AML real world evidence initiative: venetoclax versus control in patients unfit for intensive chemotherapy
In this study, Dr Aaron Goldberg from the Memorial Sloan Kettering Cancer Center presents a comparative analysis of outcomes and healthcare research utilization in patients with AML treated with venetoclax (VEN) versus conventional therapeutic approaches.
As part of the AML Real World Evidence initiative, a substantial retrospective study encompassing over 500 AML patients was conducted. Among them, 267 received VEN-based treatments, while another 267 underwent conventional regimens. The subgroup under investigation comprised patients deemed unsuitable for intensive chemotherapy, specifically those aged over 75 or with comorbidities. Ineligible chemotherapy recipients treated with VEN were matched with counterparts on non-VEN-based regimens, based on age categories (<60, 60-74, ≥75 years) and European LeukemiaNet (ELN 2017) risk stratification.
Demographic analysis revealed an anticipated older population, with median ages in their 70s, and a notable presence of high-risk mutations.
Regarding outcomes, response rates closely mirrored those observed in clinical trials. Notably, the CR rate, approximately 67%, observed in the landmark VIALE-A trial and the VEN plus azacitidine trial, aligns precisely with the real-world dataset. Intriguingly, patients on high-intensity non-VEN regimens exhibited comparable response rates. Conversely, patients undergoing low-intensity non-VEN treatment demonstrated suboptimal outcomes, consistent with prior clinical trial results. In terms of OS, the outcomes for intensively treated controls and venetoclax-treated patients were remarkably similar.
A distinctive aspect of this study lies in the analysis of healthcare resource utilization, potentially indicating a paradigm shift in AML treatment. The data reveal a longer duration of hospitalization and more days spent in the hospital for patients undergoing intensive treatments. By employing VEN, the provision of care has transitioned from inpatient to outpatient settings. Consequently, in older adults unsuitable for intensive chemotherapy, highly effective therapy can be administered, facilitating the relocation of treatment from the hospital to the outpatient clinic. This observation, however, requires confirmation in an ongoing randomized clinical trial.
Goldberg A, ASH2023. #5173
With the educational support of: