DCAG方案治疗复发/难治性急性髓系白血病的疗效和安全性分析  

Efficacy and Safety of DCAG Regimen in Patients with Relapsed/Refractory Acute Myeloid Leukemia

作　　者：周辉晟 李雨晴 王雨欣 狐亚磊 闵凯莉 高春记 刘代红 高晓宁 ZHOU Hui-Sheng;LI Yu-Qing;WANG Yu-Xin;HU Ya-Lei;MIN Kai-Li;GAO Chun-Ji;LIU Dai-Hong;GAO Xiao-Ning(Senior Department of Hematology,The Fijfth Medical Center,Chinese PLA General Hospital,Bejing 100071,China;Graduate School,Beijing 100853,China)

机构地区：[1]解放军总医院第五医学中心血液病医学部,北京100071 [2]解放军医学院,北京100853

出　　处：《中国实验血液学杂志》2025年第1期9-19,共11页Journal of Experimental Hematology

基　　金：国家自然科学基金(82070149)。

摘　　要：目的:评价DCAG(地西他滨、阿糖胞苷、蒽环类药物、粒细胞集落刺激因子)方案治疗复发/难治性(R/R)急性髓系白血病(AML)患者的疗效和安全性。方法:回顾性分析2012年1月1日至2022年12月31日在解放军总医院诊治的R/R AML患者的临床资料。主要观察终点包括疗效,通过总反应率(ORR)和安全性来衡量。次要观察终点包括总生存期(OS)、无事件生存期(EFS)和缓解持续时间(DOR)。患者从入组开始随访至死亡、或最后一次随访结束(2023年6月1日),以最先发生者为准。结果:纳入64例既往治疗失败的患者,64例患者均至少完成1个周期的治疗,26例和5例患者分别完成2个周期和3个周期DCAG方案的治疗。ORR为67.2%[39例完全缓解(CR)/CR伴血液学不完全恢复(CRi),4例部分缓解(PR)]。患者中位随访时间为62.0(1.0-120.9)个月,中位总生存期(OS)和无事件生存期分别为23.3和10.6个月。有应答者(CR/CRi/PR)的中位OS为51.7(3.4-100.0)个月,而无应答者的中位OS为8.4(6.1-10.7)个月(P<0.001)。在所有患者中均观察到3-4级的血液学毒性。4例患者在化疗后8周内死于病情快速进展。结论:DCAG方案是治疗R/R AML的一种可行、有效的治疗方法。Objective:To evaluate the efficacy and safety of DCAG(decitabine,cytarabine,anthracyclines,and granulocyte colony-stimulating factor)regimen in the treatment of patients with relapsed/refractory(R/R)acute myeloid leukemia(AML).Methods:The clinical data of 64 R/R AML patients received treatment at Chinese PLA General Hospital from January 1st,2012 to December 31st,2022 were retrospectively analyzed.Primary endpoints included efficacy measured by overall response rate(ORR)and safety.Secondary endpoints included overall survival(OS),event-free survival(EFS)and duration of response(DOR).The patients were followed from enrollment until death,or the end of last follow-up(June 1st,2023),whichever occurred first.Results:Sixty-four patients who failed prior therapy were enrolled and completed 1 cycle,and 26 and 5 patients completed 2 and 3 cycles,respectively.Objective response rate was 67.2%[39:complete remission(CR)/CR with incomplete hematologic recovery(CRi),4:partial remission(PR)].With a median follow-up of 62.0 months(1.0-120.9),the median overall survival(OS)was 23.3 and event-free survival was 10.6 months.The median OS was 51.7 months(3.4-100.0)in responders(CR/CRi/PR)while it was 8.4 months(6.1-10.7)in nonresponders(P<0.001).Grade 3-4 hematologic toxicities were observed in all patients.Four patients died from rapid disease progression within 8 weeks after chemotherapy.Conclusion:The DCAG regimen represents a feasible and effective treatment for R/R AML.

关 键 词：复发 难治 急性髓系白血病 DCAG方案 

分 类 号：R733.71[医药卫生—肿瘤]