Hepatocellular carcinoma (HCC) on liver cirrhosis (LC) is a neoplasm with a poor prognosis. Only 10-36% of patients have resectable tumors at presentation, systemic chemotherapy is seldom useful and loco-regional treatments are feasible only in selected cases. On the basis of the possible role of depression of immune function in the pathogenesis of HCC on LC, we employed thymostimulin in the treatment of patients with unresectable HCC on LC, with the aim of influencing the course of the disease. Forty-six consecutive patients with HCC were enrolled from January 1987 to December 1993. All patients, 36 males and 10 females, with a median age of 67 years (range 58-82) had coexisting LC. All patients were treated with thymostimulin (TP-1 Serono) at doses of 70 mg/day i.m. five times a week until disease progression. Eleven patients achieved an objective response, with an overall response rate of 24%. Six patients obtained a CR (13.0%) with a median duration of 19+ months (range 5+/-23). Five patients (11%) achieved PR with a median duration of 10 months (range 7+/-22). Six patients (13.0%) presented MR (median duration: 12.5 months) and 12 (26.0%) had SD (median duration: 8 months). In 17 patients (36.9%) the disease progressed. Thymostimulin treatment was well tolerated and no major side effect was observed. Thymostimulin treatment can be considered a new promising therapy for advanced HCC.

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