Details

Autor(en) / Beteiligte

• Francis, Prudence A
• Fleming, Gini F
• Láng, István
• Ciruelos, Eva M
• Bonnefoi, Hervé R
• Bellet, Meritxell
• Bernardo, Antonio
• Climent, Miguel A
• Martino, Silvana
• Bermejo, Begoña
• Burstein, Harold J
• Davidson, Nancy E
• Geyer, Jr, Charles E
• Walley, Barbara A
• Ingle, James N
• Coleman, Robert E
• Müller, Bettina
• Le Du, Fanny
• Loibl, Sibylle
• Winer, Eric P
• Ruepp, Barbara
• Loi, Sherene
• Colleoni, Marco
• Coates, Alan S
• Gelber, Richard D
• Goldhirsch, Aron
• Regan, Meredith M

Titel

Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT

Ist Teil von

• Journal of clinical oncology, 2023-03, Vol.41 (7), p.1370-1375

Ort / Verlag

United States: Wolters Kluwer Health

Erscheinungsjahr

2023

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• JCO The Suppression of Ovarian Function Trial (SOFT; ClinicalTrials.gov identifier: NCT00066690) randomly assigned premenopausal women with hormone receptor-positive breast cancer to 5 years of adjuvant tamoxifen, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. The primary analysis compared disease-free survival (DFS) between tamoxifen plus OFS versus tamoxifen alone; exemestane plus OFS versus tamoxifen was a secondary objective. After 8 years, SOFT reported a significant reduction in recurrence and improved overall survival (OS) with adjuvant tamoxifen plus OFS versus tamoxifen alone. Here, we report outcomes after median follow-up of 12 years. DFS remained significantly improved with tamoxifen plus OFS versus tamoxifen (hazard ratio, 0.82; 95% CI, 0.69 to 0.98) with a 12-year DFS of 71.9% with tamoxifen, 76.1% with tamoxifen plus OFS, and 79.0% with exemestane plus OFS. OS was improved with tamoxifen plus OFS versus tamoxifen (hazard ratio, 0.78; 95% CI, 0.60 to 1.01) and was 86.8% with tamoxifen, 89.0% with tamoxifen plus OFS, and 89.4% with exemestane plus OFS at 12 years. Among those who received prior chemotherapy for human epidermal growth factor receptor-2-negative tumors, OS was 78.8% with tamoxifen, 81.1% with tamoxifen plus OFS, and 84.4% with exemestane plus OFS. In conclusion, after 12 years, there remains a benefit from including OFS in adjuvant endocrine therapy, with an absolute improvement in OS more apparent with higher baseline risk of recurrence.[Media: see text].