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两种B细胞清除方案用于B细胞非霍奇金淋巴瘤患者的随机对照研究:利妥昔单抗体内清除与CliniMACS CD34细胞富集装置体外清除

Randomised comparison of two B-cell purging protocols for patients with B-cell non-Hodgkin lymphoma: in vivo purging with rituximab versus ex vivo purging with CliniMACS CD34 cell enrichment device.

作者信息

van Heeckeren Willem J, Vollweiler Jennifer, Fu Pingfu, Cooper Brenda W, Meyerson Howard, Lazarus Hillard M, Simic Alexandra, Laughlin Mary J, Gerson Stanton L, Koç Omer N

机构信息

Department of Medicine, Case Western Reserve University and University Hospitals of Cleveland, OH, USA.

出版信息

Br J Haematol. 2006 Jan;132(1):42-55. doi: 10.1111/j.1365-2141.2005.05827.x.

DOI:10.1111/j.1365-2141.2005.05827.x
PMID:16371019
Abstract

We investigated the feasibility, safety and efficacy of two B-cell purging methods in patients with CD20+ non-Hodgkin lymphoma (NHL) receiving autologous stsem cell transplantation. Myeloid and immune recoveries between the methods were compared. Twenty-seven patients were randomised to either in vivo purging with rituximab or ex vivo purging by CD34+ cell selection. Both purging methods were efficient at eliminating B-cells in infusates. When compared with in vivo purging, ex vivo purging was associated with CD34+ cell loss and delayed median neutrophil (10 d vs. 11 d) and platelet (12.5 d vs. 17 d) count recoveries. Lymphocyte recovery was similar in both groups, but immunoglobulin recovery was delayed after in vivo purging. Late-infectious complications were few in both arms. At a median follow-up of 27 months, 2-year probabilities of event-free survival (EFS) rates were 81% for in vivo purging and 76% for ex vivo purging (P = 0.66). When compared with 53 unpurged patients, all 27 purged patients had improved 3-year probabilities of overall survival (89% vs. 70%, P = 0.014) and a trend for improved EFS (78% vs. 57%, P = 0.075). In conclusion, although both purging methods were feasible and safe, rituximab purging was superior as it did not impair CD34+ cell mobilisation and was associated with faster myeloid recovery. Further studies are needed to determine whether rituximab purging is more effective than the use of unpurged autografts.

摘要

我们研究了两种B细胞清除方法在接受自体干细胞移植的CD20+非霍奇金淋巴瘤(NHL)患者中的可行性、安全性和有效性。比较了这两种方法之间的髓系和免疫恢复情况。27例患者被随机分为接受利妥昔单抗体内清除组或通过CD34+细胞分选进行体外清除组。两种清除方法在消除输注物中的B细胞方面均有效。与体内清除相比,体外清除与CD34+细胞丢失以及中性粒细胞(10天对11天)和血小板(12.5天对17天)计数恢复延迟有关。两组的淋巴细胞恢复情况相似,但体内清除后免疫球蛋白恢复延迟。两组的晚期感染并发症均较少。在中位随访27个月时,体内清除组的2年无事件生存率(EFS)为81%,体外清除组为76%(P = 0.66)。与53例未进行清除的患者相比,所有27例进行清除的患者3年总生存率均有所提高(89%对70%,P = 0.014),且EFS有改善趋势(78%对57%,P = 0.075)。总之,尽管两种清除方法均可行且安全,但利妥昔单抗清除更具优势,因为它不会损害CD34+细胞动员,且与更快的髓系恢复相关。需要进一步研究以确定利妥昔单抗清除是否比使用未清除的自体移植物更有效。

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The role of rituximab in autologous and allogeneic hematopoietic stem cell transplantation for non-Hodgkin's lymphoma.
利妥昔单抗在非霍奇金淋巴瘤的自体和异基因造血干细胞移植中的作用。
Curr Hematol Malig Rep. 2006 Dec;1(4):220-9. doi: 10.1007/s11899-006-0003-x.
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Role of hematopoietic stem cell transplant in the management of follicular lymphoma.造血干细胞移植在滤泡性淋巴瘤治疗中的作用。
Oncologist. 2009 Jul;14(7):726-38. doi: 10.1634/theoncologist.2009-0045. Epub 2009 Jun 26.