Nimotuzumab with Intensity Modulated Radiation Therapy (IMRT) in the Concurrent Setting of Locally Advanced Head and Neck Cancers unfit for Chemoradiation

Abstract

Purpose/Objective(s): Nimotuzumab, a humanized anti-EGFR antibody has been demonstrated to be safe and effective with radiation therapy. It has been approved in over 22 countries including India for indications like locally advanced head and neck squamous cell carcinoma (LAHNSCC). We prospectively evaluated the role of concurrent Nimotuzumab with radiation therapy in patients unfit for cisplatin due to age, renal profile or cardiac parameters. Our hypothesis was Nimotuzumab and Intensity modulated radiation therapy results in good locoregional control with equivalent efficacy & toxicity compared to concurrent cisplatin based chemoradiation in LAHNSCC. Aim: This study aims to evaluate locoregional response of nimotuzumab and intensity modulated radiation therapy (IMRT) as the primary endpoint and treatment related toxicity as the secondary endpoint. Methods: Between August 2021 to March 2023, 25 patients of oropharynx, hypopharynx & larynx cancer were treated with concurrent nimotuzumab and radiation therapy. Patients were treated with simultaneous integrated boost protocols with concurrent Inj Nimotuzumab 200mg IV weekly for 6 weeks. Results: median age of patients was 64 years & most common site was oropharynx (14 /25). With a median follow up of 18 months, 18(72%) patients were locoregional controlled; 3 (12%) patient had residual disease at primary site; 2 (8%) patient had residual disease at node and 2(8%) patient progressed to systemic disease. One patient developed grade III skin toxicities (4%) and Grade 3 mucositis was seen in 5 (20%) patients. No major treatment breaks were noticed and none of the patients had any cardiac event or renal toxicity. Conclusion: Addition of nimotuzumab to radiation therapy is safe and efficacious based on the good locoregional control and further studies are required to comment upon its long-term survival benefits in LAHNSCC.