Early TNBC: capecitabine after standard chemo fails to extend DFS in phase 3 GEICAM-CIBOMA

  • Lluch A & al.
  • J Clin Oncol
  • 5 Dec 2019

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

  • The phase 3 Spanish GEICAM-CIBOMA trial failed to show that capecitabine after standard (neo)adjuvant chemotherapy extends DFS in early triple-negative breast cancer (TNBC).
  • One subgroup, patients with nonbasal phenotype, appears to show capecitabine benefit.

Why this matters

  • Patients with nonbasal phenotype should be subject to additional validation of capecitabine's apparent benefit.

Study design

  • Phase 3 randomized controlled trial of 876 patients with operable, node-positive or node-negative, tumor size ≥1 cm early TNBC with prior anthracycline- and/or taxane-containing (neo)adjuvant chemotherapy.
  • Randomization was to observation or to 8 cycles of capecitabine (2000 mg/m2 per day on days 1-14 every 3 weeks).
  • Primary outcome was DFS.
  • Funding: F. Hoffmann-LaRoche.

Key results

  • Median follow-up, 7.3 years.
  • Median age, 49 years.
  • Lymph node negative, 55.9%; basal phenotype, 73.9%.
  • Capecitabine (vs observation) did not prolong DFS (HR, 0.82: P=.136).
    • In subgroup analysis, nonbasal phenotype showed longer DFS (HR, 0.530 vs 0.942 with basal phenotype; interaction test P=.0694) and OS (HR, 0.42 vs 1.23, respectively; interaction test, P=.0052).
  • No unexpected adverse events, with 75.2% of patients finishing the 8 capecitabine cycles.

Limitations

  • Open-label design.
  • Subjects had much lower recurrence rate than expected.