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.
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.
Authors: Aaron F H Lum; Mark A Borden; Paul A Dayton; Dustin E Kruse; Scott I Simon; Katherine W Ferrara Journal: J Control Release Date: 2005-12-27 Impact factor: 9.776
Authors: Azadeh Kheirolomoom; Paul A Dayton; Aaron F H Lum; Erika Little; Eric E Paoli; Hairong Zheng; Katherine W Ferrara Journal: J Control Release Date: 2006-12-23 Impact factor: 9.776
Authors: Giuseppe Di Lorenzo; Antonio Rea; Chiara Carlomagno; Stefano Pepe; Giovannella Palmieri; Roberto Labianca; Antonio Chirianni; Alfonso De Stefano; Vincenzo Esposito; Sabino De Placido; Vincenzo Montesarchio Journal: World J Gastroenterol Date: 2007-12-28 Impact factor: 5.742