Phase II clinical trial of h-R3 combined with radiotherapy in locally advanced nasopharyngeal carcinoma.

PURPOSE: The purpose of this study was to evaluate the short- and long-term efficacy and toxicity of the humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody h-R3 when combined with radiotherapy for the treatment of locally advanced nasopharyngeal carcinoma (NPC). METHODS: 35 patients with stage III-IVb NPC with moderate- or strong-intensity EGFR expression were randomly divided into either a radiotherapy alone group or a group receiving radiotherapy combined with h-R3. RESULTS: The complete remission (CR) rates of the combination group at three time points were significantly higher (p<0.05) than those of the radiotherapy alone group. Overall survival, 3-year local control rate, and no distant metastasis rate did not differ between the two groups. No severe toxicity was noticed. CONCLUSION: h-R3 is an agent with good safety profile which could help enhance the radiation antitumor effect in locally advanced NPC, but it did not seem to exhibit significant long-term efficacy.