A randomized trial of low doses of alpha interferon in patients with breast cancer.

A randomized Phase II study was planned to test two doses of human lymphoblastoid interferon (Wellferon) in patients with metastatic breast cancer. Thirty-seven patients were entered and received either 0.5 or 3.0 million units three times a week for three months. The dose selection was based on earlier Phase I studies in order to maximize NK (natural killer) stimulation and the amount tolerated without undue toxicity. Twenty-nine patients were evaluable. There was only one excellent partial remission, sustained for one year. There were small and statistically insignificant NK increases in both groups. From this and a review of the literature, we conclude that alpha interferon has negligible activity in breast cancer.