Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
Francis PA, Pagani O, Fleming GF, et al; SOFT and TEXT Investigators and the International Breast Cancer Study Group N Engl J Med. 2018;379:122-137
Study Summary
This study provides an update on results from the SOFT and TEXT studies of hormonal therapies for premenopausal women. Both studies accrued patients between 2003 and 2011.
The SOFT trial was designed to determine the value of adding ovarian suppression (OS) to tamoxifen and to study the role of the aromatase inhibitor exemestane plus OS. Women were randomly assigned to receive 5 years of tamoxifen, tamoxifen plus OS, or exemestane plus OS in SOFT.
The TEXT trial was designed to compare tamoxifen with exemestane for women treated with OS from the time of their breast cancer diagnosis, in addition to other disease-modifying therapies such as chemotherapy. Women were randomly assigned to receive tamoxifen plus OS or exemestane plus OS in TEXT.
Prior publications reported results of the SOFT study with a median follow-up of 5.6 years, and these did not show a significantly higher disease-free survival (DFS) with the addition of OS to tamoxifen compared with tamoxifen alone, although the addition of OS did demonstrate an improvement in outcomes for women also treated with chemotherapy. Results of the combined SOFT and TEXT analyses at that time showed that exemestane plus OS had significantly higher rates of DFS than tamoxifen plus OS.
