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一项单中心、回顾性分析比较了 filgrastim-sndz 与 filgrastim 预防化疗引起的中性粒细胞减少症和自体干细胞移植后中性粒细胞恢复的疗效和安全性。

A single-center, retrospective analysis to compare the efficacy and safety of filgrastim-sndz to filgrastim for prophylaxis of chemotherapy-induced neutropenia and for neutrophil recovery following autologous stem cell transplantation.

机构信息

Department of Pharmacy, The Mount Sinai Hospital, One Gustave L. Levy Place, Box 1211, New York, NY, 10029-6574, USA.

Division of Hematology/Oncology, Tisch Cancer Institute, New York, NY, USA.

出版信息

Support Care Cancer. 2018 Mar;26(3):1013-1016. doi: 10.1007/s00520-017-3923-1. Epub 2017 Oct 8.

DOI:10.1007/s00520-017-3923-1
PMID:28990128
Abstract

Filgrastim-sndz (Zarxio®) was approved by the FDA in March 2015 as a biosimilar product of its reference product, filgrastim (Neupogen®) for all five indications. The NCCN Clinical Practice Guidelines has incorporated filgrastim-sndz into its recommendations as a category 1 recommendation for use in settings of febrile neutropenia, myelosuppressive chemotherapy administration, and post-hematopoietic stem cell transplant (HSCT). As a cost-saving initiative, our institution switched from filgrastim to filgrastim-sndz for all indications starting in March 2016. The purpose of this study was to assess for any difference in clinical or safety outcomes between filgrastim and filgrastim-sndz. This is an IRB-approved, single institution, 1-year retrospective chart review (September 2015 to August 2016) conducted in hospitalized adults who received either filgrastim or filgrastim-sndz either for prophylaxis of chemotherapy-induced myelosuppression or for neutrophil recovery after autologous HSCT. Our data showed no differences in duration of G-CSF therapy (7.96 vs. 8.5 days, P = 0.36), white blood count (WBC) (8.99 vs. 8.04, P = 0.28), absolute neutrophil count (ANC) (7.62 vs. 6.91 × 10/L, P = 0.36) at the time of granulocyte-colony stimulating factor (G-CSF) discontinuation, or safety of filgrastim and filgrastim-sndz. The efficacy and safety of filgrastim and filgrastim-sndz were similar for prophylaxis of chemotherapy-induced neutropenia and neutrophil recovery post-autologous HSCT.

摘要

珐博进-sndz(英文商品名:Zarxio®)于 2015 年 3 月获得 FDA 批准,作为原研药非格司亭(英文商品名:Neupogen®)的生物类似药,可用于所有五种适应证。NCCN 临床实践指南已将珐博进-sndz 纳入其建议中,作为发热性中性粒细胞减少症、骨髓抑制性化疗给药以及造血干细胞移植(HSCT)后使用的 1 类推荐。作为一项节省成本的举措,我们机构自 2016 年 3 月起,在所有适应证中开始将非格司亭转换为珐博进-sndz。本研究旨在评估非格司亭和珐博进-sndz 在临床或安全性结局方面是否存在差异。这是一项经过机构审查委员会批准的、单机构、为期 1 年的回顾性图表审查(2015 年 9 月至 2016 年 8 月),在接受非格司亭或珐博进-sndz 的住院成人患者中进行,这些患者接受非格司亭或珐博进-sndz 是为了预防化疗引起的骨髓抑制,或是为了自体 HSCT 后中性粒细胞的恢复。我们的数据显示,G-CSF 治疗的持续时间(7.96 天与 8.5 天,P=0.36)、白细胞计数(WBC)(8.99 天与 8.04 天,P=0.28)、在停用粒细胞集落刺激因子(G-CSF)时的绝对中性粒细胞计数(ANC)(7.62×10/L 与 6.91×10/L,P=0.36)以及非格司亭和珐博进-sndz 的安全性方面无差异。非格司亭和珐博进-sndz 在预防化疗引起的中性粒细胞减少症和自体 HSCT 后中性粒细胞恢复方面的疗效和安全性相似。

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本文引用的文献

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J Natl Compr Canc Netw. 2017 Dec;15(12):1520-1541. doi: 10.6004/jnccn.2017.0175.
2
Evaluation of a biosimilar granulocyte colony-stimulating factor (filgrastim XM02) for peripheral blood stem cell mobilization and transplantation: a single center experience in Japan.一种生物类似物粒细胞集落刺激因子(非格司亭XM02)用于外周血干细胞动员和移植的评估:日本的单中心经验
J Blood Med. 2017 Jan 24;8:5-12. doi: 10.2147/JBM.S123374. eCollection 2017.
3
Zarxio (Filgrastim-sndz): The First Biosimilar Approved by the FDA.
择捷美(重组人粒细胞刺激因子-sndz):首个获美国食品药品监督管理局批准的生物类似药。
P T. 2017 Jan;42(1):19-23.
4
Comparison of transplant outcomes and economic costs between biosimilar and originator filgrastim in allogeneic hematopoietic stem cell transplantation.生物类似药与原研非格司亭在异基因造血干细胞移植中的移植结局及经济成本比较。
Int J Hematol. 2016 Dec;104(6):709-719. doi: 10.1007/s12185-016-2085-0. Epub 2016 Aug 26.
5
The Role of Biosimilars.生物类似药的作用。
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10
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