International Journal of Hematology

DOI: 10.1007/s12185-018-2401-y Pages: 535-540

Efficacy and safety of switching to nilotinib in patients with CML-CP in major molecular response to imatinib: results of a multicenter phase II trial (NILSw trial)

1. Osaka International Cancer Institute, Department of Hematology

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

3. Kumamoto University, Department of Hematology and Infectious Diseases

4. Kyoto Prefectural University of Medicine, Division of Hematology and Oncology, Graduate School of Medicine

5. Osaka City University, Department of Hematology, Graduate School of Medicine

6. Kyushu University, Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences

7. Okayama University, Department of Hematology and Oncology

8. Osaka University Graduate School of Medicine, Department of Hematology and Oncology

9. Harasanshin Hospital, Department of Hematology

10. Clinical Research Support Center Kyushu

Correspondence to:
Jun Ishikawa
Tel: +81-6-6945-1181



We evaluated the efficacy and safety of switching to nilotinib in CML-CP patients who had achieved MMR with continuous detectable BCR-ABL1 transcript levels after long-term imatinib treatment. Patients who had achieved MMR, but not deep molecular response (DMR), after > 18 months from the initiation of imatinib received nilotinib 400 mg twice daily for up to 24 months. BCR-ABL1 transcript levels were assessed every 3 months. Thirty-eight patients with a median age of 57.5 years (range 22–76 years) were evaluated. Twenty-seven patients completed 24 months of nilotinib treatment; 11 discontinued nilotinib due to retraction of consent (three patients), loss of MMR (1), intolerance (3) or AEs (5). Twenty patients [52.6%, (90% CI 38.2–66.7%)] achieved DMR. The cumulative incidence of achieving DMR by the time of 3, 6, 9, 12, 15, 18, and 21 months was 22.9, 37.7, 47.0, 53.7, 53.7, 53.7, and 53.7%, respectively. Adverse events were consistent with those reported in other nilotinib studies. Patients experienced each of the following cardiovascular complications: atrial fibrillation (G2), chest tightness and dyspnea (G1), myocardial infarction (G2) and heart failure (G3) (n = 1 for each complication). This study indicates nilotinib achieves strong, rapid induction of DMR for patients who achieved MMR after long-term imatinib therapy.

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