Breast cancer: subcutaneous trastuzumab similarly effective to IV formulation

  • JAMA Oncol

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

  • Final results of the phase 3 HannaH trial confirm that subcutaneous (SC) trastuzumab is comparable in safety and efficacy to intravenous (IV) trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Why this matters

  • SC trastuzumab is preferred by patients by virtue of shorter treatment times, potentially lower costs, and increased convenience.

Study design

  • Open-label, multicenter, international neoadjuvant-adjuvant randomized, phase 3 noninferiority clinical trial (n=596).
  • Patients randomly assigned to fixed-dose SC trastuzumab (600 mg) or IV trastuzumab (loading dose 8 mg/kg, then maintenance dose 6 mg/kg) every 3 weeks for 8 cycles with neoadjuvant chemotherapy+an additional 10 cycles of SC or IV trastuzumab after surgery in the adjuvant setting for a total of 1 year of anti-HER2 therapy.
  • Funding: F. Hoffmann-LaRoche Ltd.

Key results

  • Median follow-up was 5.9 years.
  • No difference between SC and IV groups:
    • 6-year event-free survival (EFS; 65% vs 65%; HR, 0.98; 95% CI, 0.74-1.29).
    • 6-year OS (84% vs 84%; HR, 0.94; 95% CI, 0.61-1.45).
  • Safety was comparable across groups:
    • incidence of adverse events (SC vs IV: 97.6% vs 94.6%);
    • grade ≥3 adverse events (53.2% vs 53.7%);
    • cardiac events (14.8% vs 14.1%); and
    • serious adverse events (21.9% vs 15.1%).

Limitations

  • Open-label design.

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