- Adding adjuvant capecitabine to standard treatment for early triple-negative breast cancer (TNBC) failed to significantly extend disease-free survival (DFS) or OS in the phase 3 CIBOMA_GEICAM trial.
Why this matters
- Some benefit was observed in a subset of patients with nonbasal-like disease, but the findings should be interpreted with caution.
- Trial of 876 patients with TNBC who received (neo)adjuvant therapy with standard anthracycline and/or taxane-containing chemotherapy and who underwent surgery with negative margins.
- Patients were randomly assigned to 8 cycles of capecitabine or observation.
- Funding: Roche.
- Funding: Dr. Martín has received speaker honoraria from Pfizer and Lilly; research grants from Novartis and Roche; and advisory board honoraria from AstraZeneca, Novartis, Roche-Genentech, Pfizer, GlaxoSmithKline, PharmaMar, Taiho Oncology, and Lilly.
- Median follow-up, 7.34 years.
- 5-year DFS was similar with capecitabine vs observation (79.6% vs 76.8%; HR, 0.82; P=.1353).
- HR remained nonsignificant (aHR, 0.79; P=.082) after adjustment for location, prior (neo)adjuvant therapy, number of nodes involved, and TNBC phenotype.
- 5-year OS was similar with capecitabine vs observation (86.2% vs 85.9%; HR, 0.92; P=.6228).
- In a subset of patients with nonbasal-like phenotype (28.3%):
- 5-year DFS was higher with capecitabine (82.6% vs 72.9%; HR, 0.53; P=.02).
- OS was also higher with capecitabine (89.5% vs 79.6%; HR, 0.42; P=.007).
- Fewer than expected relapses in the observation group.