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SABCS 2021 | The role of SOFT and TEXT in treatment decision making for patients with breast cancer
Meredith M. Regan, ScD, Harvard Medical School, Boston, MA, discusses treatment decision-making and explores the magnitude of benefit of various treatment strategies for patients with breast cancer. Dr. Regan talks about the role of SOFT (NCT00066690) and TEXT (NCT00066703) in investigating treatment decision-making based on traditionally pathological features of breast cancer and evaluating trade-offs with toxicity and potential long-term benefits. Other features were explored in these trials such as pharmacogenetics including CYP2D6 in the metabolism of tamoxifen, however, the results suggested this to be an inadequate marker for analyzing treatment strategies. This interview took place at the San Antonio Breast Cancer Symposium 2021 in San Antonio.
Transcript (edited for clarity)
With SOFT and TEXT before those in trials of post-menopausal women who were being studied with endocrine therapy, one of the things that we’ve been looking at is their baseline clinical pathologic risk. So the usual features that clinicians use every day in thinking about how to select treatment, and these still play an incredibly important role in decision making. And so we’ve been pulling together the data from the trials, SOFT and TEXT, and thinking about, we know that the therapies work, ovarian suppression, exemestane with ovarian suppression...
With SOFT and TEXT before those in trials of post-menopausal women who were being studied with endocrine therapy, one of the things that we’ve been looking at is their baseline clinical pathologic risk. So the usual features that clinicians use every day in thinking about how to select treatment, and these still play an incredibly important role in decision making. And so we’ve been pulling together the data from the trials, SOFT and TEXT, and thinking about, we know that the therapies work, ovarian suppression, exemestane with ovarian suppression. We know that they work on an average for the entire population, but we want to think about what is the magnitude of benefit for more individualized patients, depending upon what that baseline risk is. So those who have more favorable characteristics of their disease and where a physician for example, might think that the patient doesn’t need chemotherapy, that tamoxifen alone is enough. We are trying to show and provide those results for tamoxifen, tamoxifen ovarian suppression, exemestane ovarian suppression, what the magnitude of benefit may be.
On the other hand, those who are more intermediate at a higher risk based on the features of their disease, what that magnitude of benefit would be so that physicians and patients can make decisions about the trade offs of toxicity and side effects that come with these treatments and the potential long term benefits. So that’s one feature that I think is still critically important to treatment decision making are these traditional clinical pathologic features.
We have a nice tissue bank with the SOFT and TEXT trials, and we’ve been looking at various other features, some of the patient, things like pharmacogenetics. There’s been an ongoing debate about CYP2D6, which is about metabolism of tamoxifen. And so we have looked at that and SOFT and TEXT, and that was some results reported last year by Dr. Matthew Getz, led that investigation in the SOFT trial. And so we’ve been working on that. Unfortunately, the original hypothesis hasn’t been strongly supported by our data in SOFT and also in TEXT, that marker is we’re is going to be good for treatment decision making.
There’s some other ongoing work with the tissue and looking at the tumor tissue and to do some sequencing on that, to look at different alterations. And this is led by professor Sharine Lloyd with our group has some data that she’s just been bringing forward publicly to talk about potential for whether that might help us think about selection or think about further therapies for these women. So there are some other things that are going on.
We have some other collaborations with, for example, Biotheranostics. That company may have changed. So we also have a nice collaboration ongoing to look at the breast cancer index, potentially, which has some nice existing data about its potential for selection of endocrine therapy. And so that’s an ongoing investigation that we hope to have results next year. So many possibilities. And fortunately, the participants and their institutions have supported putting together the tissue banks in these trials and the forethought of the colleagues who started the trials to put together a tissue bank so that we can really further investigate these features in these young women.
The SOFT and TEXT trials are coordinated by the International Breast Cancer Study Group (IBCSG), in collaboration with the Breast International Group (BIG), BIG cooperative groups, and US National Cancer Institute National Clinical Trials Network cooperative groups. Pfizer and Ipsen provided drug supply. IBCSG has received financial support for SOFT and TEXT conduct and long-term follow-up from Pfizer, Ipsen, DebioPharm, TerSera, AstraZeneca. Dr. Regan receives grant support from the Breast Cancer Research Foundation for SOFT and TEXT, and provides consulting or advisory role to Ipsen, DebioPharm, Tolmar.