylvie van-Eyll-Rocha,
Tópico(s)Blood disorders and treatments
ResumoOBJECTIVES:To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapyinduced 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 (Fiprimas).
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