150. Multicenter, randomized study assessing the impact of amifostine on normal tissue tolerance during radiotherapy for head and neck cancer

A prospective, randomized multicenter study was conducted to assess toxicity and radioprotective effects of amifostine (EthyolŽ) in head and neck cancer radiotherapy. Assessed were also local control and overall survival. Sixty-one patients (43 men and 18 women) from five institutions were randomly assigned to radiotherapy alone (28 patients) or radiotherapy + amifostine (33 patients). Amifostine was given at a dose of 150 mg/m2 15 min prior to each fraction of radiotherapy. Definite and postoperative radiotherapy were given at a total dose of at least 66 Gy (43 patients) or 56 Gy (18 patients), respectively. Acute radiation reactions were assessed using the EORTC/RTOG scale, weekly during radiotherapy, and within 2 weeks afterwards. Late radiation reactions were assessed using SOMA-LENT scale every 3 months for 2 years. The side effects of amifostine were generally manageable. In 6 patients amifostine infusion had to be temporarily stopped and in 5 permanently terminated due to hypotension (2 patients), nausea and vomiting (1 patient), septicemia (1 patient) or fever, vertigo and visual disturbances (1 patient). No increase in the frequency of somnolence, nausea/vomiting, sneezing, dizziness, hot flushes, hiccough, shivering, hypocalcemia or allergic reactions was noted. No significant differences in the frequency and degree of radiotherapy-induced mucositis, skin reactions, xerostomia, dysphagia and leucopenia between patients who did and did not receive amifostine were observed during radiotherapy and within the first week after its termination. 2 weeks after termination of radiation musositis was more intensive in the amifostine group (p=0,0449). No significant differences in late radiation reactions were observed. The tolerance of amifostine at a dose of 150 mg/m2 is acceptable. No significant impact on acute and late radiation reactions was demonstrated.