Kayıkçı Ömür, Tekgündüz Emre, Kaya Ali Hakan, Göker Hakan, Aslan Alma, İskender Dicle, Namdaroglu Sinem, Tetik Aysegul, Koçubaba Şerife, Altuntaş Fevzi
Ankara Oncology Education Research Hospital, Hematology Stem Cell Transplantation Clinic, Ankara, Turkey.
Ankara Oncology Education Research Hospital, Hematology Stem Cell Transplantation Clinic, Ankara, Turkey.
Transfus Apher Sci. 2017 Dec;56(6):832-835. doi: 10.1016/j.transci.2017.11.016. Epub 2017 Nov 10.
Biosimilar filgrastim (Leucostim) was shown to be similar in terms of efficacy and safety in hematopoietic progenitor cell mobilization (HPCM) compared to originator filgrastim (Neupogen) and lenograstim (Granocyte) in healthy donors and chemomobilization settings. Here we report our retrospective experience with Leucostim (n: 43) compared to Neupogen (n: 71) and Granocyte (n: 32) in steady-state mobilization of patients presenting with Hodgkin lymphoma, non-Hodgkin lymphoma and multiple myeloma. The median age of patients on Leucostim (56) arm was significantly higher compared to patients who received Neupogen (50) and Granocyte (49) (p: 0.039). Patients who underwent HPCM with Leucostim received less chemotherapy lines (p: 0.026) and courses (p: 0.046) compared to others. Otherwise the study cohort was homogenous in terms of gender, primary diagnosis and various risk factors for mobilization failure. Mobilization failure was defined as failure to achieve a minimum threshold (10/μL) for peripheral blood CD34 cell concentration to initiate leukapheresis or 0.5×10/kg, 0.8×10/kg and 2×10/kg CD34 cells in first, second and fourth days of apheresis, respectively. The study groups were similar in terms of median number of CD34 progenitor cell yield (×10/kg) (Neupogen: 6.18, Granocyte: 6.2 and Leucostim: 6.2) (p: 0.959) and median number of leukapheresis sessions (p: 0.615). The treatment arms were also similar in terms of mobilization failure (Neupogen 11.3% - Granocyte 21.9% - Leucostim 16.3%; p: 0.366). No patient experienced any severe adverse effect during HPCM. Leucostim is equally effective and safe in HPCM compared to originator G-CSF (Neupogen) and lenograstim (Granocyte) in steady-state HPCM setting.
在健康供体和化疗动员的情况下，生物类似药非格司亭（Leucostim）在造血祖细胞动员（HPCM）方面的疗效和安全性与原研非格司亭（Neupogen）和来格司亭（Granocyte）相似。在此，我们报告了在霍奇金淋巴瘤、非霍奇金淋巴瘤和多发性骨髓瘤患者的稳态动员中，使用Leucostim（n = 43）与Neupogen（n = 71）和Granocyte（n = 32）相比的回顾性经验。使用Leucostim组患者的中位年龄（56岁）显著高于接受Neupogen组（50岁）和Granocyte组（49岁）（p = 0.039）。与其他组相比, 使用Leucostim进行HPCM的患者接受的化疗疗程数（p = 0.026）和化疗周期数（p = 0.046）更少。除此之外，研究队列在性别、原发诊断和动员失败的各种风险因素方面是同质的。动员失败的定义为未能达到外周血CD34细胞浓度的最低阈值（10/μL）以启动白细胞单采术，或在单采术的第一天、第二天和第四天分别未能达到0.5×10/kg、0.8×10/kg和2×10/kg的CD34细胞。研究组在CD34祖细胞产量中位数（×10/kg）（Neupogen：6.18，Granocyte：6.2，Leucostim：6.2）（p = 0.959）和白细胞单采术次数中位数（p = 0.615）方面相似。各治疗组在动员失败方面也相似（Neupogen 11.3% - Granocyte 21.9% - Leucostim 16.3%；p = 0.366）。在HPCM期间，没有患者出现任何严重不良反应。在稳态HPCM环境中，与原研G-CSF（Neupogen）和来格司亭（Granocyte）相比，Leucostim在HPCM中同样有效且安全。
