Chemotherapy and venetoclax in older patients with acute myeloid leukemia

This study aimed to investigate if venetoclax and intense chemotherapy is a safe and effective treatment in older patients with acute myeloid leukemia.  

This study concluded that this treatment was safe and effective in these patients.  

Venetoclax (Venclexta) is a targeted therapy that is used to treat chronic lymphocytic leukemia (CLL). Studies have shown it may have a role in treating acute myeloid leukemia (AML). It shows good response rates in older patients when combined with hypomethylating agents or low-dose cytarabine (Cytosar u). Cytarabine is a chemotherapy.  

The safety and effectiveness of venetoclax in combination with intensive chemotherapy in older AML patients is unknown. 

This study involved 51 patients with AML who had an average age of 72 years (range 63 – 80). Patients were treated with intensive chemotherapy and increasing doses of venetoclax. Intensive chemotherapy included cytarabine and idarubicin (Idamycin). After induction (initial treatment), patients also received 14 days of consolidation treatment with venetoclax and cytarabine–idarubicin. 7 cycles of venetoclax maintenance treatment were also permitted. Consolidation treatment is given to help deepen responses to the first treatment. Maintenance treatment is given to keep the cancer from returning. The average follow-up was 22.9 months.

The maximum tolerated dose was 600 mg/day. Overall, 72% of the patients responded to treatment. 41% of patients had a complete response (CR) and 31% had a CR with incompletely normalized blood cell counts. Patients who have developed AML without previous blood anti-cancer treatment had a 97% response. This was compared to a 43% response in patients who developed AML after treatment for another blood cancer.

The main serious side effects during initial treatment were low white blood cells with fever (55%) and infection spread in the blood (35%).

This study concluded that venetoclax combined with chemotherapy was safe and effective in fit older patients with AML.  

This study had a small number of participants and a short follow-up. There was no comparison group. This study was supported by Abbvie, the manufacturer of venetoclax.