(099) Evaluation of Healthcare Resource Utilization Following Initiation of Azacitidine Versus Decitabine in Combination with Venetoclax in Patients with Acute Myeloid Leukemia (Top Ten Poster)

Poster Abstract:

Background:
Acute myeloid leukemia (AML) is an aggressive myeloid neoplasm with an overall poor prognosis, especially in older adults who are unable to tolerate intensive induction chemotherapy.(1,2) Combination therapy with venetoclax and hypomethylating agents (HMAs; azacitidine or decitabine) is recommended by the National Comprehensive Cancer Network for patients ineligible for intensive induction chemotherapy.(3) While HMA and venetoclax regimens are considered better tolerated than standard intensive induction chemotherapy, they still carry the risk for adverse effects like tumor lysis syndrome (TLS) and febrile neutropenia (FN) which can lead to prolonged hospitalizations, re-admissions, and delay of treatment.(4,5) To date, a large, prospective, randomized controlled trial comparing outcomes with azacitidine versus decitabine in combination with venetoclax has not been conducted. Furthermore, the difference in total number of days hospitalized between the regimens over the course of therapy, including re-admissions or prolonged stays for toxicity management, is unknown.

Objectives:
The primary objective of this study is to evaluate healthcare resource utilization following initiation of treatment with azacitidine versus decitabine in combination with venetoclax in patients with newly diagnosed AML. Secondary objectives include comparing response rates and incidence of adverse effects, including TLS and FN.


Methods:
This single-center, retrospective cohort study included patients ≥18 years with newly diagnosed AML per WHO 2016 criteria who received upfront treatment with HMA and venetoclax between November 21, 2018 and September 30, 2023 at Atrium Health Wake Forest Baptist. Patients were excluded if they had a diagnosis of acute promyelocytic leukemia, prior venetoclax exposure, were initiated on a 10-day decitabine regimen, or were treated with HMA and venetoclax as part of a research protocol. Patients were identified through a query of EPIC Beacon treatment plans. The primary endpoint was the number of days hospitalized during the first 90 days after initiation of treatment. Secondary endpoints included the number of days hospitalized during the first 90 days following completion of cycle 1 intravenous chemotherapy, re-admission rate, number of hospitalizations, number of intensive care unit stays, response rate, time to best response, incidence of TLS, and incidence of FN. The primary outcome, baseline characteristics, number of hospitalizations, and response rates will be assessed with a T-test or Wilcoxon rank-sum test. Incidence of TLS and FN will be assessed using a Chi squared or Fisher’s exact test. Kaplan-Meier will be utilized for time to best response.

Results: Pending

Discussion/

Conclusions: Pending

References (must also be included in final poster): 1. Acute Myeloid Leukemia - Cancer Stat Facts. SEER. Accessed September 4, 2023. https://seer.cancer.gov/statfacts/html/amyl.html
2. SEER*Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute; 2023 Apr 19. [updated: 2023 Jun 8; cited 2023 Sep 4]. Available from: https://seer.cancer.gov/statistics-network/explorer/. Data source(s): SEER Incidence Data, November 2022 Submission (1975-2020), SEER 22 registries (excluding Illinois and Massachusetts). Expected Survival Life Tables by Socio-Economic Standards.
3. National Comprehensive Cancer Network. Acute Myeloid Leukemia. (Version 4.2023). https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1411
4. DiNardo CD, Pratz K, Pullarkat V, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133(1):7-17.
5. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. New England Journal of Medicine. 2020;383(7):617-629. doi:10.1056/NEJMoa2012971