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Patients with acute myeloid leukemia (AML) who are considered “not fit” for standard cytotoxic induction chemotherapy — cytarabine plus an anthracycline (“7+3”) — are often treated with a hypomethylating agent plus venetoclax. To test whether this less-intensive regimen might also benefit “fit” patients, researchers conducted an industry-funded, phase 2 trial (PARADIGM). They randomized 172 patients with newly diagnosed AML who were induction chemotherapy–eligible to receive azacitidine–venetoclax or 7+3 induction chemotherapy. Patients with AML that had core binding factor fusions, FLT3 mutations, or NPM1 mutations (if age <60 years) were excluded.
At a median follow-up of 22 months, median event-free survival was signific…