- Title
- Adjuvant exemestane with ovarian suppression in premenopausal breast cancer
- Creator
- Pagani, Olivia; Regan, Meredith; Ciruelos, Eva; Stearns, Vered; Bonnefoi, Herve; Martino, Silvana; Geyer, Charles; Pinotti, Graziella; Puglisi, Fabio; Crivellari, Diana; Ruhstaller, Thomas; Winer, ERic; Walley, Barbara; Rabaglio-Poretti, Manuella; Maibach, Rudolf; Ruepp, Barbara; Giobbie-Herder, Anita; Price, Karen; Bernhard, Jurg; Luo, Weixiu; Ribi, Karin; Viali, Guiseppe; Coates, Alan; Fliming, Gini; Gelber, Richard; Goldhirsch, Aron; Francis, Prudence; Colleoni, Marco; Lang, Istvan; Gomez, Henry; Tondini, Carlo; Burstein, Harold; Perez, Edith
- Relation
- NHMRC.351161
- Relation
- The New England Journal of Medicine Vol. 371, Issue 2, p. 107-118
- Publisher Link
- http://dx.doi.org/10.1056/NEJMoa1404037
- Publisher
- Massachusetts Medical Society
- Resource Type
- journal article
- Date
- 2014
- Description
- 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.
- Subject
- breast-cancer cells; premenopause; ovarian suppression; exemestane
- Identifier
- http://hdl.handle.net/1959.13/1057865
- Identifier
- uon:16287
- Identifier
- ISSN:0028-4793
- Rights
- From The New England Journal of Medicine, Pagani et. al., Adjuvant exemestane with ovarian suppression in premenopausal breast cancer, Volume No. 371, Page No. 2 Copyright © 2014 Massachusetts Medical Society. Reprinted with permission
- Language
- eng
- Full Text
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