[Randomized phase II study with VP-16-213 (etoposide) in the treatment of advanced breast cancer]

Thirty patients with an advanced and previously heavily pretreated breast cancer were treated in a randomized phase II trial with the new podophyllotoxinderivative VP-16-213. The therapeutic result can be assessed in 28 cases. Half of these patients received the cytotoxic drug orally 150 mg/m2/day during 5 days once every 3 weeks. The other half were randomized to receive the drug i.v. 150 mg/m2 weekly. No clear-cut partial remission was detected among the treated patients. In 3 cases a tumor regression was observed, which only met the criteria for a minor regression. These data are consistent with the single agent activity reported in the literature, which encompass mostly heterogeneous series with a few patients. The antitumoractivity of VP-16-213 in the treatment of breast cancer seems to be moderate. However, this should not prevent its incorporation into future, suitable combination chemotherapies.