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Use of biosimilar filgrastim compared with lenograstim in autologous haematopoietic stem-cell transplant and in sibling allogeneic transplant

机译:与非诺格司汀相比,仿制药非格司亭在自体造血干细胞移植和同种异体同种移植中的应用

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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. 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?×?106/kg (lymphoma), ?4.0?×?106/kg (MM ?60 years old) or ?8.0?×?106/kg (MM 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 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). 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.
机译:对于血液系统恶性肿瘤患者,将生物仿制药非格司亭与来那格司亭用于自体造血干细胞移植(HSCT)进行了比较。还报道了来自同种异体HSCT的另一组同胞供体的数据。将接受自体HSCT并使用仿制药非格司亭的淋巴瘤或多发性骨髓瘤(MM)患者与接受来格司亭治疗的历史对照组进行比较。连续7-8天注射粒细胞集落刺激因子(G-CSF)后监测外周血(PB)细胞计数,如果PB CD34 +细胞计数≥10?细胞/μl,则在第8天进行单采血液分离术。 PB CD34 +细胞的目标剂量为?2.0?×?106 / kg(淋巴瘤)、? 4.0?×?106 / kg(MM为60岁)或?8.0?×?106 / kg(MM),共259位患者包括在自体HSCT比较中(生物仿制药非格司亭,n = 104);雷诺格司汀,n = 155)在淋巴瘤患者和老年MM患者(60岁)中,两组之间无显着差异MM患者为6 / kg,总共13位捐献者需要第二次血液采血,4位需要第三次采血,在接受者中,ANC恢复的中位数天数为16(10-28)为13(9–54)。对于60岁以上的淋巴瘤或MM患者,生物仿制药非格司亭与自体HSCT一样有效。

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