37. Multicenter, randomized study assessing the impact of amifostine on normal tissue radiation tolerance during head and neck cancer radiotherapy

Abstract

A prospective, randomized multicenter study was conducted to assess the value of amifostine (Ethyol^®) as a radioprotectant in head and neck cancer radiotherapy. The aim of the study was to evaluate the impact of the addition of daily amifostine (150 mg/m2) on the degree of early (mucositis, dysphagia, xerostomia) and late (mucosal, cutaneous, salivary gland, mandible and spinal cord) radiation reactions. Assessed were also patients’ quality of life, local control and overall survival. Sixty two patients from five Polish institutions were randomly assigned to radiotherapy alone (Arm A – 28 patients) or radiotherapy + amifostine (Arm B – 34 patients). There were 43 men and 19 women. Primary tumor was located in the oral cavity (27 patients), oropharynx (25 patients), nasopharynx (2 patients) and larynx/hypopharynx (8 patients). In 43 patients radiotherapy was used as the sole modality of treatment and 19 patients were irradiated postoperatively. The side effects of amifostine were manageable. In 6 patients amifostine infusion had to be temporarily stopped due to hypotension and in 5 patients its administration was permanently terminated due to hypotension, nausea and vomiting, septicemia or fever and visual disturbances. The early results of the study, focusing on early radiation reactions, will be presented at the conference.