Evaluation of a biosimilar granulocyte colony-stimulating factor (filgrastim XM02) for peripheral blood stem cell mobilization and transplantation: a single center experience in Japan.
Evaluation of a biosimilar granulocyte colony-stimulating factor (filgrastim XM02) for peripheral blood stem cell mobilization and transplantation: a single center experience in Japan.
复制标题
生物仿制药粒细胞刺激因子（Filgrastim XM02）评估外周血干细胞动员和移植：日本的单一中心体验。
DOI：
10.2147/jbm.s123374
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发表时间：
2017
影响因子：
2
通讯作者：
Nomura S
中科院分区：
文献类型：
--
作者：
Yoshimura H;Hotta M;Nakanishi T;Fujita S;Nakaya A;Satake A;Ito T;Ishii K;Nomura S
生物类似药粒细胞集落刺激因子（G-CSF）最近已被引入临床实践。G-CSF用于动员CD 34+细胞并加速移植后的植入。然而，在亚洲，特别是在日本，目前缺乏这种生物仿制药G-CSF动员外周血干细胞（PBSC）的数据。因此，需要在日本背景下评价生物仿制药G-CSF用于造血干细胞移植的临床疗效和安全性。受试者包括两组恶性淋巴瘤和多发性骨髓瘤患者。所有患者均接受化疗预动员PBSC。所有患者均接受化疗，随后给予生物仿制药G-CSF、非格司亭XM 02（FBNK）或原研药非格司亭或来格司亭。FBNK、非格司亭和来格司亭治疗组在收获的PBSC中的CD 34+细胞数量、粒细胞/巨噬细胞集落形成单位评分或恶性淋巴瘤和多发性骨髓瘤患者（作为单独或联合队列进行评价）方面无显著差异。此外，在安全性、副作用、并发症或自体造血干细胞移植后的植入时间方面没有显著差异。生物仿制药FBNK在促进接受干细胞移植的日本恶性淋巴瘤和多发性骨髓瘤患者的骨髓恢复方面显示出与原研药G-CSF相同的疗效和安全性。此外，它比原始人更便宜，减少了住院费用。
Biosimilar granulocyte colony-stimulating factor (G-CSF) has recently been introduced into clinical practice. G-CSFs are used to mobilize CD34+ cells and accelerate engraftment after transplantation. However, in Asia, particularly in Japan, data for peripheral blood stem cell (PBSC) mobilization by this biosimilar G-CSF are currently lacking. Therefore, the clinical efficacy and safety of biosimilar G-CSF for hematopoietic stem cell transplantation needs to be evaluated in a Japanese context. The subjects included two groups of patients with malignant lymphoma and multiple myeloma. All patients received chemotherapy priming for the mobilization of PBSCs. All patients were treated with chemotherapy followed by the administration of either the biosimilar G-CSF, filgrastim XM02 (FBNK), or the originators, filgrastim, or lenograstim. There were no significant differences among FBNK, filgrastim, and lenograstim treatments in the numbers of CD34+ cells in harvested PBSCs, the scores for granulocyte/macrophage colony forming units, or for malignant lymphoma and multiple myeloma patients evaluated as separate or combined cohorts. In addition, there were no significant differences in safety, side effects, complications, or the time to engraftment after autologous hematopoietic stem cell transplantation. Biosimilar FBNK shows the same efficacy and safety as originator G-CSFs for facilitating bone marrow recovery in Japanese malignant lymphoma and multiple myeloma patients undergoing stem cell transplantation. In addition, it is less expensive than the originators, reducing hospitalization costs.