Hepatocellular carcinoma (HCC) on liver cirrhosis (LC) is a neoplasm w
ith a poor prognosis. Only 10-36% of patients have resectable tumors a
t presentation, systemic chemotherapy is seldom useful and loco-region
al 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 wit
h unresectable HCC on LC, with the aim of influencing the course of th
e 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 pat
ients 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+ month
s (range 5+/-23). Five patients (11%) achieved PR with a median durati
on of 10 months (range 7+/-22). Six patients (13.0%) presented MR (med
ian duration: 12.5 months) and 12 (26.0%) had SD (median duration: 8 m
onths). In 17 patients (36.9%) the disease progressed. Thymostimulin t
reatment was well tolerated and no major side effect was observed. Thy
mostimulin treatment can be considered a new promising therapy for adv
anced HCC.