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首页> 美国卫生研究院文献>Current Oncology >Real World Clinical Experience of Biosimilar G-CSF (Grastofil) for Autologous Peripheral Blood Stem Cell Mobilization: Single Center Experience in Canada Following Early Adoption
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Real World Clinical Experience of Biosimilar G-CSF (Grastofil) for Autologous Peripheral Blood Stem Cell Mobilization: Single Center Experience in Canada Following Early Adoption

机译：生物仿制性G-CSF（Grastofil）的真实世界临床经验用于自体外周血干细胞动员：加拿大单一中心经验早期采用后

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Introduction: Granulocyte colony-stimulating factor (G-CSF) is the first line treatment for mobilization, most commonly using a regimen of daily filgrastim. The use of biosimilars can provide substantial cost savings to the health care system while delivering comparable efficacy outcomes. In 2016, the Saskatchewan Cancer Agency was a leader in Canada, instituting formulary changed from a G-CSF originator product to a cost savings alternative biosimilar for stem cell mobilization prior to autologous stem cell transplant (ASCT) and for engraftment. The purpose of this study was to investigate the clinical comparability of biosimilar G-CSF to its reference product in a real-world clinical setting and to validate use of the biosimilar in mobilization and engraftment—an indication which had been granted by extrapolation. Methods: A retrospective chart review was completed including all patients diagnosed with a hematological malignancy between 2012 and 2018 who underwent ASCT. To assess real-world outcomes across a diverse population, successful CD34+ stem cell collection was compared between patients mobilized with originator filgrastim, Neupogen, and biosimilar filgrastim, Grastofil. Additional comparisons included the number of apheresis required, time to absolute neutrophil count (ANC) engraftment, platelet engraftment, length of hospital stay, and Plerixafor use. Results: 217 patients were mobilized and transplanted during the study period. There was no statistically significant difference in success rate between patients mobilized with biosimilar filgrastim and those who had received originator G-CSF (100% vs. 92.4%, p = 0.075). Neither disease type, nor concurrent chemomobilization regimen resulted in a detectable difference between the two G-CSF products in successful stem cell harvest. Engraftment was highly similar between groups, as demonstrated by ANC recovery (11.6 days Neupogen vs. 11.6 days Grastofil), platelet recovery (14.0 days Neupogen vs. 14.2 days Grastofil), and total length of hospital stay (22.4 days Neupogen vs. 22.3 days Grastofil). No statistically significant difference in adjunctive use of Plerixafor® was observed between Neupogen and Grastofil patients (25.9% vs. 23.4%, p = 0.72). Conclusion: Extrapolation of indications for biosimilars is justified. This real-world evidence builds upon registrational studies to confirm that no clinically meaningful differences were detected between originator Neupogen and biosimilar Grastofil in the setting of PBSC mobilization and engraftment post ASCT. Biosimilars are as safe and effective as originator products. Implementation across all approved indications without hesitation maximizes cost savings to the provincial system, allowing for more optimal allocation of health care resources.
机译：介绍：粒细胞菌落刺激因子（G-CSF）是动员的第一线处理，最常用的是使用每日菲格拉特的方案。生物仿制物的使用可以在提供可比疗效结果的同时为医疗保健系统提供大量成本节省。 2016年，萨斯喀彻温癌癌症局是加拿大的领导者，在自体干细胞移植（ASCT）和植入之前，从G-CSF发起人员产品改变为节省替代生物仿制剂的成本储蓄替代生物仿制物。本研究的目的是在实际临床环境中探讨生物邮件G-CSF对其参考产品的临床可比性，并验证生物仿制性和植入中的使用 - 这是通过外推授予的指示。方法：备注图表综述，包括诊断患有2012年和2018年的血液恶性肿瘤的所有患者。为了评估各种人群的现实成果，比较了用发芽丝绒，新核原因和生物仿制物菲拉米氏菌，Grastofil动员的患者的CD34 +干细胞收集。额外的比较包括所需的吸血病次数，绝对中性粒细胞计数（ANC）植入，血小板植入，住院时间长度和Plerixafor使用。结果：在研究期间动员和移植217名患者。使用生物仿生菲拉斯群体和收发者G-CSF的人（100％与92.4％，P = 0.075）之间没有统计学上显着差异。既不都是疾病类型，也不是同时的化学毒化方案导致两种G-CSF产品之间成功的干细胞收获的可检测差异。植入在群体之间具有高度相似，如ANC恢复（11.6天Neupogen vs.11.6天Grastofil），血小板回收（14.0天Neupogen vs.14.2天Grastofil），以及住院住宿总长度（22.4天Neupogen vs.2.3天grastofil）。在Neupogen和Grastofil患者之间观察到Plerixafor®的辅助使用差异差异（25.9％，P = 0.72）。结论：生物仿制性的引起的外推是合理的。这种现实世界的证据基于注册研究，以确认在发起的PBSC动员和植入后的发起植物Neupogen和BioSimilar Grastofil之间未检测到临床上有意义的差异。生物仿制剂与发起者产品一样安全有效。在毫不犹豫地实现所有批准的指示，最大限度地提高了省级系统的成本，从而允许更优化的医疗保健资源分配。

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