Phase II Clinical Study of Gemcitabine in the Treatment of Patients with Advanced Nasopharyngeal Carcinoma After the Failure of Platinum-based Chemotherapy

Purpose: This study was designed to evaluate the anti-tumor activity and toxicity profile of gemcitabine in the treatment of patients with advanced nasopharyngeal carcinoma (NPC) who had been pretreated with platinum-based chemotherapy.

Method: This is an open label, single arm phase II trial. All patients were treated with single agent of gemcitabine. Gemcitabine was given in the dosage of 1.0 g/m(2) on days 1, 8, 15, each cycle repeated every 4 weeks. Gemcitabine was added to 100 ml normal saline infused over 30 min.

Result: About 32 patients were enrolled in this trial. Thirty patients were assessable for response to treatment. Fourteen patients had a partial response (PR), giving an overall response rate of 43.8% (14/32); 9 patients had stable disease (28.1%) and 7 progressed disease (21.9%). The median time to progression was 5.1 months and median survival time was 16 months, 1 year survival rate was 67%, 2 year overall survival rate was 12%. A total of 11 patients (34.4%) experienced grade 3 and 4 toxicity and the main toxicity was myelosuppression. the non-hematology toxicity was minimal.

Conclusion: The effectiveness of gemcitabine was higher and side effects were minimal in advanced NPC patients after platinum-based chemotherapy failed.