Francis, P. A. and Pagani, O. and Fleming, G. F. and Walley, B. A. and Colleoni, M. and Lang, I. and Gomez, H. L. and Tondini, C. and Ciruelos, E. and Burstein, H. J. and Bonnefoi, H. R. and Bellet, M. and Martino, S. and Geyer, C. E. and Goetz, M. P. and Stearns, V. and Pinotti, G. and Puglisi, F. and Spazzapan, S. and Climent, M. A. and Pavesi, L. and Ruhstaller, T. and Davidson, N. E. and Coleman, R. and Debled, M. and Buchholz, S. and Ingle, J. N. and Winer, E. P. and Maibach, R. and Rabaglio-Poretti, M. and Ruepp, B. and Di Leo, A. and Coates, A. S. and Gelber, R. D. and Goldhirsch, A. and Regan, M. M. (2018) Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. NEW ENGLAND JOURNAL OF MEDICINE, 379 (2). pp. 122-137. ISSN 0028-4793, 1533-4406
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND In the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT), the 5-year rates of recurrence of breast cancer were significantly lower among premenopausal women who received the aromatase inhibitor exemestane plus ovarian suppression than among those who received tamoxifen plus ovarian suppression. The addition of ovarian suppression to tamoxifen did not result in significantly lower recurrence rates than those with tamoxifen alone. Here, we report the updated results from the two trials. METHODS Premenopausal women were randomly assigned to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression in SOFT and to receive tamoxifen plus ovarian suppression or exemestane plus ovarian suppression in TEXT. Randomization was stratified according to the receipt of chemotherapy. RESULTS In SOFT, the 8-year disease-free survival rate was 78.9% with tamoxifen alone, 83.2% with tamoxifen plus ovarian suppression, and 85.9% with exemestane plus ovarian suppression (P = 0.009 for tamoxifen alone vs. tamoxifen plus ovarian suppression). The 8-year rate of overall survival was 91.5% with tamoxifen alone, 93.3% with tamoxifen plus ovarian suppression, and 92.1% with exemestane plus ovarian suppression (P = 0.01 for tamoxifen alone vs. tamoxifen plus ovarian suppression); among the women who remained premenopausal after chemotherapy, the rates were 85.1%, 89.4%, and 87.2%, respectively. Among the women with cancers that were negative for HER2 who received chemotherapy, the 8-year rate of distant recurrence with exemestane plus ovarian suppression was lower than the rate with tamoxifen plus ovarian suppression (by 7.0 percentage points in SOFT and by 5.0 percentage points in TEXT). Grade 3 or higher adverse events were reported in 24.6% of the tamoxifen-alone group, 31.0% of the tamoxifen-ovarian suppression group, and 32.3% of the exemestane-ovarian suppression group. CONCLUSIONS Among premenopausal women with breast cancer, the addition of ovarian suppression to tamoxifen resulted in significantly higher 8-year rates of both disease-free and overall survival than tamoxifen alone. The use of exemestane plus ovarian suppression resulted in even higher rates of freedom from recurrence. The frequency of adverse events was higher in the two groups that received ovarian suppression than in the tamoxifen-alone group.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | OVARIAN-FUNCTION SUPPRESSION; PATIENT-LEVEL METAANALYSIS; POPULATION-BASED COHORT; RANDOMIZED-TRIALS; YOUNG-WOMEN; REPORTED OUTCOMES; SOFT TRIALS; TAMOXIFEN; TEXT; OOPHORECTOMY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Frauenheilkunde und Geburtshilfe (Schwerpunkt Frauenheilkunde) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 06 Mar 2020 14:21 |
| Last Modified: | 06 Mar 2020 14:21 |
| URI: | https://pred.uni-regensburg.de/id/eprint/14240 |
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