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

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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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Acknowledgements

We thank the patients, their families, the investigators, and nurses, who participated in this trial. This research was funded by Bristol-Myers Squibb. Third-party writing assistance was funded by Bristol-Myers Squibb and provided by Manette Williams, PhD.

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Authors and Affiliations

  1. Peking University People’s Hospital, Beijing, 100044, China

    Xiaojun Huang & Qian Jiang

  2. Fujian Medical University Union Hospital, Fuzhou, 350004, China

    Jianda Hu

  3. The First Affiliated Hospital with Nanjing Medical University, Nanjing, 210029, China

    Jianyong Li

  4. The First Affiliated Hospital of The College of Medicine, Zhejiang University, Hangzhou, 310058, China

    Jie Jin

  5. Guangzhou Nanfang Hospital, Guangzhou, 510515, China

    Fanyi Meng

  6. Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China

    Zhixiang Shen

  7. West China Hospital, Sichuan University, Chengdu, 610041, China

    Ting Liu

  8. The First Affiliated Hospital of Soochow University, Suzhou, 215006, China

    Depei Wu

  9. Changhai Hospital of Shanghai, Shanghai, 200433, China

    Jianmin Wang

  10. The Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Tianjin, 300020, China

    Jianxiang Wang

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  1. Xiaojun Huang
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Correspondence to Jianxiang Wang.

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Huang, X., Jiang, Q., Hu, J. et al. Four-year follow-up of patients with imatinib-resistant or intolerant chronic myeloid leukemia receiving dasatinib: efficacy and safety. Front. Med. 13, 344–353 (2019). https://doi.org/10.1007/s11684-018-0639-7

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  • DOI: https://doi.org/10.1007/s11684-018-0639-7

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