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<p>Treatment-free remission (TFR) is an established therapeutic goal for patients with chronic myeloid leukemia (CML) achieving sustained deep molecular response (DMR) on tyrosine kinase inhibitors (TKIs). However, evidence on TFR following bosutinib discontinuation remains limited. BOSUTFR is a multicenter, retrospective study by the Spanish CML Group (GELMC) evaluating TFR feasibility after bosutinib cessation in patients with chronic-phase CML. Twenty-five adults from 15 centers who maintained ≥MR4.0 for at least 2 years or discontinued for intolerance were included. The primary endpoint was TFR rate at 12 months. Thirteen patients (52%) stopped treatment after sustained MR4.0 and 12 (48%) due to intolerance, including 2 patients from fifth-line therapy. After a median follow-up of 4.6 years, 17/25 (68.0%) maintained TFR, with TFR rates at 12 and 24 months of 70.4% and 64.5%. No disease progressions or deaths occurred. All patients with molecular recurrence regained DMR after restarting bosutinib (<i>n</i> = 6) or switching to asciminib (<i>n</i> = 2). Median duration of bosutinib therapy before discontinuation was 4.5 years, and median DMR duration was 36 months. Notably, 9 of 11 patients (81.8%) who discontinued due to intolerance remained in TFR, including 4 of 5 who stopped in MMR. This is the largest real-world cohort of bosutinib discontinuations to date. Results confirm that bosutinib discontinuation is feasible and safe in real-world practice, including for patients who discontinue for intolerance, heavily pretreated patients, and patients with less stringent molecular response criteria.</p>

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Treatment-free remission after bosutinib discontinuation (BOSUTFR): results from a multicenter real-world study by the Spanish CML group

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月1日

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  • R De Paz Arias,
  • G Maortua Langdon,
  • R Stuckey,
  • P Giraldo,
  • B Xicoy,
  • J Martínez López,
  • G Bautista,
  • JM Alonso Alonso,
  • MS Noya,
  • M Sierra,
  • N de las Heras,
  • R Pérez López,
  • S Saavedra,
  • V Gómez-García de Soria,
  • TH Chen-Liang,
  • Marta Santaliestra,
  • V García Gutiérrez

摘要

Treatment-free remission (TFR) is an established therapeutic goal for patients with chronic myeloid leukemia (CML) achieving sustained deep molecular response (DMR) on tyrosine kinase inhibitors (TKIs). However, evidence on TFR following bosutinib discontinuation remains limited. BOSUTFR is a multicenter, retrospective study by the Spanish CML Group (GELMC) evaluating TFR feasibility after bosutinib cessation in patients with chronic-phase CML. Twenty-five adults from 15 centers who maintained ≥MR4.0 for at least 2 years or discontinued for intolerance were included. The primary endpoint was TFR rate at 12 months. Thirteen patients (52%) stopped treatment after sustained MR4.0 and 12 (48%) due to intolerance, including 2 patients from fifth-line therapy. After a median follow-up of 4.6 years, 17/25 (68.0%) maintained TFR, with TFR rates at 12 and 24 months of 70.4% and 64.5%. No disease progressions or deaths occurred. All patients with molecular recurrence regained DMR after restarting bosutinib (n = 6) or switching to asciminib (n = 2). Median duration of bosutinib therapy before discontinuation was 4.5 years, and median DMR duration was 36 months. Notably, 9 of 11 patients (81.8%) who discontinued due to intolerance remained in TFR, including 4 of 5 who stopped in MMR. This is the largest real-world cohort of bosutinib discontinuations to date. Results confirm that bosutinib discontinuation is feasible and safe in real-world practice, including for patients who discontinue for intolerance, heavily pretreated patients, and patients with less stringent molecular response criteria.