首页> 美国卫生研究院文献>Annals of Oncology >Comparison of EP2006 a filgrastim biosimilar to the reference: a phase III randomized double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

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Comparison of EP2006 a filgrastim biosimilar to the reference: a phase III randomized double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

机译：非格司亭生物仿制药EP2006与参考文献的比较：一项III期随机双盲临床研究用于预防接受骨髓抑制性化疗的乳腺癌患者的严重中性粒细胞减少

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BackgroundBiosimilars of filgrastim are in widespread clinical use in Europe. This phase III study compares biosimilar filgrastim (EP2006), with the US-licensed reference product, Neupogen^®, in breast cancer patients receiving (neo)adjuvant myelosuppressive chemotherapy (TAC).

机译：背景技术非格司亭的生物仿制药在欧洲已广泛用于临床。这项III期研究比较了接受（新）辅助骨髓抑制化疗（TAC）的乳腺癌患者中的生物仿制药非格司亭（EP2006）和美国许可的参考产品Neupogen ^®。

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期刊名称 Annals of Oncology
作者
K. Blackwell; V. Semiglazov; D. Krasnozhon; I. Davidenko; L. Nelyubina; R. Nakov; G. Stiegler; P. Singh; A. Schwebig; S. Kramer; N. Harbeck;
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年(卷),期 -1(26),9
年度 -1
页码 1948–1953
总页数 6
原文格式 PDF
正文语种
中图分类肿瘤学;
关键词
granulocyte colony-stimulating factor filgrastim neutropenia biosimilars;

机译：粒细胞集落刺激因子;非格司亭;中性粒细胞减少症;生物仿制药;

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1. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy [J] . Blackwell K., Semiglazov V., Krasnozhon D., Annals of oncology: official journal of the European Society for Medical Oncology . 2015,第9期

机译：非格司亭生物仿制药EP2006与参考文献的比较：一项III期随机双盲临床研究，用于预防接受骨髓抑制性化疗的乳腺癌患者的严重中性粒细胞减少
2. Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy [J] . KBlackwell, PGascon, AKrendyukov, Annals of oncology: official journal of the European Society for Medical Oncology . 2018,第1期

机译：与EP2006，菲格拉特灭蚊和参考菲拉特交替治疗的安全性和有效性：III期，随机，双盲临床研究预防乳腺癌患者患髓抑制化疗的乳腺癌患者
3. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial [J] . Blackwell Kimberly, Donskih Roman, Jones C. Michael, The oncologist . 2016,第7期

机译：拟议的生物仿制药LA-EP2006与参考培格非司亭预防早期乳腺癌接受骨髓抑制辅助或新辅助化疗的中性粒细胞减少症的比较：培格非司亭随机肿瘤治疗（支持治疗）以评估比较治疗（PROTECT-2），a第三阶段，随机双盲试验
4. Effects of primary prophylaxis of neutropenia on outcomes, utilization and expenditures for elderly breast cancer patients receiving chemotherapy. [D] . Rajan, Suja S. 2009

机译：一级预防中性粒细胞减少对老年接受化疗的乳腺癌患者的结局，利用和支出的影响。
5. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) a Phase III Randomized Double-Blind Trial [O] . Kimberly Blackwell, Roman Donskih, C. Michael Jones, 2016

机译：拟议的生物仿制药LA-EP2006与参考培格非司亭预防早期乳腺癌接受骨髓抑制辅助或新辅助化疗的中性粒细胞减少症的比较：培格非司亭随机肿瘤治疗（支持治疗）以评估比较治疗（PROTECT-2）a第三阶段随机双盲试验
6. 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 [O] . Roberto Hegg, André Mattar, João Nunes de Matos-Neto, 100

机译：一项III期，随机，非劣效性研究，比较生物仿制药非格司亭与原发性非格司亭治疗乳腺癌患者化疗诱导的中性粒细胞减少症的疗效和安全性
7. Psychological Stress, Neutropenia and Infectious Disease in Patients Receiving Chemotherapy Treatment for Breast Cancer [R] . Bovbjerg, D. 1999

机译：乳腺癌化疗治疗患者的心理应激，中性粒细胞减少和传染病

Comparison of EP2006 a filgrastim biosimilar to the reference: a phase III randomized double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

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