International Journal of Hematology

DOI: 10.1007/s12185-018-2459-6 Pages: 176-183

Switching to nilotinib is associated with deeper molecular responses in chronic myeloid leukemia chronic phase with major molecular responses to imatinib: STAT1 trial in Japan

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

2. International University of Health and Welfare School of Medicine, Department of Hematology

3. Chiba University Hospital, Department of Hematology

4. Jikei University Kashiwa Hospital, Department of Oncology and Hematology

5. Odate Municipal Hospital, Department of Hematology and Oncology

6. Mie University Hospital, Department of Transfusion Service

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

8. Juntendo University Urayasu Hospital, Department of Hematology

9. Northern Fukushima Medical Center, Department of Hematology

10. Gunma University Hospital, Department of Hematology

11. Dokkyo Medical University, Department of Hematology and Oncology

12. Akita University Hospital, Department of Pharmacy

13. Japanese Red Cross Narita Hospital, Department of Hematology and Oncology

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



The purpose of this clinical trial was to evaluate the efficacy of 2-year consolidation therapy using nilotinib (NIL) for achieving a molecular response (MR4.5, BCR-ABL1IS ≤ 0.0032% on the International Scale) in patients with chronic myeloid leukemia in the chronic phase (CML-CP) who had achieved a major molecular response (MMR, BCR-ABL1IS ≤ 0.1%) with imatinib (IM). We recruited 76 Japanese patients for this trial. Nilotinib 300 mg, twice daily, was administered for 2 years, and 74 patients were evaluated in the study. The median age was 55.0 years. The median duration of IM treatment was 69.0 months. All patients showed MMR at the time of entry into the study; the median time to MMR on IM therapy was 20.4 months. The proportion of patients who achieved MR4.5 increased over time. The rates of MR4.5 in the 74 evaluable patients were 27.0% [90% confidence interval (CI) (18.7–36.8%)] and 44.6% [90% CI (34.7–54.8%)] at 12 and 24 months, respectively. The frequency of ABCG2 421C/A + A/A was an independent predictive biomarker for achieving a 24-month MR4.5. Switching to NIL led to safer, deeper molecular responses in patients with MMR on long-term IM therapy for future treatment-free remission.

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