Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer
By O. Pagani, M. Regan, B. Walley, G. Fleming, M. Colleoni, I. Láng, H. Gómez, C. Tondini, H. Burstein, Edith A. Perez and 23 more. New England Journal of Medicine, 2014
707 citations recorded by the source corpus.
BACKGROUND Adjuvant therapy with an aromatase inhibitor improves outcomes, as compared with tamoxifen, in postmenopausal women with hormone-receptor–positive breast cancer. METHODS In two phase 3 trials, we randomly assigned premenopausal women with hormone-receptor–positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years. Suppression of ovarian estrogen production was achieved with the use of the gonadotropin-releasing-hormone agonist triptorelin, oophorectomy, or ovarian irradiation. The primary analysis combined data from 4690 patients in the two trials. RESULTS After a median follow-up of 68 months, disease-free survival at 5 years was 91.1% in the exemestane–ovarian suppression group and 87.3% in the tamoxifen–ovarian suppression group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.72; 95% confidence interval [CI], 0.60 to 0.85; P<0.001). The rate of freedom from breast cancer at 5 years was 92.8% in the exemestane–ovarian suppression group, as compared with 88.8% in the tamoxifen–ovarian suppression group (hazard ratio for recurrence, 0.66; 95% CI, 0.55 to 0.80; P<0.001). With 194 deaths (4.1% of the patients), overall survival did not differ significantly between the two groups (hazard ratio for death in the exemestane–ovarian suppression group, 1.14; 95% CI, 0.86 to 1.51; P = 0.37). Selected adverse events of grade 3 or 4 were reported for 30.6% of the patients in the exemestane–ovarian suppression group and 29.4% of those in the tamoxifen–ovarian suppression group, with profiles similar to those for postmenopausal women. CONCLUSIONS In premenopausal women with hormone-receptor–positive early breast cancer, adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppression, significantly reduced recurrence. (Funded by Pfizer and others; TEXT and SOFT ClinicalTrials.gov numbers, NCT00066703 and NCT00066690, respectively.)
Subfields: Cancer Research, Genetics
View Paper: https://www.semanticscholar.org/paper/c6b2455fae9e352e90c54c51b9334647f812371c
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
- 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): “The Panel believed OFS could be paired with either tamoxifen or an AI (Table 4) [33, 34].”
- 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]”
- Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2015, background): “The role of GnRH agonists in preventing chemotherapy-related ovarian failure has been recently supported by the efficacy data (less premature ovarian failures and more pregnancies) from the POEMS trial (ER-negative patients) and safety data from TEXT trial (ER-positive patients) [II, B] [106, 108].”