DR RUGO: So we had started — myself and Joyce O’Shaughnessy, actually — using a steroid-compounded formula with hydrocortisone and a statin some time ago and found, anecdotally, that we just weren’t seeing stomatitis anymore. So both of us actually have run trials looking at mouthwashes to try and see if we could reduce the rate compared to the historical control of BOLERO-2. Our trial used an over-the-counter, alcohol-free dexamethasone solution that’s used for pediatric dosing.

And patients swished it in their mouth and spit it out 4 times a day. And we used the 8-week incidence of Grade 2 or greater stomatitis as our endpoint, because in a previous publication, we’ve shown that at least 80% of stomatitis, Grade 2 or greater, occurs by 8 weeks.

The study that Joyce O’Shaughnessy has done has actually looked at 2 different steroid formulations to try and see if there’s a better one or not. And we don’t know those results yet.

We reported our data on more than 90 patients using this mouthwash with an 8-week endpoint that showed no Grade 3 stomatitis and a marked reduction in Grade 2 stomatitis as well as Grade 1, actually. So we went from over 17% to about 2.4% of Grade 2 stomatitis. And Grade 1 also was reduced. Patients tolerated it very well. Only 2 patients had any fungus in their mouth. And we used nystatin as a chaser in some patients, and that was able to control the fungus very well. Nobody had any serious fungal infections.

One of the patients interestingly developed Grade 3 stomatitis very late. So after our 8-week endpoint. And that patient had had Grade 2 stomatitis and was dose reduced but kept having Grade 2 stomatitis, and then it eventually turned, just barely, to Grade 3. And she really did meet the criteria for Grade 3 stomatitis. So I think that there will clearly, no matter what you do to prevent a toxicity, there will clearly be patients who just are uniquely sensitive.

And it seems to be also a window on to how much drug the patient’s actually seeing. Because we did a meta-analysis, and it seemed like patients did at least as well, if not a little better, who got stomatitis. So they must be seeing, at least in some cases, more drug. But I believe that this should now be our standard of care for patients receiving the mTOR inhibitor everolimus, because we can tremendously improve the rate of stomatitis and, therefore, quality of life, although we didn’t specifically study quality of life.

DR LOVE: How often do they take it and for how long?

DR RUGO: So we used the mouthwash, 10 ccs, to swish, hold for 2 minutes and spit 4 times a day. And then at 8 weeks, you could either continue or stop. And almost all patients continued. But what I found in one of my patients who had a nice long response to everolimus is that — she’s a physician. And she would reduce the frequency. She’d just get busy and stop using it. And then she’d get an aphthous ulcer. She’d start it up again. So most patients, at least in my experience, found that it continued to be useful over time if they were going to get mouth sores.

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