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Clinical Trial
. 2012 Jun 26;107(1):7-11.
doi: 10.1038/bjc.2012.210. Epub 2012 May 22.

Effect of (Neo)adjuvant zoledronic acid on disease-free and overall survival in clinical stage II/III breast cancer

R L Aft  1 , M Naughton, K Trinkaus, K Weilbaecher
Affiliations
Clinical Trial

Effect of (Neo)adjuvant zoledronic acid on disease-free and overall survival in clinical stage II/III breast cancer

R L Aft et al. Br J Cancer. .

Abstract

Background: Despite neoadjuvant/adjuvant chemotherapy, women with resectable stage II/III breast cancer (BC) have high risk of recurrent disease. Recent data suggest that zoledronic acid (ZOL) therapy concurrent with adjuvant treatments may improve cancer-related outcomes in patients with BC.

Methods: Disease-free survival (DFS; secondary end point) and overall survival (OS; tertiary end point) were evaluated in 119 women with stage II/III BC randomised to intravenous ZOL 4 mg every 3 weeks for 1 year or no ZOL (control) starting with the first chemotherapy cycle.

Results: At 61.9 months' median follow-up, there was no significant difference in recurrence or survival between study arms. However, time to recurrence or death (DFS) was significantly different between subgroups defined by oestrogen receptor (ER) status (interaction P=0.010 for DFS and 0.025 for OS). Hazard ratios (HRs) for disease recurrence and death were significantly less among patients with ER-negative (ER(-)) tumours who received ZOL vs no ZOL (DFS: HR=0.361, 95% confidence interval (CI) 0.148, 0.880; OS: HR=0.375, 95% CI 0.143, 0.985).

Conclusion: ZOL administered with chemotherapy may improve DFS and OS in a subset of BC patients with ER(-) tumours. This study was not powered to compare subgroups of patients; thus, these findings should be considered hypothesis generating.

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Conflict of interest statement

R Aft and M Naughton have received honoraria from Novartis. The remaining authors have no conflict of interest.

Figures

Figure 1
Figure 1
Study design. Abbreviations: DFS=disease-free survival; DTC=disseminated tumour cells; IV=intravenous; OS=overall survival; ZOL=zoledronic acid (4 mg every 3 weeks).
Figure 2
Figure 2
Disease-free survival (A) and overall survival (B) were similar between the ZOL and no-ZOL arms for the overall trial population. Abbreviations: DFS=disease-free survival; OS=overall survival; ZOL=zoledronic acid (4 mg every 3 weeks); ○=censored.
Figure 3
Figure 3
Kaplan–Meier estimates of (A) disease-free survival and (B) overall survival in all patients according to the ER status of their tumours. Abbreviations: DFS=disease-free survival; ER=oestrogen receptor; ZOL=zoledronic acid (4 mg every 3 weeks); ○=censored.
See this image and copyright information in PMC

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