Less harsh, more effective: European study led by Dresden researchers successfully tests new therapeutic approach for particularly aggressive form of leukemia

For over a decade, a European consortium has been researching how to treat adults with a rare but extremely life-threatening subtype of myeloid leukemia more gently and effectively. The APOLLO Phase III trial, conducted under the auspices of TUD Dresden University of Technology and led by hematologist and oncologist Prof. Uwe Platzbecker, Medical Director of Dresden University Hospital, has discovered a new therapeutic approach that has become the new global standard of care. The results have now been published in the renowned Journal of Clinical Oncology.

Acute promyelocytic leukemia (APL) is a rare subtype of acute myeloid leukemia that leads to rapid death if left untreated. The APOLLO Phase III trial examined whether a treatment regimen of arsenic trioxide (ATO) plus all-trans retinoic acid (ATRA), a vitamin A derivative, supplemented with a small amount of idarubicin (a chemotherapy drug), would be more tolerable and effective for patients than the current standard therapy with ATRA and intensive chemotherapy (idarubicin-based, ATRA-CHT).

After two years, the research showed that the event-free survival (EFS) rate was significantly higher for patients treated with a combination of ATRA and ATO at 88 percent than for those who received standard therapy at 71 percent. There were also fewer relapses (1.5 percent versus 12.3 percent) and fewer side effects. Based on these findings, international guidelines for treating acute promyelocytic leukemia have already been updated.

“With lower toxicity, fewer relapses, and improved survival prospects, this study contributes to a better quality of care for APL patients,” explains Prof. Uwe Platzbecker. “The study therefore has the potential to change clinical practice. It is particularly noteworthy that patients can be cured with minimal chemotherapy.” “This work was only possible thanks to the great dedication of many partners. It is truly a European team effort, driven by the study center at Medical Clinic I,” says Prof. Martin Bornhäuser, co-author and director of Medical Clinic I at the University Hospital Dresden and the National Center for Tumor Diseases (NCT/UCC) Dresden.

"This study is an impressive example of how close integration between the clinic and research at the Faculty of Medicine contributes to patient well-being,” adds Prof. Esther Troost, Dean of the Faculty of Medicine at the TU Dresden.

Background
Publication: “Arsenic Trioxide and All-Trans Retinoic Acid Combination Therapy for the Treatment of High-Risk Acute Promyelocytic Leukemia: Results From the APOLLO Trial”: https://ascopubs.org/doi/10.1200/JCO-25-00535

Methods:
Phase III APOLLO trial, patients with newly diagnosed high-risk APL
Comparison: Standard (ATRA + chemotherapy) versus ATRA + ATO + low-dose idarubicin
Results: Significantly better 2-year EFS (88% vs. 71%), fewer relapses (1.5% vs. 12.3%), fewer severe side effects (32% vs. 68%)

Funding:
The trial was funded by the Federal Ministry of Research, Technology, and Space (BMFTR), formerly the Federal Ministry of Education and Research (BMBF), with two million euros. TU Dresden was responsible for initiating, organizing, financing, and monitoring the study. The SAL – Studienallianz Leukämie (Study Alliance Leukemia), which is also based in Dresden (MK1), acted as an honorary sponsor.

Contact:
Anne-Stephanie Vetter
Staff Unit Public Relations of the Carl Gustav Carus Faculty of Medicine
at TUD Dresden University of Technology
National Center for Tumor Diseases (NCT/UCC) Dresden
+49 (0) 351 458 17903

www.tu-dresden.de/med

Academic contact:
Prof. Dr. med. Uwe Platzbecker
Medical Director at the University Hospital Carl Gustav Carus Dresden
+49 (0) 351 458 4020