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DR GRADISHAR: I think there might be a temptation to combine this mTOR inhibitor with endocrine therapy, sort of “out of the gates.” And we simply don’t have the data yet with that. So it’s really, this notion that’s a more resistant population —

DR LOVE: “Out of the gate” being in somebody who hasn’t had hormone therapy.

DR GRADISHAR: Right. Metastatic disease right from the beginning. So we don’t have that data. The other thing we don’t have, and we’ll get to this later, I know, is the way this trial was designed, it lends itself to the question of how would this combination compare with higher-dose fulvestrant. How would this compare to this revisiting of the idea of combining fulvestrant with an AI? And there are problems with that trial because of the doses of fulvestrant. So again, there are nuances to all these trials. And I think we have to think about those when we make treatment decisions.

DR LOVE: Chuck, how are you sorting through these issues that Bill outlined, in terms of if everolimus were available, fulvestrant/AI, high-dose fulvestrant?

DR VOGEL: The combination fulvestrant/AI was interesting, but it comes within the context of Bergh’s data from two years before using an identical dose of fulvestrant that was as negative a trial as you can see. So I would be very interested to wait to see the final publication to try to sort out why these trials are so diametrically opposed in terms of end result. And I agree that if you’re faced with a second-line situation, let’s say, that everolimus is available. So now you have the combination of exemestane/everolimus and you have fulvestrant. And you have the relative toxicity profiles with fulvestrant having virtually none, except for local reactions, and what we’re hearing about everolimus is that this is not a hormonal “walk in the park.” And so the clinicians are going to be faced with that dilemma if they are attuned to giving a hormone to an individual patient, at that particular juncture, whether to go with everolimus/exemestane, whether to go with fulvestrant.

DR LOVE: Ana Maria?

DR GONZALEZ-ANGULO: So I’ve been using everolimus for a long time because I’ve done clinical trials with it. For the patients that we put in BOLERO and the patients that I’ve treated with — sometimes with daily doses — we’ve had to dose reduce, mainly because of mucositis, to 5 milligrams daily. But if you look at the data in BOLERO, the number of patients that actually had to reduce the dose was not that high.