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Posted by on Jul 31, 2019 in Leukemia | 0 comments

In a nutshell

This study aimed to investigate the long-term safety of ibrutinib as a single-agent treatment for patients with chronic lymphocytic leukemia. 

This study concluded that side effects were mainly grade 1 or 2 and were manageable during prolonged ibrutinib treatment in these patients. 

Some background

Ibrutinib (Imbruvica) is a tyrosine kinase inhibitor (TKI) which is a type of targeted therapy. It is commonly used in the treatment of chronic lymphocytic leukemia (CLL) until disease progression or severe side effects occur.  

It is not known if ibrutinib is safe as a single long-term treatment for patients with CLL.   

Methods & findings

This study involved 424 patients with CLL from 3 clinical trials. Patients were treated with ibrutinib as a single therapy for up to 67 months. Side effects were evaluated. 

Adverse events (AEs) are side effects and can be graded from 1 to 4. Grade 4 AEs would be the most severe. 52% of patients experienced diarrhea of grade 1 or 2. 5% of patients experienced diarrhea of any grade. 36% of patients experienced fatigue of grade 1 or 2. 3% of patients experienced fatigue of any-grade.  

18% of patients experienced grade 3 or 4 neutropenia. Neutropenia is when there is a low level of white blood cells. 12% of patients experienced pneumonia of grade 3 or 4.  

Over time, the frequency of AEs such as diarrhea, fatigue, infections, bleeding and neutropenia decreased. The frequency of hypertension (high blood pressure) increased over time but decreased after year 1.  

 AEs led to dose reductions in 13% of patients and stopping of the treatment in 11%. Dose modifications due to AEs were most common during year 1 and decreased after.  

The most common AEs leading to stopping the treatment were pneumonia, anemia (low level of red blood cells) and irregular heartbeat. 

The bottom line

This study concluded that AEs were mainly grade 1 or 2 and were manageable during prolonged ibrutinib treatment in patients with CLL.   

What’s next?

Consult your physician if you have concerns about ibrutinib treatment.   

Published By :

Blood advances

Date :

Jun 25, 2019

Original Title :

Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.

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