15-year outcomes for women with premenopausal hormone receptor-positive early breast cancer (BC) in the SOFT and TEXT trials assessing benefits from adjuvant exemestane (E) + ovarian function suppression (OFS) or tamoxifen (T)+OFS.

作者：Prudence A. Francis, Gini F. Fleming, Olivia Pagani, Barbara Walley, Sherene Loi, Marco Colleoni, Meredith M. Regan, on behalf of SOFT and TEXT Investigators, IBCSG, BIG and North American BC Groups · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.505 · 被引用次数：17 · 研究领域：Estrogen and related hormone effects、Cancer, Lipids, and Metabolism

505 Background: Long-term follow-up of the SOFT and TEXT randomized trials has shown persistent reduction of recurrence from inclusion of OFS in adjuvant endocrine therapy, and clinically meaningful improvement in overall survival (OS) among patients at higher baseline risk of recurrence. We report a final update after a median follow-up of 15y in SOFT and 16.6y in TEXT. Methods: SOFT and TEXT enrolled premenopausal women with HR+ early BC from November 2003 to April 2011 (2660 in TEXT, 3047 in SOFT intention-to-treat populations). TEXT randomized women within 12 weeks of surgery to 5y E+OFS vs T+OFS; chemotherapy (CT) was optional and concurrent with OFS. SOFT randomized women to 5y E+OFS vs T+OFS vs T alone, within 12 weeks of surgery if no CT planned, or within 8 months of completing (neo)adjuvant CT. Both trials were stratified by CT use. The primary endpoint was disease free survival (DFS) which included invasive local, regional, distant and contralateral breast events, second non-breast malignancies and deaths. Secondary endpoints included invasive breast cancer-free interval (BCFI), distant recurrence free interval (DRFI) and OS. 20y data collection was completed in Q4’2024: 80% of surviving patients had final follow-up during or subsequent to 2020, for 70% it was during 2023-2024. 15y Kaplan-Meier estimates and hazard ratios (HR) with 95% CIs are reported. Results: There were 815 DFS events and 388 deaths reported in SOFT; and 669 DFS events and 325 deaths in TEXT. In...