Details

Autor(en) / Beteiligte

• Pagani, Olivia
• Walley, Barbara A
• Fleming, Gini F
• Colleoni, Marco
• Láng, István
• Gomez, Henry L
• Tondini, Carlo
• Burstein, Harold J
• Goetz, Matthew P
• Ciruelos, Eva M
• Stearns, Vered
• Bonnefoi, Hervé R
• Martino, Silvana
• Geyer, Jr, Charles E
• Chini, Claudio
• Puglisi, Fabio
• Spazzapan, Simon
• Ruhstaller, Thomas
• Winer, Eric P
• Ruepp, Barbara
• Loi, Sherene
• Coates, Alan S
• Gelber, Richard D
• Goldhirsch, Aron
• Regan, Meredith M
• Francis, Prudence A

Titel

Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials

Ist Teil von

• Journal of clinical oncology, 2023-03, Vol.41 (7), p.1376-1382

Ort / Verlag

United States: Wolters Kluwer Health

Erscheinungsjahr

2023

Quelle

MEDLINE

Beschreibungen/Notizen

• JCO The combined analysis of SOFT-TEXT compared outcomes in 4,690 premenopausal women with estrogen/progesterone receptor-positive (ER/PgR+) early breast cancer randomly assigned to 5 years of exemestane + ovarian function suppression (OFS) versus tamoxifen + OFS. After a median follow-up of 9 years, exemestane + OFS significantly improved disease-free survival (DFS) and distant recurrence-free interval (DRFI), but not overall survival, compared with tamoxifen + OFS. We now report DFS, DRFI, and overall survival after a median follow-up of 13 years. In the intention-to-treat (ITT) population, the 12-year DFS (4.6% absolute improvement, hazard ratio [HR], 0.79; 95% CI, 0.70 to 0.90; < .001) and DRFI (1.8% absolute improvement, HR, 0.83; 95% CI, 0.70 to 0.98; = .03), but not overall survival (90.1% 89.1%, HR, 0.93; 95% CI, 0.78 to 1.11), continued to be significantly improved for patients assigned exemestane + OFS over tamoxifen + OFS. Among patients with human epidermal growth factor receptor 2-negative tumors (86.0% of the ITT population), the absolute improvement in 12-year overall survival with exemestane + OFS was 2.0% (HR, 0.85; 95% CI, 0.70 to 1.04) and 3.3% in those who received chemotherapy (45.9% of the ITT population). Overall survival benefit was clinically significant in high-risk patients, eg, women age < 35 years (4.0%) and those with > 2 cm (4.5%) or grade 3 tumors (5.5%). These sustained reductions of the risk of recurrence with adjuvant exemestane + OFS, compared with tamoxifen + OFS, provide guidance for selecting patients for whom exemestane should be preferred over tamoxifen in the setting of OFS.[Media: see text].