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Thalidomide in advanced hepatocellular carcinoma as antiangiogenic treatment approach: a phase I/II trial.

Abstract：

BACKGROUND:The high vascularity of hepatocellular carcinoma (HCC) seems to be a potential therapeutic target. We evaluated the efficacy, toxicity, and histologic response to thalidomide in advanced HCC in a single center phase I/II pilot trial. METHODS:Between September 2000 and August 2004 patients with HCC uneligible for any established therapy were enrolled in the study. The initial thalidomide dosage of 100 mg/day was escalated in 100 mg steps weekly up to 300 mg/day based on tolerability. Discontinuation and dose reduction were based on toxicity. Tumor biopsies were scheduled to assess tumor microvessel density and serum levels of angiogenic factors, vascular endothelial growth factor, basic fibroblast growth factor, and endostatin were determined. RESULTS:Twenty-eight patients with histologically proven HCC were entered into this study. The median maximum-tolerated dose of thalidomide was 300 mg/day. Most common toxicities were fatigue (75%), dizziness (64%), nausea (43%), and constipation (39%). Two patients had stable disease for 2.6 and 5.4 months, the remaining 26 patients had disease progression. The median overall survival was 5.1 months. Well preserved liver function was associated with longer overall survival on univariate analysis (P=0.0279). The serum concentrations of vascular endothelial growth factor and endostatin increased significantly (P=0.039 and P=0.024, respectively) after 3 months of thalidomide treatment. No clear differences were observed between the serum basic fibroblast growth factor concentrations at study entry and after 3 months (P=0.983). Microvessel density did not decrease significantly during thalidomide therapy (P=0.109). CONCLUSION:Thalidomide is moderately tolerated and minimally effective in large HCC.

journal_name

Eur J Gastroenterol Hepatol

journal_title

European journal of gastroenterology & hepatology

authors

Pinter M,Wichlas M,Schmid K,Plank C,Müller C,Wrba F,Peck-Radosavljevic M

doi

10.1097/MEG.0b013e3283036740

subject

Has Abstract

pub_date

2008-10-01 00:00:00

pages

1012-9

issue

eissn

0954-691X

issn

1473-5687

pii

00042737-200810000-00012

journal_volume

pub_type

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Thalidomide in advanced hepatocellular carcinoma as antiangiogenic treatment approach: a phase I/II trial.