DR HURVITZ: The way it was designed was it allowed patients who had either received 5 years of tamoxifen followed by 5 years of an AI to go on and be randomized to receive another 5 years of an AI. And about 80% of the patients in that study fell into that category, where they had already received 10 years total of endocrine therapy, or patients who’d not had tamoxifen but just had 5 years of an AI, randomized to receive 5 years of an AI or not.

And what the results showed was that by doing the additional 5 years of the aromatase inhibitor after having 5 years, so 10 years of an AI, did actually improve outcomes. So there was about a 3% reduction in invasive disease-free survival events by the use of extended aromatase inhibitor therapy. So 10% of patients in the placebo arm had disease-free survival events and about 7% who had received the extended therapy. But this did not come without a cost.

Patients who did do extended aromatase inhibitor therapy had higher rates of osteoporosis. They also had higher rates of fracture, so 9% versus 14% of patients having fracture. So I think it brings up an important point that we need to look at the patient sitting in front of us. What is their bone mineral density telling us? How high risk are they for fracture? How high risk are they for recurrence? And kind of do that scale analysis of risks versus benefits in deciding whether or not to apply these data to the patient sitting before you.

In terms of quality of life, it was surprisingly quite similar between the 2 treatment arms. And I find that very surprising, because most of my patients have a lot of difficulty with aromatase inhibitors in terms of joint pain and stiffness and cognitive fog, et cetera. So it could be that the patients were very selected because they’d already completed 5 years of an AI and already tolerated it, so we’re looking at a very select patient population.

DR LOVE: The one thing about this is, I mean, the hazard rate in terms of recurrence was actually pretty significant. It was a hazard rate of 0.66 with 34% reduction in relapse — no survival benefit, which maybe you wouldn’t expect, but also a real huge drop in contralateral disease in terms of prevention. It was pretty significant. What’s this mean to you in terms of your own practice?

DR HURVITZ: What I kind of jumped to was the forest plot to see if there are subgroups that particularly benefit. And it did seem to indicate that lymph node-positive was deriving more benefit, as you would expect. So just yesterday in clinic, I discussed this data with 2 patients, and one of whom was Stage I, well differentiated and has severe osteopenia, not yet osteoporosis. She came off therapy 6 months ago. And I said, “I don’t feel like we should put you back on therapy, because we may be tipping the balance against you in terms of osteoporosis and fracture risk.”

However, a different patient with lymph node-positive disease I’d be inclined to go forward, especially if she had many nodes positive or higher-grade disease, hadn’t had chemo, et cetera. I think I would be more in favor of applying these data.

Genomic assays and (neo)adjuvant treatment decision-making

Early-stage breast cancer in the adjuvant and neoadjuvant settings

Management of metastatic breast cancer (mBC)

CDK4/6 inhibitors for the treatment of breast cancer

Checkpoint inhibitors and other novel immunotherapeutic approaches to breast cancer

Triple-negative and BRCA mutation-positive breast cancers