A phase II trial of subcutaneous amifostine and radiation therapy in patients with head and neck cancer.

This phase II trial was designed to verify that subcutaneous (SC) administration of Amifostine (Ethyol) protects against radiation therapy (RT)-induced xerostomia and ameliorates amifostine-related side effects (including nausea, vomiting, and hypotension). Patients receiving amifostine SC plus RT had a 56% incidence of acute xerostomia, comparable with previous phase III data with intravenous administration of amifostine. There was good tolerability, with cutaneous toxicity as the most significant side effect. These data suggest that amifostine SC provided comparable protection against RT-induced acute xerostomia as amifostine intravenously. Copyright 2002, Elsevier Science (USA). All rights reserved.