机构：[1]Department of Pediatrics, State Key Laboratory of Experimental Haematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem,Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China[2]Department of haematology/Oncology, Children's Hospital of Fudan University, Shanghai, China[3]Department of haematology/Oncology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, National Health Committee Key Laboratoryof Pediatric haematology & Oncology, Shanghai, China[4]Department of haematology/Oncology, Chongqing Medical University Affiliated Children's Hospital, Chongqing, China[5]Department of haematology/Oncology, Children's Hospital of Soochow University, Suzhou, China[6]Department of haematology/Oncology, Children's Hospital of Nanjing Medical University, Nanjing, China[7]Department of Pediatrics, West China Second University Hospital, Sichuan University, Key Laboratory of Birth Defects and Related Disease of Women and Children,Ministry of Education, Chengdu, China[8]Department of haematology/Oncology, Guangzhou Women and Children's Medical centre, Guangzhou, China[9]Department of Pediatrics, Xiangya Hospital Central South University, Changsha, China[10]Department of haematology/Oncology, Jiangxi Provincial Children's Hospital, Nanchang, China[11]Department of Pediatrics, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院[12]Department of haematology/Oncology, KunMing Children's Hospital, Kunming, China[13]Department of Pediatrics, Qilu Hospital of Shandong University, Jinan, China[14]Department of Pediatrics, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[15]Department of haematology/Oncology, Children's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China[16]Department of haematology/Oncology, Xi'an Northwest Women's and Children's Hospital, Xi'an, China[17]Department of Pediatrics, Anhui Medical University Second Affiliated Hospital, Anhui, China[18]Department of Pediatrics, Affiliated Hospital of Qingdao University, Qingdao, China[19]Department of Pediatrics, Hong Kong Children's Hospital, The Chinese University of Hong Kong, Hong Kong, SAR, China[20]Department of Pediatrics, Nanfang Hospital, Southern Medical University, Guangzhou, China[21]Departments of Oncology, Global Pediatric Medicine, Biostatistics and Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee, USA
The effect of prolonged pulse therapy with vincristine and dexamethasone (VD) during maintenance therapy on the outcome of paediatric patients with TCF3-PBX1 positive acute lymphoblastic leukaemia (ALL) remains uncertain. We conducted non-inferiority analysis of 263 newly diagnosed TCF3-PBX1 positive ALL children who were stratified and randomly assigned (1:1) to receive seven additional VD pulses (the control group) or not (the experimental group) in the CCCG-ALL-2015 clinical trial from January 2015 to December 2019 (ChiCTR-IPR-14005706). There was no significant difference in baseline characteristics between the two groups. With a median follow-up of 4.2 years, the 5-year event-free survival (EFS) and 5-year overall survival (OS) in the control group were 90.1% (95% confidence interval [CI] 85.1-95.4) and 94.7% (95% CI, 90.9-98.6) comparable to those in the experimental group 89.2% (95% CI 84.1-94.7) and 95.6% (95% CI 91.8-99.6), respectively. Non-inferiority was established as a one-sided 95% upper confidence bound for the difference in probability of 5-year EFS was 0.003, and that for 5-year OS was 0.01 by as-treated analysis. Thus, omission of pulse therapy with VD beyond one year of treatment did not affect the outcome of children with TCF3-PBX1 positive ALL.
基金：
Chinese Academy of Medical Sciences
Innovation Fund for Medical Sciences, Grant/
Award Number: (2016-I2M-
1-
002)
(XFZ);
the National Natural Science Foundation of
China, Grant/Award Number: (81870131)
(XFZ), (81670136) (JCa) and (82141125)
(XWZ); Shanghai Health Commission
Clinical Research Project, Grant/Award
Number: (202140161) (JCa); Shanghai
Sailing Program, Science and Technology
Commission of Shanghai Municipality, Grant/
Award Number: (20YF1403000) (HHZ); the
National Natural Science Foundation of China,
Shanghai Municipal Committee of Science
and Technology, Grant/Award Number:
(21Y31900302) (XWZ); U.S. National Cancer
Institute, Grant/Award Number: (CA21765) (C-HP);
VIVA China Children’s Cancer Foundation;
National Institutes of Health; American
Lebanese Syrian Associated Charities; National
Cancer Institute; National Natural Science
Foundation of China; Science and Technology
Commission of Shanghai Municipality;
Innovation Fund; Chinese Academy of Medical
Sciences; National Natural Science Foundation of
China; Children's Cancer Foundation
第一作者机构：[1]Department of Pediatrics, State Key Laboratory of Experimental Haematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem,Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Pediatrics, State Key Laboratory of Experimental Haematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem,Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China[21]Departments of Oncology, Global Pediatric Medicine, Biostatistics and Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee, USA[*1]Department of Pediatrics, State Key Laboratory of Experimental Haematology, National Clinical Research Centre for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 288 Nanjing Road, Tianjin, China. 300020.[*2]Department of Oncology, St. Jude Children's Research Hospital, Memphis TN 38105, USA.
推荐引用方式(GB/T 7714)：
Yang Wan,Honghong Zhang,Li Zhang,et al.Extended vincristine and dexamethasone pulse therapy may not be necessary for children with TCF3-PBX1 positive acute lymphoblastic leukaemia[J].BRITISH JOURNAL OF HAEMATOLOGY.2022,199(4):587-596.doi:10.1111/bjh.18437.
APA：
Yang Wan,Honghong Zhang,Li Zhang,Jiaoyang Cai,Jie Yu...&Xiaofan Zhu.(2022).Extended vincristine and dexamethasone pulse therapy may not be necessary for children with TCF3-PBX1 positive acute lymphoblastic leukaemia.BRITISH JOURNAL OF HAEMATOLOGY,199,(4)
MLA：
Yang Wan,et al."Extended vincristine and dexamethasone pulse therapy may not be necessary for children with TCF3-PBX1 positive acute lymphoblastic leukaemia".BRITISH JOURNAL OF HAEMATOLOGY 199..4(2022):587-596
医学