气候变化领域集成服务门户(CCPortal): Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial)

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DOI	10.1073/pnas.2020382118
	Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial)
	Chen L.; Zhu H.-M.; Li Y.; Liu Q.-F.; Hu Y.; Zhou J.-F.; Jin J.; Hu J.-D.; Liu T.; Wu D.-P.; Chen J.-P.; Lai Y.-R.; Wang J.-X.; Li J.; Li J.-Y.; Du X.; Wang X.; Yang M.-Z.; Yan J.-S.; Ouyang G.-F.; Liu L.; Hou M.; Huang X.-J.; Yan X.-J.; Xu D.; Li W.-M.; Li D.-J.; Lou Y.-J.; Wu Z.-J.; Niu T.; Wang Y.; Li X.-Y.; You J.-H.; Zhao H.-J.; Chen Y.; Shen Y.; Chen Q.-S.; Chen Y.; Li J.; Wang B.-S.; Zhao W.-L.; Mi J.-Q.; Wang K.-K.; Hu J.; Chen Z.; Chen S.-J.; Li J.-M.
发表日期	2021
ISSN	00278424
卷号	118 期号:6
英文摘要	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). © 2021 National Academy of Sciences. All rights reserved.
英文关键词	Acute promyelocytic leukemia; All-trans retinoic acid; Arsenic trioxide; Consolidation therapy; Risk stratification
语种	英语
scopus关键词	anthracycline; arsenic trioxide; cytarabine; dexamethasone; methotrexate; retinoic acid; adult; aged; Article; blood toxicity; cancer grading; cancer incidence; cohort analysis; consolidation chemotherapy; controlled study; disease free survival; drug withdrawal; female; follow up; high risk patient; human; hyperlipidemia; induction chemotherapy; intermediate risk patient; kidney disease; leukemia remission; liver toxicity; low risk patient; major clinical study; male; neutropenia; priority journal; promyelocytic leukemia; QT prolongation; rash; risk assessment; thrombocytopenia
来源期刊	Proceedings of the National Academy of Sciences of the United States of America
文献类型	期刊论文
条目标识符	http://gcip.llas.ac.cn/handle/2XKMVOVA/180773
作者单位	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, Shanghai, 200025, China; Department of Hematology, First Hospital of China Medical University, Shenyang, 110001, China; Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China; Department of Hematology, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China; Department of Hematology, Tong Ji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China; Department of Hematology, The First Affiliated Hospital of Zhejiang University, College of Medicine, Hangzhou, 310006, China; Department of Hematology, Fujian Medical University, Union Hospital, Fuzhou, 350001, China; Department of Hematology, West China Hospital, Sichuan University, Chengdu, 610041,...
推荐引用方式 GB/T 7714	Chen L.,Zhu H.-M.,Li Y.,et al. Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial)[J],2021,118(6).
APA	Chen L..,Zhu H.-M..,Li Y..,Liu Q.-F..,Hu Y..,...&Li J.-M..(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 L.,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).