Multicenter safety study on cetuximab combined with intensity modulated radiotherapy and concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma

Abstract

Objective To evaluate the safety of cetuximab combined with intensity-modulated radiotherapy (IMRT) plus concurrent cisplatin chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC) in a Chinese multicenter clinical study.Methods From July 2008 to April 2009,100Patients with primary stage Ⅲ- Ⅳb non-keratinizing NPC were enrolled.The planned dose of IMRT to gross tumor volume and positive cervical lymph nodes was 66.0-75.9 Gy and 60-70 Gy in 30-33 fractions.Cisplatin (80 mg/m2,q3 week (w)) and cetuximab (400 mg/m2 one w before radiation,and then 250mg/m2 per w) were given concurrently.The adverse events (AEs) were graded according to common terminology criteria for adverse events v3.0.Results The compliance of the entire group of patient was satisfactory.Actual median dose to gross tumor volume was 69.96 Gy,and the median dose to positive cervical lymph nodes was 68 Gy.Median dose of cisplatin was 133 mg,median first-dose of cetuximab was 690 mg,and median weekly dose was 410 mg.AEs were well tolerated and manageable,mainly consisting of acneiform skin eruptions,dermatitis and mucositis.Grade 4 mucositis was observed in 2％ of the patients and no other grade 4 AEs were observed.Conclusions The combined treatment modality of IMRT +concurrent chemotherapy + cetuximab in loco-regionally advanced NPC is well tolerated. Key words: Nasopharyngeal neoplasms/radiotherapy; Chemotherapy; Target therapy; Adverse event