Maintenance Metronomic Capecitabine Extends DFS in TNBC
One year of maintenance metronomic capecitabine therapy after standard treatment significantly improved disease-free survival (DFS) and was shown to be safe and tolerable in patients with operable triple-negative breast cancer (TNBC), according to study findings being presented at the virtual 2020 ASCO Annual Meeting.
“[TNBC] has a relatively high relapse rate and poor outcome after standard therapy among all subtypes of breast cancer. Effective strategies to reduce risk of relapse and death are unmet medical needs,” explained XI Wang, MD, Departments of Breast Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, and co-investigators.
Overall, 434 patients with operable TNBC were enrolled in the phase 3 study and randomized to receive metronomic capecitabine 650 mg/m2 twice daily continuously for one year as maintenance therapy (n = 221) or observation (n = 213) following standard local and systemic treatment.
DFS was the primary end point, and secondary end points included distant DFS (DDFS), overall survival (OS), and safety.
Ultimately, 202 (91.4%) patients completed 1 year of capecitabine therapy as planned.
As of a median follow-up of 56.5 months, the 5-year DFS rate with capecitabine was significantly better than with observation (83% vs 73%, respectively; hazard ratio [HR], 0.63; 95% CI, 0.42-0.96; P = .027).
Furthermore, the 5-year DDFS rate was significantly better with capecitabine versus observation (85% vs 76%, respectively; HR, 0.56; 95% CI, 0.37-0.90; P = .016).
Of note, the 5-year OS rate did not significantly differ between the 2 treatment arms (85% vs 81%, respectively; HR, 0.74; 95% CI, 0.47-1.18; P = .203).
Hand-foot syndrome (46%), leukopenia (24%), hyperbilirubinemia (13%), gastrointestinal pain (7%) and elevated serum transaminases (5%) were the most frequently reported capecitabine-related adverse events.
“Maintenance therapy with metronomic capecitabine for one year following standard treatment significantly improved DFS in operable TNBC, which was safe and well tolerated,” Dr Wang and colleagues concluded.—Hina M. Porcelli
Wang X, Wang SS, Huang H, et al. Phase III trial of metronomic capecitabine maintenance after standard treatment in operable triple-negative breast cancer (SYSUCC-001). Presented at: the 2020 ASCO Annual Meeting; May 29-31, 2020. Abstract 507.
