ADVERTISEMENT
First-Line Venetoclax Plus Azacitidine vs Intensive Chemotherapy for Patients With AML in the Real-World Setting
In the real-world setting, use of intensive chemotherapy was more common than venetoclax plus azacitidine for patients aged 60-75 years with acute myeloid leukemia (AML) and was also associated with better remission rate and survival, according to a study presented at the ASH Annual Meeting.
The BCL-2 inhibitor, venetoclax, was approved in combination with azacitidine for the treatment of patients aged ≥75 years with newly diagnosed AML in 2018. Randomized trials have demonstrated the efficacy of this regimen based on complete remission rates.
“It is important to understand the patterns of use of this combination relative to intensive chemotherapy in adult pts with newly-diagnosed AML treated in real-world clinical practice, particularly when induction decisions for some pts can be challenging,” explained Amer M. Zeidan, MD, Department of Internal Medicine, School of Medicine and Yale Cancer Center, Yale University, New Haven, CT, and colleagues.
This study aimed to describe real-world complete remission (CR) rates, overall survival (OS), and relapse-free survival (RFS) associated with intensive chemotherapy vs venetoclax plus azacitidine for the first-line treatment of AML.
The Flatiron Health electronic medical records (EMR) database was used to identify patients with newly diagnosed AML who received induction with either of the study regimens between November 21, 2018, and Nov 30, 2020, and had ≥2 months of follow-up. Patients were separate based on age: 18-59 years, 60-75 years, and >75 years.
A total of 888 patients who received intensive chemotherapy (n = 547) or venetoclax plus azacitidine (n = 341) were identified and included in the study. Baseline characteristics were similar between the two groups regarding sex (57.7% male) and practice type (74.9% community practice). However, patients in the venetoclax plus azacitidine group were significantly older than those in the intensive chemotherapy group (mean age 58.1 vs 73.8 years, respectively; P < .001).
There were 283 patients aged 18-59 years; 261 received intensive chemotherapy and 22 received venetoclax plus azacitidine. Of 393 patients aged 60-75 years, 252 received intensive chemotherapy and 141 received venetoclax plus azacitidine. Of 212 patients aged >75 years, 34 received intensive chemotherapy and 178 received venetoclax plus azacitidine.
The CR rate in the intensive chemotherapy group was 76.2% and in the venetoclax plus azacitidine group was 48.1%. In the 60-75 years subgroup, remission rates were 75% and 53.9%, respectively. The proportion of patients who underwent transplant in the 60-75 years group 32.4% in the intensive chemotherapy group and 12.8% in the venetoclax plus azacitidine group.
The median follow-up from diagnosis was 1 year in the intensive chemotherapy group vs 292 days in the venetoclax plus azacitidine group. The overall mortality rates for patients aged 60-75 years were 35.3% and 45.4%, respectively. The estimated OS for all patients was not reached and 392 days for the two groups, respectively. In the subgroup of patients aged 60-75 years, the OS was not reached and 531 days, respectively. The estimated RFS was 544 days in the intensive chemotherapy group and was 316 days in the venetoclax plus azacitidine group. In the subgroup of patients aged 60–75 years, median RFS was 522 days and 342 days, respectively.
