LABC: add-on bevacizumab safe, effective in phase 2 trial

  • Tampaki EC & al.
  • Clin Drug Investig
  • 9 May 2018

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

  • In a phase 2 trial, bevacizumab added on to liposomal doxorubicin, cyclophosphamide, and paclitaxel is safe and effective for treating premenopausal women with grade 3 locally advanced breast cancer (LABC; tumor size >3 cm) that is human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor (HR)-positive, or triple-negative breast cancer (TNBC) subtype.

Why this matters

  • Progression to phase 3 trial is warranted.

Study design

  • 62 patients were given intravenous liposomal doxorubicin 30 mg/m2, cyclophosphamide 600 mg/m2, paclitaxel 120 mg/m2, and bevacizumab 8 mg/kg on day 1 of 15-day cycles for 4 cycles.
  • Primary outcomes were clinical complete response (cCR) and pathologic complete response (pCR).
  • Patients were followed for 3 years.
  • Funding: None.

Key results

  • 32.3% of patients were hormone-receptor positive (HR+), 67.7% were TNBC, and all received surgery.
  • cCR was 25.8%.
  • pCR was 38.7%:
    • For TNBC patients pCR was 42.9%;
    • For HR+ patients pCR was 30%.
  • DFS was 87.1%.
  • Hematologic adverse events (AEs) included neutropenia (74.2% across all grades; 22.6% grade [G] 3) and febrile neutropenia (6.5% G3).
  • Nonhematologic AEs G3 included nausea (6.5%), mucositis (9.7%), and grade 1/2 infection (3.2%), all managed effectively.

Limitations

  • Small sample size.
  • No control group.

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