机构：[1]Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China[2]Department of Hematology, First Hospital of China Medical University, 110001 Shenyang, China[3]Department of Hematology, Nanfang Hospital of Southern Medical University, 510515 Guangzhou, China[4]Department of Hematology, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, China华中科技大学同济医学院附属协和医院[5]Department of Hematology, Tong Ji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 Wuhan, China[6]Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, 310006 Hangzhou, China ]浙江大学医学院附属第一医院[7]Department of Hematology, Fujian Medical University Union Hospital, 350001 Fuzhou, China[8]Department of Hematology, West China Hospital, Sichuan University, 610041 Chengdu, China四川大学华西医院[9]Department of Hematology, The First Affiliated Hospital of Soochow University, 215006 Suzhou, China[10]Department of Hematology, Southwest Hospital, Third Military Medical University, 400038 Chongqing, China[11]Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, 530021 Nanning, China[12]Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 300020 Tianjin, China[13]Department of Hematology, The First Affiliated Hospital of Sun Yat-sen University, 510080 Guangzhou, China中山大学附属第一医院[14]Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, 210029 Nanjing, China江苏省人民医院[15]Department of Hematology, Guangdong Province People’s Hospital, Guangdong Academy of Medical Sciences, 510055 Guangzhou, China[16]Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, 250021 Jinan, China[17]Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China[18]Department of Hematology, The Second Affiliated Hospital of Dalian Medical University, 116027 Dalian, China[19]Department of Hematology, Ningbo First Hospital, 315010 Ningbo, China[20]Department of Hematology, Tangdu Hospital, Fourth Military Medical University, 710038 Xi’an, China[21]Department of Hematology, Qilu Hospital of Shandong University, 250012 Jinan, China[22]Department of Hematology, Peking University People’s Hospital, 100044 Beijing, China[23]Department of Hematology, Ruijin Hospital North Affiliated to Shanghai Jiao Tong University School of Medicine, 201801 Shanghai, China[24]Clinical Research Center, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China[25]Department of Biostatistics, Clinical Research Center, Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China
As all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) are widely accepted in treating acute promyelocytic leukemia (APL), deescalating toxicity becomes a research hotspot. Here, we evaluated whether chemotherapy could be replaced or reduced by ATO in APL patients at different risks. After achieving complete remission with ATRA-ATO-based induction therapy, patients were randomized (1:1) into ATO and non-ATO groups for consolidation: ATRA-ATO versus ATRA-anthracycline for low-/intermediate-risk patients, or ATRA-ATO-anthracycline versus ATRA-anthracycline-cytarabine for high-risk patients. The primary end point was to assess disease-free survival (DFS) at 3 y by a noninferiority margin of -5%; 855 patients were enrolled with a median follow-up of 54.9 mo, and 658 of 755 patients could be evaluated at 3 y. In the ATO group, 96.1% (319/332) achieved 3-y DFS, compared to 92.6% (302/326) in the non-ATO group. The difference was 3.45% (95% CI -0.07 to 6.97), confirming noninferiority (P < 0.001). Using the Kaplan-Meier method, the estimated 7-y DFS was 95.7% (95% CI 93.6 to 97.9) in ATO and 92.6% (95% CI 89.8 to 95.4) in non-ATO groups (P = 0.066). Concerning secondary end points, the 7-y cumulative incidence of relapse (CIR) was significantly lower in ATO (2.2% [95% CI 1.1 to 4.2]) than in non-ATO group (6.1% [95% CI 3.9 to 9.5], P = 0.011). In addition, grade 3 to 4 hematological toxicities were significantly reduced in the ATO group during consolidation. Hence, ATRA-ATO in both chemotherapy-replacing and -reducing settings in consolidation is not inferior to ATRA-chemotherapy (https://www.clinicaltrials.gov/, NCT01987297).
第一作者机构：[1]Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China
通讯作者：
推荐引用方式(GB/T 7714)：
Chen Li,Zhu Hong-Ming,Li Yan,et al.Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial).[J].PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA.2021,118(6):doi:10.1073/pnas.2020382118.
APA：
Chen Li,Zhu Hong-Ming,Li Yan,Liu Qi-Fa,Hu Yu...&Li Jun-Min.(2021).Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial)..PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA,118,(6)
MLA：
Chen Li,et al."Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial).".PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA 118..6(2021)
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