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Treatment Regimen Using Non–Anthracycline-Containing Backbone is Effective for Older Patients With AML
Venetoclax added to cladribine and low-dose cytarabine alternating with venetoclax and 5-azacitidine was found to be an effective regimen for older or unfit patients with newly diagnosed acute myeloid leukemia, showing promising rates of overall survival (OS) and disease-free survival (DFS).
Tapan M. Kadia, MD, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, and colleagues hypothesized that the addition of venetoclax to cladribine and low-dose cytarabine alternating with 5-azacitidine backbone may improve outcomes in this patient population.
To investigate this hypothesis, they conducted a phase 2 study exploring this treatment strategy among older (≥ 60 years) or unfit patients with newly diagnosed AML. The primary objective was composite complete response (CR) rate (CR plus CR with incomplete blood count recovery), and the secondary end points included OS, DFS, overall response rate, and toxicity, respectively.
The study included 60 patients, with a median age of 68 years. Overall, 23% of patients were considered favorable, 33% were considered intermediate, and 43% were considered adverse risk. A total of 56 patients experienced a response (composite CR: 93%) and 84% were negative for measurable residual disease.
There was 1 death (2%) within 4 weeks. With a median follow-up of 22.1 months, the median OS and DFS have not yet been reached. The most frequent grade 3/4 nonhematologic adverse events were febrile neutropenia (n = 33) and pneumonia (n = 14), while 1 patient developed grade 4 tumor lysis syndrome, they noted.
“Further study of this non–anthracycline-containing backbone in younger patients, unfit for intensive chemotherapy, as well as comparisons to standard frontline therapies is warranted,” concluded Dr Kadia and colleagues.
Source:
Kadia TM, Reville PK, Wang X, et al. Phase II Study of Venetoclax Added to Cladribine Plus Low-Dose Cytarabine Alternating With 5-Azacitidine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia. J Clin Oncol. Published online June 15, 2022. doi:10.1200/jco.21.02823
