Acute toxicity of postoperative radiochemotherapy with amifostine vs radiochemotherapy alone in head and neck cancer patients. Preliminary results ofa randomized trial

Purpose: Experimental and clincial data suggest a reduction of radiation-in duced acute toxicity by amifostine. We investigated this issue in a randomi zed trial comparing radiochemotherapy (RCT) versus radiochemotherapy and am ifostine (RCT + A) in patients with head and neck cancer. Patients and Methods: Forty-seven patients with pharyngeal or laryngeal can cer (T1-2 N1-2 G(3), T3-4 N0-2 G(1-3)) were randomized to receive RCT alone (21 patients) or RCT + A (21 patients). Patients were irradiated up to 60 Gy (R-0) or 70 Gy (R-1/2). Chemotherapy consisted of 70 mg/m(2) carboplatin and was administered over 5 days in the 1st and 5th week of the radiothera py course. 250 mg amifostine were applied daily just before each radiothera py session. Acute toxicity was evaluated according to the Common Toxicity C riteria (CTC). As for xerostomia no patients with laryngeal cancer were ass essed because in these cases only small volumes of the salivary glands were within the treatment volume. To evaluate the overall toxicity a summarized CTC score of all observed side effects was calculated. Results: Forty-two patients were evaluable. Clinical characteristics (age, sex, Karnofsky index, tumor-staging) were well balanced in both treatment g roups (Tables 2 and 3). Amifostine provided reduction in xerostomia and muc ositis (Figures 5 and 6) but had no obvious influence on Karnofsky index, b ody weight, cutaneous side effects and alopezia (Figures 1 to 4). Conclusions: According to our preliminary results amifostine has a radiopro tective effect on salivary glands. Mucositis can be reduced during radioche motherapy. At this point of patient accrual the difference between both gro ups are statistically not significant. To improve the radioprotective effec ts of amifostine in clinical practice the application of a higher dose (> 2 50 mg) seems to be necessary.