PMID- 30043130
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20220114
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 38
IP  - 9
DP  - 2018 Sep
TI  - Pattern of Use and Long-Term Safety of Tyrosine Kinase Inhibitors: A Decade of 
      Real-World Management of Chronic Myeloid Leukemia.
PG  - 837-844
LID - 10.1007/s40261-018-0676-7 [doi]
AB  - BACKGROUND AND OBJECTIVES: First-line treatment of chronic phase (CP) chronic 
      myeloid leukemia (CML) is based on the first-generation tyrosine kinase inhibitor 
      (TKI) imatinib or the second-generation TKIs dasatinib or nilotinib. Thanks to 
      the efficacy of TKIs, CML has switched from a fatal to a 'chronic' pathology, and 
      data from clinical trials have become insufficient to drive physicians' 
      prescription choices and address long-term treatment outcomes. On the brink of 
      commercialization of generic imatinib, this study aims to evaluate the 
      therapeutic pattern of CP-CML and the occurrence of adverse events (AEs) over a 
      decade of local real clinical practice. METHODS: A retrospective cohort study was 
      performed on CP-CML patients followed up in the Local Health Unit of Treviso 
      (Veneto Region, Italy) during the period 2005-2015. Data were captured from both 
      administrative databases and physicians' patient diaries. RESULTS: Of 81 CP-CML 
      patients, 73 were treated with first-line imatinib; among the second-generation 
      TKIs, only nilotinib was used (n = 8). Overall, 38% of imatinib-treated subjects 
      needed to switch, mainly due to intolerance, whereas no switches occurred in the 
      nilotinib cohort. Osteoarticular pain was the most common AE and was 
      significantly more frequent in the imatinib cohort (68.49 vs. 25.00%, p = 0.022). 
      Other common AEs were dermatologic manifestations, asthenia, and diarrhea. 
      CONCLUSION: Although based on a small population, this study represents an 
      unbiased reference on the long-term management of CML in an Italian clinical 
      setting. Our results indicate a better profile of first-line nilotinib, both in 
      terms of persistency and tolerability. AEs remain a major concern, highlighting 
      the importance of close monitoring.
FAU - Bettiol, Alessandra
AU  - Bettiol A
AD  - Department of Pharmaceutical and Pharmacological Sciences, University of Padua, 
      Padua, Italy. alessandra.bettiol@unifi.it.
AD  - Department of Neurosciences, Psychology, Drug Research and Children's Health, 
      University of Florence, Florence, Italy. alessandra.bettiol@unifi.it.
FAU - Marconi, Ettore
AU  - Marconi E
AD  - Department of Neurosciences, Psychology, Drug Research and Children's Health, 
      University of Florence, Florence, Italy.
FAU - Lombardi, Niccolo
AU  - Lombardi N
AD  - Department of Neurosciences, Psychology, Drug Research and Children's Health, 
      University of Florence, Florence, Italy.
FAU - Crescioli, Giada
AU  - Crescioli G
AD  - Department of Neurosciences, Psychology, Drug Research and Children's Health, 
      University of Florence, Florence, Italy.
FAU - Gherlinzoni, Filippo
AU  - Gherlinzoni F
AD  - Department of Hematology, Local Health Unit n.2 Marca Trevigiana, Treviso, Italy.
FAU - Walley, Thomas
AU  - Walley T
AD  - Institute of Psychology Health and Society, University of Liverpool, Liverpool, 
      UK.
FAU - Vannacci, Alfredo
AU  - Vannacci A
AD  - Department of Neurosciences, Psychology, Drug Research and Children's Health, 
      University of Florence, Florence, Italy.
FAU - Chinellato, Alessandro
AU  - Chinellato A
AD  - Pharmaceutical Service, Local Health Unit n.3 Serenissima, Venice, Italy.
FAU - Giusti, Pietro
AU  - Giusti P
AD  - Department of Pharmaceutical and Pharmacological Sciences, University of Padua, 
      Padua, Italy.
LA  - eng
PT  - Journal Article
PT  - Pragmatic Clinical Trial
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 8A1O1M485B (Imatinib Mesylate)
RN  - EC 2.7.10.1 (Protein-Tyrosine Kinases)
RN  - F41401512X (nilotinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cohort Studies
MH  - Exanthema/chemically induced
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Imatinib Mesylate/adverse effects/*therapeutic use
MH  - Italy/epidemiology
MH  - Leukemia, Myelogenous, Chronic, BCR-ABL Positive/*drug therapy/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Pain/chemically induced
MH  - Protein Kinase Inhibitors/*therapeutic use
MH  - Protein-Tyrosine Kinases/antagonists & inhibitors
MH  - Pyrimidines/adverse effects/*therapeutic use
MH  - Retrospective Studies
MH  - Time Factors
MH  - Young Adult
EDAT- 2018/07/26 06:00
MHDA- 2018/12/12 06:00
CRDT- 2018/07/26 06:00
PHST- 2018/07/26 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2018/07/26 06:00 [entrez]
AID - 10.1007/s40261-018-0676-7 [pii]
AID - 10.1007/s40261-018-0676-7 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2018 Sep;38(9):837-844. doi: 10.1007/s40261-018-0676-7.