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Frontiers of Medicine >> 2019, Volume 13, Issue 3 doi: 10.1007/s11684-018-0639-7

Four-year follow-up of patients with imatinib-resistant or intolerant chronic myeloid leukemia receiving dasatinib: efficacy and safety

. Peking University People’s Hospital, Beijing 100044, China;.. Fujian Medical University Union Hospital, Fuzhou 350004, China;.. The First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, China;.. The First Affiliated Hospital of The College of Medicine, Zhejiang University, Hangzhou 310058, China;.. Guangzhou Nanfang Hospital, Guangzhou 510515, China;.. Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China;.. West China Hospital, Sichuan University, Chengdu 610041, China;.. The First Affiliated Hospital of Soochow University, Suzhou 215006, China;.. Changhai Hospital of Shanghai, Shanghai 200433, China;.. The Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Tianjin 300020, China

Accepted: 2018-08-31 Available online: 2018-08-31

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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.

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