Kefah Mokbel, Chair of Breast Cancer Surgery at London Breast Institute and Honorary Professor of Medicine at Cardiff University School of Medicine, shared a post on LinkedIn:
“15-Year Final Outcomes: SOFT and TEXT Trials – What They Mean for Clinical Practice.
The landmark SOFT and TEXT trials have now reported their final 15-year outcomes in premenopausal HR+/HER2− early breast cancer, published today in Annals of Oncology. These data consolidate and extend what we already knew – but the nuances matter enormously for how we counsel patients.
Key findings at 15 years
In SOFT, escalating endocrine therapy continued to reduce recurrence across all three arms:
- E+OFS: 78.6% breast cancer-free interval
- T+OFS: 75.7%
- Tamoxifen alone: 72.1%
In the combined SOFT/TEXT HER2-negative cohort (n=4,035), E+OFS reduced distant recurrence versus T+OFS (HR 0.75), though the survival benefit was more modest (HR 0.89) and reached meaningful magnitude only in high-risk subgroups.
The most striking signal: women under 35
In HER2-negative women under 35 years of age (n=241), 15-year overall survival was:
- E+OFS: 82.5%
- T+OFS: 77.9%
- Tamoxifen alone: 68.1%
A 14.4 percentage-point OS difference between E+OFS and tamoxifen alone in this group is clinically significant and should anchor our conversations with very young patients about OFS.
The equally important message: for lower-risk disease, tamoxifen alone performs well
In the no-chemotherapy cohort – largely lower-risk disease – DRFI and overall survival remained high regardless of endocrine therapy assignment. OFS reduced breast cancer events, but did not translate into meaningful survival gains. Reflexively escalating all premenopausal patients to OFS-based therapy is not supported by these data.
Practical implications.
These 15-year data reinforce a risk-stratified approach:
- OFS + exemestane should be the standard for high-risk premenopausal HR+/HER2− disease, particularly in women under 35, high-grade tumours, and those who have received chemotherapy.
- Tamoxifen alone remains a reasonable option for lower-risk premenopausal disease where the toxicity and quality-of-life burden of OFS may not be justified.
- The survival curves continue to separate beyond 10 years, reminding us that late recurrence remains a real risk in HR+ disease and longer follow-up matters.
Limitations worth acknowledging
The trials enrolled from 2003-2011; systemic therapy has evolved significantly, with CDK4/6 inhibitors now reshaping the high-risk adjuvant landscape (MonarchE, NATALEE).
How OFS-based therapy interacts with abemaciclib or ribociclib in the premenopausal setting requires further integration. Additionally, the young women subgroup (n=241) is small, and while directionally compelling, the absolute numbers should temper over-precise interpretation.
These are mature, definitive data from a rigorously conducted programme. The message is not ‘escalate everyone‘ – it is “identify who truly benefits and treat accordingly.”
Title: Final outcomes of the SOFT and TEXT phase III trials in premenopausal hormone receptor-positive early breast cancer
Authors: Prue A. Francis, Olivia Pagani, Gini F. Fleming, Barbara A. Walley, Marco Colleoni, Gabriella Rubovszky, Corrado Tondini, Eva M. Ciruelos, Henry L. Gomez, Hélène R. Bonnefoi, Harold J. Burstein, Cristina Chini, Fabio Puglisi, Sara Spazzapan, Alessandra Bernardo, Maria A. Climent, Meritxell Bellet, Thomas Ruhstaller, Beatriz Bermejo, Stephen K.L. Chia, Steven Martino, Charles E. Geyer Jr., Matthew P. Goetz, James N. Ingle, Vered Stearns, Nancy E. Davidson, Fabienne Le Du, Beat Müller, Robert E. Coleman, Sibylle Loibl, Eric P. Winer, Barbara Ruepp, Sherene Loi, István Láng, Alan S. Coates, Richard D. Gelber, Aron Goldhirsch, Meredith M. Regan
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