We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
A randomised phase II study of pegylated arginine deiminase (ADI-PEG 20) in Asian advanced hepatocellular carcinoma patients.
- Authors
Yang, T.-S.; Lu, S.-N.; Chao, Y.; Sheen, I.-S.; Lin, C.-C.; Wang, T.-E.; Chen, S.-C.; Wang, J.-H.; Liao, L.-Y.; Thomson, J. A.; Wang-Peng, J.; Chen, P.-J.; Chen, L.-T.
- Abstract
<bold>Background: </bold>Human hepatocellular carcinoma (HCC) cells are largely deficient of argininosuccinate synthetase and thus auxotrophic for arginine. This study aims to investigate the efficacy and pharmacodynamics of pegylated arginine deiminase (ADI-PEG 20), a systemic arginine deprivation agent, in Asian HCC patients.<bold>Methods: </bold>Patients with advanced HCC who were not candidates for local therapy were eligible and randomly assigned to receive weekly intramuscular injections of ADI-PEG 20 at doses of 160 or 320 IU m(-2). The primary end point was disease-control rate (DCR).<bold>Results: </bold>Of the 71 accruals, 43.6% had failed previous systemic treatment. There were no objective responders. The DCR and the median overall survival (OS) of the intent-to-treat population were 31.0% (95% confidence interval (CI): 20.5-43.1) and 7.3 (95% CI: 4.7-9.9) months respectively. Both efficacy parameters were comparable between the two study arms. The median OS of patients with undetectable circulating arginine for more than or equal to and <4 weeks was 10.0 (95% CI: 2.1-17.9) and 5.8 (95% CI: 1.4-10.1) months respectively (P=0.251, log-rank test). The major treatment-related adverse events were grades 1-2 local and/or allergic reactions.<bold>Conclusions: </bold>ADI-PEG 20 is safe and efficacious in stabilising the progression of heavily pretreated advanced HCC in an Asian population, and deserves further exploration.
- Subjects
LIVER cancer; CELLS; AGMATINE; ARGININE; CANCER patients; ASIANS; CANCER; THERAPEUTICS
- Publication
British Journal of Cancer, 2010, Vol 103, Issue 7, p954
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/sj.bjc.6605856