Abstract

Background: The purpose of this study was to evaluate QOL and Time Without Symptom and Treatment Toxicity of Nimotuzumab vs chemotherapy (weekly cisplatin) along with Radiotherapy inpatients with stage IIIB or less Squamous cell carcinoma of Head and neck regions. Methods: This is a retrospective data analysis of single institution between 2012 to 2015 with two years of follow up. All patients were of Squamous cell carcinoma of Head and neck regions with stage IIIB or less. Case records from hospital were analyzed. Thirty six patients received Nimotuzumab and matched [for stage, age and other variables] records of another 36 patients receiving chemotherapy were retrieved as controls. Patients received Nimotuzumab 200 mg weekly for 6 weeks or chemotherapy (weekly cisplatin 40 mg/m2) for 6 weeks along with Radiotherapy (IMRT). The QOL questioner was a part of dissertation thesis was used for analysis along with clinical case records for adverse events, grade, survival and time with good QOL. Results: A total of 72 patients were analyzed. The objective response rate was significantly higher in the Nimotuzumab group than in the control group in the intent-to-treat population (88% versus 64.5%; P = 0.04). No significant differences in median progression-free survival and overall survival were observed. Nimotuzimab had maximum TWIST score of 567 + 245 (Mean+ SD) days and better overall QOL improvement 4.8 + 1.2 compared to the chemo arm [465 + 189 days and QOL improvement of 3.2 + 1.5 points]. Conclusions: Based on the results of this retrospective analysis, Nimotuzumab weekly as single agent appears as an attractive alternative regimen for patients with HNSCC receiving definitive Radiotherapy and had better QOL and TWIST. A prospective study was planned and submitted to the local ethics committee based on above results to validate these results. If the trends are proven, this could be a choice with patients having borderline renal function and poor performance status. Clinical trial indentification: CRF Continental Hospitals Legal entity responsible for the study: Suresh AVS Funding: None Disclosure: D. Pawar: Works for Pharmaceutical Company All other authors have declared no conflicts of interest.

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