A Study Comparing Acute Toxicities of Cetuximab and Cisplatin in Patients Undergoing Definitive Chemoradiation With Intensity-Modulated Radiotherapy for Locally Advanced Carcinoma Head and Neck.

Abstract

PurposeTo study the acute toxicities of weekly cetuximab used concurrently with intensity-modulated radiotherapy (IMRT) versus weekly cisplatin with concurrent IMRT in locoregionally advanced head and neck squamous cell carcinoma (HNSCC).Materials and methodsFifty eligible patients were randomly assigned to study group (cetuximab group) and control group (cisplatin group) to receive cetuximab 400 mg/m2 intravenously one week prior to the start of RT followed by 250 mg/m2/week, or weekly cisplatin intravenously 40 mg/m2, during RT. RT dose received was 70Gy in 35 fractions with 2Gy/fraction in both the arms with IMRT technique. Patients are reviewed every week and Patients were evaluated for acute toxicities according to radiation therapy oncology group (RTOG) toxicity scoring criteria and toxicities grade was reported.ResultsThe incidence of acute toxicities like oral mucositis, dysphagia, nausea, vomiting, and leukopenia were much less in cetuximab arm and statistically significant difference was observed as compared to cisplatin arm. and no major systemic toxicities were encountered in the cetuximab arm.ConclusionWeekly cetuximab with concurrent radiotherapy in locally advanced HNSCC is a promising regimen with well tolerable toxicity profile. Larger prospective randomized studies with a longer duration of follow-up with direct comparison of both the regimens are needed for strong evaluation of efficacy and toxicity profile.