DR FLOWERS: This is something that, at least out in the community, has been used for patients with CLL even though it has not been subjected to the same kind of Phase III data that you’ll hear about here. In the first trial, that was a trial that looked at identifying patients with CLL and randomized patients across 5 different countries to look at the effect of CLL maintenance with lenalidomide.

When you look at the patient population that was examined, this was a typical patient population with CLL, with a median age of 64 years, so what you might expect for most older patients with CLL. 17p mutations occurred in about 11% of the population, so again, with perhaps a little bit more high-risk patients than what you might expect for the general population with CLL but about on par with what you should see for this population.

The toxicities associated with lenalidomide seen were pretty typical for what’s been seen in other settings in CLL and in other diseases, with the majority of the toxicities really being cytopenias and gastrointestinal toxicities. There was a little bit of toxicity of the nervous system disorder, which is a little bit unclear as to what that really constitutes, whether that was neuropathy. That was seen in 30% of patients versus 14% of the patients with placebo.

So I think that’s something that needs to be teased out. And the dermatologic toxicity seen in this setting, hopefully the most of that was really just the typical rash you see with CLL, but occurring in 60% of patients, it’s something that there are really a little bit more details needed to know whether this maintenance therapy was behaving in a different fashion than what you might see for lenalidomide in general.

But when you look at the median progression-free survival, it was not reached in the group that received lenalidomide maintenance, versus about 15 months for the group in observation. So this is clearly a benefit in terms of progression-free survival seen in this particular trial.

DR LOVE: How about the other study, the so-called CONTINUUM trial?

DR FLOWERS: So the second Phase III trial, the CONTINUUM trial, is one that was presented by another group of investigators that performed a second randomization trial looking at lenalidomide in the second-line therapy who were randomized either to receive lenalidomide maintenance at 2.5 mg daily on a continuous basis versus placebo.

I think the thing to think about for those in the community who typically treat myeloma, this is a much, much lower dose than what we typically would give lenalidomide with. So you can’t walk up to a CLL patient and give them the standard myeloma dose, particularly starting at a dose of 25 mg. You have to start low and, often cases in CLL, you need to stay low. And patients can even see responses with doses that low. The lenalidomide was then escalated up to 5 mg daily from cycle 2 further and then the 10 mg daily after cycle 7 for those patients who were tolerating those lower doses of lenalidomide.

This also showed benefits in terms of progression-free survival and, I think, is an approach that we should think about for patients with CLL.

DR LOVE: So bottom line when you look at these 2 papers, have you used lenalidomide maintenance in CLL in any situation prior to this? And are you thinking about it now?

DR FLOWERS: I think the terminology becomes a little bit fuzzy here in terms of what lenalidomide maintenance means in CLL, particularly in the relapsed setting. Essentially, every single patient that you would think about starting lenalidomide in the relapsed setting for CLL is receiving maintenance, because it’s a therapy that you start, and you plan to continue until disease progression. So that’s not exactly the way these 2 trials were designed, where therapy was given and then lenalidomide was given after the therapy. But I think it’s an approach, at least in the former setting that I described, that I have used for patients with lenalidomide.

And it is one that I would consider for patients who receive responses, that you might think of this as a way of keeping them from going on to other therapies, if you’re able to maintain them on len with very limited toxicities.

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