Abstract OT3-02-03: Long-term follow-up of TEXT and SOFT trials of adjuvant endocrine therapies for premenopausal women with HR+ early breast cancer

BackgroundFirst results of the TEXT and SOFT international phase III trials were practice-changing, indicating that: i) 5y adjuvant exemestane+ovarian function suppression (E+OFS) reduces recurrence risk relative to tamoxifen(T)+OFS or to T alone, ii) T+OFS reduces recurrence risk vs T in women who are at sufficient risk to warrant chemotherapy (CT) and remain premenopausal afterwards, and iii) T alone remains appropriate for some premenopausal women. However, median follow-up (FU) was only 5.5y and 90% continued in FU.Long-term FUUpdated results are planned for FU through Dec16, with ∼8y median FU. Pts finished 5y treatment by Apr16. Yearly visits continue; data collection includes weight, performance status, menstrual status, pregnancy attempts, GYN procedures, late AEs (cardiovascular, bone fracture), extended adjuvant therapy, invasive recurrence at first and subsequent sites, second non-BC malignancy, in situ cancers, OS.FU through 2020 is planned, for min and median FU of 10 and 12y, roughly doubling the numbers of endpoints events since the first report. This will be critical to determine whether short-term treatment benefits persist for late recurrence, improve power to detect treatment effects on distant recurrence and OS endpoints with lower event rates occurring later in FU, and define associated late toxicities and side effects of early menopause. A consortium to fund long-term FU is being pursued.Citation Format: Francis PA, Fleming GF, Regan MM, Pagani O, Wall...

Source: Cancer Research - February 13, 2017 Category: Cancer & Oncology Authors: PA Francis, GF Fleming, MM Regan, O Pagani, BA Walley, KN Price, AS Coates, A Goldhirsch, R Gelber Tags: Ongoing Clinical Trials Source Type: research