DR GARCIA-MANERO: First of all, the compound lenalidomide is not really approved for this indication. So to be honest, I sometimes will consider this type of approach. Sometimes some insurances will approve this, and they will deliver drugs. Sometimes it doesn’t work out. And I never understand what goes in the mind of these people.

So, for instance, I’m going give you an extreme phenotype of this. So these are rare diseases. They actually consider mixed myelodysplastic/myeloproliferative neoplasm that is called refractory anemia with ringed sideroblasts and thrombocytosis RARS-T. This disease, rare, half of the patients have JAK2 mutations.

They, I can tell you from experience, very nicely respond. And I started using lenalidomide when I could in this context, based on the regional data from the lenalidomide trial. So when you look at the regional studies that led to the approval of this compound, there were 2 key characteristics that were associated with response: (1) 5q minus. Everybody knows this. But there is something that, to me, is even more important, actually, that is patients had a platelet count to 100,000, they did significantly better.

So that data, people don’t talk about this. But that’s probably an important predictor of response to lenalidomide than having a 5q. Indeed, actually, on this study called MDS-005, that is a Phase III randomized study asking this question. One of the questions that I ask, or was part of that study is, can we look at the effect of platelet numbers on the response to lenalidomide?

So I actually agree with both of you. If I have a patient with good platelet count, with anemia as the sole manifestation, if I could, actually, I will try to give them a trial of lenalidomide the same way you did. It may or may not happen. And again, this is an intervention that is really not indicated right now by the FDA.

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