Highlights

In most studies, overall survival represents the pivotal endpoint, and my feeling is that this is correct. However, I think we could consider at this moment other endpoints. First of all event-free survival, or relapse-free survival, because there is a close correlation between relapse-free [survival] and overall survival. Also, we [should] consider the economic point of view, the reduction of relapse results obviously in less treatment, less hospitalization, less transplants, and so on. The default CR, MRD negativity – not yet, maybe in the near future, but currently I don’t think this happens in AML, that MRD should be considered as an endpoint, maybe in a well-conducted clinical trial with standardization and centralization.

The vast majority of young relapsed adults receive intensive chemo, apart from the population with FLT3 mutation, all of these are currently given gilteritinib. Obviously, we perform a new analysis at relapse, because you may find an FLT3 mutation in a small proportion of patients who are negative at diagnosis. And if we find an FLT3 mutation, either ITD or TKD, we consider gilteritinib. All others will be given a high dose Ara-C-based combination, in most cases FLAG-Ida or MEC.