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Ann Oncol. 2015 Feb;26(2):313-20. doi: 10.1093/annonc/mdu544. Epub 2014 Nov 17.

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.

Author information

1
Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna michael.gnant@meduniwien.ac.at.
2
Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg.
3
Clinical Department of Oncology, Medical University of Graz, Graz.
4
Department of General and Visceral Surgery, Hospital of the Sisters of Charity, Linz.
5
Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna.
6
Department of Gynecology and Obstetrics, Medical University of Innsbruck, Innsbruck, Austria.
7
Gynecology and Obstetrics Clinic, University of Schleswig-Holstein, Kiel.
8
Gynecology and Gynecological Oncology, IOZ-München, Munich, Germany.
9
Department of Surgery, Wiener Neustadt Hospital, Wiener Neustadt.
10
Department of Surgery, Hanusch Hospital, Vienna.
11
Center of Hematology and Medical Oncology, General Hospital Linz, Linz.
12
Department of Surgery, Practice of Dr Wette, Sankt Veit an der Glan.
13
Hospital Hietzing, Vienna.
14
Department of Statistics, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.

Abstract

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.

CLINICALTRIALSGOV:

NCT00295646 (http://www.clinicaltrials.gov/ct2/results?term=00295646).

KEYWORDS:

LHRH agonists; anastrozol; bisphosphonates; early breast cancer; tamoxifen; zoledronic acid

PMID:
25403582
DOI:
10.1093/annonc/mdu544
[Indexed for MEDLINE]

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