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