In a disease-oriented phase II study, 26 patients with hepatocellular carcinoma were treated with oral VP-16-213 at 120 mg/m2/day for 5 consecutive days, repeated every 3 weeks. Of 24 evaluable patients, 3 achieved partial remission (PR) for 12, 16 and 35 weeks respectively. Minor regression or stabilization of the disease (NC) was achieved in 8 patients for a median duration of 15 weeks. Patients with PR and NC experienced similar median survival (22 weeks), whereas non-responders had a median survival of less than 8 weeks. Results of this trial indicate that VP-16-213 has limited but definite anti-tumor activity in hepatocellular carcinoma.
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