Prognosis of primarily treated localized laryngeal carcinoma ameliorated through levamisole treatment: a randomized pilot study.

A placebo-controlled treatment with the immunorestorative agent levamisole as an adjuvant to surgery and/or radiation was evaluated in a pilot study of 24 patients with squamous cell cancer of the larynx or hypopharynx. During the randomized treatment, started as close as possible to the beginning of the operation or to the irradiation sessions, 12 patients received a placebo and the 123 others levamisole in a dose of 50 mg t.i.d. for 3 consecutive days every 2 weeks. The recurrence rate in the control group was 50% after about 20 months and in the levamisole group only 20% after 2 years which is a significant difference. Also regarding cancer deaths there was a trend to the advantage of levamisole. The most promising effects were seen in patients with stages III or IV. Some evidence was found that an early start might be decisive for an optimal effect of levamisole. The beneficial effect of levamisole was only seen in the group of patients with a low pretreatment level of circulating lymphocytes.