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氟达拉滨-马法兰与氟达拉滨-噻替哌作为异基因造血细胞移植预处理方案的比较:EBMT 急性白血病工作组的注册研究。

Comparison of fludarabine-melphalan and fludarabine-treosulfan as conditioning prior to allogeneic hematopoietic cell transplantation-a registry study on behalf of the EBMT Acute Leukemia Working Party.

机构信息

Department of Hematology/Oncology, Faculty of Medicine, University of Freiburg Medical Center, Freiburg, Germany.

EBMT Paris Study Office, Hopital Saint Antoine, Paris, France.

出版信息

Bone Marrow Transplant. 2022 Aug;57(8):1269-1276. doi: 10.1038/s41409-022-01646-1. Epub 2022 May 14.

Abstract

In recent years considerable variations in conditioning protocols for allogeneic hematopoietic cell transplantation (allo-HCT) protocols have been introduced for higher efficacy, lower toxicity, and better outcomes. To overcome the limitations of the classical definition of reduced intensity and myeloablative conditioning, a transplantation conditioning intensity (TCI) score had been developed. In this study, we compared outcome after two frequently used single alkylator-based conditioning protocols from the intermediate TCI score category, fludarabine/melphalan 140 mg/m (FluMel) and fludarabine/treosulfan 42 g/m (FluTreo) for patients with acute myeloid leukemia (AML) in complete remission (CR). This retrospective analysis from the registry of the Acute Leukemia Working Party (ALWP) of the European Society of Bone Marrow Transplantation (EBMT) database included 1427 adult patients (median age 58.2 years) receiving either Flu/Mel (n = 1005) or Flu/Treo (n = 422). Both groups showed similar 3-year overall survival (OS) (54% vs 51.2%, p value 0.49) for patients conditioned with FluMel and FluTreo, respectively. However, patients treated with FluMel showed a reduced 3-year relapse incidence (32.4% vs. 40.4%, p value < 0.001) and slightly increased non-relapse mortality (NRM) (25.7% vs. 20.2%, p value = 0.06) compared to patients treated with FluTreo. Our data may serve as a basis for further studies examining the role of additional agents/ intensifications in conditioning prior to allo-HCT.

摘要

近年来,为了提高疗效、降低毒性和改善结果,异体造血细胞移植(allo-HCT)方案中的预处理方案发生了很大变化。为了克服经典的减强度和清髓性预处理定义的局限性,已经开发了移植预处理强度(TCI)评分。在这项研究中,我们比较了两种常用于中间 TCI 评分类别的基于单烷化剂的预处理方案的结果,即氟达拉滨/美法仑 140mg/m2(FluMel)和氟达拉滨/替莫唑胺 42g/m2(FluTreo),用于完全缓解(CR)的急性髓系白血病(AML)患者。这项来自欧洲骨髓移植学会(EBMT)急性白血病工作组(ALWP)注册中心的回顾性分析包括 1427 名接受氟达拉滨/美法仑(n=1005)或氟达拉滨/替莫唑胺(n=422)预处理的成年患者(中位年龄 58.2 岁)。两组患者的 3 年总生存率(OS)相似(FluMel 组为 54%,FluTreo 组为 51.2%,p 值为 0.49)。然而,与接受 FluTreo 治疗的患者相比,接受 FluMel 治疗的患者 3 年复发率降低(32.4% vs. 40.4%,p 值<0.001),非复发死亡率(NRM)略有增加(25.7% vs. 20.2%,p 值=0.06)。我们的数据可以为进一步研究在 allo-HCT 前预处理中添加其他药物/强化剂的作用提供基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/236c/9352579/f11201e28b1d/41409_2022_1646_Fig1_HTML.jpg

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