Nimotuzumab in management of recurrent/metastatic head and neck cancer: A pilot study

Abstract

Background: Roleof nimotuzumab in locally advanced head and neck cancer (HNC) is well established in India, however no clinical evidence is available for its role in recur-rent/metastatic HNC. We conducted a pilot study to evaluate efficacy and safety of nimotuzumab when added to conventional therapy in management ofrecurrent/meta-static HNC. Methods: The hospital records of 16 patients who were diagnosed with recurrent or metastatic HNC with histologically confirmed squamous cell carcinoma and treated with nimotuzumab from December 2010 till December 2016 were evaluated. Of these, 2 patients who were treated with cetuximab were excluded and 14 patients were considered for final analysis. Demographic details, risk factors, ECOG score, tumour charac-teristics such as anatomical subsites, histopathological grades, TNM staging were noted. Tumour response was calculated as per RECIST criteria 1.1. Overall survival was calculated from date of diagnosis using Kaplan-Meier method. All patients were assessed for toxicity and adverse events (AEs) were reported as per CTCAE version 4.0. Statistical analysis was done using STATA (V. 12) software. Results: A total of 14 patients (12 male/2 female, median age 58.5 6 14.56 years) were considered for the analysis. Oral cavity was most commonly involved region (N=5) followed by hypopharynx (3), oropharynx (4) and unknown primary (2). All patients were treated with nimotuzumab along with conventional treatment. At 24 weeks after completion of treatment, overall response rate (complete response [CR] θ partial response [PR]) was 75% and 25% patients had progression of disease. Survival at 1 year, 2 year and 3 year was 77.80%, 64.81% and 64.81% respectively. At median follow up of 15.17 months, median overall survival was not reached. All adverse events were either grade I (67%) or grade II (33%). No grade III or grade IV adverse events were observed. No added toxicity was observed due to nimotuzumab. Conclusions: In first of its kind study, addition of nimotuzumab to conventional treatment showed promising response rate as well as survival outcomes in recurrent/meta-static HNC patients without producing additional toxicity. These results need to be validated with a randomised controlled trial.