Nimotuzumab with Induction Chemotherapy and Chemo-Radiation in Patients with Advanced Head and Neck Cancer

Abstract

Background: Head and neck squamous cell carcinoma (HNSCC), is a common malignancy in the Indian Population. In locally advanced disease, chemoradiation is the standard of care. Although induction chemotherapy has been much studied, no clear benefit has been identified apart from laryngeal preservation. A few randomized trials have demonstrated improved response rate, disease free survival, and overall survival, with induction chemotherapy. Nimotuzumab is a humanized monoclonal antibody targeting epidermal growth factor receptors (EGFR). Unlike other Anti-EGFR monoclonal antibodies, it is demonstrated to be safer when combined with chemotherapy and/or radiotherapy. Aim: To evaluate the safety and efficacy of concurrently administered nimotuzumab with chemo-radiotherapy in patients with HNSCC in usual health care setting. Methods: This was an open-label, single arm study, with retrospective analysis of results. Patients above 18 years of age, and having histologically confirmed, advanced HNSCC were included in the study. The patients were treated with 3 cycles of induction chemotherapy consisting of modified TPF regimen along with nimotuzumab (200 mg IV) on Day 1, followed by radiotherapy for a dose of 66 Gy along with concurrent weekly cisplatin (30 mg/m 2 ) and nimotuzumab (200 mg) throughout the course of radiation. Patients were evaluated using RECIST criteria, 4 weeks after the last cycle of chemotherapy. Results: Sixteen patients were included in this study, with mean age of 54 ± 11 years. Most common sub-site of cancer was oral cavity in 69% (n = 11), followed by pharynx in 19% (n = 3). Four patients had metastasis at the time of presentation. Six patients (37.5%) had progressive disease and four patients (25%) were lost to follow-up. The combination chemotherapy with nimotuzumab was well tolerated. Addition of nimotuzumab to TPF regimen was not associated with added toxicity. Conclusion: Addition of anti-EGFR monocloncal antibody (nimotuzumab) to induction chemotherapy and chemoradiation may be a promising alternative to concurrent chemoradiotherapy in HNSCC due to known over expression of EGFR receptors. The results of this study need further evaluation in a larger study setting.