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Chemotherapy and venetoclax in elderly acute myeloid leukemia trial (CAVEAT): A phase Ib dose-escalation study of venetoclax combined with modified intensive chemotherapy

Journal of Clinical Oncology Oct 22, 2020

Chua CC, Roberts AW, Reynolds J, et al. - Researchers tested venetoclax (B-cell lymphoma 2 inhibitor) in combination with intensive chemotherapy, in terms of tolerability and efficacy in acute myeloid leukemia (AML). Participants were AML patients aged ≥ 65 years (≥ 60 years if monosomal karyotype) who were eligible for intensive chemotherapy. The participants were assigned to venetoclax dose-escalation cohorts (range, 50-600 mg). During induction, a 7-day prephase/dose ramp-up (days −6 to 0) was followed by an additional 7 days of venetoclax integrated with infusional cytarabine 100 mg/m2 on days 1-5 and idarubicin 12 mg/m2 intravenously on days 2-3 (ie, 5 + 2). In this study with 51 patients with a median age of 72 years, findings demonstrated the safety as well as the tolerability of venetoclax combined with 5 + 2 induction chemotherapy among eligible older patients suffering from AML. The overall response rate was 72%; it was 97% in de novo AML and was 43% in secondary AML. Although the best postremission therapy is yet to be ascertained, the high remission rate in de novo AML invites additional inquiry.

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