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Venetoclax therapy in combination with azacytidine or cytarabine resulted in a higher and longer-sustained health-related quality of life (QOL) for patients with acute myeloid leukemia (AML) compared with monotherapies. These findings were presented during the American Society of Hematology (ASH) 62nd Annual Meeting and Exposition.
Patients with AML who were treatment naïve and ineligible for intensive chemotherapy were recruited for these studies. They were randomized in a 2:1 ratio to receive, in 1 study, azacytidine with venetoclax (n=286) or placebo (n=145), and in the other study, low-dose cytarabine with venetoclax (n=143) or placebo (n=68). Patients were assessed for physical functioning and QOL.
In the azacytidine treatment group, 60% were men, median age 76 years; and in the low-dose cytarabine group, 55% were men, median age 76 years. All patients had similar performance status at baseline.
Compared with placebo, venetoclax and azacytidine recipients exhibited significantly longer time to deterioration as measured by health-related QOL (median in months, 10.7 [95% CI, 7.53-18.64] vs 3.9 [95% CI, 2.37-7.40]; P <.001) and physical functioning (median in months, 9.7 [95% CI, 6.71-16.01] vs 6.2 [95% CI, 4.67-9.47]; P =.028).
Compared with placebo, venetoclax and low-dose cytarabine had significantly longer time to deterioration as assessed by fatigue (median in months, 8.1 [95% CI, 5.79-¥] vs 2.6 [95% CI, 2.07-9.47]; P =.004), health-related QOL (median in months, 11.3 [95% CI, 4.18-¥] vs 2.6 [95% CI, 2.04-9.30]; P =.011), and physical functioning (median in months, 5.8 [95% CI, 3.09-¥] vs 2.9 [95% CI, 1.97-8.12]; P =.020).
This study was limited by its sample sizes and the fact that many patients were enrolled late in their therapy; however, the investigators felt the early and significantly different trajectories of the time to deterioration curves among the patient groups indicated these results were robust.
“Overall, venetoclax appears to have a positive impact on health-related quality of life for patients with AML who are ineligible for intensive chemotherapy, leading to a long-term preservation of functioning and overall health status,” concluded Keith W. Pratz, MD, coauthor of the study.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Pratz K W, Panayiotidis P, Recher C, et al. Delays in time to deterioration of health-related quality of life were observed in patients with acute myeloid leukemia receiving venetoclax in combination with azacitidine or in combination with low-dose cytarabine. Presented at: American Society of Hematology (ASH) 62nd Annual Meeting and Exposition; December 5-8, 2020. Abstr 589.