Scholarlink

<p>Treatment-free remission (TFR) is an emerging goal for patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI). However, long-term TFR durability in real-world settings remains understudied. The J-SKI study, a large observational study, was conducted to evaluate long-term TFR outcomes in Japanese patients with CML. This interim analysis included 795 eligible patients from the prospective (n = 283) and retrospective (n = 512) cohorts. With a median follow-up of 32&#xa0;months (range 0.8–168) after TKI discontinuation, the 5-year TFR rate was 65.2% (95% confidence interval [CI]: 59.6–70.6%). Among patients who experienced molecular relapse, 99% (95% CI: 97–100%) regained a major molecular response after resuming TKI therapy, with no observed disease progression. Multivariate analysis identified the duration of deep molecular response (DMR) as the sole independent predictor of successful TFR, with each additional year of DMR reducing the relapse risk by 12.5% (HR: 0.875, <i>p</i> &lt; 0.0001). A second TFR attempt was successful in 41% (95% CI: 22–59%) of the 32 patients. This study demonstrated that TKI discontinuation is a safe and feasible strategy in a real-world clinical setting. A sustained DMR is critical for TFR success, supporting its importance as a key therapeutic objective.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Five-year interim analysis of J-SKI: an observational study of TKI discontinuation in patients with CML in Japan

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月1日

查看全文
  • Naoto Takahashi,
  • Shinya Kimura,
  • Eri Matsuki,
  • Takaaki Ono,
  • Noriko Doki,
  • Masaki Iino,
  • Masashi Sawa,
  • Yoshio Saburi,
  • Kazunori Murai,
  • Katsumichi Fujimaki,
  • Shingo Kurahashi,
  • Noriyoshi Iriyama,
  • Takashi Onaka,
  • Emiko Sakaida,
  • Chikashi Yoshida,
  • Keijiro Sato,
  • Toshihiro Miyamoto,
  • Tomoiku Takaku,
  • Motoaki Shiratsuchi,
  • Fumihiko Kimura,
  • Seiichiro Katagiri,
  • Matsuo Yamamoto,
  • Akiko M. Saito,
  • Hitoshi Kiyoi,
  • Itaru Matsumura

摘要

Treatment-free remission (TFR) is an emerging goal for patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKI). However, long-term TFR durability in real-world settings remains understudied. The J-SKI study, a large observational study, was conducted to evaluate long-term TFR outcomes in Japanese patients with CML. This interim analysis included 795 eligible patients from the prospective (n = 283) and retrospective (n = 512) cohorts. With a median follow-up of 32 months (range 0.8–168) after TKI discontinuation, the 5-year TFR rate was 65.2% (95% confidence interval [CI]: 59.6–70.6%). Among patients who experienced molecular relapse, 99% (95% CI: 97–100%) regained a major molecular response after resuming TKI therapy, with no observed disease progression. Multivariate analysis identified the duration of deep molecular response (DMR) as the sole independent predictor of successful TFR, with each additional year of DMR reducing the relapse risk by 12.5% (HR: 0.875, p < 0.0001). A second TFR attempt was successful in 41% (95% CI: 22–59%) of the 32 patients. This study demonstrated that TKI discontinuation is a safe and feasible strategy in a real-world clinical setting. A sustained DMR is critical for TFR success, supporting its importance as a key therapeutic objective.