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Tytuł pozycji:

Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial).

Tytuł:
Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial).
Autorzy:
Chen L; 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.
Zhu HM; 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.
Li Y; Department of Hematology, First Hospital of China Medical University, 110001 Shenyang, China.
Liu QF; Department of Hematology, Nanfang Hospital of Southern Medical University, 510515 Guangzhou, China.
Hu Y; Department of Hematology, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, China.
Zhou JF; Department of Hematology, Tong Ji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 Wuhan, China.
Jin J; Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, 310006 Hangzhou, China.
Hu JD; Department of Hematology, Fujian Medical University Union Hospital, 350001 Fuzhou, China.
Liu T; Department of Hematology, West China Hospital, Sichuan University, 610041 Chengdu, China.
Wu DP; Department of Hematology, The First Affiliated Hospital of Soochow University, 215006 Suzhou, China.
Chen JP; Department of Hematology, Southwest Hospital, Third Military Medical University, 400038 Chongqing, China.
Lai YR; Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, 530021 Nanning, China.
Wang JX; Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 300020 Tianjin, China.
Li J; Department of Hematology, The First Affiliated Hospital of Sun Yat-sen University, 510080 Guangzhou, China.
Li JY; Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, 210029 Nanjing, China.
Du X; Department of Hematology, Guangdong Province People's Hospital, Guangdong Academy of Medical Sciences, 510055 Guangzhou, China.
Wang X; Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, 250021 Jinan, China.
Yang MZ; Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.
Yan JS; Department of Hematology, The Second Affiliated Hospital of Dalian Medical University, 116027 Dalian, China.
Ouyang GF; Department of Hematology, Ningbo First Hospital, 315010 Ningbo, China.
Liu L; Department of Hematology, Tangdu Hospital, Fourth Military Medical University, 710038 Xi'an, China.
Hou M; Department of Hematology, Qilu Hospital of Shandong University, 250012 Jinan, China.
Huang XJ; Department of Hematology, Peking University People's Hospital, 100044 Beijing, China.
Yan XJ; Department of Hematology, First Hospital of China Medical University, 110001 Shenyang, China.
Xu D; Department of Hematology, Nanfang Hospital of Southern Medical University, 510515 Guangzhou, China.
Li WM; Department of Hematology, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, China.
Li DJ; Department of Hematology, Tong Ji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 Wuhan, China.
Lou YJ; Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, 310006 Hangzhou, China.
Wu ZJ; Department of Hematology, Fujian Medical University Union Hospital, 350001 Fuzhou, China.
Niu T; Department of Hematology, West China Hospital, Sichuan University, 610041 Chengdu, China.
Wang Y; Department of Hematology, The First Affiliated Hospital of Soochow University, 215006 Suzhou, China.
Li XY; 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.
You JH; 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.
Zhao HJ; 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.
Chen Y; 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.
Shen Y; 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.
Chen QS; 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.
Chen Y; 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.; Department of Hematology, Ruijin Hospital North Affiliated to Shanghai Jiao Tong University School of Medicine, 201801 Shanghai, China.
Li J; Clinical Research Center, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.
Wang BS; Department of Biostatistics, Clinical Research Center, Shanghai Jiao Tong University School of Medicine, 200025 Shanghai, China.
Zhao WL; 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.
Mi JQ; 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.
Wang KK; 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.
Hu J; 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.
Chen Z; 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; .
Chen SJ; 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; .
Li JM; 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; .
Źródło:
Proceedings of the National Academy of Sciences of the United States of America [Proc Natl Acad Sci U S A] 2021 Feb 09; Vol. 118 (6).
Typ publikacji:
Journal Article; Pragmatic Clinical Trial; Research Support, Non-U.S. Gov't
Język:
English
Imprint Name(s):
Original Publication: Washington, DC : National Academy of Sciences
MeSH Terms:
Antineoplastic Combined Chemotherapy Protocols/*administration & dosage
Arsenic Trioxide/*administration & dosage
Leukemia, Promyelocytic, Acute/*drug therapy
Tretinoin/*administration & dosage
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Arsenic Trioxide/adverse effects ; Consolidation Chemotherapy/adverse effects ; Cytarabine/administration & dosage ; Cytarabine/adverse effects ; Disease-Free Survival ; Female ; Humans ; Male ; Middle Aged ; Remission Induction ; Treatment Outcome ; Tretinoin/adverse effects
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Contributed Indexing:
Keywords: acute promyelocytic leukemia; all-trans retinoic acid; arsenic trioxide; consolidation therapy; risk stratification
Molecular Sequence:
ClinicalTrials.gov NCT01987297
Substance Nomenclature:
04079A1RDZ (Cytarabine)
5688UTC01R (Tretinoin)
S7V92P67HO (Arsenic Trioxide)
Entry Date(s):
Date Created: 20210126 Date Completed: 20210624 Latest Revision: 20210726
Update Code:
20240105
PubMed Central ID:
PMC8017727
DOI:
10.1073/pnas.2020382118
PMID:
33495363
Czasopismo naukowe
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).
Competing Interests: The authors declare no competing interest.

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