When combined with azacitidine, a 7-day course of venetoclax demonstrated similar remission rates and was more tolerable compared to the standard 28-day course for older or chemotherapy-ineligible patients with newly diagnosed AML.
Results from the retrospective multi-center analysis were presented by Alexandre Bazinet, M.D., assistant professor of Leukemia.
Both groups had a composite complete remission rate of 72%, and the median OS for the shorter duration cohort was 11.2 months compared with 10.1 months for the longer duration cohort. Interestingly, OS with standard dosing was longer in patients without high-risk mutations, suggesting these patients have a more “sensitive” leukaemia that responds well to more venetoclax exposure.
Additionally, the 8-week mortality rate was significantly higher in the 28-day treatment group compared to the 7-day group at 16% vs 6%, respectively.
“Our findings suggest shorter courses of venetoclax for the treatment of AML may help reduce side effects and improve patients’ tolerability of treatment without compromising response rates,” Bazinet said. “Older patients tend to experience more side effects and often have additional medical issues which increases the risk of serious complications. It’s important to identify treatment options that can produce similar rates of remission and survival for these patients.”
In a retrospective analysis, researchers compared data from 82 patients treated with the shorter 7-day venetoclax course to that of 166 patients treated with the current recommended 28-day course.
Responses were slower with the 7-day course compared to the standard course, often requiring more than one cycle to achieve the first response.
However, most patients eventually responded with added cycles, resulting in an equal composite complete remission rate between the cohorts.
Researchers observed a significantly lower need for platelet transfusions and lower early mortality in patients receiving the 7-day course, suggesting the shorter course was more tolerable.
The study supports use of shorter courses of venetoclax in triplet regimens such as those being developed by MD Anderson researchers to treat older or chemotherapy-ineligible patients.
Source: ASCO