Clinical trials using polyadenylic-polyuridylic acid as an adjuvant to surgery in treating different human tumors.

The results of a randomized trial of polyadenylic-polyuridylic [poly(A).poly(U)] acid given as adjuvant treatment for operable breast cancer were reviewed after a mean follow-up period of 87 months. The overall survival was significantly improved in patients given the adjuvant (155 cases) as compared with the controls (145 cases). A significant benefit was observed in patients with invaded axillary nodes; the best results were obtained in the group of patients with up to three nodes involved, who showed a significant increase in both overall and relapse-free survival. The biological response modifications observed after treatment with poly(A).poly(U), namely, production of interferon and increase of natural killer cell activity, are described and their possible role in the mechanism of action of the complex is discussed. The results of a Phase I clinical tolerance study of the duplex in cancer patients will be reported. The aims and protocols of new clinical trials with adjuvant poly(A).poly(U) in different types of tumors will be presented.