5538 Background: Nasopharyngeal carcinoma (NPC) is a disease with distinctive epidemiology and clinical behavior compared with Head and neck cancer (HNC) and more common in South-East Asia. Sorafenib monotherapy has been shown modest anticancer activity in HNC and NPC (C Elser et al; JCO 2007). This study was to evaluate the efficacy and tolerability of sorafenib combined with cisplatin and 5-fluorouracil (5-FU) for patients with recurrent or metastatic NPC. Methods: A phase II, single arm clinical trial was conducted in three centers in China. Chemotherapy-naive histologically confirmed NPC patients with recurrent or metastatic disease were enrolled. Patients received oral sorafenib 400mg bid continuously until disease progression or unacceptable toxicity, cisplatin 80mg/m2 intravenously (iv) on day 1-5, and 5-FU 400mg/m2 iv infusion for 96 hours on day 1. Treatment was repeated every 21 days for a maximum of 6 cycles. Results: 54 patients were enrolled. Most patients were with bone metastases (70.0%), followed by liver (56%) and lung metastases (56%). The median chemotherapy administrated was 4.0 cycles (range, 2 - 6 cycles). The disease control rate (DCR) reached 90.7%, including one complete response (CR), 41 partial responses (PR) and 7 stable diseases (SD). Median PFS was 7.2 months (95% CI 6.8-8.4 months) and median OS was 11.8 months (95% CI 10.6-18.7 months). Tumor cavitation after treatment was observed in 32.1% of patients with lung metastases. Decreased percentage of contrast update in responder patients (PR and CR) with liver metastases was also observed by Contrast-Enhanced Doppler ultrasound. The major toxicities include hand foot syndrome (HFS), myelo-suppression and gastrointestinal reaction.Dose reduction of sorafenib was required in 22 patients (40.7%) and dose interruption in 14 patients (25.9%) because of toxicity. Conclusions: Sorafenib combined with cisplatin and 5-FU has an encouraging efficacy profile with tolerable toxicity. Further randomized studies are needed to confirm the clinical benefit of sorafenib combined with chemotherapy in recurrent or metastatic NPC.
A phase II study evaluating the safety and efficacy of an adenovirus-ΔLMP1-LMP2 transduced dendritic cell vaccine in patients with advanced metastatic nasopharyngeal carcinoma
