In a phase Ib/II trial reported in the Journal of Clinical Oncology, Wei et al found that the combination of venetoclax and low-dose cytarabine produced a high response rate in previously untreated older patients with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy.
In the international study, 82 patients aged ≥ 60 years received the phase II dose of oral venetoclax at 600 mg/d in 28-day cycles, with low-dose cytarabine at 20 mg/m2/d administered subcutaneously on days 1 to 10. Patients had a median age of 74 years, 49% had secondary AML, 29% had prior treatment with hypomethylating agents for myelodysplastic syndrome, and 32% had poor-risk cytogenetic features.
Early (30-day) mortality was 6%. Complete remission or complete remission with incomplete blood count recovery occurred in 54% of patients, with a median time to first response of 1.4 months. The median duration of response was 8.1 months. Median overall survival was 10.1 months. Among patients without prior hypomethylating agent exposure, complete remission or complete remission with incomplete blood count recovery was achieved in 62%, median duration of response was 14.8 months, and median overall survival was 13.5 months
The most common grade 3 or 4 adverse events were febrile neutropenia (42%), thrombocytopenia (38%), decreased white blood cell count (34%), anemia (27%), and neutropenia (27%).
The investigators concluded, “Venetoclax plus low-dose cytarabine has a manageable safety profile, producing rapid and durable remissions in older adults with AML ineligible for intensive chemotherapy. High remission rate and low early mortality combined with rapid and durable remission make venetoclax and low-dose cytarabine an attractive and novel treatment for older adults not suitable for intensive chemotherapy.”
Andrew H. Wei, MBBS, PhD, of the Department of Haematology, The Alfred Hospital and Monash University, Melbourne, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by AbbVie and Genentech, National Health and Medical Research Council of Australia, Medical Research Future Fund, Victorian Cancer Agency, and Leukemia Lymphoma Society Specialized Centre of Research. The study authors’ full disclosures can be found at jco.ascopubs.org.
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