Portal de Periódicos da CAPES

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

2014; Elsevier BV; Volume: 26; Issue: 2 Linguagem: Inglês

10.1093/annonc/mdu544

1569-8041

Michael Gnant, Brigitte Mlineritsch, Herbert Stoeger, G. Luschin-Ebengreuth, Michael Knauer, Martin Moik, R. Jakesz, Michael Seifert, Susanne Taucher, Vesna Bjelic‐Radisic, Marija Balić, Holger Eidtmann, W. Eiermann, Guenther G. Steger, W. Kwasny, Peter Dubsky, U Selim, Florian Fitzal, Gerhard Hochreiner, V. Wette, P. Sevelda, F. Ploner, Rupert Bartsch, Christian Fesl, Richard Greil,

Prostate Cancer Treatment and Research

ABSTRACT These final results from ABCSG-12 confirm that twice-yearly ZOL safely enhances the efficacy of adjuvant endocrine therapy. Tamoxifen together with Goserelin for now remains the endocrine standard of care. In general, overall survival of more than 95% at 8 years' median follow-up supports the efficacy of endocrine-only regimens in this premenopausal patient population. Background 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 and methods 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. Results 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. Conclusion 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. ClinicalTrials.gov NCT00295646 (http://www.clinicaltrials.gov/ct2/results?term=00295646).