Metronomic capecitabine maintenance after standard treatment has been shown to be a successful therapy for patients with triple-negative breast cancer (TNBC) in a recent study. Results of this study will be reported on later this week in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program.
Relapse and unfavorable outcomes are still issues among patients with TNBC. According to lead study author XI Wang, MD of the Department of Breast Oncology at Sun Yat-Sen University Cancer Center in Guangzhou, China, and colleagues, "[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 needs."
Efficacy was shown in a phase 3 clinical trial called SYSUCC-001 (NCT01112826) that enrolled patients with operable TNBC. Of the 434 patients that were enrolled in the study, 221 were designated to receive metronomic capecitabine at a dose of 650 mg/m2 twice daily for one year, while the rest were put in an observation group. Disease-free survival (DFS) was the primary end point. Secondary end points were distant disease-free survival (DDFS), overall survival (OS), and safety.
After a median follow-up of 56.5 months, DFS was significantly increased in the capecitabine group compared with the observation group (83% vs 73%). In addition, participants in the capecitabine group achieved a higher DDFS than those in the observation group (85% vs 76%). Overall survival was not significantly different between the two groups (85% vs 81%). Treatment-related adverse events that appeared in the capecitabine group included hand-foot syndrome (46%), leukopenia (24%), hyperbilirubinemia (13%), gastrointestinal pain (7%), and elevated serum transaminases (5%).
These results reveal that not only is metronomic capecitabine maintenance more effective than observation in patients with TNBC, but also it is a safe and well-tolerated treatment.
For More Information
Clinicaltrials.gov (2020). Efficacy of capecitabine metronomic chemotherapy to triple-negative breast cancer (SYSUCC-001). NLM Identifier: NCT01112826.
Wang XI, Wang SS, Huang H, et al (2020). Phase III trial of metronomic capecitabine maintenance after standard treatment in operable triple-negative breast cancer (SYSUCC-001). J Clin Oncol (ASCO Virtual Scientific Program), 38(suppl_15). Abstract 507. DOI:101200/JCO.2020.38.15_suppl.507
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