A prospective study comparing response and toxicity with or without nimotuzumab in concurrent chemoradiotherapy in locally advanced head and neck cancer.

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Background: Head and neck is the second most common in India and seventh most common worldwide malignancy. In India tobacco use in form of smoking (cigarettes, bidi, hukah) and chewing (khaini, gutka, paan). Alcohol consumption acts as a catalyst for cancer when combined with tobacco. Betel nut (paan) chewing common in India. Due to lower education and lack of awareness most patient present in locally advance stage but whole part of treatment (surgery, chemotherapy, radiotherapy) are free in India. In locally advanced head and neck cancer concurrent chemo with radiotherapy is standard treatment. Epidermal growth factor receptor (EGFR) is overexpressed in majority head and neck tumor. Nimotuzumab a humanized ant-EGFR monoclonal antibody, has shown promising efficacy with low toxicity. Methods: This study was conducted at SMS Medical College and Attached Hospital, Jaipur between Dec 2023 to Nov 2025. Total 108 patient histologically confirmed locally advanced head and neck cancer were enrolled. Randomization done by chit box method. Group A: Concurrent chemoradiotherapy (inj. cisplatin 30 mg/m ² weekly with 2GY/#/day five day in week total 70Gy/35# in seven week). Group B: Concurrent chemoradiotherapy according to group A with Inj nimotuzumab 200mg/weekly. Treatment response was assessed using RECIST criteria after 3 month and 6 month. Acute toxicities were evaluated according to CTCAE weekly during treatment, after 1 month, 3 month, 6 month. Results: Tumor response rate in group A and B 72% (complete response 38.1%) and 91% (complete response 58.2%).Toxicity was grade 2 and 3 in both group some patient only grade 4 toxicity in both arm. Conclusions: Use of nimotuzumab with concurrent chemoradiotherapy achieve superior therapeutic response without increased toxicity.