机构：[1]State Key Laboratory of Experimental Hematology, Department of Clinical Hematology, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, China[2]Shanghai Institute of Hematology, Shanghai Ruijin Hospital, Shanghai, China[3]Department of Clinical and Biological Sciences, San Luigi Hospital, University of Turin, Orbassano, Italy[4]Department of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang Province, China浙江大学医学院附属第一医院[5]Institute of Hematology, Wuhan Union Hospital, Tongji Medical College, Wuhan Hubei, China华中科技大学同济医学院附属协和医院[6]Department of Hematology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou Guangdong, China广东省人民医院[7]Department of Hematology, Jiangsu Province People’s Hospital, Nan Jing, China[8]Department of Hematology, Nanfang Hospital, Guangzhou Southern Medical University, Guangzhou Guangdong, China[9]Department of Hematology, West China Hospital of Sichuan University, Chengdu Sichuan, China四川大学华西医院[10]Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, China[11]Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China[12]Department of Hematology, Qilu Hospital, Shandong University, Jinan, China[13]Novartis Pharma AG, Basel, Switzerland[14]Novartis Pharmaceuticals Corporation, East Hanover, NJ[15]Beijing Novartis Pharma Company, Limited, Beijing, China[16]Department of Hematology-Oncology, and the Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna, Bologna, Italy[17]Peking University People’s Hospital and Institute of Hematology, Beijing, China
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.
第一作者机构：[1]State Key Laboratory of Experimental Hematology, Department of Clinical Hematology, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, China
通讯作者：
通讯机构：[17]Peking University People’s Hospital and Institute of Hematology, Beijing, China[*1]Peking University People’s Hospital, Peking University Institute of Hematology, 11 Xizhimen South Street, Beijing 100044, China
推荐引用方式(GB/T 7714)：
Jianxiang Wang,Zhi-Xiang Shen,Giuseppe Saglio,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.doi:10.1182/blood-2014-09-601674.
APA：
Jianxiang Wang,Zhi-Xiang Shen,Giuseppe Saglio,Jie Jin,He Huang...&Xiaojun Huang.(2015).Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina.Blood,125,(18)
MLA：
Jianxiang Wang,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
医学