J Clin Oncol:白消安 vs 全身放疗联合环磷酰胺治疗成人急性B淋巴细胞白血病

2022-09-17 MedSci原创 MedSci原创

对于拟接受HLA匹配的allo-HSCT的获得首次完全缓解的标准风险的B细胞ALL成人患者,BuCy方案具有非劣于TBI-Cy方案的效果和安全性

在接受异基因造血干细胞移植(allo-HSCT)的急性淋巴细胞白血病 (ALL) 患者中,基于白消安的方案与基于全身放射 (TBI) 的方案是否具有可比性仍然存在争议。该研究评估了白消安联合环磷酰胺(BuCy)与TBI联合环磷酰胺(TBI-Cy)在拟进行allo-HSCT的获得首次完全缓解(CR1)的标准风险的B细胞ALL成人患者中的疗效和毒性。

这是一项我国13家医院联合开展的开放标签、随机化的3期临床试验,招募了14-65岁的获得CR1的标准风险的ALL患者。受试患者被1:1随机分至BuCy组(白消安,0.8 mg/kg,4次/天,第-7天和第-4天;环磷酰胺,60 mg/kg,1次/天,第-3天和第-2天)或TBI-Cy组(4.5 Gy TBI,第-5天和-4天;环磷酰胺,60 mg/kg,1次/天,第-3天和第-2天)。主要终点是2年总生存率。


两组的总生存率和累积复发率

2016年1月至2020年2月期间,两组各分配了275位患者,BuCy组有273位、TBI-Cy组有272位被纳入评估。BuCy组和TBI-Cy组的2年总生存率分别是76.6%和79.4%(p=0.457;差值 2.9%,p=0.022),表明了BuCy的非劣效性。BuCy组和TBI-Cy组的两年复发率分别是20.2%和18.4%(p=0.616),非复发死亡率均是11.0%(p=0.988)。两组的方案相关毒性及移植物抗宿主病均无明显差异。

综上,对于拟接受HLA匹配的allo-HSCT的获得首次完全缓解的标准风险的B细胞ALL成人患者,BuCy方案具有非劣于TBI-Cy方案的效果和安全性。

原始出处:

Haiyan Zhang, et al. Busulfan Plus Cyclophosphamide Versus Total Body Irradiation Plus Cyclophosphamide for Adults Acute B Lymphoblastic Leukemia: An Open-Label, Multicenter, Phase III Trial. J Clin Oncol. September 9, 2022. https://ascopubs.org/doi/full/10.1200/JCO.22.00767

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    2022-11-09 minlingfeng
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