Treatment Results of Capecitabine Metronomic Chemotherapy in Locally Advanced Nasopharyngeal Carcinoma after Standard Chemoradiotherapy– A Single- Arm Phase II Study

Background: High recurrence risk exists for patients with locoregionally 
advanced nasopharyngeal carcinoma (NPC) thus adjuvant therapies are required 
to lower the risk of recurrence and mortality. This phase II trial was designed for 
evaluating the effectiveness and safety of adding metronomic capecitabine as an 
adjuvant therapy to chemoradiation in patients with locally advanced NPC.
Methods: This prospective single-arm phase II single trial involved 41 patients 
aged from 18 to 75 years, with locally advanced NPC (Stage III - Stage IVA) 
with no previous treatment or distant metastases at diagnosis. Oral metronomic 
capecitabine (Xeloda; 650 mg/m² body surface area was administered twice 
daily for 1 year. Clinical or imaging exams were conducted. Individuals were 
assessed to have had a full response when they showed no recorded signs of the 
disease following the completion of therapy and were free from disease for three 
months at least. The duration of follow-up was for 24 months.
Results: Locoregional recurrence was developed in 6 (14.63%). Rates of twoyear overall survival (OS) for all patients (n = 41) in this trial was 92.68%, the 
2-year disease free survival (DFS) rate for them was 85.37% and progression 
free survival (PFS) was 78.05%.
Conclusions: Metronomic chemotherapy with capecitabine was a promising 
treatment for patients with locally advanced NPC. The 2-year OS and PFS were 
improved, and the acute and late toxicities were tolerated.