Multicenter phase 3 trial of adjuvant metronomic capecitabine in locoregionally advanced nasopharyngeal carcinoma: long-term outcomes

A multicenter phase 3 trial in China randomized 406 patients with locoregionally advanced nasopharyngeal carcinoma (NPC) who had completed definitive chemoradiotherapy 1:1 to either adjuvant metronomic capecitabine (650 mg/m² twice daily for one year) or observation. The trial met its primary endpoint of failure-free survival. Long-term outcomes have now been reported. With a median follow-up of 71.3 months, metronomic capecitabine significantly improved overall survival (HR 0.53; p=0.019). Grade 3 adverse events occurred in 17% of patients in the metronomic capecitabine group and 6% of patients in the observation group; one case of grade 4 neutropenia was observed. Patients with a higher post-radiotherapy neutrophil-to-lymphocyte ratio derived greater benefit from metronomic capecitabine. The authors conclude that these findings demonstrate the long-term therapeutic benefit from adjuvant metronomic capecitabine in locoregionally advanced NPC.