Back to Search
Start Over
Nilotinib 300 mg twice daily: an academic single-arm study of newly diagnosed chronic phase chronic myeloid leukemia patients
- Source :
- Haematologica. 101:1200-1207
- Publication Year :
- 2016
- Publisher :
- Ferrata Storti Foundation (Haematologica), 2016.
-
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).
- Subjects :
- Blood Glucose
Myeloid
Male
030204 cardiovascular system & hematology
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
High-density lipoprotein
80 and over
Chronic Myelogenous Leukemia
Aged, 80 and over
Leukemia
Hematology
Incidence (epidemiology)
Remission Induction
Myeloid leukemia
Articles
Middle Aged
Cholesterol
Treatment Outcome
030220 oncology & carcinogenesis
Leukemia, Myeloid, Chronic-Phase
Female
medicine.drug
Adult
medicine.medical_specialty
Adolescent
Molecular response
Young Adult
03 medical and health sciences
Aged
Humans
Protein Kinase Inhibitors
Pyrimidines
Thrombosis
Triglycerides
chronic myeloid leukemia
Internal medicine
medicine
Adverse effect
Tyrosine kinase inhibitors
business.industry
Nilotinib
Discontinuation
Surgery
chemistry
Arterial Thrombosi
Chronic-Phase
Glycated hemoglobin
business
Subjects
Details
- ISSN :
- 15928721 and 03906078
- Volume :
- 101
- Database :
- OpenAIRE
- Journal :
- Haematologica
- Accession number :
- edsair.doi.dedup.....67aede7eee197508237e3d43548b0ec5