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

Francis, PA; Fleming, GF; Lang, I; Ciruelos, EM; Bonnefoi, HR; Bellet, M; Bernardo, A; Climent, MA; Martino, S; Bermejo, B; Burstein, HJ; Davidson, NE; Geyer, CE, Jr; Walley, BA; Ingle, JN; Coleman, RE; Muller, B; Le Du, F; Loibl, S; Winer, EP; Ruepp, B; Loi, S; Colleoni, M; Coates, AS; Gelber, RD; Goldhirsch, A; Regan, MM; SOFT Investigators; International Breast Cancer Study Group

Author(s): Francis, PA; Fleming, GF; Lang, I; Ciruelos, EM; Bonnefoi, HR; Bellet, M; Bernardo, A; Climent, MA; Martino, S; Bermejo, B; Burstein, HJ; Davidson, NE; Geyer, CE, Jr; Walley, BA; Ingle, JN; Coleman, RE; Muller, B; Le Du, F; Loibl, S; Winer, EP; Ruepp, B; Loi, S; Colleoni, M; Coates, AS; Gelber, RD; Goldhirsch, A; Regan, MM; SOFT Investigators; International Breast Cancer Study Group;
Details: Publication Year 2023-03-01,Volume 41,Issue #7,Page 1370-1375
Journal Title: Journal of Clinical Oncology
Publication Type: Research article
Abstract: Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.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].
Publisher: American Society of Clinical Oncology
Keywords: Female; Humans; *Breast Neoplasms/drug therapy; Antineoplastic Agents, Hormonal/therapeutic use; Chemotherapy, Adjuvant; Tamoxifen/therapeutic use; Combined Modality Therapy; Disease-Free Survival; Antineoplastic Combined Chemotherapy Protocols/therapeutic use; Adjuvants, Immunologic/therapeutic use; Premenopause
Department(s): Medical Oncology
PubMed ID: 36493334
Publisher's Version: https://doi.org/10.1200/JCO.22.01065
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-06-28 01:48:28

Last Modified: 2023-06-28 01:48:52