Randomized comparison of adjuvant aromatase inhibitor (AI) exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): Joint analysis of IBCSG TEXT and SOFT trials.

• DOI: 10.1200/jco.2014.32.18_suppl.lba1
• Publication Date: 2017-02-24T11:13:28Z
• Authors: Olivia Pagani; Meredith M. Regan; Barbara Walley; Gini F. Fleming; Marco Colleoni; Istvan Lang; Henry Leonidas Gomez; Carlo Tondini; Harold J. Burstein; Edith A. Perez; Eva Ciruelos; Vered Stearns; Herve R. Bonnefoi; Silvana Martino; Charles E. Geyer; Manuela Rabaglio-...; Alan S. Coates; Richard D. Gelber; Aron Goldhirsch; Prudence A. Francis
• Keywords: Exemestane; Triptorelin; Aromatase inhibitor; Clinical endpoint

LBA1 Background: Adjuvant endocrine therapy with AI vs T improves outcomes in postmenopausal HR+ BC. TEXT and SOFT were designed to test whether adjuvant premenopausal women BC treated OFS (AI question) determine the value of who remain are suitable for (OFS question). Methods: SOFT, randomized phase 3 trials, enrolled 5,738 early from Nov03 Apr11 (2672 TEXT; 3066 SOFT). within 12wk surgery 5y E+OFS T+OFS; chemotherapy (CT) was optional concurrent OFS. T+OFS alone, either if no CT planned, or 8mo completing (neo)adjuvant CT. by choice triptorelin, oophorectomy, ovarian irradiation. The primary endpoint is disease-free survival (DFS: randomization until invasive local, regional, distant recurrence, contralateral breast; 2nd malignancy; death). Due low event rates, protocol amendments 2011 changed analysis plans answer question (E+OFS T+OFS) joint SOFT. By Q3’2013 >5y median follow-up, 436 DFS events projected, providing 84% power HR=0.75 (stratified logrank 2-sided α=0.05). Results: At 5.7y 514 (11%) reported ITT population comparing (n=2346) (n=2344). Patients assigned had significantly reduced hazard (HR=0.72; 95% CI, 0.60-0.86; P=0.0002) 91.1% 87.3%. Reductions similar secondary endpoints BC-free interval (HR=0.66 (0.55-0.80) BCFI 92.8% 88.8%) recurrence-free (HR=0.78 (0.62-0.97)), though not overall (HR=1.14 (0.86-1.51)) at this follow-up (194 (4%) deaths). Grade 3-4 targeted AEs 31% 29% patients. Conclusion: In BC, treatment risk recurrence compared T+OFS. Clinical trial information: NCT00066703 / NCT00066690 .