Abstract：
:The introduction and the extended clinical use of nilotinib in the first-line treatment of chronic myeloid leukemia have been based on company-sponsored trials. Independent confirmations are extremely important. We report an investigator-sponsored study of nilotinib 300 mg twice daily in 130 chronic myeloid leukemia patients in early chronic phase. A deep molecular response was achieved in 46% (MR4.0) and 17% (MR4.5) of patients at 2 years; 58% of the enrolled patients achieved a MR4.0 at least once, with a sustained MR4.0 in 52% of them. With a median observation of 29 months (range 24-37 months), 77% of patients were still on treatment with nilotinib. The reasons for permanent discontinuation were: 3% progression, 5% failure or suboptimal response, 8% adverse events, 1% treatment-free remission, and 5% other reasons. Thirteen thrombotic arterial events were reported in 12 patients. A prospective evaluation of metabolic effects showed an increase of fasting glucose without significant variations of glycated hemoglobin, an increase of total cholesterol (both low density lipoprotein and high density lipoprotein fractions) and a decrease of triglycerides. This study confirms a high and rapid efficacy of nilotinib 300 mg twice daily and provides detailed information on the type and incidence of non-hematologic and metabolic adverse events (clinicaltrials.gov identifier: 01535391).
journal_name
Haematologicajournal_title
Haematologicaauthors
Castagnetti F,Breccia M,Gugliotta G,Martino B,D'Adda M,Stagno F,Carella AM,Avanzini P,Tiribelli M,Trabacchi E,Visani G,Gobbi M,Salvucci M,Levato L,Binotto G,Capalbo SF,Bochicchio MT,Soverini S,Cavo M,Martinelli G,doi
10.3324/haematol.2016.144949subject
Has Abstractpub_date
2016-10-01 00:00:00pages
1200-1207issue
10eissn
0390-6078issn
1592-8721pii
haematol.2016.144949journal_volume
101pub_type
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