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Oral Tetra-Arsenic Tetra-Sulfide Formula Versus Intravenous Arsenic Trioxide As First-Line Treatment of Acute Promyelocytic Leukemia: A Multicenter Randomized Controlled Trial
Zhu, Hong-Hu1; Wu, De-Pei2; Jin, Jie3; Li, Jian-Yong4; Ma, Jun5; Wang, Jian-Xiang6,7,8; Jiang, Hao1; Chen, Sai-Juan9; Huang, Xiao-Jun1
刊名JOURNAL OF CLINICAL ONCOLOGY
2013-11-20
DOI10.1200/JCO.2013.48.8312
31期:33页:4215-+
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology
资助者National High-Tech RD (863) Program ; Mega Project of the Ministry of Science and Technology ; Beijing Municipal Science &amp ; Technology Commission ; National High-Tech RD (863) Program ; Mega Project of the Ministry of Science and Technology ; Beijing Municipal Science &amp ; Technology Commission
研究领域[WOS]Oncology
关键词[WOS]TRANS-RETINOIC ACID ; RISK-ADAPTED TREATMENT ; CLINICAL-EFFICACY ; THERAPY ; CELLS ; PHARMACOKINETICS ; ANTHRACYCLINE ; COMBINATION ; MECHANISMS ; MANAGEMENT
英文摘要

Purpose This randomized, multicenter, phase III noninferiority trial was designed to test the efficacy and safety of an oral tetra-arsenic tetra-sulfide (As4S4) -containing formula named the Realgar-Indigo naturalis formula (RIF) compared with intravenous arsenic trioxide (ATO) as both induction and maintenance therapies for newly diagnosed acute promyelocytic leukemia (APL).

Patients and Methods In all, 242 patients with APL were randomly assigned (1:1) to oral RIF (60 mg/kg) or ATO (0.16 mg/kg) combined with all-trans retinoic acid (ATRA; 25 mg/m(2)) during induction therapy. After achieving complete remission (CR), all patients received three courses of consolidation chemotherapy and maintenance treatment with sequential ATRA followed by either RIF or ATO for 2 years. The primary end point was the rate of disease-free survival (DFS) at 2 years, which was assessed for noninferiority with a 10% noninferiority margin.

Results The median follow-up time was 39 months. DFS at 2 years was 98.1% (106 of 108) in the RIF group and 95.5% (107 of 112) in the ATO group. The DFS difference was 2.6% (95% CI, -3.0% to 8.0%). The lower limit of the 95% CI of DFS difference was greater than the -10% noninferiority margin, confirming noninferiority (P < .001). No significant differences were noted between the RIF and ATO groups with regard to the CR rate (99.1% v 97.2%; P = .62) or the overall survival at 3 years (99.1% v 96.6%; P = .18). The rates of adverse events were similar in the two groups.

Conclusion Oral RIF plus ATRA is not inferior to intravenous ATO plus ATRA as first-line treatment of APL and may be considered as a routine treatment option for appropriate patients.

语种英语
所属项目编号2006AA02A405 ; 2012AA02A505 ; 2008ZX09312-026 ; Z111107067311070
资助者National High-Tech RD (863) Program ; Mega Project of the Ministry of Science and Technology ; Beijing Municipal Science &amp ; Technology Commission ; National High-Tech RD (863) Program ; Mega Project of the Ministry of Science and Technology ; Beijing Municipal Science &amp ; Technology Commission
WOS记录号WOS:000327088000008
引用统计
被引频次:50[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/66292
专题北京大学第二临床医学院
作者单位1.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
2.Harbin Inst Hematol & Oncol, Harbin, Peoples R China
3.Soochow Univ, Affiliated Hosp 1, Suzhou, Jiangsu, Peoples R China
4.Zhejiang Univ, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
5.Nanjing Med Univ, Affiliated Hosp 1, Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China
6.Chinese Acad Med Sci, Inst Hematol, Tianjin, Peoples R China
7.Chinese Acad Med Sci, Blood Dis Hosp, Tianjin, Peoples R China
8.Peking Union Med Coll, Tianjin, Peoples R China
9.Shanghai Jiao Tong Univ, Rui Jin Hosp, Sch Med, Shanghai 200030, Peoples R China
推荐引用方式
GB/T 7714
Zhu, Hong-Hu,Wu, De-Pei,Jin, Jie,et al. Oral Tetra-Arsenic Tetra-Sulfide Formula Versus Intravenous Arsenic Trioxide As First-Line Treatment of Acute Promyelocytic Leukemia: A Multicenter Randomized Controlled Trial[J]. JOURNAL OF CLINICAL ONCOLOGY,2013,31(33):4215-+.
APA Zhu, Hong-Hu.,Wu, De-Pei.,Jin, Jie.,Li, Jian-Yong.,Ma, Jun.,...&Huang, Xiao-Jun.(2013).Oral Tetra-Arsenic Tetra-Sulfide Formula Versus Intravenous Arsenic Trioxide As First-Line Treatment of Acute Promyelocytic Leukemia: A Multicenter Randomized Controlled Trial.JOURNAL OF CLINICAL ONCOLOGY,31(33),4215-+.
MLA Zhu, Hong-Hu,et al."Oral Tetra-Arsenic Tetra-Sulfide Formula Versus Intravenous Arsenic Trioxide As First-Line Treatment of Acute Promyelocytic Leukemia: A Multicenter Randomized Controlled Trial".JOURNAL OF CLINICAL ONCOLOGY 31.33(2013):4215-+.
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