Dana-Farber's Meredith Regan, ScD presented an update on the SOFT/TEXT clinical trials at the 2021 San Antonio Breast Cancer Symposium.
MEREDITH ragan. I'm a biostatistician at Dana Farber Cancer Institute and I also work with the international breast cancer study group at the saN Antonio breast cancer symposium, I presented an update of results from the softer text randomized clinical trials, which studied adjuvant endocrine therapy for premenopausal women with hormone receptor positive early breast cancer. And over 5700 women were enrolled in these trials who are 43 years of age, on average at the time of enrollment. And they were enrolled in 27 countries. And we presented earlier analysis of the trials which had shown that the use of tamoxifen with ovarian suppression reduces recurrence of breast cancer and appear to improve survival versus tamoxifen alone for five years. And also that the use of the aromatase inhibitor XMS stain with ovarian suppression further reduces recurrence compared to tamoxifen. Ovarian suppression. But it was without further improvement in survival. And so now the new results that they're updated with an average follow up of about 12.5 years. These results have now shown that the ovarian suppression with either tamoxifen or XMS stain versus tamoxifen alone plus for five years provides a persistent long term reduction in the risk of distant recurrence and that the reduction is greatest with suggesting plus ovarian suppression. And we continue to see that the use of ovarian suppression reduces risk of death in the long term and in absolute terms the reductions were more clinically substantial for those patients who who were at higher clinical risk at the time of diagnosis, But it was a reduction on the order of 10% points. Um and the reduction of death at 12 years since initiating the endocrine therapy, interestingly, we now see a later emergent reduction in death with the use of the XMS stained with ovarian suppression over tamoxifen, ovarian suppression. So a final point that I'd make about the results of the trials was also the soft long term follow up also continues to support that. The use of tamoxifen alone is appropriate for some selected patients. As the there was a group of patients enrolled who their clinician had decided not to give them chemotherapy. Mostly, they had very Clinically lower risk uh features of their breast cancer. And these patients fared very well in the long term, more than 95% of them are surviving uh across all three treatment groups. So I just say as a final point, the long term follow up for these young women is quite important because of a continued risk of experience recurrence of their breast cancer even after 10 years. And I be csG plans five more years to follow up with these women