期刊
BRITISH JOURNAL OF CANCER
卷 108, 期 1, 页码 21-24出版社
SPRINGERNATURE
DOI: 10.1038/bjc.2012.556
关键词
hepatocellular carcinoma; liver cirrhosis; liver function; MET inhibitor; tivantinib
类别
资金
- Instituto de Salud Carlos III [PI 11/01830, FI09/00510]
- Spanish Biomedical Research Network (CIBER) for the area of Hepatic and Digestive disorders
- ArQule, Inc., Woburn, MA, USA
- Daiichi Sankyo, Inc.
- Daiichi Sankyo Co., Ltd., Tokyo, Japan
- ArQule
Background: The mesenchymal-epithelial transition factor (MET) receptor is dysregulated in hepatocellular carcinoma (HCC), and tivantinib (ARQ 197) is an oral, selective, MET inhibitor. Methods: This Phase-1b study assessed tivantinib safety as primary objective in patients with previously treated HCC and Child-Pugh A or B liver cirrhosis. Patients received oral tivantinib 360mg twice daily until disease progression or unacceptable toxicity. Results: Among 21 HCC patients, common drug-related adverse events (AEs) were neutropaenia, anaemia, asthenia, leucopaenia, anorexia, diarrhoea, and fatigue. No drug-related worsening of liver function or performance status occurred, but one Child-Pugh B patient experienced drug-related bilirubin increase. Four patients had drug-related serious AEs, including one neutropaenia-related death. Haematologic toxicities were more frequent than in previous tivantinib studies but were manageable with prompt therapy. Best response was stable disease (median, 5.3 months) in 9 of 16 evaluable patients (56%). Median time to progression was 3.3 months. Conclusion: Tivantinib demonstrated a manageable safety profile and preliminary antitumour activity in patients with HCC and Child-Pugh A or B cirrhosis.
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