地西他滨在先，挽救性脐带血移植在后，用于未缓解的急性髓系白血病/骨髓增生异常综合征。
Decitabine prior to salvaged cord blood transplantation for acute myeloid leukaemia/myelodysplastic syndrome not in remission.
机构信息
Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Sciences and Technology of China, Hefei, Anhui, P. R. China.
Department of Hematology, The Lu'an Affiliated Hospital of Anhui Medical University, Lu'an, P. R. China.
出版信息
J Clin Pharm Ther. 2020 Dec;45(6):1372-1381. doi: 10.1111/jcpt.13231. Epub 2020 Oct 3.
WHAT IS KNOWN AND OBJECTIVE
Many refractory/relapsed haematological malignancies, in non-remission state, still have poor prognosis even after allogeneic haematopoietic stem cell transplantation. Recently, decitabine or umbilical cord blood transplantation (UCBT) seemed to be effective in these patients. However, few studies have added decitabine to myeloablative conditioning regimens for UCBT in patients with haematological malignancies not in remission. Therefore, the objective was to evaluate the clinical outcomes of patients with refractory/relapsed acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) using decitabine as part of a myeloablative conditioning regimen prior to salvaged unrelated UCBT at our centre.
METHODS
We enrolled 20 consecutive patients with refractory/relapsed AML/MDS between 2013 and 2018. All patients were in non-remission state before transplantation. All transplants were performed with decitabine as part of the myeloablative conditioning regimen, which was decitabine + fludarabine/busulfan/cyclophosphamide.
RESULTS AND DISCUSSION
All patients achieved neutrophil and platelet engraftment. Incidence of grade III/IV acute graft-vs-host disease (GVHD) was 20.0%, which was also decreased compared to non-decitabine group (P = .025). The median follow-up time after UCBT was 29 months (range 14-64 months). The 2-year probability of GVHD-free relapse-free survival (GRFS) was higher in the decitabine group. Univariate showed that the decitabine group was associated with a higher GRFS than the non-decitabine group. The estimated probability of overall survival and relapse was 55% and 20.0%, respectively.
WHAT IS NEW AND CONCLUSIONS
Our results suggest that addition of decitabine as part of the myeloablative conditioning regimen prior to UCBT for refractory/relapsed AML/MDS in patients who are not in remission is safe and might be an effective treatment option.
已知和目的
许多难治/复发的血液系统恶性肿瘤，在非缓解状态下，即使在异基因造血干细胞移植后，预后仍然很差。最近，地西他滨或脐血移植（UCBT）似乎对这些患者有效。然而，很少有研究将地西他滨加入到未缓解的血液系统恶性肿瘤患者的清髓性预处理方案中。因此，我们的目的是评估我们中心使用地西他滨作为挽救性无关 UCBT 前清髓性预处理方案一部分治疗难治/复发急性髓系白血病（AML）或骨髓增生异常综合征（MDS）患者的临床结果。
方法
我们纳入了 2013 年至 2018 年期间 20 例难治/复发 AML/MDS 连续患者。所有患者在移植前均处于非缓解状态。所有移植均采用地西他滨作为清髓性预处理方案的一部分，该方案为地西他滨+氟达拉滨/白消安/环磷酰胺。
结果与讨论
所有患者均实现了中性粒细胞和血小板植入。III/IV 级急性移植物抗宿主病（GVHD）的发生率为 20.0%，与非地西他滨组相比有所降低（P=0.025）。UCBT 后中位随访时间为 29 个月（范围 14-64 个月）。地西他滨组的 2 年无 GVHD 无复发生存（GRFS）概率更高。单因素分析显示，地西他滨组的 GRFS 高于非地西他滨组。估计的总生存率和复发率分别为 55%和 20.0%。
新发现和结论
我们的结果表明，对于未缓解的难治/复发 AML/MDS 患者，在 UCBT 前将地西他滨加入到清髓性预处理方案中是安全的，可能是一种有效的治疗选择。
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