Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer

Olivia Pagani(Institute of Oncology Research), Meredith M. Regan(International Breast Cancer Study Group), Barbara Walley, Gini F. Fleming(University of Chicago Medical Center), Marco Colleoni(European Institute of Oncology), István Láng(National Institute of Oncology), Henry Gómez(Instituto Nacional de Enfermedades Neoplásicas), Carlo Tondini(Ospedale Papa Giovanni XXIII), Harold J. Burstein(Dana-Farber Cancer Institute), Edith A. Perez(Mayo Clinic in Florida), Eva Ciruelos(Hospital Universitario 12 De Octubre), Vered Stearns(Sidney Kimmel Comprehensive Cancer Center), Hervé Bonnefoi(Inserm), Silvana Martino(Angeles Clinic and Research Institute), Charles E. Geyer, Graziella Pinotti(Ospedale di Circolo e Fondazione Macchi), Fabio Puglisi(University of Udine), Diana Crivellari(Centro di Riferimento Oncologico), Thomas Ruhstaller(Breast Center), Eric P. Winer(Dana-Farber Cancer Institute), Manuela Rabaglio(University Hospital of Bern), Rudolf Maibach(The Coordinating Center), Barbara Ruepp(The Coordinating Center), Anita Giobbie‐Hurder(Dana-Farber Cancer Institute), Karen N. Price(Frontier Science & Technology Research Foundation), Jürg Bernhard(University Hospital of Bern), Weixiu Luo(International Breast Cancer Study Group), Karin Ribi, Giuseppe Viale(European Institute of Oncology), Alan S. Coates(University of Sydney), Richard D. Gelber(Harvard University), Aron Goldhirsch(European Institute of Oncology), Prudence A. Francis(St. Vincent's Hospital)
New England Journal of Medicine
June 1, 2014
10.1056/nejmoa1404037
Cited by 745Open Access
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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.).

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