Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Gnant, M; Mlineritsch, B; Stoeger, H; Luschin-Ebengreuth, G; Knauer, M; Moik, M; Jakesz, R; Seifert, M; Taucher, S; Bjelic-Radisic, V; Balic, M; Eidtmann, H; Eiermann, W; Steger, G; Kwasny, W; Dubsky, P; Selim, U; Fitzal, F; Hochreiner, G; Wette, V; Sevelda, P; Ploner, F; Bartsch, R; Fesl, C; Greil, R; Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.
Zoledronic acid combined with adjuvant endocrine therapy of tamoxifen versus anastrozol plus ovarian function suppression in premenopausal early breast cancer: final analysis of the Austrian Breast and Colorectal Cancer Study Group Trial 12.
Ann Oncol. 2015; 26(2):313-320
Doi: 10.1093/annonc/mdu544
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- Co-Autor*innen der Med Uni Graz
- Balic Marija
- Bjelic-Radisic Vesna
- Hofmann Guenter
- Luschin-Ebengreuth Gero
- Ploner Ferdinand
- Stöger Herbert
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- Abstract:
- Zoledronic acid (ZOL) plus adjuvant endocrine therapy significantly improved disease-free survival (DFS) at 48- and 62-month follow-up in the ABCSG-12 trial. We present efficacy results of a final additional analysis after 94.4 months. Patients were premenopausal women who had undergone primary surgery for stage I/II estrogen-receptor-positive and/or progesterone-receptor-positive breast cancer with <10 positive lymph nodes, and were scheduled for standard goserelin therapy. All 1803 patients received goserelin (3.6 mg every 28 days) and were randomized to tamoxifen (20 mg/days) or anastrozole (1 mg/days), both with or without ZOL (4 mg every 6 months) for 3 years. The primary end point was DFS; recurrence-free survival and overall survival (OS) were secondary end points. After 94.4-month median follow-up (range, 0-114 months), relative risks of disease progression [hazard ratio (HR) = 0.77; 95% confidence interval (CI) 0.60-0.99; P = 0.042] and of death (HR = 0.66; 95% CI 0.43-1.02; P = 0.064) are still reduced by ZOL although no longer significant at the predefined significance level. Overall, 251 DFS events and 86 deaths were reported. Absolute risk reductions with ZOL were 3.4% for DFS and 2.2% for OS. There was no DFS difference between tamoxifen alone versus anastrozole alone, but there was a pronounced higher risk of death for anastrozole-treated patients (HR = 1.63; 95% CI 1.05-1.45; P = 0.030). Treatments were generally well tolerated, with no reports of renal failure or osteonecrosis of the jaw. These final results from ABCSG 12 suggest that twice-yearly ZOL enhances the efficacy of adjuvant endocrine treatment, and this benefit is maintained long-term. NCT00295646 (http://www.clinicaltrials.gov/ct2/results?term=00295646). © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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