Ataergin Selmin, Arpaci Fikret, Turan Mustafa, Solchaga Luis, Cetin Turker, Ozturk Mustafa, Ozet Ahmet, Komurcu Seref, Ozturk Bekir
GATA (Gulhane) Faculty of Medicine, Department of Medical Oncology and Bone Marrow Transplantation Unit, 06018 Etlik, Ankara, Turkey.
Am J Hematol. 2008 Aug;83(8):644-8. doi: 10.1002/ajh.21206.
In vitro studies have demonstrated a 27% increased efficacy of lenograstim over filgrastim. However, equal doses of 10 microg/kg/day of filgrastim and lenograstim have been recommended for mobilization of CD34+ cells without associated chemotherapy. In this study, we investigated whether a 25% reduced dose of lenograstim at 7.5 microg/kg/day is equavalent to 10 microg/kg/day filgrastim for autologous peripheral blood stem cell (PBSC) mobilization and transplantation. A total of 40 consecutive patients were randomized to either filgrastim (n = 20) or lenograstim (n = 20). The two cohorts were similar in regard to disease, sex, body weight, body surface area, conditioning regimens, previous chemotherapy cycles and radiotherapy. Each growth factor was administered for 4 consecutive days. The first PBSC apheresis was done on the 5th day. In the posttransplant period, the same G-CSF was given at 5 microg/kg/day until leukocyte engraftment. Successful mobilization was achieved in 95% of patients. Successful mobilization with the first apheresis, was achieved in 10/20 (50%) patients in the filgrastim group versus 9/20 (46%) patients in the lenograstim group. No significant difference was seen in the median number of CD34+cells mobilized, as well as the median number of apheresis, median volume of apheresis, percentage of CD34+ cells, and CD34+ cell number. Leukocyte and platelet engraftments, the number of days requiring G-CSF and parenteral antibiotics, the number of transfusions were similar in both groups in the posttransplant period. Lenograstim 7.5 microg/kg/day is as efficious as filgrastim 10 microg/kg/day for autologous PBSC mobilization and transplantation.
体外研究表明,来格司亭的疗效比非格司亭高27%。然而,对于不进行相关化疗的CD34+细胞动员,已推荐使用相同剂量(10微克/千克/天)的非格司亭和来格司亭。在本研究中,我们调查了每天7.5微克/千克剂量的来格司亭,即剂量降低25%时,对于自体外周血干细胞(PBSC)动员和移植是否等同于每天10微克/千克的非格司亭。共有40例连续患者被随机分为非格司亭组(n = 20)或来格司亭组(n = 20)。两组在疾病、性别、体重、体表面积、预处理方案、既往化疗周期和放疗方面相似。每种生长因子连续给药4天。首次PBSC单采在第5天进行。在移植后阶段,给予相同的粒细胞集落刺激因子(G-CSF),剂量为5微克/千克/天,直至白细胞植入。95%的患者成功实现动员。非格司亭组20例患者中有10例(50%)通过首次单采成功实现动员,而来格司亭组20例患者中有9例(46%)。在动员的CD34+细胞中位数、单采中位数、单采体积中位数、CD34+细胞百分比和CD34+细胞数量方面,未观察到显著差异。两组在移植后阶段的白细胞和血小板植入情况、需要G-CSF和胃肠外抗生素的天数、输血次数相似。对于自体PBSC动员和移植,每天7.5微克/千克的来格司亭与每天10微克/千克的非格司亭效果相同。