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
Adjuvant exemestane with ovarian suppression in premenopausal breast cancer / O. Pagani, M.M. Regan, B.A. Walley, G.F. Fleming, M.L. Colleoni, I. Láng, H.L. Gomez, C. Tondini, H.J. Burstein, E.A. Perez, E. Ciruelos, V. Stearns, H.R. Bonnefoi, S. Martino, C.E. Geyer Jr., G. Pinotti, F. Puglisi, D. Crivellari, T. Ruhstaller, E.P. Winer, M. Rabaglio-Poretti, R. Maibach, B. Ruepp, A. Giobbie-Hurder, K.N. Price, J. Bernhard, W. Luo, K. Ribi, G. Viale, A.S. Coates, R.D. Gelber, A. Goldhirsch, P.A. Francis. - In: NEW ENGLAND JOURNAL OF MEDICINE. - ISSN 0028-4793. - 371:2(2014 Jul 10), pp. 107-118.
|Titolo:||Adjuvant exemestane with ovarian suppression in premenopausal breast cancer|
VIALE, GIUSEPPE (Corresponding)
|Settore Scientifico Disciplinare:||Settore MED/08 - Anatomia Patologica|
|Data di pubblicazione:||10-lug-2014|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1056/NEJMoa1404037|
|Appare nelle tipologie:||01 - Articolo su periodico|