Combination of levamisole immunotherapy and polychemotherapy in advanced breast cancer.

In a randomized double-blind study, 101 female patients with breast cancer treated with Adriamycin chemotherapy in combination with vincristine and cyclophosphamide received either levamisole immunotherapy or placebo. The investigation was preceded by a pilot study involving 44 patients, of whom 25 received levamisole; the intermittent four-drug schedule of cyclophosphamide, vinblastine, methotrexate, and 5-fluorouracil, however, formed the basis of chemotherapy. In both studies, levamisole increased the response rates (P = 0.03), and in the present controlled trial it also significantly lengthened survival (P = 0.05). The results correlated with initial and levamisole-induced improvement of cell-mediated immunity.