维奈克拉联合去甲基化药物治疗复发/难治性急性髓细胞白血病老年患者的临床分析  

Clinical analysis of venetoclax combined with hypomethylating agents in treatment of elderly patients with relapsed/refractory acute myeloid leukemia

作　　者：朱晶晶 李渭阳 乔曼 马骁 Zhu Jingjing;Li Weiyang;Qiao Man;Ma Xiao(Department of Hematology,Soochow Hopes Hematonosis Hospital,Suzhou 215100,Jiangsu Province,China)

机构地区：[1]弘慈血液病医院血液科,苏州215100

出　　处：《国际输血及血液学杂志》2023年第1期34-39,共6页International Journal of Blood Transfusion and Hematology

摘　　要：目的探讨维奈克拉(VEN)联合去甲基化药物(HMA)方案治疗复发/难治性急性髓细胞白血病(R/R AML)老年患者的疗效。方法选择2019年12月至2021年8月苏州弘慈血液病医院收治的14例接受VEN联合HMA治疗的R/R AML老年患者作为研究对象。其中,男性患者为6例,女性为8例,患者中位年龄为69岁(66,71岁)。采用回顾性研究方法,收集本组所有患者血常规、肝肾功能、心电图、骨髓细胞形态学、免疫分型、微小残留病(MRD)、细胞遗传学和分子生物学检测结果等临床资料。采用Fisher确切概率法比较不同类型患者完全缓解(CR)率。采用Kaplan-Meier法绘制14例患者的总体生存(OS)和无白血病生存(LFS)曲线,采用log-rank检验比较不同类型患者生存期。本研究遵循的程序符合苏州弘慈血液病医院医学伦理委员会所制定的伦理学标准,通过该伦理委员会批准[批准文号:(2023)伦研批第001号]。结果①本研究14例接受VEN联合HMA治疗的R/R AML老年患者中,难治性、复发性AML患者分别为10和4例,中、高危组患者分别为1和13例,合并复杂异常染色体核型者为10例,13例进行基因检测患者均存在基因突变。②本组14例患者接受VEN联合HMA治疗15 d时,疗效达CR患者为10例,部分缓解(PR)为1例,未缓解为3例。难治性、复发性AML患者的CR率分别为90%(9/10)和50%(2/4),二者比较,差异无统计学意义(P=0.176)。③本组14例患者的2年OS率为56.6%,中位OS期为41.3个月(11.4,54.7个月);1年LFS率为18.8%,中位LFS期为6.0个月(2.0,10.9个月)。难治性AML患者中位OS期为16.9个月(6.0,41.3个月),低于复发性AML患者的54.7个月(11.4,54.7个月),但差异无统计学意义(χ^(2)=1.447,P=0.229)。④本组14例患者治疗后均出现≥Ⅲ级血液学不良反应,≥Ⅲ级非血液学不良反应为感染(9例),经对症支持治疗有所缓解。结论VEN联合HMA治疗R/R AML老年患者疗效显著,并改善其预后。Objective To investigate the effect of venetoclax(VEN)in combination with hypomethylating agents(HMA)therapy on elderly patients with relapsed/refractory acute myeloid leukemia(R/R AML).Methods From December 2019 to August 2021,a total of 14 elderly patients with R/R AML who accepted treatment of VEN combined with HMA were selected as the study subjects.There were 6 males and 8 females,with a median age of 69 years(66,71 years).A retrospective study was conducted to collect clinical data such as blood routine,liver and kidney function,electrocardiogram,bone marrow cell morphology,immune classification,minimal residual disease(MRD),cytogenetics,and molecular biology test results from all patients in this study.Fisher′s exact probability method was used to compare the complete remission(CR)rates between different types of patients.Kaplan-Meier method was used to plot the overall survival(OS)and leukemia free survival(LFS)curves of 14 patients,and log-rank test was used to compare the survival time between different types of patients.The procedures followed in this study comply with the ethical standards established by the Medical Ethics Committee of Soochow Hopes Hematonosis Hospital,and was approved by the ethics committee[Approval No.(2023)file of Ethical Committee Approval No.001].Results①Among 14 elderly patients with R/R AML who accepted VEN combined with HMA treatment in this study,10 cases were refractory and 4 cases were recurrent AML,while 1 and 13 cases were in the middle and high risk groups,respectively.There were 10 cases patients with complex abnormal chromosome karyotypes,and 13 cases with genetic testing had gene mutations.②On the 15th day of VEN combined with HMA treatment there were 10 patients with CR,1 case with partial remission(PR),and 3 cases with non-remission.The CR rates of refractory and recurrent AML patients were 90%(9/10)and 50%(2/4),respectively,and no statistically significant difference was found between them(P=0.176).③The 2-year OS rate of 14 patients in this study was 56.6

关 键 词：白血病 髓样 急性 复发 维奈克拉 难治 老年人 

分 类 号：R733.71[医药卫生—肿瘤]