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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 received 45 mg/m² ATRA twice daily and 12 mg/m² idarubicin once daily on days 1, 3, 5, and 7, followed by three cycles of chemotherapy-based consolidation and 2 years of maintenance therapy.
• Event-free survival at 2 years served as the primary study endpoint.

TAKEAWAY:

• After a median follow-up of 37 months, 2-year event-free survival was 88% in the ATRA-ATO arm vs 71% in the ATRA-CHT arm (hazard ratio [HR], 0.4; 95% CI, 0.17-0.92; P = .02).
• Molecular relapse occurred in 1.5% of ATRA-ATO patients vs 12.3% of ATRA-CHT patients at a median of 7.8 and 12.1 months from complete remission achievement (P = .014).
• Serious treatment-emergent adverse events were reported in 32% of ATRA-ATO patients compared to 68% of ATRA-CHT patients (P < .01).

IN PRACTICE:

“The results of the APOLLO trial show that a near-chemo-free ATRA-ATO treatment significantly improves outcomes of patients with high-risk APL when compared with the standard ATRA-CHT regimen,” the authors of the study wrote.

SOURCE:

The study was led by Uwe Platzbecker, MD, University Hospital Carl Gustav Carus and TU Dresden — Faculty of Medicine in Dresden, Germany. It was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study was discontinued prematurely due to slow accrual during the COVID-19 pandemic, which may have affected the statistical power and generalizability of the results.

DISCLOSURES:

The study was supported by the German Federal Ministry of Education and Research. Additional disclosures are reported in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.