当前位置: X-MOL 学术Bone Marrow Transpl. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Fludarabine-treosulfan versus fludarabine-melphalan or busulfan-cyclophosphamide conditioning in older AML or MDS patients – A clinical trial to registry data comparison
Bone Marrow Transplantation ( IF 4.5 ) Pub Date : 2024-02-21 , DOI: 10.1038/s41409-024-02241-2
Dietrich Wilhelm Beelen 1 , Simona Iacobelli 2 , Linda Koster 3 , Dirk-Jan Eikema 3 , Anja van Biezen 3 , Friedrich Stölzel 4, 5 , Fabio Ciceri 6 , Wolfgang Bethge 7 , Peter Dreger 8 , Eva-Maria Wagner-Drouet 9 , Péter Reményi 10 , Matthias Stelljes 11 , Miroslaw Markiewicz 12 , Donal P McLornan 13 , Ibrahim Yakoub-Agha 14 , Mohamad Mohty 15
Affiliation  

A randomized study (acronym: MC-FludT.14/L Trial II) demonstrated that fludarabine plus treosulfan (30 g/m²) was an effective and well tolerated conditioning regimen for allogeneic hematopoietic cell transplantation (allo-HCT) in older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). To further evaluate this regimen, all 252 study patients aged 50 to 70 years were compared with similar patients, who underwent allo-HCT after fludarabine/melphalan (140 mg/m²) (FluMel) or busulfan (12.8 mg/kg)/cyclophosphamide (120 mg/kg) (BuCy) regimens and whose data was provided by the European Society for Blood and Marrow Transplantation registry. In 1:1 propensity-score matched-paired analysis (PSA) of AML patients, there was no difference in 2-year-relapse-incidence after FluTreo compared with either FluMel (n = 110, p = 0.28) or BuCy (n = 78, p = 0.98). However, 2-year-non-relapse-mortality (NRM) was lower compared with FluMel (p = 0.019) and BuCy (p < 0.001). Consequently, 2-year-overall-survival (OS) after FluTreo was higher compared with FluMel (p = 0.04) and BuCy (p < 0.001). For MDS patients, no endpoint differences between FluTreo and FluMel (n = 30) were evident, whereas 2-year-OS after FluTreo was higher compared with BuCy (n = 25, p = 0.01) due to lower 2-year-NRM. Multivariate sensitivity analysis confirmed all significant results of PSA. Consequently, FluTreo (30 g/m²) seems to retain efficacy compared with FluMel and BuCy, but is better tolerated by older patients.



中文翻译:


氟达拉滨-三硫丹与氟达拉滨-美法仑或白消安-环磷酰胺在老年 AML 或 MDS 患者中的调理——注册数据比较的临床试验



一项随骨髓性白血病(AML)和骨髓增生异常综合征(MDS)。为了进一步评估该方案,所有 252 名年龄 50 至 70 岁的研究患者与相似患者进行了比较,这些患者在氟达拉滨/美法仑 (140 mg/m²) (FluMel) 或白消安 (12.8 mg/kg)/环磷酰胺 (FluMel) 治疗后接受了异基因 HCT。 120 mg/kg) (BuCy) 方案,其数据由欧洲血液和骨髓移植协会登记处提供。在 AML 患者的 1:1 倾向评分配对分析 (PSA) 中,FluTreo 与 FluMel( n = 110, p = 0.28)或 BuCy( n = 78, p = 0.98)。然而,与 FluMel ( p = 0.019) 和 BuCy ( p < 0.001) 相比,2 年非复发死亡率 (NRM) 较低。因此,与 FluMel ( p = 0.04) 和 BuCy ( p < 0.001) 相比,FluTreo 后的 2 年总生存率 (OS) 更高。对于 MDS 患者,FluTreo 和 FluMel 之间没有明显的终点差异( n = 30),而 FluTreo 后的 2 年 OS 高于 BuCy( n = 25, p = 0.01),因为 2 年 NRM 较低。多变量敏感性分析证实了 PSA 的所有显着结果。因此,与 FluMel 和 BuCy 相比,FluTreo (30 g/m²) 似乎保留了疗效,但老年患者的耐受性更好。

更新日期:2024-02-22
down
wechat
bug