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Importance of TKI treatment duration in treatment-free remission of chronic myeloid leukemia: results of the D-FREE study

発表形態:
原著論文
主要業績:
主要業績
単著・共著:
共著
発表年月:
2023年05月
DOI:
10.1007/s12185-023-03549-3
会議属性:
指定なし
査読:
有り
リンク情報:

日本語フィールド

著者:
*Yoshida C, Yamaguchi H, Doki N, Murai K, Iino M, Hatta Y, Onizuka M, Yokose N, Fujimaki K, Hagihara M, Oshikawa G, Murayama K, Kumagai T, Kimura S, Najima Y, Iriyama N, Tsutsumi I, Oba K, Kojima H, Sakamaki H, Inokuchi K; Kanto CML Study Group
題名:
Importance of TKI treatment duration in treatment-free remission of chronic myeloid leukemia: results of the D-FREE study
発表情報:
Int J Hematol 巻: 117 号: 5 ページ: 694-705
キーワード:
Chronic myeloid leukemia; Dasatinib; Treatment-free remission
概要:
Treatment-free remission (TFR) is a new goal for patients with chronic myeloid leukemia in chronic phase (CML-CP) with a sustained deep molecular response (DMR) to treatment with tyrosine kinase inhibitors (TKIs). However, optimal conditions for successful TFR in patients treated with second-generation (2G)-TKIs are not fully defined. In this D-FREE study, treatment discontinuation was attempted in newly diagnosed CML-CP patients treated with the 2G-TKI dasatinib who achieved BCR-ABL1 levels of ? 0.0032% (MR4.5) on the international scale (BCR-ABL1IS) and maintained these levels for exactly 1 year. Of the 173 patients who received dasatinib induction therapy for up to 2 years, 123 completed and 60 (48.8%) reached MR 4.5. Among the first 21 patients who maintained MR4.5 for 1 year and discontinued dasatinib, 17 experienced molecular relapse defined as loss of major molecular response (BCR-ABL1IS > 0.1%) confirmed once, or loss of MR4 (BCR-ABL1IS > 0.01%) confirmed on 2 consecutive assessments. The estimated molecular relapse-free survival rate was 16.7% at 12 months. This study was prematurely terminated according to the protocol's safety monitoring criteria. The conclusion was that sustained DMR for just 1 year is insufficient for TFR in CML-CP patients receiving dasatinib for less than a total of 3 years of treatment.
抄録:

英語フィールド

Author:
*Yoshida C, Yamaguchi H, Doki N, Murai K, Iino M, Hatta Y, Onizuka M, Yokose N, Fujimaki K, Hagihara M, Oshikawa G, Murayama K, Kumagai T, Kimura S, Najima Y, Iriyama N, Tsutsumi I, Oba K, Kojima H, Sakamaki H, Inokuchi K; Kanto CML Study Group
Title:
Importance of TKI treatment duration in treatment-free remission of chronic myeloid leukemia: results of the D-FREE study
Announcement information:
Int J Hematol Vol: 117 Issue: 5 Page: 694-705
Keyword:
Chronic myeloid leukemia; Dasatinib; Treatment-free remission
An abstract:
Treatment-free remission (TFR) is a new goal for patients with chronic myeloid leukemia in chronic phase (CML-CP) with a sustained deep molecular response (DMR) to treatment with tyrosine kinase inhibitors (TKIs). However, optimal conditions for successful TFR in patients treated with second-generation (2G)-TKIs are not fully defined. In this D-FREE study, treatment discontinuation was attempted in newly diagnosed CML-CP patients treated with the 2G-TKI dasatinib who achieved BCR-ABL1 levels of ? 0.0032% (MR4.5) on the international scale (BCR-ABL1IS) and maintained these levels for exactly 1 year. Of the 173 patients who received dasatinib induction therapy for up to 2 years, 123 completed and 60 (48.8%) reached MR 4.5. Among the first 21 patients who maintained MR4.5 for 1 year and discontinued dasatinib, 17 experienced molecular relapse defined as loss of major molecular response (BCR-ABL1IS > 0.1%) confirmed once, or loss of MR4 (BCR-ABL1IS > 0.01%) confirmed on 2 consecutive assessments. The estimated molecular relapse-free survival rate was 16.7% at 12 months. This study was prematurely terminated according to the protocol's safety monitoring criteria. The conclusion was that sustained DMR for just 1 year is insufficient for TFR in CML-CP patients receiving dasatinib for less than a total of 3 years of treatment.


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