TOPLINE:

In a phase 3 trial of 133 patients with high-risk acute promyelocytic leukemia (APL), all-trans retinoic acid and arsenic trioxide (ATRA-ATO) therapy demonstrated superior 2-year event-free survival of 88% vs 71% with standard treatment. ATRA-ATO was associated with significantly lower rates of molecular relapse (1.5% vs 12.3%) and serious adverse events (32% vs 68%) than ATRA plus anthracycline-based chemotherapy (ATRA-CHT).

METHODOLOGY:

A phase III randomized trial enrolled 133 eligible patients with newly diagnosed high-risk APL between June 2016 and August 2022.

Participants in the ATRA-ATO arm received 0.15 mg/kg ATO once daily and 45 mg/m² ATRA twice daily until complete remission, with two doses of 12 mg/m² idarubicin on days 1 and 3.

Patients in the ATRA-CHT arm recei

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