DR MAMOUNAS: So essentially the study was negative. There was no significant benefit. The trial was negative for its primary endpoint. If you then break it down to women over the age of 50 versus under 50, there was more benefit in the older woman than in the younger woman. And that sort of trend has been seen in some other studies, particularly in the AZURE trial, which was also a negative study.
It appears there’s some benefit from oral bisphosphonates at reducing bone and, perhaps, even nonbone metastases. It appears that maybe that benefit is mostly in women in a low-estrogen state, either because they’re postmenopausal for long periods of time or they were rendered abruptly postmenopausal by an LHRH agonist or maybe like, say, an oophorectomy. But certainly premenopausal women don’t seem to benefit a lot.
So clearly it’s not something we’re going to be doing as a standard of care. Obviously, a lot of women on AI will get the bisphosphonate for improving the bone density, and that may have a softer effect in disease-free survival. But again, overall, I think somewhat disappointing data.