TNBC: add-on capecitabine improves DFS in phase 3 trial

  • Li J & al.
  • J Clin Oncol
  • 10 Apr 2020

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

  • A phase 3 trial from China finds that add-on capecitabine improved DFS in patients with nonmetastatic, newly diagnosed triple-negative breast cancer (TNBC).

Why this matters

  • Current treatment guidelines mention the benefit of add-on capecitabine, but without a firm recommendation because of a lack of evidence to date.
  • The results of this trial suggest that capecitabine should be formally incorporated into treatment guidelines.

Study design

  • Phase 3, open-label, randomized controlled trial (RCT; CBCSG010) of add-on capecitabine vs control (N=585).
  • Add-on capecitabine consisted of 3 cycles of capecitabine plus docetaxel followed by 3 cycles of capecitabine plus epirubicin and cyclophosphamide.
  • Control consisted of 3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide.
  • Funding: Chinese Ministry of Education; other.

Key results

  • Median follow-up, 67 months.
  • The capecitabine group had a higher 5-year DFS rate vs the control group (86.3% vs 80.4%; HR, 0.66; P=.044).
  • The capecitabine had numerically higher but not significantly better 5-year OS (93.3% vs 90.7%, respectively).
  • No new safety signal emerged, but 39.1% of capecitabine patients needed dose reductions.

Limitation

  • Open-label design.