The role of amifostine in prophylaxis of radiotherapy induced mucositis and xerostomia in head and neck cancer

5568 Background: To evaluate the use of amifostine prophylactically in radiochemotherapy induced acute mucositis and xerostomia in patients with head and neck carcinoma. Methods: One hundred and seventy patients of head and neck carcinoma were randomized to receive radiochemotherapy with or without amifostine. All the patients were suffering from locally advanced malignancy. A total of 66–72 gy was delivered conventionally with 40 mg/m2 weekly cisplatin. Amifostine 250mg was infused 10 min. prior to RT for four days a week to the patients in study group. Parotid scintigraphy was done before starting the treatment and at 3,6,12 and 24 months after completion of treatment. Mucositis and xerostomia were evaluated using RTOG criteria. Disease control was assessed at each follow up for two years. Results: The control group experienced an earlier onset of mucositis than the study group. By the end of 2nd week 74/85 control patients experienced grade II mucositis while similar toxicity was observed in 64/85 in the study group (p=0.05). All the patients had grade 3 or 4 mucositis in the control group whereas such severity was seen in 75/85 patients in the control group (p<0.001). The post radiation recovery of mucositis was faster in study group. By the end of 5 weeks of completion of radiation therapy 73/85 and 64/85 had no mucositis in the study and control group respectively (p<0.001). At 3 months follow up xerostomia grade 2 or more was found in 42/85 in control group compared with 32/85 in study group (p=0.017). By the end of 12 months of treatment in study group 37/85 experienced grade 1 or no xerostomia as compared to 59/85 in the control groups (p=0.002). However, treatment result remained unaffected in the amifostine groups. There were 49/85 disease free patients in control group compared with 52/85 in the study group (p=0.987). Conclusions: Amifostine was effective in reducing the severity and it delayed the onset of mucositis, a side effect with concurrent radiochemotherapy in head and neck carcinoma. It also decreased the severity of delayed xerostomia. Amifostine does not alter the response or the survival. No significant financial relationships to disclose.