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生物类似药(格拉索费尔)与参比生物制品(诺保思泰)在乳腺癌和淋巴瘤中的真实世界经验:一项加拿大单中心回顾性研究。

The Real-World Experience of the Biosimilar (Grastofil) to the Reference Biologic (Neupogen) in Breast Cancer and Lymphoma: A Canadian Single-Centre Retrospective Study.

作者信息

Wong Gina, Wang Katie, Pasetka Mark, Zhang Liying, Lou Julia, Majeed Habeeb, Flores Jerome, Lam Emily, DeAngelis Carlo

机构信息

Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON M4N 3M5, Canada.

Macrostat Inc., Toronto, ON L4B 4P4, Canada.

出版信息

Curr Oncol. 2022 Feb 23;29(3):1349-1369. doi: 10.3390/curroncol29030115.

Abstract

Febrile neutropenia (FN) is a common side effect of cytotoxic chemotherapy that may result in poor treatment outcomes. The short acting granulocyte colony stimulating factors (G-CSF) act to stimulate granulocytes to increase production of white blood cells. The filgrastim biosimilar is useful, as it may provide a cheaper and equally effective treatment to FN. This study explored the usage of the filgrastim biosimilar (Grastofil) and the reference biologic (Neupogen) in breast cancer and lymphoma patients. A retrospective chart review of patients receiving Grastofil from January 2017 to June 2019 or Neupogen for primary prophylaxis of FN from January 2013 to December 2017 was conducted. The endpoints included the incidence of FN and the occurrence of dose reduction (DR) and dose delay (DD). One hundred and fifty-three Grastofil patients were matched to 153 Neupogen patients. This cohort was further split into breast cancer ( = 275) and non-Hodgkin's lymphoma ( = 31) cohorts. After adjusting for chemotherapy cycles, the biosimilar filgrastim was non-inferior to the reference biologic based on FN incidence in addition to related outcomes including DR and DD.

摘要

发热性中性粒细胞减少症(FN)是细胞毒性化疗常见的副作用,可能导致治疗效果不佳。短效粒细胞集落刺激因子(G-CSF)可刺激粒细胞增加白细胞生成。非格司亭生物类似药很有用,因为它可能为FN提供更便宜且同样有效的治疗。本研究探讨了非格司亭生物类似药(Grastofil)和参比生物制品(Neupogen)在乳腺癌和淋巴瘤患者中的使用情况。对2017年1月至2019年6月接受Grastofil或2013年1月至2017年12月接受Neupogen进行FN一级预防的患者进行了回顾性病历审查。终点指标包括FN的发生率以及剂量减少(DR)和剂量延迟(DD)的发生情况。153例使用Grastofil的患者与153例使用Neupogen的患者进行匹配。该队列进一步分为乳腺癌(n = 275)和非霍奇金淋巴瘤(n = 31)队列。在调整化疗周期后,基于FN发生率以及包括DR和DD在内的相关结局,非格司亭生物类似药不劣于参比生物制品。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b2c/8947031/56fc2c0df54d/curroncol-29-00115-g001.jpg

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