摘要
目的评估去甲氧柔红霉素、阿糖胞苷联合环磷酰胺(IAC)方案治疗复发/难治急性髓系白血病(AML)的疗效和安全性。方法研究设计为前瞻性随机对照临床试验。纳入2016年7月1日至2019年10月9日于中国医学科学院血液病医院确诊的除急性早幼粒细胞白血病以外的复发/难治AML患者。入组患者进行分层随机分组,试验组选择IAC方案再诱导治疗,对照组的治疗方案由医师根据经验从多个再诱导治疗方案中选择。符合条件患者在挽救治疗后尽可能进行异基因造血干细胞移植(allo-HSCT)。分析两组的疗效及安全性。结果42例患者入组,IAC组22例,对照组20例,中位年龄为36(15~58)岁。①两组患者总有效率(ORR)分别为71.4%和40.0%(P=0.062);完全缓解(CR)率分别为66.7%和40.0%(P=0.121)。中位随访时间为10.5(1.7~32.8)个月,IAC组中位总生存(OS)时间为14.1(0.6~49.1)个月,对照组为9.9(2.0~53.8)个月(P=0.305)。1年OS率两组分别为54.5%(95%CI 33.7%~75.3%)和48.2%(95%CI 25.9%~70.5%),差异无统计学意义(P=0.305)。②不良反应主要表现为骨髓抑制导致的血细胞减少。IAC组和对照组3~4级血液学不良反应发生率分别为100%(22/22)和95%(19/20)。化疗后粒细胞缺乏持续的中位时间分别为20(8~30)d和14(5~50)d(P=0.023)。③早期复发(12个月内复发)组CR率为46.7%,晚期复发(12个月后复发)组CR率为72.7%(P=0.173),两组中位OS时间分别为9.9(1.7~53.8)个月和19.3(0.6~40.8)个月(P=0.420),1年OS率分别为45.3%(95%CI 27.2%~63.3%)和66.7%(95%CI 40.0%~93.4%)(P=0.420),差异均无统计学意义。④对于挽救治疗后的患者,根据是否接受allo-HSCT分组,移植组和未移植组1年OS率分别为87.5%(95%CI 71.2%~100%)和6.3%(95%CI 5.7%~18.3%),移植组明显高于未移植组(P<0.001)。结论IAC方案与根据经验选择的方案对复发/难治AML患者具有相似的疗效及安全性,复发/难治患者应及早进行allo-HSCT,以期获得长期生存。
Objective To evaluate the efficacy and toxicity profiles of idarubicin,cytarabine,and cyclophosphamide(IAC)in relapse/refractory acute myeloid leukemia(AML).Methods This study was a prospective,randomized controlled clinical trial with the registration number NCT02937662.The patients were randomly divided into two groups.The experimental group was treated with an IAC regimen,and the regimen of the control group was selected by doctors according to medication experience.After salvage chemotherapy,allogeneic hematopoietic stem cell transplantation(allo-HSCT)was conducted as far as possible according to the situation of the patients.We aimed to observe the efficacy,safety,and toxicity of the IAC regimen in relapse/refractory AML and to explore which is the better regimen.Results Forty-two patients were enrolled in the clinical trial,with a median age of 36 years(IAC group,22 cases and control groups,20 cases).①The objective response rate was 71.4%in the IAC group and 40.0%in the control group(P=0.062);the complete remission(CR)rate was 66.7%in the IAC group and 40.0%in the control group(P=0.121).The median follow-up time of surviving patients was 10.5(range:1.7-32.8)months;the median overall survival(OS)was 14.1(range:0.6-49.1)months in the IAC group and 9.9(range:2.0-53.8)months in the control group(P=0.305).The 1-year OS was 54.5%(95%CI 33.7%-75.3%)in the IAC group and 48.2%(95%CI 25.9%-70.5%)in the control group(P=0.305),with no significant difference between these two regimens.②The main hematologic adverse events(AEs)were anemia,thrombocytopenia,and neutropenia.The incidence of grade 3-4 hematologic AEs in the two groups was 100%(22/22)in the IAC group and 95%(19/20)in the control group.The median time of neutropenia after chemotherapy in the IAC group and control group was 20(IQR:8-30)and 14(IQR:5-50)days,respectively(P=0.023).③The CR rate of the early relapse(relapse within 12 months)group was 46.7%and that of the late relapse(relapse after 12 months)group was 72.7%(P=0.17).The median OS time of early re
作者
李春红
魏述宁
邱少伟
宫本法
弓晓媛
李艳
刘云涛
房秋云
张广吉
刘凯奇
周春林
林冬
刘兵城
王迎
秘营昌
魏辉
王建祥
Li Chunhong;Wei Shuning;Qiu Shaowei;Gong Benfa;Gong Xiaoyuan;Li Yan;Liu Yuntao;Fang Qiuyun;Zhang Guangji;Liu Kaiqi;Zhou Chunlin;Lin Dong;Liu Bingcheng;Wang Ying;Mi Yingchang;Wei Hui;Wang Jianxiang(Institute of Hematology&Blood Diseases Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,State Key Laboratory of Experimental Hematology,Haihe Laboratory of Cell Ecosystem,National Clinical Research Center for Blood Diseases,Tianjin 300020,China)
出处
《中华血液学杂志》
CAS
CSCD
北大核心
2022年第4期287-292,共6页
Chinese Journal of Hematology
基金
国家重点研发计划(2021YFC2500300)
国家自然科学基金(82141122)
细胞生态海河实验室(HH22KYZX0039)
中国医学科学院医学与健康科技创新工程项目(2020-I2M-C&T-A-019)
天津市公共卫生重大科技专项项目(21ZXGWSY00030)。
关键词
白血病
髓系
急性
复发
难治
抗肿瘤联合化疗方案
Leukemia,myeloid,acute
Refractory
Relapsed
Antineoplastic combined chemotherapy protocols
