Pegylated liposomal doxorubicin and gemcitabine in patients with advanced hepatocellular carcinoma: Results of a phase 2 study

Giuseppe Lombardi, Fable Zustovich, Fabio Farinati, Umberto Cillo, Alessandro Vitale, Giacomo Zanus, Martin Donach, Miriam Farina, Stefania Zovato, Davide Pastorelli

Research output: Contribution to journalArticlepeer-review


BACKGROUND: Over the years, doxorubicin and gemcitabine have been among the most widely used drugs for hepatocellular carcinoma (HCC), with relative efficacy. The authors report the results of a phase 2 study of the combination of gemcitabine plus pegylated liposomal doxorubicin. METHODS: Patients with advanced HCC received combination chemotherapy with gemcitabine 1000 mg/m 2 on Days 1 and 8, followed by pegylated liposomal doxorubicin 30 mg/m2 on Day 1. Treatment was repeated every 4 weeks to a maximum of 8 cycles. Primary endpoint was overall response rate, and secondary endpoints were time to disease progression (TTP), overall survival (OS), and toxicity. RESULTS: Forty-one patients were enrolled and were evaluable for response, toxicity, and survival. A total of 194 cycles of treatment were administered. Three (7%) patients had a complete response, and 1 of these patients underwent liver transplantation. Seven (17%) patients had a partial response and, among these patients, 1 patient underwent surgical resection. Among the 31 patients who had initial alpha-fetoprotein levels >400 ng/mL, 20 (64.5%) had a >20% decrease after 2 cycles of treatment. The median TTP and OS were 5.8 and 22.5 months, respectively. Hematologic toxicity was the most common side effect, including neutropenia (17%) and anemia (7%). CONCLUSIONS: The combination of gemcitabine plus pegylated liposomal doxorubicin was active and safe in advanced HCC. Moreover, this treatment induced some complete responses and converted some untreatable HCCs into lesions eligible for resection or transplantation.

Original languageEnglish
Pages (from-to)125-133
Number of pages9
Issue number1
Publication statusPublished - Jan 1 2011


  • chemotherapy
  • gemcitabine
  • hepatocellular carcinoma
  • liver
  • pegylated liposomal doxorubicin
  • sorafenib

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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