Subcutaneous Amifostine Feasible During Radiotherapy for Head and Neck Cancer

NEW YORK FEB 28, 2006 (Reuters Health) - The use of subcutaneous amifostine to reduce the toxic effects of radiation therapy and chemotherapy is feasible in patients with head and neck cancer, Swiss physicians report.  However, nausea and vomiting and hypotension are relatively common adverse events associated with the drug.

Amifostine (Ethyol; Essex-Chemie AG, Lucerne, Switzerland) is an organic thiophosphate that protects normal tissues from free radicals produced by radiation therapy or chemotherapy.  It is FDA approved as an intravenously administered drug, but subcutaneous administration is believed to have less toxic effects.

Dr. Mahmut Ozsahin and colleagues at Centre Hospitalier Universitaire Vaudois in Lausanne retrospectively evaluated 33 consecutive patients treated with accelerated concomitant-boost radiation therapy, 26 of whom also received cisplatin alone or cisplatin plus fluorouracil.  The parotid glands were included in the planning radiation therapy volume.

According to their report in the Archives of Otolaryngology Head and Neck Surgery for February, the patients received a 200-mg dose of the oral anti-emetic dolasetron mesylate 1 to 2 hours prior to amifostine treatment.  Amifostine 500 mg was injected subcutaneously into the abdomen 15 to 30 minutes prior to radiation therapy.

Fifteen patients appeared to be tolerant to amifostine, whereas 11 discontinued its use because of nausea and vomiting and 6 discontinued because of hypotension.

Acute effects of treatment included grades 1 to 3 dysphagia, mucositis and skin erythema.  Late toxic effects included grade 2 or higher xerostomia in 8 of 19 patients who received at least 20 amifostine injections and in 9 of 14 patients who received fewer amifostine treatments (p = 0.15).

Two-year overall survival was 74%.

Dr. Ozsahin"s group concludes that subcutaneous amifostine administration is feasible for patients undergoing treatment for head and neck cancer.

In a related editorial, Dr. David I. Rosenthal, from the University of Texas M. D. Anderson Cancer Center in Houston, notes that well-designed, prospective phase III clinical trials will be needed to see if amifostine benefits patients undergoing radiation for head and neck cancer.

He adds: "if Ozsahin and colleagues had used adequate premedication, hydration prior to amifostine administration, and therapy for breakthrough symptoms, then the impact of adverse events on the rate of study completion might have been mitigated."

SOURCE:

• Arch Otolaryngol Head Neck Surg 2006;132:129-130,141-145.