- Adding zoledronic acid (ZA) to neoadjuvant chemotherapy worsened OS but had no effect on disease-free survival (DFS) in a secondary analysis of data from the phase 3 NEOZOTAC trial of human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Why this matters
- Findings confirm the lack of improvement in the primary outcome (pathologic complete response) published in 2014.
- Findings suggest that the bisphosphonate ZA carries no benefit for patients with breast cancer.
- Randomized controlled trial (n=246) of HER2-negative breast cancer patients (stage II/III) given the standard 6 cycles of neoadjuvant TAC (docetaxel/doxorubicin/cyclophosphamide) ± 4 mg intravenous ZA within 24 hours of chemotherapy.
- Secondary outcomes: DFS, OS.
- Funding: Dutch Cancer Society; Novartis; Sanofi Aventis; Amgen.
- Median follow-up, 6.43 years.
- ZA recipients (vs no ZA) had worse OS on multivariate analysis (HR, 0.468; P=.040).
- No difference between groups (ZA vs no ZA) in DFS.
- Although baseline insulin growth factor-1 receptor expression was not associated with DFS or OS, lower baseline serum insulin levels were associated with improved DFS (HR, 1.025; P=.014) in a predefined additional study.
- Small sample size.