BACKGROUNDHepatocellular carcinoma (HCC) with portal venous invasion (PVI) has a very poor prognosis, with a median survival of 3 months and virtually no survival at 1 year. The combination of intraarterial 5‐fluorouracil (FU) and systemic interferon‐α (IFNα) was recently reported to be effective against HCC with PVI, but these were small pilot studies.METHODSOne hundred and sixteen patients with HCC with PVI received IFNα (5,000,000 U intramuscularly on Days 1, 3, and 5 of each week of treatment) and 5‐FU (500 mg into hepatic artery on Days 1‐5 of the first and second week of each 4‐week cycle). The therapy was either terminated at the end of the first cycle in cases with progressive disease, or continued for at least 3 cycles, when responses to treatment were evaluated by Eastern Cooperative Oncology Group criteria. The survival rate was compared with that of historical controls (n = 40).RESULTSNineteen (16%) patients showed complete response and another 42 (36%) showed partial response. Adverse events were limited to nausea and appetite loss. The survival rates at 12 and 24 months among overall patients were 34% and 18%, respectively, in contrast to 15% and 5% among the historical controls. Survival rates at 12 and 24 months were 81% and 59% among complete responders, respectively, and 43% and 18% among partial responders.CONCLUSIONThe combination therapy with 5‐FU and IFN was safe, and substantially improved the survival rate among the complete responders. These results provide a rationale for future randomized controlled trials. Cancer 2006. © 2006 American Cancer Society.

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