FALCON Trial Data in HR+ Metastatic Breast Cancer

Transcript:Adam M. Brufsky, MD, PhD: Let’s change topics to advanced breast cancer, which we’ve not talked about yet and this is an advanced breast cancer video. Really, we’ve talked about hormone receptor-positive breast cancer in the early stage setting. It’s really now, where are we in 2017 with the treatment of hormone receptor-positive metastatic disease? And I’ll start with Aditya. I think that there are 2 big questions people ask. The first one is, given the FALCON and FIRST trials, the data that have just come out—and we can talk about what those trials were—what do we do? Do we use fulvestrant before an aromatase inhibitor now? What do we do?

Aditya Bardia, MD, MPH: Yes. Life was simple before ESMO 2016. For someone with metastatic ER-positive breast cancer, the recommended first-line therapy was letrozole/palbociclib based on the PALOMA trial. But now with the FALCON data that were presented at ESMO, which essentially was a randomized clinical trial looking at patients with advanced ER-positive breast cancer, they were randomized to receive fulvestrant versus an aromatase inhibitor (AI) as their first-line therapy. And it was in a study population where patients had not received any prior AI. So, these were patients who had de novo metastatic disease and they were randomized to receive fulvestrant versus an aromatase inhibitor. The study showed that the fulvestrant arm had an improvement in disease-free survival or progression-free survival compared to the aromatase inhibitor group. And, if you look at subset analysis, the bone metastases group had a marked improvement with the use of fulvestrant as opposed to the aromatase inhibitor. So, I think, in general, we would still use letrozole plus palbociclib as the first-line therapy for ER-positive metastatic breast cancer, particularly in patients who have already received prior endocrine therapy because FALCON did not study that population. But if you have someone who’s in their 70s and has minimal bone metastases—say 2 or 3 lesions that are seen on scans—you do have data from FALCON that you could consider using fulvestrant first and then, down the road, consider a CDK4/6 inhibitor.

Transcript Edited for Clarity