A Phase Ii Study Of Nimotuzumab (Theracim-Hr3) Concurrent With Cisplatin/Radiotherapy In Patients With Locally Advanced Head And Neck Squamous Cell Carcinoma

Background The efficacy of a combination of nimotuzumab, a humanized monoclonal antibody to the epidermal growth factor receptor, with chemoradiation in locally advanced head and neck squamous cell carcinoma (HNSCC) was evaluated in a phase II study.Methods Patients with stage III/IV HNSCC received 3-weekly cisplatin 100 mg/m(2) for three cycles and weekly nimotuzumab 200 mg for 8 weeks concurrently with radiotherapy. Primary endpoint was best overall response (BOR) and secondary endpoint was progression-free survival (PFS).Results Thirty-seven patients were included; the majority were Chinese (76%), male (89%), and had stage IVA/IVB HNSCC (92%). BOR of complete and partial response was seen in 22/37 (59%) and 10/37 (27%) patients, respectively. Median PFS was 17.5 months (95% CI: 11.1-54.5) and 3-year PFS was 40.4% (95% CI: 24.3-55.9). The frequency and type of adverse events observed were similar to standard chemoradiation.Conclusion The combination of nimotuzumab with cisplatin and radiotherapy was safe and achieved high response rates in HNSCC.