Adjuvant Ovarian Suppression in Premenopausal Breast Cancer
By P. Francis, M. Regan, G. Fleming, I. Láng, E. Ciruelos, M. Bellet, H. Bonnefoi, M. Climent, G. D. Da Prada, H. Burstein and 19 more. New England Journal of Medicine, 2014
624 citations recorded by the source corpus.
BACKGROUND Suppression of ovarian estrogen production reduces the recurrence of hormone-receptor– positive early breast cancer in premenopausal women, but its value when added to tamoxifen is uncertain. METHODS We randomly assigned 3066 premenopausal women, stratified according to prior receipt or nonreceipt of chemotherapy, to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression. The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival, as compared with tamoxifen alone. In the primary analysis, 46.7% of the patients had not received chemotherapy previously, and 53.3% had received chemotherapy and remained premenopausal. RESULTS After a median follow-up of 67 months, the estimated disease-free survival rate at 5 years was 86.6% in the tamoxifen–ovarian suppression group and 84.7% in the tamoxifen group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.83; 95% confidence interval [CI], 0.66 to 1.04; P = 0.10). Multivariable allowance for prognostic factors suggested a greater treatment effect with tamoxifen plus ovarian suppression than with tamoxifen alone (hazard ratio, 0.78; 95% CI, 0.62 to 0.98). Most recurrences occurred in patients who had received prior chemotherapy, among whom the rate of freedom from breast cancer at 5 years was 82.5% in the tamoxifen–ovarian suppression group and 78.0% in the tamoxifen group (hazard ratio for recurrence, 0.78; 95% CI, 0.60 to 1.02). At 5 years, the rate of freedom from breast cancer was 85.7% in the exemestane–ovarian suppression group (hazard ratio for recurrence vs. tamoxifen, 0.65; 95% CI, 0.49 to 0.87). CONCLUSIONS Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of ovarian suppression improved disease outcomes. Further improvement was seen with the use of exemestane plus ovarian suppression. (Funded by Pfizer and others; SOFT ClinicalTrials.gov number, NCT00066690.)
Subfields: Cancer Research, Genetics
View Paper: https://www.semanticscholar.org/paper/0fd085a11011472241c882cf10074af8e5ab6a6e
How researchers see this paper
The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.
In Cancer Research
Citations in the corpus
- Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer (2018, neutral): “Mastectomy 516 (32) 935 (28) 917 (28) 368 (26)”
- Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015 (2015, background): “tamoxifen or OFS plus exemestane See criteria in papers [3, 4, 116]”
- De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017 (2018, background): “Adjuvant therapy—endocrine therapy In premenopausal women with ER positive breast cancer, ovarian suppression reduces recurrence in high-risk tumors but is associated with more menopausal symptoms [32, 68].”
- Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2015, background): “Not all clinical situations have been adequately represented in the SOFT trial and a case-by-case decision should be taken, after careful discussion with the patient regarding potential benefits and substantially different side-effect profiles [I, B] [104].”