Pirarubicin, UFT, Leucovorin Chemotherapy in Non-embolizable and Transcatheter Arterial Chemoembolization-Failed Hepatocellular Carcinoma Patients; A Phase II Clinical Study.

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Hepatocellular carcinomas are one of the most common malignancies in the world. However, no effective therapeutic modality has been proven to prolong the survival of patients in an inoperable stage. The purpose of this study was to determine the response rate and the toxicities of a combination of pirarubicin, UFT and leucovorin in patients with non-embolizable hepatocellular carcinomas, or who had progressed during their transcatheter arterial chemoembolization treatment. Of 23 patients with a hepatocellular carcinoma, 11 had progressed during a transcatheter arterial chemoembolization, with the other 12 being transcatheter arterial chemoembolization-naive. All the patients were treated with pirarubicin (70 mg/m2 i.v., day 1), UFT (350 mg/m2 P.O., day 1~21), and leucovorin (25 mg/m2 P.O., day 1~21). Twenty patients were able to be evaluated, with a partial response being achieved in four, giving an overall response rate of 20% (95% confidence interval, 7~44%). The median overall survival time was 6 months, and the median survival time of the transcatheter arterial chemoembolization-naive patients was significantly longer than that of those treated by transcatheter arterial chemoembolization (p=0.012). The most significant dose-limiting toxicity was leucopenia and thrombocytopenia. The combination of pirarubicin, UFT and leucovorin therapies showed marginal antitumor activity and significant toxicity in patients with non-embolizable or failed transcatheter arterial chemoembolization hepatocellular carcinomas.