Department of Oncology, Karmanos Cancer Institute/Wayne State University, 4100 John R, HW04H0, Detroit, MI, 48201, USA.
Biostatistics Core, Karmanos Cancer Institute, Department of Oncology, Wayne State University, Detroit, MI, 48201, USA.
Ann Hematol. 2021 Apr;100(4):969-978. doi: 10.1007/s00277-021-04445-8. Epub 2021 Feb 16.
A head-to-head comparison of outcomes of unrelated donor allogeneic peripheral blood stem cell transplantation for AML between reduced intensity conditioning (RIC) and myeloablative conditioning (MAC) regimens using thymoglobulin for GVHD prophylaxis is limited. We evaluated outcomes of 122 AML patients who received either busulfan (Bu)/fludarabine (Flu)/low-dose total body irradiation (TBI) as RIC (n = 64, 52%) or Bu/Flu as MAC (n = 58, 48%), and thymoglobulin 4.5 mg/kg total dose between day - 3 to - 1 for GVHD prophylaxis. Grades III-IV acute GVHD (aGVHD) was lower with Bu/Flu/TBI compared with Bu/Flu (6.2% vs 26.1%, p = 0.009). At 1 year, Bu/Flu/TBI was associated with similar chronic GVHD (41.2% vs 44.8%, p = 0.75), OS (61.9% vs 56.9%, p = 0.69), relapse rate (29.9% vs 20.7%, p = 0.24), relapse-free survival (52.8% vs 50%, p = 0.80), non-relapse mortality (17.4% vs 29.3%, p = 0.41), and GVHD-free relapse-free survival (24.2% vs 27.5%, p = 0.80) compared with Bu/Flu. Multivariable analysis did not reveal any difference in outcomes between both regimens. In summary, thymoglobulin at 4.5 mg/kg did not have any adverse impact on survival when used with RIC regimen. Both Bu/Flu/TBI and Bu/Flu conditioning regimens yielded similar survival.
在使用他克莫司预防移植物抗宿主病（GVHD）的情况下，比较非亲缘供体外周血造血干细胞移植治疗急性髓系白血病（AML）中，采用减低强度预处理（RIC）与清髓性预处理（MAC）方案的结局，采用环孢素 A 或他克莫司预防GVHD 的随机对照研究很少。我们评估了 122 例接受以下方案治疗的 AML 患者的结局：白消安（Bu）/氟达拉滨（Flu）/低剂量全身照射（TBI）作为 RIC（n = 64，52%）或 Bu/Flu 作为 MAC（n = 58，48%），并在预处理期间给予他克莫司 4.5mg/kg 总剂量，从第 3 天至第 1 天给药预防 GVHD。与 Bu/Flu 相比，Bu/Flu/TBI 方案发生 III-IV 级急性 GVHD（aGVHD）的比例更低（6.2% vs. 26.1%，p = 0.009）。1 年时，Bu/Flu/TBI 方案与 Bu/Flu 方案比较，慢性 GVHD（41.2% vs. 44.8%，p = 0.75）、总生存（61.9% vs. 56.9%，p = 0.69）、复发率（29.9% vs. 20.7%，p = 0.24）、无复发生存率（52.8% vs. 50%，p = 0.80）、非复发相关死亡率（17.4% vs. 29.3%，p = 0.41）和 GVHD 无复发生存（24.2% vs. 27.5%，p = 0.80）无显著差异。多变量分析显示两种方案的结局无差异。总之，在 RIC 方案中使用他克莫司 4.5mg/kg 不会对生存产生任何不良影响。Bu/Flu/TBI 和 Bu/Flu 两种预处理方案的生存结局相似。
