In a nutshell
This study aimed to investigate if venetoclax was safe and effective in older patients with relapsed/refractory chronic lymphocytic leukemia outside of clinical trials.
This study concluded that venetoclax is safe and effective in these patients.
Chronic lymphocytic leukemia (CLL) is commonly diagnosed in older people. These patients can also have additional medical conditions and are rarely included in clinical trials. Ibrutinib (Imbruvica) is a tyrosine kinase inhibitor (TKI) drug used for the treatment of CLL. However, it can cause significant side effects in older patients. Venetoclax (Venclexta) is another targeted therapy used to treat CLL.
It was unknown if venetoclax would be safe and effective in older patients with relapsed or unresponsive CLL.
Methods & findings
This study involved 342 patients with relapsed or unresponsive CLL. Patients were separated into 2 groups based on their age. Group 1 included patients aged 75 and under and group 2 included those aged over 75 years. 79% of patients received venetoclax alone and 21% received it as a combination therapy. Patients had an average of 3 prior therapies. They were followed for an average of 11.6 months.
The overall response rate (ORR) was 82% for the under 75 group compared to 81.6% for the over 75 group. Complete responses were seen in 32.6% of group 1 compared to 35.2% in group 2.
The 1-year progression-free survival (PFS) rate was 73% for group 1 compared to 79% in group 2. The 1-year overall survival (OS) was 83% for group 1 compared to 77% for group 2. There was no difference in side effects between the two groups.
42% of patients discontinued treatment and 20% of these discontinued due to toxicity. 6.6% of the under 75 group discontinued due to toxicity compared to 14% of the over 75 group.
The bottom line
The authors concluded that venetoclax was safe and effective in older patients with relapsed or unresponsive CLL.
Published By :
British Journal of Haematology
Nov 04, 2019