The updated results of the combined SOFT-TEXT analysis after 13 years of follow-up presented at the San Antonio Breast Cancer Symposium 2021 were published in the Journal of Clinical Oncology JCO.
The SOFT and TEXT clinical trials produced practice-changing results that persist over time. The combined SOFT and TEXT analysis was performed to evaluate the role of exemestane (an aromatase inhibitor) and tamoxifen and ovarian function suppression (OFS) after surgery in premenopausal women with hormone receptor (HR)-positive breast cancer. Given that HR-positive breast cancer often recurs many years after initial diagnosis and treatment (“distant recurrence”), and that postmenopausal women with this type of breast cancer who receive aromatase inhibitors instead of tamoxifen have been shown to live longer, , reporting long-term effects is crucial.
After a median follow-up of 13 years, the updated analysis reported by Dr. Olivia Pagani and co-authors confirmed that post-surgical (adjuvant) treatment with exemestane and OFS was better than tamoxifen and OFS in reducing relapses long-term. Overall survival was similar for both treatments.
The primary results of the studies were first published in the New England Journal of Medicine in 2014 and were supported by a 5-year analysis presented at the 2017 San Antonio Breast Cancer Symposium (SABCS). In 2021, these practice changing results were bolstered by the 12,5-year follow-up presented during SABCS. They showed a persistent long-term reduction of risk of distant recurrence when OFS is added to tamoxifen or exemestane, with the greatest reduction found in combination with exemestane. They also demonstrated a reduction in death with both combinations, although the reduction was higher with exemestane.
These results that persist over time provide important adjuvant treatment options for young women with HR-positive early breast cancer who may have a higher risk of cancer recurrence after surgery. And they give hope to young women around the globe.
The SOFT trial is sponsored by ETOP IBCSG Partners Foundation in collaboration with Cancer and Leukemia Group B, National Cancer Institute (NCI), NSABP Foundation Inc, NCIC Clinical Trials Group, North Central Cancer Treatment Group, Southwest Oncology Group and Breast International Group.
The TEXT trial is sponsored by ETOP IBCSG Partners Foundation in collaboration with National Cancer Institute (NCI) and Breast International Group.