A randomized trial of amifostine as radioprotector in the radiotherapy of head and neck cancer.
OBJECTIVE
Radiotherapy (RT) for head and neck cancer typically involves the major salivary glands bilaterally and can cause acute and chronic xerostomia and mucositis. The degree of xerostomia has been reported to depend on the radiation dose and the salivary gland volume irradiated. In this study, we evaluated the efficacy of the radioprotector amifostine to improve xerostomia and mucositis in head and neck cancer patients who received RT.


METHODS
A total of 53 patients with head and neck cancer entered this prospective randomized study. Patients were randomly assigned to undergo RT or RT plus short intravenous (i.v.) infusion of amifostine 210 mg/m(2) before each RT fraction.


RESULTS
No statistically significant difference was seen between the 2 arms in terms of mucositis. Acute xerostomia occurred in 31 (93.9%) patients in the amifostine arm and all of the patients in the RT-alone arm (p <0.05). Grade 3 acute xerostomia occurred in 13 (39.3%) patients in the amifostine arm, and in 9 (45%) patients in the RT-alone arm (p=0.04). Late xerostomia occurred in 19 (57.5%) patients in the amifostine arm, and in 14 (70%) patients in RT-alone arm (p=0.03).


CONCLUSIONS
The administration of amifostine in head and neck cancer patients receiving RT improved significantly acute and late xerostomia, while did not offer protection in the prevention of mucositis. Further prospective studies are needed in order to better define the role of this agent.
Karacetin
D
D
Sisli Etfal Hospital, Department of Radiation Oncology, Istanbul, Turkey.
Yücel
B
B
Leblebicioğlu
B
B
Aksakal
O
O
Maral
O
O
Incekara
O
O