Data from a phase II study of subcutaneous amifostine(Drug information on amifostine) (Ethyol) presented at the 43rd annual meeting of the American Society for Therapeutic Radiology and Oncology suggested that subcutaneously administered amifostine may provide the same protective effects against radiation therapy-induced xerostomia as intravenous administration.
"We are pleased with the growing popularity of amifostine among radiation oncologists to prevent xerostomia in patients receiving radiotherapy for head and neck cancers," said Robert Hirsch, phd, vice president of medical affairs at MedImmune, Inc (manufacturer of Ethyol). "While the drug is effective when administered intravenously, we believe a subcutaneous formulation would make it significantly more convenient for both patients and radiation oncologists. We are planning to study subcutaneous administration of amifostine through additional clinical testing in early 2002."
Adverse Effects Similar With IV Administration
In the study, 54 patients were treated with subcutaneous injections of amifostine 60 minutes prior to receiving radiation therapy. Following treatment, acute xerostomia was observed in 56% of these patients, a rate comparable to the 51% of patients experiencing acute xerostomia after receiving intravenous amifostine during the drug’s pivotal phase III trial. Moreover, there were no reports of grade 3 hypotension or nausea/vomiting following subcutaneous amifostine (3% and 7%, respectively). Cutaneous toxicity was the most significant side effect, with grade 3 cutaneous toxicity occurring in 13% of patients.