SOFT Trial Landing at SABCS

SOFT and Chili Winds Over San Antonio

Hi, everyone, it's Dr Kathy Miller from Indiana University. It is a blustery fall day here in Central Indiana, and for many of us, that has our thoughts turning towards fireplaces and turkeys and holiday celebrations. But if you're part of the breast cancer world, at this time of year your thoughts turn to chilies, the River Walk, and the San Antonio Breast Cancer Symposium (SABCS).

I've been getting ready and scoping out the program to see what we might look forward to this year. Perhaps the most anticipated results will answer the question: Does adding ovarian suppression to hormone therapy in premenopausal patients with ER-positive disease improve their outcome? You'll recall the history: Hormone therapy with ovarian suppression was the very first targeted therapy, but as we moved on, as we developed tamoxifen, as we developed chemotherapy and better local therapy techniques, we wondered whether hormone therapy with ovarian suppression still played a role. We will finally see the results of the ovarian suppression vs no ovarian suppression arm of the SOFT trial.^[1]

We've also learned a lot about resistance to hormone therapy. We've learned from our laboratory colleagues that the PI3 kinase pathway is frequently mutated or activated in ER-positive tumors. We will now see the results of the first randomized phase 2 study looking at hormone therapy alone vs hormone therapy with a specific PI3 kinase inhibitor,^[2] to see whether blocking that known resistance mechanism improves outcome.

Practice-Changing Results in TNBC, DCIS?

For our patients with triple-negative and BRCA-mutated disease, we have wondered whether DNA-damaging therapies might be a better choice for them. We'll see the results of the randomized TNT trial, looking at a straight-up randomization to a platinum or a taxane in those patients with triple-negative disease or known BRCA-mutated disease^[3]—another randomized trial that may change our practice.

Finally, we are still making improvements in local therapy. We'll see one of the first randomized trials comparing partial breast radiation to whole breast radiation.^[4] We've seen some preliminary data from earlier studies that looked at that comparison simply from the standpoint of toxicity and acute side effects. This will be the first study to give us 5-year data, which should provide some good comparisons of efficacy in local recurrence rates.

We'll also get the first study looking at the DCIS score, a score initially developed in the 5194 trial,^[5] which looked at patients with very low-risk ductal carcinoma in situ (DCIS) treated with lumpectomy alone. The study suggested that the molecular biology of their DCIS, at least as indicated by this score, might allow us to identify patients at such low risk for local recurrence that they might defer radiation. But that was a single-arm trial. Many wondered whether that assay might be able to predict patients who could forego radiation, or whether radiation still might play a role even in those patients with low risk scores. That score has now been applied to a randomized trial in DCIS,^[6] and that data will be presented at SABCS. That trial is important not only because of the potentially prognostic value of the DCIS score, but also because it has wider eligibility criteria than the very restrictive 5194 trial. We'll now see the ability of that score to inform us about the prognosis of patients with a much wider spectrum of DCIS. Hopefully these results will make this score much more applicable to our everyday practices.

I'm sure there will be more. There are always some surprises. If you're going to be at San Antonio, please stop by, say hello, and introduce yourself. I'd love a chance to get your thoughts and talk to you more.

Please stay tuned. I've arranged some interviews with several of my favorite guests to talk about these results in depth and what they might mean for our practice.

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