贝林妥欧单抗治疗40例儿童急性淋巴细胞白血病的短期有效性和安全性分析
Short-term efficacy and safety of blinatumomab in 40 children of acute lymphocytic leukemia
黄思颖 1张观梅 1余莉华 1林丹娜 1黄露露 1吴莉 1赖肖蓉 1张亚芥 1杨丽华1
作者信息
- 1. 510280 广州,南方医科大学珠江医院小儿血液科
- 折叠
摘要
目的 分析贝林妥欧单抗治疗微小残留病(MRD)复发和初治急性B淋巴细胞白血病(B-ALL)患儿的短期有效性和安全性.方法 以2022年1月—2023年9月接受贝林妥欧单抗治疗的40例B-ALL患儿作为研究对象,回顾性分析患儿临床研究数据.结果 40例患儿中,11例为MRD复发患儿,29例为初治患儿.18例贝林妥欧单抗治疗前MRD阳性患儿中,88.89％获得了MRD 应答(＜0.01％).MRD＜0.1％患儿应答率高于 MRD≥0.1％患儿(100.00％vs.84.62％);初治患儿应答率高于MRD复发患儿(100.00％vs.80.00％).贝林妥欧单抗治疗期间不良反应发生率为72.50％(29/40).治疗前MRD≥20％是CRS发生的危险因素(P＜0.05).且对治疗前MRD阳性/MRD阴性患儿来说,当IL-6/IL-10在治疗过程中升高3.65倍/1.75倍时对CRS的发生有最佳的预测效度(P＜0.05,敏感性:88.2％/76.9％,特异性:71.1％/84.4％).结论 贝林妥欧单抗对MRD复发和初治B-ALL患儿均有较好的疗效,且贝林妥欧单抗总体安全性良好.长期疗效需扩大样本量进一步观察.
Abstract
Objective To analyze the short-term efficacy and safety of blinatuomoab in children with minimal residual disease(MRD)relapse or primary-treatment acute B lymphoblastic leukemia(B-ALL).Methods Forty children with B-ALL treated with blinatuomoab from January 2022 to September 2023 were collected as study subjects,and data from the children's clinical studies were retrospectively analyzed.Results Of the 40 children,11 were MRD relapse and 29 were primary-treatment.88.89％of the 18 children with MRD+before blinatuomoab treatment achieved an MRD response(＜0.01％).The response rate was higher in children with MRD＜0.1％than in children with MRD ≥0.1％(100.00％vs.84.62％);and the response rate was higher in primary-treatment than in children with MRD relapse(100.0％vs.80.0％).The incidence of adverse reactions during blinatuomoab treatment was 72.5％(29/40).MRD≥20％was a risk factor for the development of CRS(P＜0.05).Moreover,for MRD+children,the best predictive validity for the occurrence of CRS was found when IL-6 was elevated 3.65-fold during the course of treatment(P＜0.05,sensitivity:88.2％,specificity:71.1％),and for MRD-children when IL-10 was elevated 1.75-fold during the course of treatment(p＜0.05,sensitivity:76％,specificity:71.1％).Conclusions Blinatuomoab has good efficacy in both MRD relapse and primary-treatment children,and the overall safety profile of blinatuomoab is favorable.Long-term efficacy needs to be further observed by expanding the sample size.
关键词
急性淋巴细胞白血病,儿童/贝林妥欧单抗/安全性/短期疗效Key words
Acute lymphoblastic leukemia,Child/Blinatumomab/Safety/Short-term effectiveness引用本文复制引用
出版年
2024
NETL
NSTL
万方数据