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Randomized Controlled Trial
. 2023 Mar 1;41(7):1376-1382.
doi: 10.1200/JCO.22.01064. Epub 2022 Dec 15.

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

Olivia Pagani  1   2 , Barbara A Walley  3 , Gini F Fleming  4 , Marco Colleoni  5 , István Láng  6   7 , Henry L Gomez  8   9 , Carlo Tondini  10 , Harold J Burstein  11 , Matthew P Goetz  12 , Eva M Ciruelos  13 , Vered Stearns  14 , Hervé R Bonnefoi  15 , Silvana Martino  16 , Charles E Geyer Jr  17 , Claudio Chini  18 , Fabio Puglisi  19 , Simon Spazzapan  20 , Thomas Ruhstaller  21 , Eric P Winer  11   22 , Barbara Ruepp  23 , Sherene Loi  24 , Alan S Coates  25 , Richard D Gelber  26 , Aron Goldhirsch  27   28 , Meredith M Regan  29 , Prudence A Francis  30   31 ; SOFT and TEXT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation)
Affiliations
Randomized Controlled Trial

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

Olivia Pagani et al. J Clin Oncol. .

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 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; P < .001) and DRFI (1.8% absolute improvement, HR, 0.83; 95% CI, 0.70 to 0.98; P = .03), but not overall survival (90.1% v 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].

Trial registration: ClinicalTrials.gov NCT00066703 NCT00066690.

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Conflict of interest statement

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

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

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Figures

FIG 1.
FIG 1.
Outcomes after a 13-year median follow-up. Kaplan-Meier estimates of (A) DFS, (B) DRFI, (C) OS distributions in the ITT population, and (D) OS in the predominant subgroup with HER2-negative cancers. Reported are 5- and 12-year event-free percentages and 12-year difference (E + OFS minus T + OFS; with 95% CI). Stratified HRs with 95% CIs are reported, with log-rank P values in the ITT population only. In addition, numbers of events, pyfu, and HRs are provided for time intervals of 0 to < 5 years, ≥ 5 to < 10 years, and ≥ 10 years. DFS, disease-free survival; DRFI, distant recurrence-free interval; E, exemestane; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; ITT, intention-to-treat; OFS, ovarian function suppression; OS, overall survival; pyfu, patient-years of follow-up; T, tamoxifen.
FIG 2.
FIG 2.
Kaplan-Meier estimates of 12-year outcomes (with 95% CIs) according to treatment assignment. The median follow-up is 13 years. Estimates and difference (exemestane + OFS minus tamoxifen + OFS) are presented for (A) DRFI and overall survival in the ITT population, in HER2 subgroups, and within HER2 status according to the cohort or trial and (B) for overall survival among 4,035 patients who had hormone receptor–positive/HER2-negative cancers in clinicopathologic subgroups. DRFI, distant recurrence-free interval; E, exemestane; HER2, human epidermal growth factor receptor 2; ITT, intention-to-treat; OFS, ovarian function suppression; T, tamoxifen.
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References

    1. Francis PA, Pagani O, Fleming GF, et al. : Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med 379:122-137, 2018 - PMC - PubMed
    1. Pan H, Gray R, Braybrooke J, et al. : 20-Year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med 377:1836-1846, 2017 - PMC - PubMed
    1. Pedersen RN, Esen B, Mellemkjær L, et al. : The incidence of breast cancer recurrence 10-32 years after primary diagnosis. J Natl Cancer Inst 114:391-399, 2022 - PMC - PubMed
    1. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) : Aromatase inhibitors versus tamoxifen in early breast cancer: Patient-level meta-analysis of the randomised trials. Lancet 386:1341-1352, 2015 - PubMed
    1. Pagani O, Regan MM, Walley BA, et al. : Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med 371:107-118, 2014 - PMC - PubMed

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