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ABSTRACT: 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.
Patients with metastatic NPC received cisplatin 100 mg/m(2) day 1 plus capecitabine 1000 mg/m(2) twice daily on days 1 to 14 every 3 weeks for 6-8 cycles. The primary endpoint was overall response rate.
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, 5.6-9.9 months) and median overall survival was 28.0 months (95% CI, 14.5 months-not reached). Common grade 3/4 adverse events were neutropenia (50%), vomiting (11%), thrombocytopenia (9%), and nausea (7%).
Capecitabine plus cisplatin is an active first-line combination in metastatic NPC that requires a short hospital stay.
Head & Neck 11/2011; 34(9):1225-30. · 2.83 Impact Factor