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学科主题: 临床医学
题名:
Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina
作者: Wang, Jianxiang1; Shen, Zhi-Xiang2; Saglio, Giuseppe3; Jin, Jie4; Huang, He4; Hu, Yu5; Du, Xin6; Li, Jianyong7; Meng, Fanyi8; Zhu, Huanling9; Hu, Jianda10; Wang, Jianmin11; Hou, Ming12; Hertle, Sabine13; Menssen, Hans D.13; Ortmann, Christine-Elke13; Tribouley, Catherine14; Yuan, Ye15; Baccarani, Michele16,17; Huang, Xiaojun18,19
刊名: BLOOD
发表日期: 2015-04-30
DOI: 10.1182/blood-2014-09-601674
卷: 125, 期:18, 页:2771-2778
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Hematology
研究领域[WOS]: Hematology
关键词[WOS]: EARLY MOLECULAR RESPONSE ; TYROSINE KINASE INHIBITORS ; EUROPEAN LEUKEMIANET ; OCCLUSIVE DISEASE ; FOLLOW-UP ; SURVIVAL ; CML ; INTERFERON ; THERAPY
英文摘要:

Treatment with a tyrosine kinase inhibitor (TKI) targeting BCR-ABL1 is currently the standard of care for patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP). In this study, we present results of the ENESTchina (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-China) that was conducted to investigate nilotinib 300 mg twice daily vs imatinib 400 mg once daily in a Chinese population. ENESTchina met its primary end point with a statistically significant higher rate of major molecular response (MMR; BCR-ABL1 <= 0.1% on the International Scale) at 12 months in the nilotinib arm vs the imatinib arm (52.2% vs 27.8%; P < .0001), andMMRrates remained higher with nilotinib vs imatinib throughout the follow-up period. Rates of complete cytogenetic response (0% Philadelphia chromosome-positive [Ph1] metaphases by standard cytogenetics) were comparable and >= 80% by 24 months in both arms. The estimated rate of freedom from progression to accelerated phase/blast crisis at 24 months was 95.4% in each arm. The safety profiles of both drugs were similar to those from previous studies. In conclusion, rates of MMR at 12 months were superior with nilotinib vs imatinib in Chinese patients with newly diagnosed Ph1 CML-CP.

语种: 英语
项目资助者: Novartis Pharmaceuticals Corporation
WOS记录号: WOS:000355686600009
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63730
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Jiangsu Prov Peoples Hosp, Dept Hematol, Nan Jing, Peoples R China
2.Novartis Pharma AG, Basel, Switzerland
3.Novartis Pharmaceut, E Hanover, NJ USA
4.Beijing Novartis Pharma Co Ltd, Beijing, Peoples R China
5.Univ Bologna, Dept Hematol Oncol, Bologna, Italy
6.Peking Univ, Peoples Hosp, Beijing 100044, Peoples R China
7.Inst Hematol, Beijing, Peoples R China
8.Chinese Acad Med Sci, Inst Hematol, Dept Clin Hematol, State Key Lab Expt Hematol, Tianjin, Peoples R China
9.Shanghai Ruijin Hosp, Shanghai Inst Hematol, Shanghai, Peoples R China
10.Univ Turin, San Luigi Hosp, Dept Clin & Biol Sci, Orbassano, Italy
11.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Dept Hematol, Hangzhou 310003, Zhejiang, Peoples R China
12.Wuhan Union Hosp, Tongji Med Coll, Inst Hematol, Wuhan, Hubei, Peoples R China
13.Guangdong Acad Med Sci, Guangdong Gen Hosp, Dept Hematol, Guangzhou, Guangdong, Peoples R China
14.Guangzhou Southern Med Univ, Nanfang Hosp, Dept Hematol, Guangzhou, Guangdong, Peoples R China
15.Sichuan Univ, West China Hosp, Dept Hematol, Chengdu 610064, Sichuan, Peoples R China
16.Fujian Med Univ, Union Hosp, Dept Hematol, Fuzhou, Peoples R China
17.Second Mil Med Univ, Changhai Hosp, Dept Hematol, Shanghai, Peoples R China
18.Shandong Univ, Qilu Hosp, Dept Hematol, Jinan 250100, Peoples R China
19.Univ Bologna, Dept Expt Diagnost & Specialty Med, Bologna, Italy

Recommended Citation:
Wang, Jianxiang,Shen, Zhi-Xiang,Saglio, Giuseppe,et al. Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina[J]. BLOOD,2015,125(18):2771-2778.
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