In the SOFT (NCT00066690) trial, 3,066 premenopausal women with HR-positive early breast cancer were randomised to 5 years of adjuvant tamoxifen alone or to ovarian suppression treatment (OFS) plus either tamoxifen or the aromatase inhibitor exemestane. TEXT (NCT00066703; n=2,672) had a similar design but without a single-agent tamoxifen arm. About 2,500 women did not receive additional chemotherapy. In a previous combined analysis of these studies after 5 years of follow-up, adjuvant treatment with exemestane plus OFS was shown to outperform tamoxifen plus OFS [1]. Now, Dr Meredith Regan (Dana-Farber Cancer Institute, MA, USA) presented the updated results after a longer follow-up [2].
After 12 to 13 years of follow-up, the distant metastasis-free survival rates were 88.4% with exemestane plus OFS and 86.6% with tamoxifen plus OFS (HR 0.83; P=0.03). The overall survival rates were 90.1% versus 89.1%, a non-significant difference. Tamoxifen alone, meanwhile, led to a 12-year distant metastasis-free survival rate of 84.8% and a 12-year overall survival rate of 86.8%. Low-risk patients who received no chemotherapy had a 12-year overall survival rate exceeding 95%, regardless of the endocrine strategy, including tamoxifen alone. A subgroup analysis showed that patients younger than 35, and those who received neoadjuvant chemotherapy prior to enrolment, benefited most from OFS. Within those 2 subgroups, tamoxifen plus OFS led to a 10% absolute improvement in 12-year overall survival versus tamoxifen alone, and the exemestane plus OFS combination increased the absolute difference versus single-agent tamoxifen to 15%.
"Meaningful relative reductions in distant recurrence and death persist with longer follow-up for use of ovarian suppression with either endocrine therapy versus tamoxifen alone,” said Dr Regan. “Absolute reductions are more substantial for those at higher risk, on the order of a 10% reduction in death, emphasising appropriate selection of patients to receive ovarian suppression. Notably, for those patients with low clinical-risk features who did not receive chemotherapy, the longer follow-up continues to support the use of tamoxifen alone," concluded Dr Regan.
- Pagani O, et al. N Engl J Med 2014;371:107–118.
- Regan MM, et al. Randomized comparison of adjuvant aromatase inhibitor exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): update of the combined TEXT and SOFT trials. GS2-05, SABCS 2021 Virtual Meeting, 7–10 December.
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Table of Contents: SABCS 2021
Featured articles
Early-Stage Breast Cancer
Aromatase inhibitors outperform tamoxifen in premenopausal women
Concurrent taxane plus anthracycline most beneficial in reducing risk of breast cancer
Reduced risk of recurrence with ovarian suppression plus tamoxifen/exemestane
Metformin does not improve outcomes in patients with early-stage breast cancer
Omitting sentinel lymph node biopsy improves arm symptoms
HR-positive/HER2-negative Breast Cancer
Addition of palbociclib to standard endocrine therapy does not improve outcome in adjuvant treatment
The SERD elacestrant improves outcomes for patients unresponsive to endocrine therapy
Consistent overall survival benefit of ribociclib in advanced breast cancer
Premenopausal women benefit from adjuvant chemotherapy next to endocrine therapy
Promising anti-tumour activity of the CDK7-inhibitor samuraciclib plus fulvestrant
ctDNA is prognostic and predictive for response to ribociclib plus letrozole
Early switch to fulvestrant plus palbociclib beneficial for patients with ESR1 mutation
Triple-Negative Breast Cancer
Single-cell spatial analysis can predict response to neoadjuvant immunotherapy
Neoadjuvant pembrolizumab plus chemotherapy benefits event-free survival in TNBC
Early use of ctDNA testing can identify likelihood of relapse in TNBC
Pembrolizumab plus chemotherapy benefits patients with combined positive score ≥10
Neratinib plus trastuzumab plus fulvestrant shows encouraging clinical activity
Phase 1–3 Trials
Datopotamab deruxtecan shows promising anti-tumour activity
Trastuzumab deruxtecan outperforms trastuzumab emtansine
Nivolumab plus ipilimumab serve promising dual checkpoint inhibition
Entinostat plus exemestane improves progression-free survival in Chinese patients
Efficacy of pyrotinib plus capecitabine confirmed in previously treated patients
Basic and Translational Research
Using genomics to match treatments improves outcomes
Loss of ASXL1 tumour suppressor promotes resistance to CDK4/6 inhibitors
Inducers of ferroptosis are potential drugs to target p53-mutated TNBC cells
MAPK-pathway alterations are associated with resistance to anti-HER2 therapy
Genomic signatures of DCIS define biology and correlate with clinical outcomes
BRCA2 linked to inferior outcomes with CDK4/6 inhibitors plus endocrine therapy
Miscellaneous
Olaparib is well tolerated as an additional treatment
Race effects the likelihood to develop lymphoedema following breast cancer treatment
Sentinel lymph node staging is non-inferior to complete axillary lymph node dissection
One in 7 breast cancers detected during screening are overdiagnosed
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