Gemcitabine plus cisplatin versus fluorouracil plus cisplatin as a first-line concurrent chemotherapy regimen in nasopharyngeal carcinoma: a prospective, multi-institution, randomized controlled phase II study

Abstract

Background: The objective of this study was to evaluate the efficacy and safety of gemcitabine plus cisplatin concurrent chemoradiotherapy (CCRT) in patients with nasopharyngeal carcinoma. Method: Patients with NPC were randomly assigned to the gemcitabine plus cisplatin (GP) group or fluorouracil plus cisplatin (PF) group. Primary end-point was disease-free survival (DFS); secondary endpoints: overall survival, distant metastasis-free survival (DMFS), locoregional relapse-free survival, and treatment-related adverse events. Results: Seventy-six patients were prospectively enrolled and the median follow-up time was 41 months (9–61 months). Three-year DFS were similar between the GP and PF groups (73.7% vs. 60.5%, HR 0.66, 95% CI 0.30–1.44; P = 0.30). Distant metastasis was the most common failure form in PF compared with GP (P = 0.034). Three-year DMFS was significantly better in the GP group than PF group (89.5% vs. 71.1%, P = 0.045). Grade 3–4 gastrointestinal toxicities (vomiting and diarrhea) were significantly more common in the PF group; grade 3–4 neutropenia and thrombocytopenia were more common in the GP group. Conclusion: Gemcitabine plus cisplatin could be used as an alternative regimen in CCRT for nasopharyngeal carcinoma.