在自体造血干细胞移植和同胞异基因移植中，生物类似物非格司亭与来格司亭的使用比较。
Use of biosimilar filgrastim compared with lenograstim in autologous haematopoietic stem-cell transplant and in sibling allogeneic transplant.
作者信息
Uddin Shab, Russell Pippa, Farrell Maresa, Davy Barbara, Taylor Joe, Agrawal Samir G
机构信息
Division of Haemato-Oncology, St Bartholomew's Hospital, Barts Health NHS Trust, London, UK.
Barts Health NHS Trust and Blizard Institute, Queen Mary University of London, Division of Haemato-Oncology, St Bartholomew's Hospital, London EC1A 7BE, UK.
出版信息
Ther Adv Hematol. 2015 Apr;6(2):53-60. doi: 10.1177/2040620714565962.
OBJECTIVES
Biosimilar filgrastim was compared with lenograstim for autologous haematopoietic stem-cell transplant (HSCT) in patients with haematological malignancies. Data from a separate group of sibling donors who underwent allogeneic HSCT are also reported.
METHODS
Patients with lymphoma or multiple myeloma (MM) who underwent autologous HSCT with biosimilar filgrastim were compared with a historical control group of patients who received lenograstim. Peripheral blood (PB) cells counts were monitored after 7-8 consecutive days of granulocyte-colony stimulating factor (G-CSF) injection and apheresis was performed on day 8 if PB CD34+ cell count was ⩾10 cells/µl. The target PB CD34+ cell doses were ⩾2.0 × 10(6)/kg (lymphoma), ⩾4.0 × 10(6)/kg (MM ⩾60 years old) or ⩾8.0 × 10(6)/kg (MM <60 years old).
RESULTS
A total of 259 patients were included in the autologous HSCT comparison (biosimilar filgrastim, n = 104; lenograstim, n = 155). In patients with lymphoma and older MM patients (⩾60 years old), no significant differences were observed between groups with regard to stem-cell mobilization parameters. However, in MM patients <60 years old, all parameters were significantly superior in the biosimilar filgrastim group, including the need for 1 rather than 2 apheresis procedures. No significant differences were observed between groups in median number of days to absolute neutrophil count (ANC) or platelet recovery. In the allogeneic setting, 47 sibling donors received biosimilar filgrastim. Mean CD34+ count at the first apheresis was 6.1 × 10(6)/kg. A total of 13 donors needed a second apheresis and 4 required a third. Among recipients, median days to ANC recovery was 16 (10-28) and to platelet recovery was 13 (9-54).
CONCLUSIONS
Biosimilar filgrastim is as effective as lenograstim for autologous HSCT in patients with lymphoma or MM patients ⩾60 years old. However, mobilization with biosimilar filgrastim appeared to be superior to that with lenograstim in younger MM patients.
目的
比较生物类似药非格司亭与来格司亭用于血液系统恶性肿瘤患者自体造血干细胞移植（HSCT）的效果。还报告了另一组接受异基因HSCT的同胞供者的数据。
方法
将接受生物类似药非格司亭进行自体HSCT的淋巴瘤或多发性骨髓瘤（MM）患者与接受来格司亭的历史对照组患者进行比较。在连续注射粒细胞集落刺激因子（G-CSF）7 - 8天后监测外周血（PB）细胞计数，若PB CD34+细胞计数≥10个/微升，则在第8天进行单采。目标PB CD34+细胞剂量为≥2.0×10⁶/kg（淋巴瘤）、≥4.0×10⁶/kg（60岁及以上MM）或≥8.0×10⁶/kg（60岁以下MM）。
结果
自体HSCT比较共纳入259例患者（生物类似药非格司亭组，n = 104；来格司亭组，n = 155）。在淋巴瘤患者和老年MM患者（≥60岁）中，两组间干细胞动员参数无显著差异。然而，在60岁以下的MM患者中，生物类似药非格司亭组的所有参数均显著更优，包括单采程序只需1次而非2次。两组间中性粒细胞绝对计数（ANC）或血小板恢复的中位天数无显著差异。在异基因移植情况下，47名同胞供者接受了生物类似药非格司亭。首次单采时的平均CD34+计数为6.1×10⁶/kg。共有13名供者需要进行第二次单采，4名需要第三次单采。在受者中，ANC恢复的中位天数为16（10 - 28）天，血小板恢复的中位天数为13（9 - 54）天。
结论
生物类似药非格司亭在淋巴瘤患者或60岁及以上MM患者的自体HSCT中与来格司亭效果相当。然而，在年轻MM患者中，生物类似药非格司亭的动员效果似乎优于来格司亭。
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