ATRA-ATO regimen with idarubicin could become the new standard of care in high-risk acute promyelocytic leukaemia

Dr Uwe Platzbecker - University Hospital Leipzig, Leipzig, Germany

The APOLLO trial was a large multinational randomised phase III trial investigating a novel combination, namely arsenic trioxide, ATRA plus two shots of idarubicin in patients with high risk APL. This novel regiment was compared to the standard of care at the moment which is the so-called AIDA, it’s an ATRA plus chemotherapy based regimen.

What was the study design?

The study design was an open label, randomised phase III trial with the primary endpoint of two-year event free survival.

What were the results?

The study met its primary endpoint, so the event free survival was significantly improved with the novel regimen compared to the standard ATRA plus chemotherapy arm.

What is the significance of these results?

Although the study results were still preliminary in the way that the study is still ongoing and data are monitored, we believe that this improvement of event free survival by the novel arsenic ATRA plus two shots of idarubicin arm is practice changing and should become the new treatment paradigm for high-risk patients with acute promyelocytic leukaemia.

What is next for this study?

We are still collecting data, especially on safety issues and some comparisons between the two arms so there will be a longer follow-up. But we will update the trial results with an abstract to the ASH meeting and then try to send the study results for publication.

Is there anything else you would like to add?

I’m very grateful for this European collaboration, 143 sites in six European countries contributed significantly. It was a huge effort and I’m very grateful that this study actually became positive and ended up with these encouraging results.