PURPOSE: Patients with residual nasopharyngeal carcinoma after receiving standard-of-care treatment have poor prognoses. In this trial, we aimed to assess the efficacy and safety of capecitabine maintenance therapy in patients with residual nasopharyngeal carcinoma. PATIENTS AND METHODS: This open-label, single-arm, phase 2 trial was conducted at Sun Yat-sen University Cancer Center. We recruited patients aged 18-70 years with an ECOG performance-status score of 0-1, histopathological, cytological confirmed nasopharyngeal carcinoma (without distant metastasis), who had residual disease after receiving definitive treatment. Patients received 1 year of capecitabine maintenance therapy. The primary endpoint was 2-year progression-free survival. RESULTS: Between January 1, 2019, and December 30, 2022, 111 patients were recruited and commenced capecitabine maintenance therapy for 1 year. After a median follow-up duration of 34.8 months (IQR 30.5-45.2), progression-free survival was 92% at 1-year
86% at 2 years
and 81% at 3 years. Adverse events were reported in 97.3% of patients. Hand-foot syndrome was the most common adverse event (59.5%). In addition, 28.7% of patients experienced grade 3 treatment-related adverse events, the most common of which was hand-foot syndrome (7.2%)
no grade 4-5 adverse events were recorded. 72.1% of patients received the full dosage of capecitabine. 76.6% of patients completed the 1-year capecitabine maintenance therapy. CONCLUSIONS: The anti-tumor efficacy of capecitabine maintenance therapy is promising, and the safety profile is manageable in patients with residual nasopharyngeal carcinoma after receiving standard-of-care treatment.