International Journal of Hematology

DOI: 10.1007/s12185-019-02613-1 Pages: 426-439

Efficacy and safety of tyrosine kinase inhibitors for newly diagnosed chronic-phase chronic myeloid leukemia over a 5-year period: results from the Japanese registry obtained by the New TARGET system

1. Saitama Medical University, Department of Hematology, Saitama Medical Center

2. Akita University Graduate School of Medicine, Department of Hematology, Nephrology and Rheumatology

3. Nihon University School of Medicine, Division of Hematology and Rheumatology, Department of Medicine

4. Keio University School of Medicine, Division of Hematology, Department of Medicine

5. Hamamatsu University School of Medicine, Division of Hematology, Department of Internal Medicine III

6. The Jikei University School of Medicine, Division of Clinical Oncology and Hematology, Department of Internal Medicine

7. Nippon Medical School, Department of Hematology

8. Chiba University Hospital, Department of Hematology

9. The University of Tokyo, Department of Hematology and Oncology, Graduate School of Medicine

10. Nagano Red Cross Hospital, Department of Hematology

11. National Center for Global Health and Medicine, Department of Hematology

12. Kumamoto Health Science University, Department of Medical Technology

13. Shimane University Hospital, Department of Oncology and Hematology

14. Aichi Cancer Center, Department of Hematology and Cell Therapy

15. Japanese Red Cross Aichi Blood Center

16. Kindai University Faculty of Medicine

17. National Hospital Organization Nagoya Medical Center

Correspondence to:
Naoto Takahashi
Tel: +81-18-884-6111
Email: naotot@doc.med.akita-u.ac.jp

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Abstract

We report the results of a multicenter observational study using the New TARGET system, in which the effectiveness and safety of tyrosine kinase inhibitors (TKIs) were evaluated in newly diagnosed chronic-phase chronic myeloid leukemia (CML) patients. A total of 506 patients were enrolled between April 2010 and March 2013. Median age was 56 (range 18–92) years; 35% of patients were females. As the first-line therapy, 139 (27.9%), 169 (33.9%) and 144 (28.9%) patients were treated with imatinib, nilotinib, and dasatinib, respectively. Five-year progression-free survival (PFS) and overall survival (OS) were 93.8% and 94.5%, respectively. The OS curve was significantly superior for patients treated with second-generation TKIs than imatinib (P = 0.0068), and an early molecular response (EMR) at 3 months (BCR-ABL1 < 10%) was detected in 328 of 377 patients evaluated for molecular response. The PFS curve was significantly superior for patients with EMR than without (P < 0.0001). Although 12 patients experienced vascular adverse events, no new safety issues were observed in patients with adverse events. The results of this observational study demonstrated that treating newly diagnosed CML-CP patients with TKI results in satisfactory and reliable outcomes.

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