國家衛生研究院 NHRI:Item 3990099045/5137

NHRI > National Institute of Cancer Research > Jacqueline Whang-Peng(1996-2007) > Periodical Articles > Item 3990099045/5137

Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/5137

Title:	A randomised phase II study of pegylated arginine deiminase (ADI-PEG 20) in Asian advanced hepatocellular carcinoma patients
Authors:	Yang, TS;Lu, SN;Chao, Y;Sheen, IS;Lin, CC;Wang, TE;Chen, SC;Wang, JH;Liao, LY;Thomson, JA;Wang-Peng, J;Chen, PJ;Chen, LT
Contributors:	National Institute of Cancer Research
Abstract:	Background: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. Methods: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<sup>-2</sup>. The primary end point was disease-control rate (DCR). Results: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. Conclusions:ADI-PEG 20 is safe and efficacious in stabilising the progression of heavily pretreated advanced HCC in an Asian population, and deserves further exploration.British Journal of Cancer advance online publication, 31 August 2010; doi:10.1038/sj.bjc.6605856 www.bjcancer.com.
Date:	2010-09
Relation:	British Journal of Cancer. 2010 Sep;103(7):954-960.
Link to:	http://dx.doi.org/10.1038/sj.bjc.6605856
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0007-0920&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:000282222000005
Cited Times(Scopus):	http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=77957245576
Appears in Collections:	[Jacqueline Whang-Peng(1996-2007)] Periodical Articles [Li-Tzong Chen] Periodical Articles

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