Multicenter phase II study of capecitabine combined with nedaplatin for recurrent and metastatic nasopharyngeal carcinoma patients after failure of cisplatin-based chemotherapy

Abstract

There is no standard second-line regimen for recurrent and metastatic nasopharyngeal carcinoma patients after failure of cisplatin-based chemotherapy. A multicenter phase II study was conducted to evaluate the efficacy and toxicity of capecitabine combined with nedaplatin for these patients. In the multicenter, open-label, single-arm phase II study, patients with recurrent and metastatic nasopharyngeal carcinoma who failed to previous cisplatin-based chemotherapy were enrolled. Patients received oral capecitabine (1,000mg/m(2) twice daily from day 1 to 14) and intravenous nedaplatin (80mg/m(2), day 1) every 3weeks for two cycles at least. A total of forty-eight patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. Treatment was well tolerated. Grade 3/4 toxicities included neutropenia (8.4%), anemia (2.1%), diarrhea (4.2%), stomatitis (6.3%), and hand-foot syndrome (HFS) (4.2%). There were two complete response (4.2%), eighteen partial responses (37.5%), giving an overall response rate of 41.7% [95% confidence interval (CI) 27.7-55.8]. With a median follow-up period of 12.1months, the median time to progression was 5.8months (95% CI 3.9-7.8months) and median overall survival was 12.4months (95% CI 9.6-16.8months). Capecitabine combined with nedaplatin offers a satisfactory clinical activity and an acceptable safety profile for recurrent and metastatic nasopharyngeal carcinoma patients after failure of cisplatin-based chemotherapy.