Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

Blackwell K.; Gascon P.; Jones C. M.; Nixon A.; Krendyukov A.; Nakov R.; Li Y.; Harbeck N.

首页> 外文期刊>Annals of oncology: official journal of the European Society for Medical Oncology >Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

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Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

机译：两种随机双盲试验的汇总分析比较乳腺癌中的帕格菲尔格斯利用帕格菲尔格斯的综合生物素拉 - EP2006

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Background: Following the functional and physicochemical characterization of a proposed biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar safety and efficacy to the reference product in a sensitive patient population.

机译：背景技术：在拟议的生物仿制性的比较临床研究的功能和物理化学表征之后，通过在敏感的患者群体中证明与参考产物类似的安全性和功效来帮助确认生物脂肪酸。

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《Annals of oncology: official journal of the European Society for Medical Oncology》 |2017年第9期|共6页
作者
Blackwell K.; Gascon P.; Jones C. M.; Nixon A.; Krendyukov A.; Nakov R.; Li Y.; Harbeck N.;
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作者单位

Duke Univ Dept Oncol DUMC Durham NC USA;

Hosp Gen Valle Hebron Med Oncol Dept Barcelona Spain;

Jones Clin Germantown MD USA;

Fowler Family Ctr Canc Care Jonesboro AR USA;

Hexal AG Holzkirchen Oberhaching Germany;

Hexal AG Holzkirchen Oberhaching Germany;

Sandoz Inc Princeton NJ USA;

Univ Munich LMU Dept Obstet &

Gynecol Breast Ctr Munich Germany;

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原文格式 PDF
正文语种 eng
中图分类肿瘤学;
关键词
pegfilgrastim; granulocyte colony-stimulating factor; biosimilar; breast cancer; neutropenia;

机译：pegfilgrastim;粒细胞菌落刺激因子;生物酸蛋白;乳腺癌;中性粒细胞病;

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1. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer [J] . Blackwell K., Gascon P., Jones C. M., Annals of oncology: official journal of the European Society for Medical Oncology . 2017,第9期

机译：两种随机双盲试验的汇总分析比较乳腺癌中的帕格菲尔格斯利用帕格菲尔格斯的综合生物素拉 - EP2006
2. 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] . Kimberly Blackwell, Roman Donskih, C. Michael Jones, The oncologist . 2016,第7期

机译：拟议的生物仿制药LA-EP2006与参考培格非司亭用于预防早期接受骨髓抑制或新辅助化疗的乳腺癌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
3. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer [J] . Harbeck Nadia, Lipatov Oleg, Frolova Mona, Future oncology . 2016,第11期

机译：随机双盲研究比较拟议的生物仿制药LA-EP2006与参比培非斯汀治疗乳腺癌
4. META-ANALYSIS OF RANDOMIZED TRIALS OF TAMOXIFEN FOR EARLY BREAST CANCER [C] . V. ALBA-FERNANDEZ, J. MUNOZ-GARCIA Applied Simulation and Modelling . 2001

机译：他莫昔芬用于早期乳腺癌的随机试验的meta分析
5. A Cost-utility Analysis of Biosimilar Infliximab Compared to Reference Infliximab in Adult Switch Patients with Crohn's Disease: A Canadian Analysis [D] . Hughes, Avery. 2018

机译：生物纤维生素infiximab的成本实用性分析与成人交换患者参考incriximab患者克罗恩病患者：加拿大分析
6. Pooled analysis of two randomized double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer [O] . K. Blackwell, P. Gascon, C. M. Jones, -1

机译：两项随机双盲试验的合并分析比较了拟议的生物仿制药LA-EP2006与参比派非格拉斯汀在乳腺癌中的应用
7. Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy [O] . Kalpna Desai, Priya Misra, Sanyukta Kher, 2018

机译：临床确认，证明生物仿制性PEGFILGRASTIM的相似性：用于拟议的生物仿生蛋白的3路随机性等效研究与接受骨髓抑制化疗的乳腺癌患者的美国许可和欧盟批准的参考产品
8. Randomized Prospective Trial Comparing Paravertebral Block and General Anesthesia for Operative Treatment of Breast Cancer [R] . Weltz, C. R. 2003

机译：随机前瞻性试验比较椎旁阻滞与全身麻醉手术治疗乳腺癌

Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer

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