Salvage gemcitabine-vinorelbine chemotherapy in patients with metastatic nasopharyngeal carcinoma pretreated with platinum-based chemotherapy.

OBJECTIVES: Platinum-based chemotherapy is the recognized first-line treatment for metastatic nasopharyngeal carcinoma (NPC). However there is no standard second-line treatment. This study was designed to evaluate the efficacy and safety of a gemcitabine and vinorelbine combination (GV) in patients with metastatic NPC previously treated with platinum-based chemotherapy.

METHODS: A total of 61 patients with metastatic NPC after prior platinum-based chemotherapy were enrolled. Gemcitabine (1000 mg/m(2)) and vinorelbine (25mg/m(2)) were administered intravenously on Day 1 and Day 8 every 3 weeks.

RESULTS: In this study, the overall response rate was 37.7% (95% CI, 25.5-49.9%) one complete response (1.6%) and 22 partial responses (36.1%). The median progression-free survival was 5.2 months (95% CI, 3.4-7.0 months) and the median overall survival was 14.1 months (95% CI, 11.1-17.1 months). Grade 3/4 toxicity including leucopenia (19.7%), neutropenia (18%), anemia (4.9%) and thrombocytopenia (6.5%) were tolerable. Univariate and multivariate analyses indicated age and salvage treatment after failure of GV treatment were independently significant prognostic factors.

CONCLUSION: Our preliminary result shows gemcitabine and vinorelbine combination is effective and safe for the patients with advanced NPC pretreated with platinum-based chemotherapy. Further clinical study is warranted.