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  • Title: [Clinical outcome of allogeneic hematopoietic stem cell transplantation with FLAG sequential busulfan/cyclophosphamide conditioning regimen for refractory/relapsed acute myeloid leukemia].
    Author: Liu W, Li Y, Qiu ZX, Yin Y, Sun YH, Xu WL, Wang Q, Liang ZY, Dong YJ, Wang LH, Cen QN, Wang MJ, Wang WS, Ou JP, Ren HY.
    Journal: Zhonghua Nei Ke Za Zhi; 2018 Aug 01; 57(8):576-581. PubMed ID: 30060329.
    Abstract:
    Objective: To investigate the therapeutic effects of allogeneic hematopoietic stem cell transplantation (allo-HSCT) with FLAG sequential busulfan/cyclophosphamide(Bu/Cy) conditioning regimen for refractory/relapsed acute myeloid leukemia. Methods: From February 2012 to June 2017, 21 patients with refractory/relapsed acute myeloid leukemia underwent allo-HSCT with FLAG sequential Bu/Cy conditioning regimen. Transplantation-related complications and clinical outcome were retrospectively analyzed. Results: After conditioning, no hepatic veno-occlusive disease (VOD) and grade Ⅲ hemorrhagic cystitis occurred. 76.2% (16/21) patients had fever with 4 septicemia. One patient died of septic shock before engraftment. Twenty patients achieved neutrophil engraftment with a median time of 13 days (range, 10 to 21 days). Seventeen patients achieved platelet engraftment with a median time of 18 days (range, 9 to 25 days). The cumulative incidence of acute graft-versus-host disease (aGVHD) was 39.5%, and 3 patients developed grade Ⅲ-Ⅳ aGVHD. Of 19 patients who survived more than 100 days after transplantation, 4 had local chronic graft-versus-host disease (cGVHD). Of 21 patients, the median survival time was 15 months (range, 0.5 to 67 months) post-transplantation. Transplantation-related mortality rate was 28.7%. Leukemia relapse occurred in 4 patients with a median time of 4 months (range, 3 to 8 months) after transplantation. The cumulative relapse rate at 1 year was 21.4%. The 1-year and 3-year overall survival (OS) rates were 60.7% and 54.9% respectively. Log-rank analysis revealed that bone marrow blasts ≥ 20% or extramedullary leukemia before transplantation, poor platelet engraftment and grade Ⅲ-Ⅳ aGVHD were significantly related to shortened OS (P<0.05). Conclusions: Allo-HSCT with FLAG sequential Bu/Cy conditioning regimen in patients with refractory/relapsed myeloid leukemia has acceptable transplantation-related risk and relapse rate. The 1-year and 3-year OS rates are comparable with those in remission patients. 目的： 观察采用FLAG（氟达拉滨联合大剂量阿糖胞苷及重组人粒细胞集落刺激因子）序贯马利兰/环磷酰胺（Bu/Cy）预处理方案进行异基因造血干细胞移植对于难治/复发性急性髓系白血病（AML）的疗效及安全性。 方法： 对2012年2月至2017年6月北京大学第一医院21例应用FLAG序贯Bu/Cy预处理方案进行异基因造血干细胞移植的难治/复发性AML患者资料进行回顾性分析，观察移植相关合并症及疗效情况。 结果： 预处理过程中21例患者均未出现肝静脉闭塞病及Ⅲ级以上出血性膀胱炎。76.2%（16/21）患者预处理过程中出现发热，发生败血症4例，除1例因感染中毒性休克在植入前死亡外，其余患者经抗感染治疗后均好转。20例患者获得中性粒细胞植活，中性粒细胞>0.5×10(9)/L的中位时间是13（10~21）d；17例患者获得血小板植活，血小板计数>20×10(9)/L的中位时间是18（9~25）d。发生急性移植物抗宿主病8例，累积发生率为39.5%，其中3例为Ⅲ~Ⅳ度急性移植物抗宿主病。移植后存活超过100 d的19例患者中，4例出现局限性慢性移植物抗宿主病。21例患者的中位生存时间为15（0.5~67）个月，移植相关死亡率为28.7%。4例患者在移植后3~8个月出现复发，1年累积复发率为21.4%。1年和3年的总体生存率分别为60.7%和54.6%。Log-rank分析显示，移植前骨髓内原始细胞≥20%或存在髓外病变、血小板植入不良和Ⅲ~Ⅳ度急性移植物抗宿主病显著降低患者移植后的总体生存率（P<0.05）。 结论： 采用FLAG序贯Bu/Cy预处理方案的异基因造血干细胞移植具有可接受的移植相关风险，能够降低难治/复发性AML患者的复发率，提高其生存率。.
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