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DOES STEPWISE DOSE ESCALATION METHOD OF NILOTINIB FOR CML IMPROVE MR4.5 AND TREATMENT FREE REMISSION?

PB1942

Mayama, K.1, 2; Yamaguchi, K.1, 2; Yamashita, S.1, 2; Ebina, T.1; Tachita, T.1; Kamata, K.1; Yamagata, K.1; Tamai, Y.1; Takami, H.1; Fukuda, S.1; Ota, K.3; Fujii, T.3; Akagi, T.3; Kubo, K.3

doi: 10.1097/01.HS9.0000566264.60138.78
Publication Only: Chronic myeloid leukemia - Clinical
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1Gastroenterology and Hematology, Hirosaki University Graduate School of Medicine

2Gastroenterology and Hematology, Hirosaki National Hospital, Hirosaki City

3Hematology, Aomori Prefectural Central Hospital, Aomori City, Japan

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Background:

Every TKI has it's unique adverse events (AEs) and AEs drive therapeutic outcome down in patient with CML-CP. Treatment completion rate(TCR), complete molecular response(MR4.5), and treatment free remission(TFR) were examined.

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Aims:

We conducted this study aiming at improving TCR, MR4.5, and TFR by stepwise dose escalation method of nilotinib.

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Methods:

TCR, MR4.5, and TFR (6, 12, and 18 months) were examined by stepwise dose escalation method of nilotinib (4-Stepwise method, i.e., 150mg-14day, 300mg-14day, 450mg-14day, 600mg-2years) in imatinib experienced or newly diagnosed patient with CML-CP.

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Results:

25 cases were enrolled in this study and all patient were received this method. Consequently, all patients achieved 600 mg, TCR was 100% by the method. 22 cases (88%) achieved MR4.5, and all of them transferred to treatment discontinuation phase. 7 cases out of 22 lost MMR in non-treatment period, and all of them remained in the CP phase and were administered nilotinib again. TFR at 6, 12, 18 months were 86%(19/22), 75%(15/20), 79%(15/19), respectively. NK cell activity at before treatment, one of important biomarker, showed a significant difference between not achieved MR4.5 group and achieved MR4.5 group(P = 0.04).

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Summary/Conclusion:

In this study, our stepwise dose escalation method of nilotinib (4-Stepwise method, i.e., 150mg-14day, 300mg-14day, 450mg-14day, 600mg-2years) will make good use of improving therapeutic outcome. TCR was 100%. 22 out of 25 cases (88%) achieved MR4.5, and all of them were transferred to treatment discontinuation phase. 7 out of 22 cases lost MMR, TFR at 6, 12, 18 months were 86%(19/22), 75%(15/20), 79%(15/19), respectively. NK cell activity at before treatment, showed a significant difference between not achieved MR4.5 group and achieved MR4.5 group(P = 0.04).

Copyright © 2019 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.