SABCS 2018 — Adjuvant T-DM1 may be the new standard for high-risk HER2+ breast cancer


  • Konferenzberichte Onkologie
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Takeaway

  • Adjuvant therapy with trastuzumab emtansine (T-DM1) rather than trastuzumab alone decreased invasive recurrence of human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer by 50% (HR, 0.5; P<.0001 in patients with residual invasive disease after undergoing neoadjuvant chemotherapy and her2-targeted therapy taxane before surgery.>

Why this matters

  • Residual invasive disease in the breast or axillary nodes is linked to a higher risk for recurrence and death.

Study design

  • Phase 3 trial of 1486 patients with HER2+ early breast cancer and residual invasive disease, randomly assigned 12 weeks after surgery to receive 14 cycles of trastuzumab or T-DM1 adjuvant therapy.
  • The research was funded by Roche and Genentech. Dr. Geyer has received travel support from Roche and AstraZeneca, medical writing support from AbbVie and Roche, and honoraria from Celgene.

Key Results

  • 3-year invasive disease-free survival (IDFS) was 88.3% with T-DM1 vs 77% with trastuzumab.
  • Benefits seen across all included subgroups and demographics. 
  • Adverse effects were mostly grade 1 or 2, including platelet count drop, liver enzyme elevations, and sensory neuropathy.

Limitations 

  • Confirmation of positive HER2+ relied on pretreatment core biopsy of primary tumor, not residual tumor.
  • Open-label design.