维奈克拉联合去甲基化药物治疗42例老年急性髓系白血病的疗效及安全性

Venetoclax combined with demethylation agents in the treatment of 42 elderly patients with acute myeloid leukemia

目的 探讨维奈克拉联合去甲基化药物治疗老年不适合强化疗的急性髓系白血病(AML)的疗效及安全性。方法 回顾性分析2020年1月至2022年8月在南通大学附属医院接受维奈克拉联合去甲基化药物(地西他滨,阿扎胞苷)治疗的42例老年AML的临床资料,临床观察主要终点为完全缓解率(CR)、复合完全缓解率[CR+CR伴血细胞不完全恢复(CRi)]、总反应率(ORR),次要终点是总生存(OS)及药物安全性。结果 所有患者中位随访时间为5.0个月,CR为9.5%,CRi为23.8%,CR+CRi为33.3%,ORR为66.7%。亚组分析示,初诊患者ORR为66.7%,中位生存时间为11个月;复发患者ORR为57.1%,中位生存时间为12个月;难治患者ORR为85.7%,中位生存时间为14个月,三者差异无统计学意义(P>0.05)。此外,缓解患者中位生存时间14.0个月,其95%CI(12.3~15.7)个月,未缓解患者中位生存时间2.0个月,其95%CI(0.1~6.1)个月,缓解患者的中位生存时间显著高于未缓解患者,差异有统计学意义(P<0.05)。42例患者的血细胞发生了不同程度减少,其中粒细胞减少35例(83.3%),贫血16例(38.1%),血小板减少10例(23.8%);血液系统以外常见的主要为胃肠道反应,均能控制,未出现肿瘤溶解综合征。结论 维奈克拉联合去甲基化药物治疗老年AML患者是安全有效的,且耐受性好,给无法进行强化疗的老年AML患者多一种治疗选择。

Objective To explore the efficacy and safety of venetoclax combined with demethylation drugs in the treatment of elderly patients with AML unsuitable for intensive chemotherapy.Methods A retrospective analysis was performed on the clinical data of 42 elderly patients with acute myeloid leukemia(AML)who were treated with venetoclax combined with demethylation drugs(descitabinc,azacytidine)in the Affiliated Hospital of Nantong University from January 2020 to August 2022.The primary-end points in clinical observation were complete remission(CR),composite complete remission[CR+CR with incomplete blood count recovery(CRi)]and overall response rate(ORR),and the secondary end points were overall survival(OS)and drug safety.Results The median follow-up time of all patients was 5.0 months.The efficacy results were as follows:9.5%CR,33.3%CR+CRi and 66.7%ORR.Subgroup analysis showed that the ORR of newly diagnosed patients was 66.7%,with 11 months of the median survival time;the ORR of recurrent patients was 57.1%,with 12 months of the median survival time;and the ORR of refractory patients was 85.7%,with 14 months of the median survival time.There was no significant difference among three subgroups(P>0.05).The median survival time of remission patients was significantly higher than that of patients without remission[14.0(12.3-15.7)months vs 2.0(0.1-6.1)months,P<0.05].The blood cells of 42 patients decreased to different degrees,including 35 cases of granulocytopenia(83.3%),16 cases of anemia(38.1%)and 10 cases of thrombocytopenia(23.8%).In addition,the common side effects were mainly gastrointestinal reactions,which were controlled,and no tumor lysis syndrome occurred.Conclusion In the treatment of elderly AML patients,venetoclax combined with demethylation drugs is safe,effective and well tolerated,and provides a treatment option for elderly AML patients who are not suitable for intensive chemotherapy.