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Venetoclax-Based Regimen for Patients With AML Ineligible for Intensive Chemotherapy

By: Joseph Fanelli
Posted: Monday, July 20, 2020

For patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, the small-molecule BCL2 inhibitor venetoclax plus low-dose cytarabine may be an alternative treatment option, according to findings presented in the journal Blood. The addition of venetoclax to low-dose cytarabine improved remission rates and overall survival when compared with low-dose cytarabine alone, concluded Andrew Henry Wei, PhD, of The Alfred Hospital, University of Melbourne, and colleagues.

In this phase III trial, the authors enrolled patients with untreated AML who had been deemed ineligible for chemotherapy because of age or fitness, among other factors. The patients were given either venetoclax with low-dose cytarabine (143 patients) or a placebo plus low-dose cytarabine (68 patients) in 28-day cycles. Of the patients, 38% had secondary AML, and 20% had received a prior hypomethylating agent.

The authors found that patients treated with venetoclax had a median overall survival of 7.2 months, compared with 4.1 months for those who received low-dose cytarabine alone. An additional unplanned 6-month follow-up revealed a median overall survival of 8.4 months in the venetoclax cohort (hazard ratio = 0.70). Patients treated with venetoclax had a complete remission/complete remission with an incomplete hematologic recovery rate of 48%, compared with 13% for those treated with low-dose cytarabine and a placebo.

The most common grade 3 or more adverse events were febrile neutropenia (32% with venetoclax vs. 29% with low-dose cytarabine alone), neutropenia (47% vs. 16%, respectively), and thrombocytopenia (45% vs. 37%, respectively).

Disclosure: For full disclosure of study authors, visit ashpublications.org.



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