Background and Objectives: While tyrosine kinase inhibitors (TKIs) have transformed CP-CML management, limited data exist on their use in clinical practice. Methods: SIMPLICITY (NCT01244750) is an observational study in CP-CML patients, exploring first-line (1L) TKI use and management patterns in the US and Europe. Over half of the patients recruited in Europe are from Italy (n=266). This is an analysis of the Italian cohort and a comparison with the rest of the European SIMPLICITY population. Baseline demographic, factors influencing the choice of first-line TKI, response monitoring patterns and predictors of monitoring, and treatment interruptions, discontinuations and switching by index TKIs are presented for the Italian cohort in the first year of treatment and compared with that for the overall European SIMPLICITY cohort. Results: Italian patients received 1L imatinib (IM; retrospective [(n=31]; prospective [n=106]), dasatinib (DAS; n=56) or nilotinib (NIL; n=73). Documented cytogenetic response monitoring by 12 months was lower than expected, but almost all patients had documented molecular response monitoring. Fewer patients discontinued first-line TKI by 12 months in Italy compared with the rest of the European SIMPLICITY population (p=0.003). Of those with ≥12 months follow-up since the start of 1L TKI, only 7.1% (n=19) of Italian patients switched to a second-line TKI, a third less than in the rest of the European SIMPLICITY population. Of interest, intolerance as opposed to resistance, was the main reason for switching. Conclusions: This analysis provides valuable insights into management and treatment patterns in Italian patients with CML within routine clinical practice.

Abruzzese, E., Bosi, A., Breccia, M., D'Adda, M., Renzo, N., Liberati, A., et al. (2019). Treatment patterns in patients with chronic-phase chronic myeloid leukaemia in routine clinical practice: The simplicity Italian population. MEDITERRANEAN JOURNAL OF HEMATOLOGY AND INFECTIOUS DISEASES, 11(1) [10.4084/MJHID.2019.025].

Treatment patterns in patients with chronic-phase chronic myeloid leukaemia in routine clinical practice: The simplicity Italian population

Gambacorti-Passerini C.
Ultimo
2019

Abstract

Background and Objectives: While tyrosine kinase inhibitors (TKIs) have transformed CP-CML management, limited data exist on their use in clinical practice. Methods: SIMPLICITY (NCT01244750) is an observational study in CP-CML patients, exploring first-line (1L) TKI use and management patterns in the US and Europe. Over half of the patients recruited in Europe are from Italy (n=266). This is an analysis of the Italian cohort and a comparison with the rest of the European SIMPLICITY population. Baseline demographic, factors influencing the choice of first-line TKI, response monitoring patterns and predictors of monitoring, and treatment interruptions, discontinuations and switching by index TKIs are presented for the Italian cohort in the first year of treatment and compared with that for the overall European SIMPLICITY cohort. Results: Italian patients received 1L imatinib (IM; retrospective [(n=31]; prospective [n=106]), dasatinib (DAS; n=56) or nilotinib (NIL; n=73). Documented cytogenetic response monitoring by 12 months was lower than expected, but almost all patients had documented molecular response monitoring. Fewer patients discontinued first-line TKI by 12 months in Italy compared with the rest of the European SIMPLICITY population (p=0.003). Of those with ≥12 months follow-up since the start of 1L TKI, only 7.1% (n=19) of Italian patients switched to a second-line TKI, a third less than in the rest of the European SIMPLICITY population. Of interest, intolerance as opposed to resistance, was the main reason for switching. Conclusions: This analysis provides valuable insights into management and treatment patterns in Italian patients with CML within routine clinical practice.
Articolo in rivista - Articolo scientifico
Chronic-Phase Chronic Myeloid Leukaemia; SIMPLICITY; TKI switching patterns; Response Monitoring; Italy
English
2019
11
1
e2019025
open
Abruzzese, E., Bosi, A., Breccia, M., D'Adda, M., Renzo, N., Liberati, A., et al. (2019). Treatment patterns in patients with chronic-phase chronic myeloid leukaemia in routine clinical practice: The simplicity Italian population. MEDITERRANEAN JOURNAL OF HEMATOLOGY AND INFECTIOUS DISEASES, 11(1) [10.4084/MJHID.2019.025].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/259964
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