Phase II trial of capecitabine plus cisplatin as first-line therapy in patients with metastatic nasopharyngeal cancer.

Background Capecitabine is an oral fluoropyrimidine with single-agent activity in metastatic nasopharyngeal carcinoma (NPC). This multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus cisplatin as a first-line treatment for metastatic NPC. Methods Patients with metastatic NPC received cisplatin 100 mg/m2 day 1 plus capecitabine 1000 mg/m2 twice daily on days 1 to 14 every 3 weeks for 68 cycles. The primary endpoint was overall response rate. Results Forty-four patients were enrolled; 39 patients were evaluable for efficacy. The overall response rate was 53.8% (95% confidence interval [CI], 37%70%), including 1 complete response. Median time to tumor progression was 7.3 months (95% CI, 5.69.9 months) and median overall survival was 28.0 months (95% CI, 14.5 monthsnot reached). Common grade 3/4 adverse events were neutropenia (50%), vomiting (11%), thrombocytopenia (9%), and nausea (7%). Conclusions Capecitabine plus cisplatin is an active first-line combination in metastatic NPC that requires a short hospital stay. (C) 2011 Wiley Periodicals, Inc. Head Neck, 2012