不同粒细胞集落刺激因子生物类似药在动员外周血造血干细胞（PBSCs）进行自体移植（自体外周血造血干细胞移植，auto-PBSCT）中的有效性和安全性比较。

The comparison of effectiveness and safety between different biosimilars of G-CSF in the mobilization of peripheral blood stem cells (PBSCs) for autologous transplantation (autologous peripheral blood stem cell transplantation, auto-PBSCT).

机构信息

Department of Hematology, Blood Cancer and Bone Marrow Transplantation, Wroclaw University Hospital, Wroclaw, Lower Silesia, Poland.

Wroclaw Medical University, Wroclaw, Lower Silesia, Poland.

出版信息

J Clin Apher. 2020 Jan;35(1):4-8. doi: 10.1002/jca.21750. Epub 2019 Oct 30.

DOI:10.1002/jca.21750

PMID:31663634

Abstract

BACKGROUND

Autologous peripheral blood marrow stem cell transplantation (auto-PBSCT) preceded by high-dose chemotherapy is a well-known method of treatment for patients with hematological cancers. Performing the procedure entails obtaining from the patient their own stem cells from peripheral blood using G-CSF. Currently, various filgrastim biosimilars are widely used.

AIM OF THE STUDY

The purpose of this study is to compare the efficacy and safety of three different biosimilars of filgrastim in PBSC mobilization in patients with hematological malignancies.

MATERIALS AND METHODS

This is a retrospective analysis of 282 patients (118 women and 164 men) who underwent stem cells mobilization for auto-PBSCT in the Department of Hematology in Wroclaw in 2012-2014. Three filgrastim biosimilars were used: Tevagrastim (95), Nivestim (92), and Zarzio (95). Ninety patients (32%) were diagnosed with multiple myeloma, 55 (19%) with Hodgkin's lymphoma, 90 (32%) with NHLs, 20 (7%) with acute myeloid leukemia, and 27 (10%) with another hematological cancer.

RESULTS

The mean number of CD34+ cells collected during the first leukapheresis was 5.95 × 10 /kg for Tevagrastim, 7.08 × 10 /kg for Nivestim, and 6.8 × 10 /kg for Zarzio (P > .05). The necessary number of leukapheresis for patients receiving Zarzio, Nivestim, and Tevagrastim was 1.32, 1.37, and 1.66, respectively (P > .05). The percentage of effective mobilizations was 88.2% for Zarzio, 86.2% for Nivestim, and 84.9% for Tevagrastim. The side effects included bone pain and headache.

CONCLUSION

All tested biosimilars demonstrated similar effectiveness and safety profiles in patients with hematological tumors undergoing PBSC mobilization; therefore, they can be used interchangeably.

摘要

背景

自体外周血造血干细胞移植（auto-PBSCT）在前序大剂量化疗的基础上，是一种治疗血液系统恶性肿瘤的有效方法。该过程通过使用 G-CSF 从患者外周血中获取自身干细胞来完成。目前，各种非格司亭生物类似物得到了广泛的应用。

目的

本研究旨在比较三种不同的非格司亭生物类似物在血液系统恶性肿瘤患者外周血造血干细胞动员中的疗效和安全性。

材料和方法

这是一项回顾性分析，纳入了 2012 年至 2014 年在弗罗茨瓦夫血液科接受 auto-PBSCT 的 282 例患者（118 名女性和 164 名男性）的资料。使用了三种非格司亭生物类似物：特瓦格拉（Tevagrastim）（95 例）、尼伏斯特（Nivestim）（92 例）和日达仙（Zarzio）（95 例）。90 例（32%）患者诊断为多发性骨髓瘤，55 例（19%）为霍奇金淋巴瘤，90 例（32%）为非霍奇金淋巴瘤，20 例（7%）为急性髓系白血病，27 例（10%）为其他血液系统恶性肿瘤。

结果

特瓦格拉、尼伏斯特和日达仙第一次白细胞单采时收集的 CD34+细胞的平均数量分别为 5.95×10 6 /kg、7.08×10 6 /kg 和 6.8×10 6 /kg（P>.05）。接受日达仙、尼伏斯特和特瓦格拉治疗的患者所需的白细胞单采次数分别为 1.32、1.37 和 1.66 次（P>.05）。日达仙、尼伏斯特和特瓦格拉的有效动员率分别为 88.2%、86.2%和 84.9%。副作用包括骨痛和头痛。