Levamisole in squamous cell carcinoma of the head and neck.

One hundred and thirty-four patients (118 males and 16 females) with epidermoid carcinoma of the head and neck were studied. After treatment of the primary lesion, they were randomized into two groups: 69 received levamisole, 150 mg/day orally for 3 consecutive days every other week, and 65 received placebo. Immune status was also evaluated. Positive reactions to dinitrochlorobenzene increased significantly after primary tumor therapy in both levamisole- and placebo-treated patients. There were no significant differences in immune responses between the two groups, except in recall antigen reactivity, which was decreased in both groups overall recurrence and death rates at 36 months did not differ between the two groups of patients. However, stage I and II patients treated with levamisole had a significantly higher incidence of recurrence than the placebo-treated patients (P less than 0.02), while there was some evidence that levamisole-treated stage IV patients did better. It is concluded that the overall outcome in patients with squamous cell carcinoma controlled locally by surgery or radiation was not favorably affected by levamisole in the dose and schedule used in this protocol.