Levamisole in the treatment of stage II breast cancer. Five-year follow-up of a randomized double-blind study.

The effect of levamisole combined with postoperative radiotherapy in Stage II breast cancer was investigated in a double-blind randomized study comprising 72 patients. All patients were followed for at least 5 years. Disease-free survival was slightly prolonged in the levamisole group as a whole. Among postmenopausal patients, levamisole significantly increased both disease-free and total survival (P = 0.003) and P = 0.008, respectively). The levamisole group also showed fewer distant metastases as the first sign of recurrence. Levamisole treatment was associated with a risk of granulocytopenia and agranulocytosis (10%), but, as in the authors' previous studies, this seemed to be totally reversible and did not worsen the prognosis.