"Idarubicin plus BuCy versus BuCy conditioning regimens for intermediate-risk acute myeloid leukemia in first complete remission undergoing auto-HSCT: An open-label, multicenter, randomized phase 3 trial"

作者全名："Liu, Hui; Huang, Fen; Zhang, Yu; Wu, Meiqing; Xu, Na; Fan, Zhiping; Sun, Zhiqiang; Li, Xudong; Lin, Dongjun; Xiong, Yiying; Liu, Xiaodan; Lin, Ren; Shi, Pengcheng; Xu, Jun; Wang, Zhixiang; Li, Xiaofang; Sun, Jing; Liu, Qifa; Xuan, Li"

作者地址："[Liu, Hui; Huang, Fen; Zhang, Yu; Xu, Na; Fan, Zhiping; Lin, Ren; Shi, Pengcheng; Xu, Jun; Wang, Zhixiang; Li, Xiaofang; Sun, Jing; Liu, Qifa; Xuan, Li] Southern Med Univ, Nanfang Hosp, Dept Hematol, Guangzhou, Peoples R China; [Wu, Meiqing] Guangxi Med Univ, Affiliated Hosp 1, Dept Hematol, Nanning, Peoples R China; [Sun, Zhiqiang] Southern Med Univ, Dept Hematol, Shenzhen Hosp, Shenzhen, Peoples R China; [Li, Xudong] Sun Yat Sen Univ, Affiliated Hosp 3, Dept Hematol, Guangzhou, Peoples R China; [Lin, Dongjun] Sun Yat Sen Univ, Affiliated Hosp 7, Dept Hematol, Shenzhen, Peoples R China; [Xiong, Yiying] Chongqing Med Univ, Affiliated Hosp 1, Dept Hematol, Chongqing, Peoples R China; [Liu, Xiaodan] Qingdao Univ, Dept Hematol, Affiliated Hosp, Qingdao, Peoples R China"

通信作者："Liu, QF; Xuan, L (通讯作者)，Southern Med Univ, Nanfang Hosp, Dept Hematol, Guangzhou, Peoples R China."

来源：AMERICAN JOURNAL OF HEMATOLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000906381500001

JCR分区：Q1

影响因子：10.1

年份：2023

卷号：98

期号：3

开始页：408

结束页：412

文献类型：Article

关键词：　

摘要："We report a randomized prospective phase 3 study, designed to evaluate the efficacy and tolerability of idarubicin plus busulfan and cyclophosphamide (IDA-BuCy) versus BuCy in autologous hematopoietic stem-cell transplantation (auto-HSCT) for intermediate-risk acute myeloid leukemia (IR-AML) patients in first complete remission (CR1). One hundred and fifty-four patients were enrolled and randomized to receive IDA-BuCy (IDA 15 mg/m2/day on days -12 to -10, Bu 3.2 mg/kg/day on days -7 to -4, and Cy 60 mg/kg/day on days -3 to -2) or BuCy. The 2-year incidence of relapse was 15.6% and 19.5% in IDA-BuCy and BuCy groups (p = 0.482), respectively. There was no significant overall survival (OS) and disease-free survival (DFS) benefit for IR-AML patients receiving IDA-BuCy (2-year OS 81.8% in IDA-BuCy vs. 83.1% in BuCy, p = 0.798; 2-year DFS 76.6% in IDA-BuCy vs. 79.2% in BuCy, p = 0.693). Grade 3 or worse regimen-related toxicity (RRT) was reported for 22 (28.9%) of 76 and 9 (12.0%) of 75 patients in two groups (p = 0.015), respectively. AEs within 100 days with an outcome of death were reported for 4 (5.3%) and 0 patients in two groups. In conclusion, IDA-BuCy has higher RRT and similar anti-leukemic activity compared with BuCy in IR-AML patients in CR1 undergoing auto-HSCT. Thus, caution should be taken when choosing IDA-BuCy for IR-AML patients in CR1 with auto-HSCT. This trial is registered with , NCT02671708, and is complete."

基金机构："National Key Research and Development Program of China; National Natural Science Foundation of China [2017YFA105500-4, 2021YFC2500300-4]; Clinical Research Program of Nanfang Hospital, Southern Medical University [82170213, 81970161]; Research and Development Program in Key Areas of Guangdong Province [2018CR044]; Natural Science Foundation of Guangdong Province [2019B020236004]; [2019A1515011924]"

基金资助正文："This study was supported by National Key Research and Development Program of China (No. 2017YFA105500-4, No. 2021YFC2500300-4), National Natural Science Foundation of China (No. 82170213, No. 81970161), Clinical Research Program of Nanfang Hospital, Southern Medical University (No. 2018CR044), Research and Development Program in Key Areas of Guangdong Province (No. 2019B020236004), and Natural Science Foundation of Guangdong Province (No. 2019A1515011924)."