DR GONZALEZ-ANGULO: Mucositis is a problem and pneumonitis is a problem for both. When you combine everolimus with chemotherapy you see a little bit more of the mucositis and actually a little bit more of the pneumonitis than what you see, for example, in the numbers with BOLERO-2, which was with endocrine therapy alone. Fatigue is also an important toxicity that a lot of these targeted therapies have, and we tend to forget, and it affects patients. Fatigue is important and it diminishes the quality of life.
DR LOVE: What about the pneumonitis? How often does that occur? And how much of a problem is it?
DR GONZALEZ-ANGULO: So actually, the pneumonitis is not a big problem when you give it with endocrine therapy. Anecdotally, or in addition, we did a Phase II randomized trial in combination with paclitaxel and giving everolimus at 30 milligrams weekly, and we saw about a 30 percent pneumonitis in those patients. However, if we look at the BOLERO data, there were some shortness of breath, but well-documented pneumonitis was actually a lot lower than that. So I think that it’s more of the combination with chemotherapy. And in our particular case with paclitaxel, which also has been documented, of course, in pneumonitis.
DR LOVE: And is the usual management just to stop the drug? Do you give corticosteroids?
DR GONZALEZ-ANGULO: In our clinical trial with chemotherapy, only one patient required corticosteroids.