IR@PKUHSC  > 北京大学第二临床医学院
学科主题临床医学
Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina
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
2015-04-30
DOI10.1182/blood-2014-09-601674
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
WOS记录号WOS:000355686600009
资助机构Novartis Pharmaceuticals Corporation
引用统计
被引频次:35[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/400002259/63730
专题北京大学第二临床医学院
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
推荐引用方式
GB/T 7714
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.
APA Wang, Jianxiang.,Shen, Zhi-Xiang.,Saglio, Giuseppe.,Jin, Jie.,Huang, He.,...&Huang, Xiaojun.(2015).Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina.BLOOD,125(18),2771-2778.
MLA Wang, Jianxiang,et al."Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina".BLOOD 125.18(2015):2771-2778.
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