Phase I clinical trial of liposomal daunorubicin in hepatocellular carcinoma complicating liver cirrhosis.

摘要: Chemotherapy has been proposed for patients with hepatocellular carcinoma (HCC) associated well-compensated cirrhosis who are unsuitable locoregional treatments. Anthracyclines the most active agents against HCC, although their toxicity is often unpredictable; thus, there a need new drugs safe profile. The liposomal formulation of anthracycline daunorubicin low systemic and taken up strongly by liver. We started phase I study (starting dose 80 mg/m2 every 21 days) in Child-Pugh stage A or B liver cirrhosis. At starting dose, we recorded dose-limiting toxicities (1 hyperbilirubinemia, 1 prolonged prothrombin time, persisting grade 3 neutropenia) out 4 patients. Thus, according to protocol, went down level 60 but still 2 had unacceptable hypertransaminasemia, hyperbilirubinemia encephalopathia). Finally, treated more at 40 again three them. Overall haematological was mild significant non-haematologic toxicities, other than hepatic, were not recorded. profile observed warns further assessment