HER2+ breast cancer: chemo added to trastuzumab offers no benefit for older patients

  • Sawaki M & al.
  • J Clin Oncol
  • 16 Sep 2020

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

  • Trastuzumab+chemotherapy is no better than trastuzumab alone in elderly women (aged 70-80 years) with HER2+ early breast cancer.
  • The combination also involved more adverse effects and worse QoL.

Why this matters

  • This trial is the first to examine this combination in women in this age range.

Study design

  • Open-label, randomized controlled trial of trastuzumab with and without chemotherapy (N=275).
  • Chemotherapy consisted of 7 different regimens including docetaxel, paclitaxel, and cyclophosphamide.
  • Primary outcome: DFS.
  • Funding: Public Health Research Foundation, Japan.

Key results

  • Mean follow-up, 4.1 years.
  • 3-year DFS was no different between groups (HR, 1.36; P=.51), but noninferiority was not met.
  • Restricted mean survival time at 3 years was no different between groups (−0.39 months; P=.56).
  • 3-year relapse-free survival was no different between groups (HR, 1.33; P=.53).
  • Compared with the combination, trastuzumab monotherapy was linked to better health-related QoL (using the Functional Assessment of Cancer Therapy-general) at:
    • 2 months: 31% vs 48% (P=.016).
    • 1 year: 19% vs 38% (P=.009).
  • Trastuzumab monotherapy involved fewer common adverse events compared with trastuzumab plus chemo:
    • Anorexia: 7.4% vs 44.3% (P<.0001>
    • Alopecia: 2.2% vs 71.7% (P<.0001>
    • Grade 3/4 nonhematologic adverse events: 11.9% vs 29.8% (P=.0003).

Limitations

  • Primary outcome of noninferiority of DFS was not met.
  • Open-label design.