Porrata Luis F, Burgstaler Edwin A, Winters Jeffrey L, Jacob Eapen K, Gastineau Dennis A, Suman Vera J, Inwards David J, Ansell Stephen M, Micallef Ivana N, Johnston Patrick B, Nevala Wendy, Markovic Svetomir N
Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
Biol Blood Marrow Transplant. 2016 Jun;22(6):1017-1023. doi: 10.1016/j.bbmt.2016.01.024. Epub 2016 Jan 27.
Retrospective studies have reported that the collected and infused autograft absolute lymphocyte count (A-ALC) affects clinical outcomes after autologous peripheral hematopoietic stem cell transplantation (APHSCT). We hypothesized that manipulation of the apheresis machine to target a higher A-ALC dose would translate into prolonged progression-free survival (PFS) in patients with non-Hodgkin lymphoma (NHL) undergoing APHSCT. Between December 2007 and October 2010, we performed a double-blind, phase III, randomized study randomly assigning 122 patients with NHL to undergo collection with the Fenwal Amicus Apheresis system with our standard settings (mononuclear cells offset of 1.5 and RBC offset of 5.0) or at modified settings (mononuclear cells offset of 1.5 and RBC of 6.0). The primary endpoint was PFS. Neither PFS (hazard ratio [HR] of modified to standard, 1.13; 95% confidence interval [CI], .62 to 2.08; P = .70) nor overall survival (OS) (HR modified to standard, .85; 95% CI, .39 to 1.86; P = .68) were found to differ by collection method. Collection of A-ALC between both methods was similar. Both PFS (P = .0025; HR, 2.77; 95% CI, 1.39 to 5.52) and OS (P = .004; HR, 3.38; 95% CI, 1.27 to 9.01) were inferior in patients infused with an A-ALC < .5 × 10(9) lymphocytes/kg compared with patients infused with an A-ALC ≥ .5 × 10(9) lymphocytes/kg, regardless of the method of collection. We did not detect significant differences in clinical outcomes or in the A-ALC collection between the modified and the standard Fenwal Amicus settings; however, despite physician discretion on primary number of collections and range of cells infused, higher A-ALC infused dose were associated with better survival after APHSCT.
回顾性研究报告称，采集并回输的自体移植绝对淋巴细胞计数（A-ALC）会影响自体外周造血干细胞移植（APHSCT）后的临床结局。我们推测，通过调整血细胞分离机以获取更高剂量的A-ALC，对于接受APHSCT的非霍奇金淋巴瘤（NHL）患者而言，可能会延长无进展生存期（PFS）。在2007年12月至2010年10月期间，我们开展了一项双盲、III期随机研究，将122例NHL患者随机分配，分别使用Fenwal Amicus血细胞分离系统按我们的标准设置（单核细胞偏移量为1.5，红细胞偏移量为5.0）或修改后的设置（单核细胞偏移量为1.5，红细胞偏移量为6.0）进行采集。主要终点为PFS。结果发现，无论是PFS（修改设置与标准设置的风险比[HR]为1.13；95%置信区间[CI]为0.62至2.08；P = 0.70）还是总生存期（OS）（修改设置与标准设置的HR为0.85；95%CI为0.39至1.86；P = 0.68），均未因采集方法不同而存在差异。两种方法采集的A-ALC相似。与输注A-ALC≥0.5×10⁹淋巴细胞/kg的患者相比，输注A-ALC＜0.5×10⁹淋巴细胞/kg的患者，无论采集方法如何，其PFS（P = 0.0025；HR为2.77；95%CI为1.39至5.52）和OS（P = 0.004；HR为3.38；95%CI为1.27至9.01）均较差。我们未检测到Fenwal Amicus修改设置与标准设置在临床结局或A-ALC采集方面存在显著差异；然而，尽管医生可自行决定采集的主要次数和输注的细胞范围，但较高的A-ALC输注剂量与APHSCT后更好的生存率相关。
