International Journal of Hematology

DOI: 10.1007/s12185-019-02696-w Pages: 1-8

Clinical efficacy and safety of first-line nilotinib therapy and evaluation of the clinical utility of the FRET-based drug sensitivity test

1. Hokkaido University, Department of Hematology, Faculty of Medicine and Graduate School of Medicine

2. Aiiku Hospital, Blood Disorders Center

3. Hokkaido University, Department of Cell Physiology, Faculty of Medicine and Graduate School of Medicine

4. Hokkaido University Hospital, Division of Laboratory and Transfusion Medicine

5. Hokkaido University, Department of Cancer Pathology, Faculty of Medicine

6. Kushiro Rosai Hospital, Department of Internal Medicine, Japan Labour Health and Welfare Organization

7. Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital, Department of Hematology

8. Asahikawa City Hospital, Department of Hematology

9. Sapporo City General Hospital, Department of Hematology

10. Tonan Hospital, Department of Hematology

11. Teine Keijinkai Hospital, Department of Hematology

12. Asahikawa Medical University, Division of Gastroenterology and Hematology/Oncology

13. Sapporo Hokuyu Hospital, Department of Hematology

14. National Hospital Organization Hokkaido Cancer Center, Department of Hematology

Correspondence to:
Takeshi Kondo
Tel: +81-11-563-2211
Email: t-kondoh@med.hokudai.ac.jp

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Abstract

Nilotinib is widely used for primary treatment of patients with chronic myelogenous leukemia (CML). We previously reported that use of an FRET-based drug sensitivity test at diagnosis efficiently predicts the response to treatment with imatinib or dasatinib. Here, we conducted a phase-II study to evaluate the efficacy and safety of nilotinib treatment and identify useful biomarkers, including results of the FRET-based drug sensitivity test, for predicting treatment response. Data from 42 patients were used in the analysis. Major molecular response (MMR), MR4, and MR4.5 rates at 12 months were 64.3, 42.9, and 28.6%, respectively. Grade 3/4 non-hematologic adverse events occurred in 11 patients (26.2%). The dose intensity of nilotinib (> 76.44%) and halving time (HT, < 13.312 days) were identified as significant factors for MMR at 12 months. However, when we focused on patients whose dose intensity of nilotinib was > 76.44%, the FRET-based drug sensitivity test became a predictive factor of MR4 achievement at 12 months. Our study reconfirmed the efficacy and safety of nilotinib treatment in CML patients. Moreover, our results suggest that the FRET-based drug sensitivity test is an independent predictor for achievement of MR4 in patients treated with a sufficient dose intensity of nilotinib.

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