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

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

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Purpose: Hepatocellular carcinomas are one of themost common malignancies in the world. However, noeffective therapeutic modality has been proven to prolongthe survival of patients in an inoperable stage. The purposeof this study was to determine the response rateand the toxicities of a combination of pirarubicin, UFT andleucovorin in patients with non-embolizable hepatocellularcarcinomas, or who had progressed during theirtranscatheter arterial chemoembolization treatment. Materials and Methods: Of 23 patients with a hepatocellularcarcinoma, 11 had progressed during a transcatheterarterial chemoembolization, with the other 12being transcatheter arterial chemoembolization-naive. Allthe 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). Results: Twenty patients were able to be evaluated,with a partial response being achieved in four, giving anoverall 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 arterialchemoembolization-naive patients was significantly longerthan that of those treated by transcatheter arterial chemoembolization(p=0.012). The most significant dose-limitingtoxicity was leucopenia and thrombocytopenia. Conclusion: The combination of pirarubicin, UFT andleucovorin therapies showed marginal antitumor activityand significant toxicity in patients with non-embolizableor failed transcatheter arterial chemoembolization hepatocellularcarcinomas. (Cancer Res Treat. 2002;34:280-283)

Abstract

Purpose: Hepatocellular carcinomas are one of themost common malignancies in the world. However, noeffective therapeutic modality has been proven to prolongthe survival of patients in an inoperable stage. The purposeof this study was to determine the response rateand the toxicities of a combination of pirarubicin, UFT andleucovorin in patients with non-embolizable hepatocellularcarcinomas, or who had progressed during theirtranscatheter arterial chemoembolization treatment. Materials and Methods: Of 23 patients with a hepatocellularcarcinoma, 11 had progressed during a transcatheterarterial chemoembolization, with the other 12being transcatheter arterial chemoembolization-naive. Allthe 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). Results: Twenty patients were able to be evaluated,with a partial response being achieved in four, giving anoverall 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 arterialchemoembolization-naive patients was significantly longerthan that of those treated by transcatheter arterial chemoembolization(p=0.012). The most significant dose-limitingtoxicity was leucopenia and thrombocytopenia. Conclusion: The combination of pirarubicin, UFT andleucovorin therapies showed marginal antitumor activityand significant toxicity in patients with non-embolizableor failed transcatheter arterial chemoembolization hepatocellularcarcinomas. (Cancer Res Treat. 2002;34:280-283)

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