A randomized study of very accelerated radiotherapy with and without amifostine in head and neck squamous cell carcinoma

Purpose: The aim of this study was to assess whether amifostine could minim ize acute mucositis induced by a very accelerated irradiation regimen in pa tients with advanced head and neck squamous cell carcinoma (HNSCC), Methods and Materials: Between May 1996 and February 1998, 26 patients with an inoperable nonmetastatic Stage IV HNSCC were entered in this study, The treatment consisted of very accelerated radiotherapy given 64 Gy in 3.5 we eks, The patients were randomized to receive or not 150 mg/m(2), amifostine (Ethyol, U.S. Bioscience) 15-30 min prior to each radiation session, Results: Of the 13 patients who received amifostine, definitive interruptio n of amifostine occurred in 5 cases (38%), due to tolerance problems (vomit ing, liver enzyme elevation, generalized erythema), The distribution of Gra de 4 mucositis (WHO) was 1 case versus 8 cases, with and without amifostine , respectively. The mean duration of "at least Grade 3" mucositis (WHO) was 25.1 days versus 49.2 days with and without amifostine (p = 0.03), In the amifostine group, 11/13 of the patients required a feeding tube (nasogastri c tube or medical gastrostomy), because of acute mucositis, whereas in the control group a feeding tube was necessary in all cases, The mean duration of the use of this feeding tube was 1 month versus 2.5 months with and with out amifostine respectively (p < 0.01). Local-regional control was not diff erent between both arms with a median follow-up of 15 months. Conclusion: Despite the limited number of patients, this pilot randomized s tudy suggests that amifostine was able to markedly reduce the severity and duration of mucositis induced by very accelerated radiotherapy, However, th e tolerance of this twice daily amifostine schedule was relatively poor, (C ) 2000 Elsevier Science Inc.