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Peer-reviewedCC BY-NC-NDAnnals of hematology

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

  • R De Paz Arias1
  • G Maortua Langdon1
  • R Stuckey2
  • P Giraldo3
  • B Xicoy4
  • J Martínez López5
  • G Bautista6
  • J M Alonso Alonso7
  • M S Noya8
  • M Sierra9
  • N de Las Heras10
  • R Pérez López11
6 more authors
  • S Saavedra12
  • V Gómez-García de Soria13
  • T H Chen-Liang14
  • Marta Santaliestra15
  • V García Gutiérrez16
  • Spanish CML Group (GELMC)
16 affiliations
  1. 1Hospital Universitario La Paz, Madrid, Spain.
  2. 2Hospital Universitario de Gran Canaria Dr. Negrín, Instituto de Investigación Sanitaria de Canarias, Las Palmas, Spain. [email protected].
  3. 3Hospital Universitario Quirónsalud, Zaragoza, Spain.
  4. 4Institut Català d' Oncologia-Hospital Germans Trias i Pujol, Josep Carreras Leukemia Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.
  5. 5University Hospital 12 de Octubre; i+12; CNIO; Universidad Complutense de Madrid, Madrid, Spain.
  6. 6University Hospital Puerta de Hierro, Madrid, Spain.
  7. 7Complejo Asistencial Universitario de Palencia, Palencia, Spain.
  8. 8Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
  9. 9University Hospital of Salamanca, Salamanca, Spain.
  10. 10Complejo Asistencial Universitario de León, León, Spain.
  11. 11Hospital Clínico Universitario Virgen de la Arrixaca, IMIB-Murcia, Murcia, Spain.
  12. 12Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
  13. 13Hospital Universitario de la Princesa, Madrid, Spain.
  14. 14University Hospital Morales-Messeguer, Murcia, Spain.
  15. 15Hospital Universitari Mútua Terrassa, Barcelona, Spain.
  16. 16University Hospital Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Universidad de Alcalá, Madrid, Spain. [email protected].
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Abstract

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.

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Cite

BibTeXRIS
BibTeX
@article{arias2026treatmentfree,
  title = {{Treatment-free remission after bosutinib discontinuation (BOSUTFR): results from a multicenter real-world study by the Spanish CML group.}},
  author = {R De Paz Arias and G Maortua Langdon and R Stuckey and P Giraldo and B Xicoy and J Martínez López and G Bautista and J M Alonso Alonso and M S Noya and M Sierra and N de Las Heras and R Pérez López and S Saavedra and V Gómez-García de Soria and T H Chen-Liang and Marta Santaliestra and V García Gutiérrez and Spanish CML Group (GELMC)},
  journal = {Annals of hematology},
  year = {2026},
  month = aug,
  doi = {10.1007/s00277-026-07039-4},
  url = {https://europepmc.org/article/MED/42955104},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Treatment-free remission after bosutinib discontinuation (BOSUTFR): results from a multicenter real-world study by the Spanish CML group.
AU  - R De Paz Arias
AU  - G Maortua Langdon
AU  - R Stuckey
AU  - P Giraldo
AU  - B Xicoy
AU  - J Martínez López
AU  - G Bautista
AU  - J M Alonso Alonso
AU  - M S Noya
AU  - M Sierra
AU  - N de Las Heras
AU  - R Pérez López
AU  - S Saavedra
AU  - V Gómez-García de Soria
AU  - T H Chen-Liang
AU  - Marta Santaliestra
AU  - V García Gutiérrez
AU  - Spanish CML Group (GELMC)
PY  - 2026
DA  - 2026/08/01
JO  - Annals of hematology
DO  - 10.1007/s00277-026-07039-4
UR  - https://europepmc.org/article/MED/42955104
AB  - 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.
SN  - 0939-5555
SN  - 1432-0584
ER  -