Francis, Prudence A. and Regan, Meredith M. and Fleming, Gini F. and Lang, Istvan and Ciruelos, Eva and Bellet, Meritxell and Bonnefoi, Herve R. and Climent, Miguel A. and Da Prada, Gian Antonio and Burstein, Harold J. and Martino, Silvana and Davidson, Nancy E. and Geyer, Charles E. and Walley, Barbara A. and Coleman, Robert and Kerbrat, Pierre and Buchholz, Stefan and Ingle, James N. and Winer, Eric P. and Rabaglio-Poretti, Manuela and Maibach, Rudolf and Ruepp, Barbara and Giobbie-Hurder, Anita and Price, Karen N. and Colleoni, Marco and Viale, Giuseppe and Coates, Alan S. and Goldhirsch, Aron and Gelber, Richard D. (2015) Adjuvant Ovarian Suppression in Premenopausal Breast Cancer. NEW ENGLAND JOURNAL OF MEDICINE, 372 (5). pp. 436-446. ISSN 0028-4793, 1533-4406
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND Suppression of ovarian estrogen production reduces the recurrence of hormone-receptor-positive early breast cancer in premenopausal women, but its value when added to tamoxifen is uncertain. METHODS We randomly assigned 3066 premenopausal women, stratified according to prior receipt or nonreceipt of chemotherapy, to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression. The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival, as compared with tamoxifen alone. In the primary analysis, 46.7% of the patients had not received chemotherapy previously, and 53.3% had received chemotherapy and remained premenopausal. RESULTS After a median follow-up of 67 months, the estimated disease-free survival rate at 5 years was 86.6% in the tamoxifen-ovarian suppression group and 84.7% in the tamoxifen group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.83; 95% confidence interval [CI], 0.66 to 1.04; P=0.10). Multivariable allowance for prognostic factors suggested a greater treatment effect with tamoxifen plus ovarian suppression than with tamoxifen alone (hazard ratio, 0.78; 95% CI, 0.62 to 0.98). Most recurrences occurred in patients who had received prior chemotherapy, among whom the rate of freedom from breast cancer at 5 years was 82.5% in the tamoxifen-ovarian suppression group and 78.0% in the tamoxifen group (hazard ratio for recurrence, 0.78; 95% CI, 0.60 to 1.02). At 5 years, the rate of freedom from breast cancer was 85.7% in the exemestane-ovarian suppression group (hazard ratio for recurrence vs. tamoxifen, 0.65; 95% CI, 0.49 to 0.87). CONCLUSIONS Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of ovarian suppression improved disease outcomes. Further improvement was seen with the use of exemestane plus ovarian suppression.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | YOUNG-WOMEN; CHEMOTHERAPY; THERAPY; TRIALS; METAANALYSIS; AMENORRHEA; TAMOXIFEN; GOSERELIN; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Frauenheilkunde und Geburtshilfe (Schwerpunkt Frauenheilkunde) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 25 Jul 2019 11:08 |
| Last Modified: | 25 Jul 2019 11:08 |
| URI: | https://pred.uni-regensburg.de/id/eprint/6077 |
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