Department of Internal Medicine II, Division of Hematology and Oncology, Immunology, and Rheumatology, University of Tübingen, Tübingen, Germany.
J Cancer Res Clin Oncol. 2010 Dec;136(12):1921-7. doi: 10.1007/s00432-010-0851-6. Epub 2010 Mar 9.
To determine the long-term outcome of patients after allogeneic transplantation of T-cell depleted versus unmanipulated hematopoietic stem cell grafts with respect to incidence of GvHD and overall survival in 50 consecutive patients.
In this prospective phase II study utilizing biological randomization, 50 sibling donors were mobilized with G-CSF. Positive selection of CD34+ cells (Ceprate SC; CellPro, USA) was performed in good mobilizers (n = 25; group A), but not in poor mobilizers (n = 25; group B). Patients had hematological malignancies. Median patient age was 44 years (range, 19-57). Numbers of CD3+ cells were 0.5 ± 0.4 × 10(6)/kg in group A and 216 ± 127 × 10(6)/kg in group B.
Hematological recovery was rapid in both groups. Patients in group A had no grade III-IV acute GvHD, whereas 6 out of 22 evaluable patients in group B had grade III-IV acute GvHD with fatal outcome in four cases (P < 0.01). Similarly, the incidence of chronic GvHD was lower in patients in group A (35 vs. 65%). However, there was a higher relapse rate in group A (11/25) versus group B (4/25, P < 0.05). At a follow-up of 10 years after transplantation, eight (32%) and 10 patients (40%) were relapse-free and alive in groups A and B, respectively.
Risk factors for survival in a multivariate analysis were remission status prior to transplantation (CR vs. no CR), occurrence of acute and chronic GvHD, and relapse. The use of the CellPro device for CD34 positive selection per se did not have an influence on overall survival.
在 50 例连续患者中，比较 T 细胞耗竭与未处理的造血干细胞移植物同种异体移植后，移植物抗宿主病（GVHD）发生率和总生存率的长期结果。
在这项利用生物随机化的前瞻性 II 期研究中，50 名同胞供者接受 G-CSF 动员。在良好动员者（n = 25；A 组）中进行 CD34+细胞（Ceprate SC；CellPro，美国）的阳性选择，但在动员不佳者（n = 25；B 组）中不进行。患者患有血液系统恶性肿瘤。中位患者年龄为 44 岁（范围，19-57 岁）。A 组患者的 CD3+细胞数为 0.5 ± 0.4×10(6)/kg，B 组患者的 CD3+细胞数为 216 ± 127×10(6)/kg。
两组患者的血液学恢复均较快。A 组患者无一例发生 III-IV 级急性 GVHD，而 B 组 22 例可评估患者中有 6 例发生 III-IV 级急性 GVHD，其中 4 例死亡（P < 0.01）。同样，A 组患者慢性 GVHD的发生率较低（35% vs. 65%）。然而，A 组的复发率较高（11/25 例 vs. B 组 4/25 例，P < 0.05）。移植后 10 年随访时，A 组和 B 组分别有 8 例（32%）和 10 例（40%）患者无复发且存活。
多变量分析中，影响生存的危险因素包括移植前的缓解状态（CR 与非 CR）、急性和慢性 GVHD 的发生以及复发。使用 CellPro 设备进行 CD34 阳性选择本身并不会影响总生存率。
