A phase II study of pegylated liposomal doxorubicin for treatment of advanced hepatocellular carcinoma.
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.


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.
Halm
U
U
Department of Internal Medicine II, University of Leipzig, Germany. halmu@medizin.uni-leipzig.de
Etzrodt
G
G
Schiefke
I
I
Schmidt
F
F
Witzigmann
H
H
Mössner
J
J
Berr
F
F
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008081:Liposomes; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging
D000970:Antineoplastic Agents; D008081:Liposomes; D004317:Doxorubicin