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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 . 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 ) .
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Intervention_Pharmacological
Zoledronic acid
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Intervention_Physical
combined with adjuvant endocrine therapy of
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Intervention_Pharmacological
tamoxifen
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Intervention_Physical
anastrozol plus ovarian function suppression
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Intervention_Pharmacological
Zoledronic acid ( ZOL )
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Intervention_Physical
plus adjuvant endocrine therapy
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Intervention_Pharmacological
goserelin ( 3.6 mg every 28 days )
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Intervention_Pharmacological
were randomized to tamoxifen ( 20 mg/days )
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Intervention_Pharmacological
anastrozole ( 1 mg/days )
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Intervention_Pharmacological
both with or without ZOL ( 4 mg every 6 months ) for 3 years
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Intervention_Pharmacological
ZOL
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Participant_Condition
premenopausal early breast cancer :
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Participant_Condition
Austrian Breast and Colorectal Cancer
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Participant_Sex
women
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Participant_Sample-size
1803