A phase II study of oral VP-16-213 in non-seminomatous testicular cancer

In a disease-oriented phase II study, thirty-three patients with advanced non-seminomatous testicular cancer were treated with oral VP-16-213 175 mg/m²/day for three consecutive days repeated every week. All patients had previously received extensive chemotherapy and twenty patients also had prior radiotherapy, Of 30 evaluable patients, 6 experienced partial remission for a median duration of 3.5 months, whereas minor regression or stabilization of the disease was achieved in 7 patients for a median duration of 2.5 months. Leukopenia was dose-limiting and resulted in dose reduction or treatment delay in 55% of the scheduled courses. The definite antitumor activity of VP-16-213 in non-seminomatous testicular cancer warrants its incorporation into combination chemotherapy for this disease.