Abstract

To evaluate the radioprotector Amifostine (Ami) when given during a course of head and neck (H&N) irradiation (RT), eligible pts underwent RT for H&N cancer where the major salivary glands received more than 45 Gy. Ami was administered prior to each dose of radiation. Saliva was collected and measured prior to, during and at regular intervals post RT. 99m Tc salivary scintiscans were performed prior to and post RT. Ten patients were treated on the first dose level (Ami 100 mg/m 2 ) and 2 on the second dose level (200 mg/m 2 ). Flow rates of unstimulated whole saliva decreased significantly during RT, recovering after 6 months. Stimulated whole salivary flow rate similarly decreased during RT and improved after 3 months post RT The stimulated parotid flow rate decreased during RT to 99m Tc salivary scintiscans confirmed this rebound of parotid function. Ami prior to each dose of radiation was feasible and without significant toxicity. Salivary gland function improved over time after completion of radiation, particularly the parotid. Future directions include escalation to 300 mg/m 2 and a Phase III randomized trial will be undertaken once the optimal dose is established.

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