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Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer
Open accessAbstract
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.).
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Montgomery, G. H., David, D., Kangas, M., Green, S., Sucala, M., Bovbjerg, D. H., Hallquist, M. N., & Schnur, J. B. (2014) · Journal of Clinical Oncology · doi:10.1200/jco.2013.49.3437 · Cited by 123
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Cardoso, F., Kyriakides, S., Ohno, S., Penault-Llorca, F., Poortmans, P., Rubio, I. T., Zackrisson, S., & Senkus, E. (2019) · Annals of Oncology · doi:10.1093/annonc/mdz173 · Cited by 2,214
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Curigliano, G., Burstein, H. J., Winer, E. P., Gnant, M., Dubsky, P., Loibl, S., Colleoni, M., Regan, M. M., Piccart-Gebhart, M., Senn, H.-J., et al. (2017) · Annals of Oncology · doi:10.1093/annonc/mdx308 · Cited by 1,205
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- Authors
- Pagani, O., Regan, M. M., Walley, B. A., Fleming, G. F., Colleoni, M., Láng, I., Gomez, H. L., Tondini, C., Burstein, H. J., Perez, E. A., Ciruelos, E., Stearns, V., Bonnefoi, H. R., Martino, S., Geyer, C. E., Pinotti, G., Puglisi, F., Crivellari, D., Ruhstaller, T., Winer, E. P., Rabaglio-Poretti, M., Maibach, R., Ruepp, B., Giobbie-Hurder, A., Price, K. N., Bernhard, J., Luo, W., Ribi, K., Viale, G., Coates, A. S., Gelber, R. D., Goldhirsch, A., & Francis, P. A.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-07-10
- Volume
- 371
- Issue
- 2
- Pages
- 107-118
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2118696602
- Cited by
- 749
- References
- 1
- FWCI
- 31.30
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Pagani, O., Regan, M. M., Walley, B. A., Fleming, G. F., Colleoni, M., Láng, I., Gomez, H. L., Tondini, C., Burstein, H. J., Perez, E. A., Ciruelos, E., Stearns, V., Bonnefoi, H. R., Martino, S., Geyer, C. E., Pinotti, G., Puglisi, F., Crivellari, D., Ruhstaller, T., . . . Francis, P. A. (2014). Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1404037
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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