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一项III期随机非劣效性研究,比较生物类似药非格司亭与原研非格司亭对乳腺癌患者化疗引起的中性粒细胞减少症的疗效和安全性。

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.

作者信息

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

机构信息

Hospital Pérola Byington, Centro de Referência da Saúde da Mulher, São Paulo/SP, Brazil.

Hospital Universitário de Brasília, Brasília/DF, Brazil.

出版信息

Clinics (Sao Paulo). 2016 Oct 1;71(10):586-592. doi: 10.6061/clinics/2016(10)06.

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 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¯).

摘要

目的

比较两种非格司亭制剂在控制化疗引起的中性粒细胞减少方面的疗效和安全性,并评估受试药物相对于原研药的非劣效性。

方法

本III期非劣效性研究采用随机、多中心、开放标签设计。患者按1:1的比例随机分组,每位患者随访6周。在两个研究组中,非格司亭均以每日5mg/kg体重的剂量皮下给药。主要终点是第一个治疗周期中4级中性粒细胞减少的发生率。次要终点包括4级中性粒细胞减少的持续时间、抗非格司亭抗体的产生以及不良事件、实验室异常、发热性中性粒细胞减少和任何级别的中性粒细胞减少的发生率。

结果

主要疗效分析表明受试药物与原研药相比具有非劣效性;两组中性粒细胞减少发生率的90%置信区间(CI)上限(12.61%)低于既定的非劣效界值。两种治疗在次要终点和安全性方面相似。

结论

基于第一个治疗周期中4级中性粒细胞减少的发生率,受试药物的疗效和安全性概况与原研产品相似。本研究支持巴西卫生监督局(Anvisa)批准巴西制药行业生产的首个生物类似药(Fiprima¯)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b92/5054975/364d834a3e55/cln-71-10-586-g001.jpg

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