International Journal of Hematology

DOI: 10.1007/s12185-017-2334-x Pages: 185-193

Deeper molecular response is a predictive factor for treatment-free remission after imatinib discontinuation in patients with chronic phase chronic myeloid leukemia: the JALSG-STIM213 study

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

2. Tokyo Medical University, Tokyo Medical University, Department of Hematology

3. Ichinomiya Municipal Hospital, Division of Hematology

4. Japanese Red Cross Nagoya First Hospital, Department of Hematology

5. Oita Prefectural Hospital, Department of Hematology

6. Nihon University School of Medicine, Division of Hematology and Rheumatology

7. Nagoya Medical Center, National Hospital Organization

8. National Defense Medical College, Division of Hematology

9. NTT Medical Center Tokyo, Department of Hematology

10. Kindai University, Department of Hematology and Rheumatology, Faculty of Medicine

11. National Cancer Center Hospital East, Department of Hematology

12. The Jikei University School of Medicine, Department of Clinical Oncology/Hematology

13. Tokyo Medical and Dental University, Department of Hematology

14. Saiseikai Maebashi Hospital, Leukemia Research Center

15. Saitama Medical University International Medical Center, Department of Hematology

16. Fujisawa City Hospital, Department of Hematology

17. Hyogo Cancer Center, Department of Hematology

18. Miyagi Cancer Center, Department of Hematology

19. Mie University Hospital, Department of Transfusion Medicine and Cell Therapy

20. Shimane University Hospital, Department of Oncology/Hematology

21. Sapporo Hokuyu Hospital, Department of Hematology

22. Kumamoto Shinto General Hospital, Department of Hematology

23. Otemae Hospital, Department of Hematology

24. Kochi Medical School, Department of Hematology and Respiratory Medicine

25. Chugoku Central Hospital, Department of Hematology

26. Japanese Data Center for Hematopoietic Cell Transplantation

27. Kanazawa University

28. Japanese Red Cross Aichi Blood Center

29. International University of Health and Welfare, Mita Hospital, Hematology Division

30. Nagoya University Graduate School of Medicine, Department of Hematology and Oncology

31. Nagasaki University, Department of Hematology

Correspondence to:
Naoto Takahashi
Tel: +81-18-884-6111



The objective of this prospective clinical trial (JALSG-STIM213, UMIN000011971) was to evaluate treatment-free remission (TFR) rates after discontinuation of imatinib in chronic myeloid leukemia (CML). CML patients who received imatinib treatment for at least 3 years and sustained deep molecular response for at least 2 years were eligible. Molecular recurrence was defined as loss of major molecular response (MMR). Of the 68 eligible patients, 38.2% were women, the median age was 55.0 years, and the median duration of imatinib treatment was 97.5 months. The 12-month TFR rate was 67.6%. Patients who lost MMR were immediately treated with imatinib again; all re-achieved MMR. Three-year treatment-free survival (TFS) was estimated as 64.6% using the Kaplan–Meier method. Undetectable molecular residual disease (UMRD) was defined as no BCR-ABL1 in > 100,000 ABL1 control genes using international scale polymerase chain reaction. UMRD at the study baseline was found to be predictive of continuation of TFR. Our findings suggest that CML patients who meet all the eligibility criteria that have commonly been used in the TFR trials are able to discontinue imatinib use safely. TFR may thus be valuable as a new goal for CML treatment in Japan.

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