How safe is long-term ibrutinib for chronic lymphocytic leukemia patients?

This study aimed to investigate the safety and effectiveness of ibrutinib (Imbruvica) in chronic lymphocytic leukemia.

This study concluded that long-term administration of ibrutinib was well tolerated and provided effective disease control for most patients.

Ibrutinib is a targeted therapy that can be used for patients with chronic lymphocytic leukemia (CLL) who have already received treatment. Targeted therapies look for features of cancer cells that are not seen on normal cells (such as certain proteins). This allows the cancerous cells to be destroyed without damaging the healthy cells.  

It was not known how safe and effective ibrutinib was in the long-term for treating CLL patients.  

This study involved 86 patients with CLL who were treated with 420 mg ibrutinib. 51 patients had TP53 mutated CLL (TP53 group) and 35 patients were aged 65 or older (elderly group). Both groups had patients with treatment naïve (TN) and relapsed/refractory (RR) CLL.

23.3% of patients stopped treatment due to disease progression. 5.8% of patients stopped treatment due to side effects. 20.9% of patients experienced atrial fibrillation (irregular heart beat). After 4.8 years 57% of the 86 patients remained on the study.

The TP53 group had an overall response rate (ORR) at 6 months of 95.8%. The elderly group had ORR of 93.9%. 29.2% of the TP53 group achieved complete response (CR, no sign of active disease). 27.3% of the elderly group achieved CR.

In the TP53 group, the 5-year progression free survival (time from treatment until disease progression) was 74.4% for the TN patients compared to 19.4% in the RR patients. In the TP53 group, the 5-year overall survival (OS, time from treatment until death from any cause) was 85.3% for the TN patients and 53.7% for the RR patients.

In the elderly group, PFS and OS in the RR patients were 64.8% and 71.6%. None of the patients in the TN group experienced disease progression or death.

This study concluded that long-term administration of ibrutinib was well tolerated and provided effective disease control for most patients.

Consult your physician about Ibrutinib as a treatment option for CLL.