Treatment Patterns in Patients with Chronic-Phase Chronic Myeloid Leukaemia in Routine Clinical Practice: the SIMPLICITY Italian Population.
Chronic-Phase Chronic Myeloid Leukaemia
Italy
Response Monitoring
SIMPLICITY
TKI switching patterns
Journal
Mediterranean journal of hematology and infectious diseases
ISSN: 2035-3006
Titre abrégé: Mediterr J Hematol Infect Dis
Pays: Italy
ID NLM: 101530512
Informations de publication
Date de publication:
2019
2019
Historique:
received:
10
10
2018
accepted:
28
03
2019
entrez:
18
6
2019
pubmed:
18
6
2019
medline:
18
6
2019
Statut:
epublish
Résumé
While tyrosine kinase inhibitors (TKIs) have transformed CP-CML management, limited data exist on their use in clinical practice. 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. 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. This analysis provides valuable insights into management and treatment patterns in Italian patients with CML within routine clinical practice.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
While tyrosine kinase inhibitors (TKIs) have transformed CP-CML management, limited data exist on their use in clinical practice.
METHODS
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
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
CONCLUSIONS
This analysis provides valuable insights into management and treatment patterns in Italian patients with CML within routine clinical practice.
Identifiants
pubmed: 31205629
doi: 10.4084/MJHID.2019.025
pii: mjhid-11-1-e2019025
pmc: PMC6548212
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e2019025Déclaration de conflit d'intérêts
Competing interests: The authors have declared that no competing interests exist.
Références
Blood. 2008 Oct 15;112(8):3330-8
pubmed: 18684859
Cancer. 2012 Jun 15;118(12):3123-7
pubmed: 22294282
Curr Med Res Opin. 2013 Sep;29(9):1075-82
pubmed: 23738923
Hematology Am Soc Hematol Educ Program. 2011;2011:128-35
pubmed: 22160024
Blood. 2013 Aug 8;122(6):872-84
pubmed: 23803709
Clin Lymphoma Myeloma Leuk. 2012 Aug;12(4):223-9
pubmed: 22633166
N Engl J Med. 2003 Mar 13;348(11):994-1004
pubmed: 12637609
N Engl J Med. 2010 Jun 17;362(24):2251-9
pubmed: 20525993
N Engl J Med. 2010 Jun 17;362(24):2260-70
pubmed: 20525995
Clin Ther. 2015 Jan 1;37(1):124-33
pubmed: 25467191
Drugs Aging. 2013 Aug;30(8):629-37
pubmed: 23681399
Haematologica. 2007 Jan;92(1):101-5
pubmed: 17229641
Health Syst Transit. 2014;16(4):1-168
pubmed: 25471543
J Clin Oncol. 2014 Feb 10;32(5):415-23
pubmed: 24297946
Blood. 2011 Sep 22;118(12):3228-35
pubmed: 21685374
J Clin Oncol. 2012 Jan 20;30(3):232-8
pubmed: 22067393
N Engl J Med. 2010 Dec 23;363(26):2511-21
pubmed: 21175313
Lancet Haematol. 2015 May;2(5):e186-93
pubmed: 26688093
J Natl Compr Canc Netw. 2016 Jan 01;14(14 Suppl 1):S1-S6
pubmed: 31091066
Ther Adv Hematol. 2015 Feb;6(1):3-14
pubmed: 25642311
J Oncol Pract. 2013 Sep;9(5):e212-9
pubmed: 23943889
J Med Econ. 2017 Jan;20(1):63-71
pubmed: 27603674
BioDrugs. 2014 Feb;28(1):17-26
pubmed: 24043361
J Natl Cancer Inst. 2011 Apr 6;103(7):553-61
pubmed: 21422402
Curr Med Res Opin. 2012 Nov;28(11):1831-9
pubmed: 23127201
Leukemia. 2012 Sep;26(9):2096-102
pubmed: 22446502
Leukemia. 2012 Oct;26(10):2172-5
pubmed: 22504141
Blood. 2006 Sep 15;108(6):1809-20
pubmed: 16709930
Am J Hematol. 2017 Nov;92(11):1214-1223
pubmed: 28815757