No reliable therapy has yet been established for unresectable hepatocellular carcinoma (HCC). Encouraging data in terms of response rate and survival have been reported with intra-arterial chemotherapy combined with venooclusive materials, specifically ethiodized oil and gelatin sponge. To evaluate the activity and tolerance of a new chemoembolization protocol in cirrhotic patients with HCC, 22 patients were treated with epirubicin (50 mg) and ethiodized oil (10-15 ml), administered through hepatic arterial catheters, followed by gelatin sponge. Patient characteristics were: median age 70 years (range, 59-77); ECOG performance status 0-1 in 15 and 2 in 7 cases; Child's A disease in 11 and B in 11; TNM stage II in 9, stage III in 3 and stage IVA in 10 cases. Histologically documented cirrhosis was present in all cases. A total of 53 courses of therapy has been delivered. All patients were evaluable for response and toxicity. Three partial remissions (13%), 2 stabilizations of disease and 17 progressions have been observed. Median time to progression was 4 months, with a median survival of 7.6 months (range, 1-26+ months). Significant differences in survival (p = 0.001) have been observed between patients at stage II-III (21 months) and those at stage IVA (3 months), and between patients with Child's A disease (10 months) and Child's B disease (4 months) (p= 0.02). The treatment was well tolerated, with only 2 cases of WHO grade I pain and 2 cases of grade I fever. In conclusion, our results indicate that the schedule has only limited activity and does; not seem to offer any sure advantage over other treatments modalites in HCC.

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