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