Authors

Olivia Pagani, Institute of Oncology of Southern Switzerland
Meredith M. Regan, IBCSG Statistical Center, Harvard University School of Medicine
Barbara A. Walley, Tom Baker Cancer Center
Gini F. Fleming, University of Chicago
Marco Colleoni, European Institute of Oncology
István Láng, National Institute of Oncology, Budapest
Henry L. Gomez, Instituto Nacional de Enfermedades Neoplásicas
Carlo Tondini, Ospedale Papa Giovanni XXIII
Harold J. Burstein, Harvard University School of Medicine
Edith A. Perez, Mayo Clinic, Jacksonville
Eva Ciruelos, University Hospital 12 de Octubre, Madrid
Vered Stearns, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Hervé R. Bonnefoi, University Bordeaux
Silvana Martino, The Angeles Clinic & Research Institute
Charles E. Geyer Jr., Virginia Commonwealth UniversityFollow
Graziella Pinotti, Ospedale di Circolo e Fondazione Macchi
Fabio Puglisi, University of Udine
Diana Crivellari, Centro di Riferimento Oncologico
Thomas Ruhstaller, Kantonsspital St Gallen
Eric P. Winer, Harvard University School of Medicine
Manuela Rabaglio-Poretti, University Hospital Inselspital
Rudolf Maibach, International Breast Cancer Study Group (IBCSG) Coordinating Center
Barbara Ruepp, International Breast Cancer Study Group (IBCSG) Coordinating Center
Anita Giobbie-Hurder, IBCSG Statistical Center, Dana–Farber Cancer Institute
Karen N. Price, IBCSG Statistical Center, Frontier Science and Technology Research Foundation
Jürg Bernhard, University Hospital Inselspital, International Breast Cancer Study Group (IBCSG) Coordinating Center
Weixiu Luo, IBCSG Statistical Center, Dana–Farber Cancer Institute
Karin Ribi, International Breast Cancer Study Group (IBCSG) Coordinating Center
Giuseppe Viale, IBCSG Central Pathology Center, European Institute of Oncology, University of Milan
Alan S. Coates, University of Sydney
Richard D. Gelber, IBCSG Statistical Center, Dana–Farber Cancer Institute, Harvard University School of Medicine
Aron Goldhirsch, European Institute of Oncology
Prudence A. Francis, University of Melbourne

Document Type

Article

Original Publication Date

2014

Journal/Book/Conference Title

New England Journal of Medicine

Volume

371

DOI of Original Publication

10.1056/NEJMoa1404037

Comments

Originally published at: http://dx.doi.org/10.1056/NEJMoa1404037

Date of Submission

December 2014

Abstract

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.)

Rights

From The New England Journal of Medicine, Pagini, O., Regan, M. M., Walley, B. A. et al., Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer, Vol. 371, Page 107, Copyright © 2014 Massachusetts Medical Society. Reprinted with permission.

Is Part Of

VCU Massey Cancer Center Publications

nejmoa1404037_appendix.pdf (646 kB)
Supplementary Appendix

nejmoa1404037_protocol.pdf (3352 kB)
Protocol

nejmoa1404037_disclosures.pdf (1307 kB)
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