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