Key clinical point: Low-dose capecitabine maintenance therapy for 1 year after standard adjuvant chemotherapy resulted in significantly better disease-free survival (DFS) but not overall survival (OS) in women with early triple-negative breast cancer (TNBC).
Major finding: Capecitabine vs. observation group had significantly higher estimated 5-year DFS (82.8% vs. 73%; hazard ratio [HR], 0.64; P = .03) and distant DFS (85.8% vs. 75.8%; HR, 0.60; P = .02) but not OS (85.5% vs. 81.3%; HR, 0.75; P = .22). Hand-foot syndrome (45.2%) was the most common adverse event in the capecitabine group, with 7.7% of patients experiencing grade 3 event.
Study details: Phase 3 SYSUCC-001 trial randomly allocated 434 women with early TNBC to receive either low-dose capecitabine maintenance (n=221) or undergo observation (n=213) within 4 weeks after completion of standard adjuvant chemotherapy.
Disclosures: This study was funded by Sun Yat-sen University, the National Natural Science Foundation of China, Natural Science Foundation of Guangdong Province, and F. Hoffmann-La Roche Ltd. The study investigators did not report any conflict of interest.
Source: Wang X et al. JAMA. 2021 Jan 5. doi: 10.1001/jama.2020.23370.