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Posted by on Aug 20, 2019 in Leukemia | 0 comments

In a nutshell

This study aimed to investigate outcomes for patients with chronic-phase chronic myeloid leukemia who received nilotinib as a first-line treatment.  

This study concluded that nilotinib is a valuable treatment option for these patients. 

Some background

Nilotinib (Tasigna) is a targeted therapy called a tyrosine kinase inhibitor (TKI). It is approved for the treatment of imatinib (Gleevec)-resistant chronic myeloid leukemia (CML). 

The adherence to treatment and real-life safety and effectiveness of nilotinib in patients with chronic-phase CML (CP-CML) remains under investigation.  

Methods & findings

This study involved 183 patients with newly diagnosed CP-CML who received nilotinib as first-line treatment. The outcomes measured were the molecular response, safety, quality of life (QoL) and treatment adherence. Patients were followed for an average of 24 months.  

33.3% of patients experienced premature study termination before the 24-month follow up period. 29% of patients had to stop nilotinib treatment due to treatment intolerance and inefficacy.  

After 24 months of treatment, 91.8% of patients had a molecular assessment. 95.5% of these patients achieved a major molecular response (MMR). 32.1% of patients achieved undetectable molecular disease (UMD). MMR is when most of the BCR-ABL gene is gone from the blood. BCR-ABL gene is a cancer gene.  

Out of the 94 patients who completed adherence questionnaires, 89.4% obtained a satisfactory level of treatment adherence. Treatment adherence (taking medicines correctly) is the extent to which patients take medication as prescribed by their doctors. QoL was good at the beginning of the study and was stable during the 24-month follow-up period.  

14.8% of patients experienced itching of the skin as a side effect of nilotinib treatment. Another common side effect was physical weakness or lack of energy. 3.8% of patients experienced at least one cardiovascular ischemic side effect (lack of blood and oxygen to the heart).  

The bottom line

This study concluded that nilotinib is a safe and effective first-line treatment for patients with CP-CML outside clinical trials. 

The fine print

This study had no comparison group. Also, not all patients included completed the study. Further studies are needed.

Published By :

British Journal of Haematology

Date :

Aug 08, 2019

Original Title :

Nilotinib efficacy, safety, adherence and impact on quality of life in newly diagnosed patients with chronic myeloid leukaemia in chronic phase: a prospective observational study in daily clinical practice.

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