| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | その他(不明) |
| 表題 | Early predictors of MR4.5 attainment and eligibility for TKI discontinuation in CML treated with second-generation TKIs. |
| 掲載誌名 | 正式名：Blood advances 略 称：Blood Adv ISSNコード：24739537/24739529 |
| 巻・号・頁 | pp.Online ahead of print. |
| 著者・共著者 | Takaaki Ono, Takashi Okada, Naoto Takahashi, Yosuke Minami, Chiaki Nakaseko, Noriyoshi Iriyama, Katsumichi Fujimaki, Kazuhiko Kakihana, Yoji Ogasawara, Masaya Okada, Tetsuzo Tauchi, Yoshiko Atsuta, Shigeki Ohtake, Toshihiro Miyamoto, Kazunori Ohnishi, Emiko Sakaida, Shin Fujisawa, Yukio Kobayashi, Hitoshi Kiyoi, Yasushi Miyazaki, Itaru Matsumura |
| 発行年月 | 2026/06 |
| 概要 | Among patients with chronic myeloid leukemia (CML) aiming for tyrosine kinase inhibitor (TKI) discontinuation, second-generation TKIs (2G-TKIs) are used as one of the first-line options because they induce faster and deeper molecular responses than imatinib. However, predictors of attaining and sustaining MR4.5 (BCR::ABL1 International Scale [IS] ≤ 0.0032%) during 2G-TKI therapy remain undefined. We analyzed 431 patients enrolled in the phase III Japan Adult Leukemia Study Group (JALSG) CML212 trial, comparing nilotinib at 300 mg twice daily (n = 218) and dasatinib at 100 mg once daily (n = 213) as first-line therapy. The objective was to identify predictors of MR4.5 attainment and TKI discontinuation eligibility (TDE). Candidate variables assessed within 6 months included the EUTOS long-term survival (ELTS) score; BCR::ABL1 IS at baseline, 3 months, and 6 months; and IS-derived halving times, HT(0-3) and HT(3-6). TDE was defined as ≥3 years of TKI therapy with ≥2 consecutive years of sustained MR4.5. With a median follow-up of 3.0 years, the cumulative incidence of MR4.5 was 46.6%, and 36.3% of patients achieving MR4.5 met TDE criteria. In multivariable models, HT(0-3) (subdistribution hazard ratio [HR], 2.23; 95% CI, 1.09-4.55) and the 6-month IS (HR, 0.38; 95% CI, 0.31-0.47) were independent predictors of MR4.5 attainment, whereas only the 6-month IS predicted TDE (odds ratio, 0.37; 95% CI, 0.24-0.56). This study demonstrates that molecular response at 6 months after TKI initiation has important clinical value in early stratification of MR4.5 attainment and TDE in patients receiving 2G-TKI therapy. |
| DOI | 10.1182/bloodadvances.2026019701 |
| PMID | 42275565 |