Four-year follow-up of patients with imatinib-resistant or intolerant chronic myeloid leukemia receiving dasatinib: efficacy and safety.
10.1007/s11684-018-0639-7
- Author:
Xiaojun HUANG
1
;
Qian JIANG
1
;
Jianda HU
2
;
Jianyong LI
3
;
Jie JIN
4
;
Fanyi MENG
5
;
Zhixiang SHEN
6
;
Ting LIU
7
;
Depei WU
8
;
Jianmin WANG
9
;
Jianxiang WANG
10
Author Information
1. Peking University People's Hospital, Beijing, 100044, China.
2. Fujian Medical University Union Hospital, Fuzhou, 350004, China.
3. The First Affiliated Hospital with Nanjing Medical University, Nanjing, 210029, China.
4. The First Affiliated Hospital of The College of Medicine, Zhejiang University, Hangzhou, 310058, China.
5. Guangzhou Nanfang Hospital, Guangzhou, 510515, China.
6. Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
7. West China Hospital, Sichuan University, Chengdu, 610041, China.
8. The First Affiliated Hospital of Soochow University, Suzhou, 215006, China.
9. Changhai Hospital of Shanghai, Shanghai, 200433, China.
10. The Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Tianjin, 300020, China. wangjx@ihcams.ac.cn.
- Publication Type:Journal Article
- Keywords:
chronic myeloid leukemia (CML);
dasatinib;
long-term follow-up;
tyrosine kinase inhibitor
- From:
Frontiers of Medicine
2019;13(3):344-353
- CountryChina
- Language:English
-
Abstract:
Dasatinib is a highly effective second-generation tyrosine kinase inhibitor used to treat chronic myeloid leukemia (CML). In 2007, a pivotal phase-2 study of dasatinib as second-line treatment was initiated in 140 Chinese CML patients. This report from the 4-year follow-up revealed that 73% of 59 patients in chronic phase (CML-CP) and 32% of 25 patients in accelerated phase (CML-AP) remained under treatment. The initial dosage of dasatinib for CML-CP and CML-AP patients were 100 mg once daily and 70 mg twice daily (total = 140 mg/ day), respectively. The cumulative major cytogenetic response (MCyR) rate among patients with CML-CP was 66.1% (versus 50.8% at 18 months), and the median time to MCyR was 12.7 weeks. All CML-CP patients who achieved MCyR after a 4-year follow-up also achieved a complete cytogenetic response. The cumulative complete hematological response (CHR) rate among patients with CML-AP was 64% (16/25), with three CML-AP patients achieving CHR between 18 months and 4 years of follow-up; the median time to CHR was 16.4 weeks. The adverse event (AE) profile of dasatinib at 4 years was similar to that at 6 and 18 months. The most frequently reported AEs (any grade) included pleural effusion, headache, and myelosuppression. These long-term follow-up data continue to support dasatinib as a second-line treatment for Chinese patients with CML.