Add-on zoledronic acid shows benefit in neoadjuvant breast cancer

  • Crocamo S & al.
  • Ther Adv Med Oncol
  • 1 Jan 2019

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Adding zoledronic acid to neoadjuvant chemotherapy and trastuzumab yielded a 42% pathologic complete response (pCR) rate in a phase 2 trial of human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Why this matters

  • In preclinical studies, zoledronic acid demonstrated a synergistic effect with chemotherapy, partly by interacting with the HER2 pathway.
  • Zoledronic acid is a feasible, effective, affordable, and well-tolerated therapeutic option that warrants a larger, randomized controlled trial.

Study design

  • Zo-NAnTax trial of 71 patients with stage IIa-IIIb breast cancer in a single Brazilian center.
  • Patients received 8 cycles of zoledronic acid (4 mg/dose) accompanying 4 cycles of doxorubicin/cyclophosphamide, followed by 4 cycles of docetaxel and trastuzumab before surgery.
  • Funding: None.

Key results

  • The overall pCR rate was 42% (partial response, 58%).
  • The pCR rate was higher in patients with nuclei/cytoplasmic β-catenin expression (P=.030).
  • The pCR rate was not significantly higher in hormone receptor (HR)-negative (44%; 95% CI, 31%-56%) vs HR-positive (40%; 95% CI, 27%-52%) patients.
  • The most frequent grade 3 and 4 adverse events with the entire treatment regimen were febrile neutropenia (20% and 3%, respectively) and diarrhea (12% and 0%, respectively).
  • No cases of cardiotoxicity or jaw osteonecrosis were observed.

Limitations

  • Nonrandomized design.
  • No control group.
  • Single-center study.