A phase II study of pegylated liposomal doxorubicin for treatment of advanced hepatocellular carcinoma. Academic Article uri icon

Overview

abstract

  • BACKGROUND: Pegylated liposomal doxorubicin has an enhanced efficacy and reduced toxicity compared with free doxorubicin. The efficacy and toxicity of pegylated liposomal doxorubicin was investigated in patients with hepatocellular carcinoma. PATIENTS AND METHODS: Patients with histologically confirmed, locally advanced or metastatic hepatocellular carcinoma and a Karnofsky index > 60% were included in this prospective single-arm study. Exclusion criteria were liver cirrhosis stage Child-Pugh C, previous chemotherapy, or chemoembolization. Pegylated liposomal doxorubicin was given in a dose of 30 mg/m2 every three weeks until progression of disease. After inclusion of five patients the dose could be escalated to 40 mg/m2 in absence of toxicity grade 3 and 4. RESULTS: Sixteen patients were evaluable for response. No objective response was achieved. The median survival time was 140 days (95% confidence interval: 126-154 days). Treatment toxicities grade > or = 3 comprised increased liver enzymes in patients with preexisting grade 1 or 2 elevation (n = 6), hematologic toxicity (n = 5), and hypersensitivity (n = 2). CONCLUSIONS: Pegylated liposomal doxorubicin is not effective for treatment of advanced hepatocellular carcinoma. The favorable toxicity profile was confirmed even in patients with underlying liver disease.

publication date

  • January 1, 2000

Research

keywords

  • Antineoplastic Agents
  • Carcinoma, Hepatocellular
  • Doxorubicin
  • Liver Neoplasms

Identity

Scopus Document Identifier

  • 0033950350

Digital Object Identifier (DOI)

  • 10.1023/a:1008386822906

PubMed ID

  • 10690399

Additional Document Info

volume

  • 11

issue

  • 1