Raida Ludek, Tucek Pavel, Faber Edgar, Vondrakova Jana, Rusinakova Zuzana, Skoumalova Iva, Hubacek Jaromir, Jarosova Marie, Katrincsakova Beata, Pikalova Zuzana, Kurfurst Pavel, Indrak Karel
Department of Hemato-Oncology, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic.
Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Dec;155(4):327-32. doi: 10.5507/bp.2011.040.
This study compares the outcomes of patients with high-risk acute myeloid leukemia (AML) who underwent allogeneic stem cell transplantation (SCT) after conditioning combining busulfan (16 mg/kg orally) and cyclophosphamide (120 mg/kg intravenously) (BU-CY) with those allografted after administration of fludarabine (150 mg/m(2) intravenously), busulfan (12 mg/kg orally) and thymoglobulin (6 mg/kg intravenously) (FLU-BU12-TG).
SCT after BU-CY and FLU-BU12-TG was performed in 21 and 10 AML patients. There were no significant differences between groups in number of patients treated in complete disease remission, gender, age, donors, CD34+, mononuclear cell (MNC) count in the graft and follow-up period. However, significantly more SCTs from unrelated (90% vs. 19%; p=0.00018) and HLA-mismatched donors (50% vs. 0%; p=0.0004) were performed in the FLU-BU12-TG group. The Cox proportional hazards model was used to assess the risk of post-transplant AML relapse and non-relapse mortality (NRM). The probability of post-transplant 2-year event-free survival (EFS) and overall survival (OS) were calculated using the Kaplan-Meier method.
No significant differences were found between the FLU-BU12-TG and BU-CY groups in risk of AML relapse (HR=1.036; 95% CI [0.102 - 10.47]; p=0.9), post-transplant NRM (HR=0.25; 95% CI [0.031 - 1.96]; p=0.18), 2-year EFS (89% vs. 43%; p=0.19) or OS (79% vs. 57%; p=0.23).
These pilot results demonstrate the efficacy of the new FLU-BU12-TG conditioning regimen in patients allografted for high-risk AML. This conditioning might become an alternative approach in patients at high risk of severe post-transplant complications after the standard BU-CY myeloablative regimen.
本研究比较了高危急性髓系白血病（AML）患者在接受白消安（16mg/kg口服）和环磷酰胺（120mg/kg静脉注射）（BU-CY）联合预处理后进行异基因干细胞移植（SCT）的结果，以及在接受氟达拉滨（150mg/m²静脉注射）、白消安（12mg/kg口服）和抗胸腺细胞球蛋白（6mg/kg静脉注射）（FLU-BU12-TG）后进行同种异体移植的患者的结果。
21例和10例AML患者分别接受了BU-CY和FLU-BU12-TG后的SCT。两组在完全疾病缓解时接受治疗的患者数量、性别、年龄、供体、移植物中的CD34⁺、单核细胞（MNC）计数以及随访期方面均无显著差异。然而，FLU-BU12-TG组中来自无关供体（90%对19%；p=0.00018）和HLA不匹配供体（50%对0%；p=0.0004）的SCT明显更多。采用Cox比例风险模型评估移植后AML复发和非复发死亡率（NRM）的风险。使用Kaplan-Meier方法计算移植后2年无事件生存期（EFS）和总生存期（OS）的概率。
FLU-BU12-TG组和BU-CY组在AML复发风险（HR=1.036；95%CI[0.102 - 10.47]；p=0.9）、移植后NRM（HR=0.25；95%CI[0.031 - 1.96]；p=0.18）、2年EFS（89%对43%；p=0.19）或OS（79%对57%；p=0.23）方面均未发现显著差异。
这些初步结果证明了新的FLU-BU12-TG预处理方案在高危AML同种异体移植患者中的疗效。这种预处理可能成为标准BU-CY清髓方案后有严重移植后并发症高风险患者的替代方法。
