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学科主题: 临床医学
题名:
Homoharringtonine-based induction regimens for patients with de-novo acute myeloid leukaemia: a multicentre, open-label, randomised, controlled phase 3 trial
作者: Jin, Jie1; Wang, Jian-Xiang3,4,5; Chen, Fei-Fei1; Wu, De-Pei6; Hu, Jiong7; Zhou, Jian-Feng8; Hu, Jian-Da9; Wang, Jian-Min10; Li, Jian-Yong11; Huang, Xiao-Jun12; Ma, Jun13; Ji, Chun-Yan; Xu, Xiao-Ping14; Yu, Kang15; Ren, Han-Yun16; Zhou, Yu-Hong17; Tong, Yin1; Lou, Yin-Jun1; Ni, Wan-Mao1; Tong, Hong-Yan1; Wang, Hua-Feng1; Mi, Ying-Chang3,4,5; Du, Xin18; Chen, Bao-An19; Shen, Yi2; Chen, Zhu7; Chen, Sai-Juan7
刊名: LANCET ONCOLOGY
发表日期: 2013-06-01
DOI: 10.1016/S1470-2045(13)70152-9
卷: 14, 期:7, 页:599-608
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology
研究领域[WOS]: Oncology
关键词[WOS]: ACUTE MYELOGENOUS LEUKEMIA ; ADULT PATIENTS ; DAUNORUBICIN ; THERAPY ; CYTARABINE ; CANCER ; CELLS ; CHEMOTHERAPY ; COMBINATION ; ETOPOSIDE
英文摘要:

Background Homoharringtonine-based induction regimens have been widely used in China for patients with acute myeloid leukaemia. However, their efficacy has not been tested in a multicentre randomised controlled trial in a large population. We assessed the efficacy and safety of homoharringtonine-based induction treatment for management of newly diagnosed acute myeloid leukaemia.

Methods This open-label, randomised, controlled, phase 3 study was done in 17 institutions in China between September, 2007, and July, 2011. Untreated patients aged 14-59 years with acute myeloid leukaemia were randomly assigned (by a computer-generated allocation schedule without stratification) to receive one of three induction regimens in a 1:1:1 ratio: homoharringtonine 2 mg/m(2) per day on days 1-7, cytarabine 100 mg/m(2) per day on days 1-7, and aclarubicin 20 mg/day on days 1-7 (HAA); homoharringtonine 2 mg/m(2) per day on days 1-7, cytarabine 100 mg/m(2) per day on days 1-7, and daunorubicin 40 mg/m(2) per day on days 1-3 (HAD); or daunorubicin 40-45 mg/m(2) per day on days 1-3 and cytarabine 100 mg/m(2) per day on days 1-7 (DA). Patients in complete remission were offered two cycles of intermediate-dose cytarabine (2 g/m(2) every 12 h on days 1-3). The primary endpoints were the proportion of patients who achieved complete remission after two cycles of induction treatment and event-free survival in the intention-to-treat population. The trial is registered in the Chinese Clinical Trial Register, number ChiCTR-TRC-06000054.

Findings We enrolled 620 patients, of whom 609 were included in the intention-to-treat analysis. 150 of 206 patients (73%) in the HAA group achieved complete remission versus 125 of 205 (61%) in the DA group (p=0.0108); 3-year event-free survival was 35.4% (95% CI 28.6-42.2) versus 23.1% (95% CI 17.4-29.3; p=0.0023). 133 of 198 patients (67%) in the HAD group had complete remission (vs DA, p=0.20) and 3-year event-free survival was 32.7% (95% CI 26.1-39.5; vs DA, p=0.08). Adverse events were much the same in all groups, except that more patients in the HAA (12 of 206 [5.8%]) and HAD (13 of 198 [6.6%]) groups died within 30 days than in the DA group (two of 205 [1%]; p=0.0067 vs HAA; p=0.0030 vs HAD).

Interpretation A regimen of homoharringtonine, cytarabine, and aclarubicin is a treatment option for young, newly diagnosed patients with acute myeloid leukaemia.

语种: 英语
所属项目编号: 863 ; 2006AA02A405 ; 2008ZX09312 ; 81070418H0812
项目资助者: National Clinical Key Specialty Construction Project ; Chinese National High Tech Programme ; Key Special Research Foundation of the Ministry of Science and Technology of China ; National Nature Science Foundation of China ; National Clinical Key Specialty Construction Project (First Affiliated Hospital, College of Medicine, Zhejiang University)
WOS记录号: WOS:000320371100046
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/68195
Appears in Collections:北京大学第二临床医学院_血液科_期刊论文

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作者单位: 1.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
2.Zhejiang Univ, Coll Med, Fac Publ Hlth, Hangzhou 310003, Zhejiang, Peoples R China
3.Chinese Acad Med Sci, Hangzhou Inst Hematol, Tianjin, Peoples R China
4.Chinese Acad Med Sci, Blood Dis Hosp, Tianjin, Peoples R China
5.Peking Union Med Coll, Tianjin, Peoples R China
6.Soochow Univ, Affiliated Hosp 1, Suzhou, Peoples R China
7.Shanghai Jiao Tong Univ, Shanghai Inst Hematol, Rui Jin Hosp, Sch Med, Shanghai 200030, Peoples R China
8.Tongji Hosp, Wuhan, Peoples R China
9.Fujian Med Univ, Fujian Inst Hematol, Union Hosp, Fuzhou, Peoples R China
10.Second Mil Med Univ, Changhai Hosp, Shanghai, Peoples R China
11.Nanjing Med Univ, Affiliated Hosp 1, Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China
12.Peking Univ, Peoples Hosp, Inst Hematol, Beijing 100871, Peoples R China
13.Harbin Inst Hematol & Oncol, Harbin, Peoples R China
14.Fudan Univ, Huashan Hosp, Shanghai 200433, Peoples R China
15.Wenzhou Med Coll, Affiliated Hosp 1, Wenzhou, Peoples R China
16.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
17.TCM Hosp Zhejiang Prov, Hangzhou, Zhejiang, Peoples R China
18.Guangdong Prov People Hosp, Guangzhou, Guangdong, Peoples R China
19.Southeast Univ, Zhongda Hosp, Sch Med, Nanjing, Jiangsu, Peoples R China

Recommended Citation:
Jin, Jie,Wang, Jian-Xiang,Chen, Fei-Fei,et al. Homoharringtonine-based induction regimens for patients with de-novo acute myeloid leukaemia: a multicentre, open-label, randomised, controlled phase 3 trial[J]. LANCET ONCOLOGY,2013,14(7):599-608.
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