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Homoharringtonine-Based Induction Regimen Improved the Remission Rate and Survival Rate in Chinese Childhood AML: A Report From the CCLG-AML 2015 Protocol Study

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机构： [1]Hematology Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China. [2]Beijing Key Laboratory of Pediatric Hematology Oncology, Beijing, China. [3]National Key Clinical Discipline of Pediatric Hematology, National Key Discipline of Pediatrics (Capital Medical University), Beijing, China. [4]Key Laboratory of Major Diseases in Children, Ministry of Education, Beijing, China. [5]West China Second University Hospital, Sichuan University, Chengdu, China. [6]Key Laboratory of Chronobiology (Sichuan University), National Health Commission of China, Chengdu, China. [7]Xi'an Children's Hospital, Xian, China. [8]Children's Hospital of Henan Province, Zhengzhou, China. [9]Wuhan Children's Hospital, Wuhan, China. [10]Jiangxi Provincial Children's Hospital, Nanchang, China. [11]Children's Hospital of Nanjing Medical University, Nanjing, China. [12]Shandong First Medical University Affiliated Shandong Provincial Hospital, Jinan, China. [13]Shanghai Children's Hospital, Shanghai, China. [14]Department of Pediatrics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [15]Affiliated Hospital of Qingdao University, Qingdao, China. [16]Children's Hospital of Hebei Province, Shijiazhuang, China. [17]Department of Pediatrics, Xiangya Hospital Central South University, Changsha, China. [18]The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China. [19]Children's Hospital of Fudan University, Shanghai, China. [20]Capital Institute of Pediatrics' Children's Hospital, Beijing, China. [21]Kunming Children's Hospital, Kunming, China. [22]Qilu Hospital of Shandong University, Jinan, China. [23]Children's Hospital of Guizhou Province, Affiliated Hospital of Zunyi Medical University, Zunyi, China. [24]Children's Hospital of Shanxi Province, Taiyuan, China. [25]Peking University People's Hospital, Beijing, China. [26]Women and Children's Hospital, Qingdao University, Qingdao, China. [27]Tianjin Children's Hospital, Tianjin, China. [28]Guiyang Children's Hospital, Guiyang, China. [29]Qinghai Women's and Children's Hospital, Xining, China. [30]The Affiliated Hospital of Guizhou Medical University, Guiyang, China. [31]Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [32]Northwest Women's and Children's Hospital, Xian, China. [33]Linyi People's Hospital, Linyi, China. [34]Chengdu Women's and Children's Central Hospital, Chengdu, China. [35]Children's Hospital of Liaocheng, Liaocheng, China. [36]Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China. [37]First Hospital, Peking University, Beijing, China. [38]Yantai Yuhuangding Hospital, Yantai, China. [39]Second Affiliated Hospital of Shantou University Medical College, Shantou, China. [40]Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China. [41]Laboratory of Hematologic Diseases, Beijing Pediatric Research Institute, Beijing, China. [42]Children's Hospital of Zhejiang University School of Medicine, the Pediatric Leukemia Diagnostic and Therapeutic Technology Research Center of Zhejiang Province, National Clinical Research Center for Child Health, Hangzhou, China. [43]Center for Clinical Epidemiology and Evidence-Based Medicine, Beijing Children's Hospital, Capital Medical University, Beijing, China.

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Homoharringtonine (HHT) is commonly used for the treatment of Chinese adult AML, and all-trans retinoic acid (ATRA) has been verified in acute promyelocytic leukemia (APL). However, the efficacy and safety of HHT-based induction therapy have not been confirmed for childhood AML, and ATRA-based treatment has not been evaluated among patients with non-APL AML.This open-label, multicenter, randomized Chinese Children's Leukemia Group-AML 2015 study was performed across 35 centers in China. Patients with newly diagnosed childhood AML were first randomly assigned to receive an HHT-based (H arm) or etoposide-based (E arm) induction regimen and then randomly allocated to receive cytarabine-based (AC arm) or ATRA-based (AT arm) maintenance therapy. The primary end points were the complete remission (CR) rate after induction therapy, and the secondary end points were the overall survival (OS) and event-free survival (EFS) at 3 years.We enrolled 1,258 patients, of whom 1,253 were included in the intent-to-treat analysis. The overall CR rate was significantly higher in the H arm than in the E arm (79.9% v 73.9%, P = .014). According to the intention-to-treat analysis, the 3-year OS was 69.2% (95% CI, 65.1 to 72.9) in the H arm and 62.8% (95% CI, 58.7 to 66.6) in the E arm (P = .025); the 3-year EFS was 61.1% (95% CI, 56.8 to 65.0) in the H arm and 53.4% (95% CI, 49.2 to 57.3) in the E arm (P = .022). Among the per-protocol population, who received maintenance therapy, the 3-year EFS did not differ significantly across the four arms (H + AT arm: 70.7%, 95% CI, 61.1 to 78.3; H + AC arm: 74.8%, 95% CI, 67.0 to 81.0, P = .933; E + AC arm: 72.9%, 95% CI, 65.1 to 79.2, P = .789; E + AT arm: 66.2%, 95% CI, 56.8 to 74.0, P = .336).HHT is an alternative combination regimen for childhood AML. The effects of ATRA-based maintenance are comparable with those of cytarabine-based maintenance therapy.

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出版当年[2023]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

最新[2023]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

第一作者：

第一作者机构： [1]Hematology Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China. [2]Beijing Key Laboratory of Pediatric Hematology Oncology, Beijing, China. [3]National Key Clinical Discipline of Pediatric Hematology, National Key Discipline of Pediatrics (Capital Medical University), Beijing, China. [4]Key Laboratory of Major Diseases in Children, Ministry of Education, Beijing, China.

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通讯作者：

通讯机构： [1]Hematology Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China. [2]Beijing Key Laboratory of Pediatric Hematology Oncology, Beijing, China. [3]National Key Clinical Discipline of Pediatric Hematology, National Key Discipline of Pediatrics (Capital Medical University), Beijing, China. [4]Key Laboratory of Major Diseases in Children, Ministry of Education, Beijing, China.

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