TREATMENT PATTERNS IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKAEMIA IN ROUTINE CLINICAL PRACTICE: THE SIMPLICITY ITALIAN POPULATION
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 i...
Main Author: | |
---|---|
Format: | Article |
Language: | English |
Published: |
PAGEPress Publications
2019-04-01
|
Series: | Mediterranean Journal of Hematology and Infectious Diseases |
Subjects: | |
Online Access: | https://www.mjhid.org/index.php/mjhid/article/view/3754 |
id |
doaj-26efd25149f14da290281adedbffc0da |
---|---|
record_format |
Article |
spelling |
doaj-26efd25149f14da290281adedbffc0da2020-11-25T00:20:24ZengPAGEPress PublicationsMediterranean Journal of Hematology and Infectious Diseases2035-30062019-04-0111110.4084/mjhid.2019.025TREATMENT PATTERNS IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKAEMIA IN ROUTINE CLINICAL PRACTICE: THE SIMPLICITY ITALIAN POPULATIONElisabetta AbruzzeseBackground 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 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 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. Conclusion This analysis provides valuable insights into management and treatment patterns in Italian patients with CML within routine clinical practice. https://www.mjhid.org/index.php/mjhid/article/view/3754SIMPLICITYChronic-Phase Chronic Myeloid LeukaemiaResponse MonitoringTKI switching patternsItaly |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Elisabetta Abruzzese |
spellingShingle |
Elisabetta Abruzzese 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 SIMPLICITY Chronic-Phase Chronic Myeloid Leukaemia Response Monitoring TKI switching patterns Italy |
author_facet |
Elisabetta Abruzzese |
author_sort |
Elisabetta Abruzzese |
title |
TREATMENT PATTERNS IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKAEMIA IN ROUTINE CLINICAL PRACTICE: THE SIMPLICITY ITALIAN POPULATION |
title_short |
TREATMENT PATTERNS IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKAEMIA IN ROUTINE CLINICAL PRACTICE: THE SIMPLICITY ITALIAN POPULATION |
title_full |
TREATMENT PATTERNS IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKAEMIA IN ROUTINE CLINICAL PRACTICE: THE SIMPLICITY ITALIAN POPULATION |
title_fullStr |
TREATMENT PATTERNS IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKAEMIA IN ROUTINE CLINICAL PRACTICE: THE SIMPLICITY ITALIAN POPULATION |
title_full_unstemmed |
TREATMENT PATTERNS IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKAEMIA IN ROUTINE CLINICAL PRACTICE: THE SIMPLICITY ITALIAN POPULATION |
title_sort |
treatment patterns in patients with chronic-phase chronic myeloid leukaemia in routine clinical practice: the simplicity italian population |
publisher |
PAGEPress Publications |
series |
Mediterranean Journal of Hematology and Infectious Diseases |
issn |
2035-3006 |
publishDate |
2019-04-01 |
description |
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 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 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.
Conclusion
This analysis provides valuable insights into management and treatment patterns in Italian patients with CML within routine clinical practice.
|
topic |
SIMPLICITY Chronic-Phase Chronic Myeloid Leukaemia Response Monitoring TKI switching patterns Italy |
url |
https://www.mjhid.org/index.php/mjhid/article/view/3754 |
work_keys_str_mv |
AT elisabettaabruzzese treatmentpatternsinpatientswithchronicphasechronicmyeloidleukaemiainroutineclinicalpracticethesimplicityitalianpopulation |
_version_ |
1725367886801797120 |