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Ten-year outcome of chronic-phase chronic myeloid leukemia patients treated with imatinib in real life

  • Matteo Molica
  • Gioia Colafigli
  • Emilia Scalzulli
  • Danilo Alunni Fegatelli
  • Sofia Chiatamone Ranieri
  • Lorenzo Rizzo
  • Daniela Diverio
  • Fabio Efficace
  • Roberto Latagliata
  • Robin Foà
  • Massimo BrecciaEmail author
Original Article

Abstract

Imatinib, the first BCR/ABL kinase inhibitor approved for the treatment of chronic myeloid leukemia (CML), has changed the long-term outcome of patients affected by this disease. The aim of our analysis was to report, after a median follow-up of 10.2 years (range 5.8–14.8), the long-term outcome, efficacy, and safety of imatinib treatment (frontline and after interferon failure) in a single institution cohort of 459 patients with CML in chronic phase treated outside of clinical trials. The 10-year overall survival of the whole cohort was 77.1%, while the 10-year probability of dying due to CML and other causes was 7.8% and 16%, respectively. The prognostic value of the BCR-ABL1 ratio at 3 months (⩽ 10%) and of complete cytogenetic response and major molecular response at 1 year was confirmed also in the real-life practice. The EUTOS long-term survival score better stratified the baseline risk of dying of CML compared with other risk scores. Two hundred thirty-six (51.4%) patients achieved a deep molecular response during imatinib treatment after a median time of 4.57 years, and 95 (20.6%) had a stable deep molecular response maintained for at least 2 consecutive years. Imatinib was associated with a low rate of serious cardiovascular events and second neoplasia. This 10-year real-life follow-up study shows that imatinib maintains efficacy over time and that long-term administration of imatinib is not associated with notable cumulative or late toxic effects.

Keywords

Chronic myeloid leukemia Long-term follow-up Imatinib Real-life experience 

Notes

Authors’ contribution

MB designed the study, wrote and revised the manuscript; MM collected data and wrote the manuscript; DAF and FE analyzed data; ES, LR, RL, and SCR followed patients; DD and GC performed molecular analysis; RF critically revised the paper and approved the final version.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in this study were in accordance with the ethical standards of the institutional committee and with the 1964 Helsinki declaration and its later amendments.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Matteo Molica
    • 1
  • Gioia Colafigli
    • 1
  • Emilia Scalzulli
    • 1
  • Danilo Alunni Fegatelli
    • 2
  • Sofia Chiatamone Ranieri
    • 1
  • Lorenzo Rizzo
    • 1
  • Daniela Diverio
    • 1
  • Fabio Efficace
    • 3
  • Roberto Latagliata
    • 1
  • Robin Foà
    • 1
  • Massimo Breccia
    • 1
    Email author
  1. 1.Hematology, Department of Translational and Precision MedicineSapienza UniversityRomeItaly
  2. 2.Department of Statistical SciencesSapienza UniversityRomeItaly
  3. 3.Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA)RomeItaly

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