(015) Assessment of Efficacy and Safety of Hypomethylating agent/Venetoclax versus Cytarabine/Anthracycline (7+3) for Acute Myeloid Leukemia Induction Therapy in 50- to 70-year-old Patients

Poster Abstract:

Background:
In patients with acute myeloid leukemia (AML), initial treatment selection depends on the patient’s eligibility for intensive induction therapy. For patients who are eligible for intensive induction therapy, first-line treatment is typically standard-dose cytarabine with an anthracycline (7+3). In patients who are not eligible for intensive induction chemotherapy, a regimen of a hypomethylating agent, such as decitabine or azacitidine, in combination with venetoclax (HMA/venetoclax) is preferred. The approval of this regimen for patients age 75 years and older provided practitioners with a new treatment option for older patients in whom traditional chemotherapy agents may pose a greater risk than benefit. However, there are many younger patients who may have worse overall fitness for intensive chemotherapy due to factors beyond age, such as comorbidities, performance status, prognosis, and burden of disease. In these patients, treatment selection may be a more nuanced discussion between the patient and a multi-disciplinary team of providers. While there are some studies examining the use of more intensive chemotherapy regimens in patients older than 60 years, there is little literature to provide guidance for selection of intensity in younger patients with AML who nevertheless may be less-ideal candidates for intensive induction.
Objective(s):
The primary objective of this evaluation is to compare one-year event free survival (defined as overall survival, complete response after induction chemotherapy, and lack of recurrence) in 50- to 70-year-old patients who received 7+3 induction chemotherapy versus those who received HMA/venetoclax. Secondary outcomes include one-year overall survival, response rate to induction chemotherapy, one–year relapse-free survival, and toxicities such as infection, hepatic dysfunction, mucositis, cardiac event, or ICU admission within 30 days of treatment initiation.

Methods:
This is a retrospective, single-center, cohort study at Duke University Hospital (DUH). Patients were included if they were between the ages of 50 to 70 years with a new diagnosis of AML receiving first-line therapy with 7+3 or HMA/venetoclax at DUH. Patients who received any alternative agent, such as midostaurin, gemtuzumab ozogomicin, or liposomal daunorubicin-cytarabine, were excluded. Once included, pre-specified data collection points were obtained from the electronic health record and entered into a secure REDCap database for each patient. Outcomes were evaluated for one year from the date of treatment initiation.

Results:
Results pending and will be available at time of presentation.
Discussion/conclusions:
Results pending and will be available at time of presentation.

References (must also be included in final poster): 1. Pollyea DA, Bixby D, Perl A, et al. NCCN Guidelines Insights: Acute Myeloid Leukemia, Version 2.2021. J Natl Compr Canc Netw. 2021 Jan 6;19(1):16-27. doi: 10.6004/jnccn.2021.0002. PMID: 33406488.
2. Walter RB, Othus M, Borthakur G, et al. Prediction of early death after induction therapy for newly diagnosed acute myeloid leukemia with pretreatment risk scores: a novel paradigm for treatment assignment. J Clin Oncol. 2011 Nov 20;29(33):4417-23.
3. Matthews AH, Perl AE, Luger SM, et al. Real-world effectiveness of intensive chemotherapy with 7&3 versus venetoclax and hypomethylating agent in acute myeloid leukemia. Am J Hematol. 2023 Aug;98(8):1254-1264.
4. Dohner H, Wei AH, Appelbaum FR, et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022 Sep 22;140(12):1345-1377.