國家衛生研究院 NHRI:Item 3990099045/2938
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/2938


    Title: Phase I and pharmacokinetic study of oral thalidomide in patients with advanced hepatocellular carcinoma
    Authors: Shiah, HS;Chao, Y;Chen, LT;Yao, TJ;Huang, JD;Chang, JY;Chen, PJ;Chuang, TR;Chin, YH;Whang-Peng, J;Liu, TW
    Contributors: National Institute of Cancer Research;Division of Biostatistics and Bioinformatics;Division of Biotechnology and Pharmaceutical Research
    Abstract: Purpose: To evaluate the dose-limiting toxicities (DLT), maximum tolerated dose (MTD), and pharmacokinetics of thalidomide in patients with advanced hepatocellular carcinoma (HCC). Methods: Patients with advanced HCC who were not feasible for definitive local therapy were eligible. Patients were enrolled in a cohort of three to receive thalidomide twice daily for 1 week to determine the MTD. Intra-patient dose escalation was permitted. Pharmacokinetic studies were performed at the first dose level and repeated at the second dose level of each patient. Results: Fifteen patients were accrued at four dose levels with the starting dose range 100-400 mg/day. Two patients at 400 mg/day experienced DLT (grade 3 angioedema and dyspnea, respectively). The MTD of twice-daily schedule was determined as 300 mg/day. The mean steady-state maximal blood concentration and mean steady-state area under the curve had a trend toward positive correlation, but non-linear proportionate, to the daily dose of thalidomide. Pharmacokinetic parameters are comparable for patients of Child-Pugh's A and B. Apparent mild, transient drug-induced transaminitis was early onset, self-limited, which occurred in 30.7% of patients. Serum hepatitis B or C viral titers was largely not affected. Conclusion: The absorption and elimination of thalidomide are not significantly different in HCC patients with compensated or decompensated hepatic dysfunction.
    Keywords: Oncology;Pharmacology & Pharmacy
    Date: 2006-11
    Relation: Cancer Chemotherapy and Pharmacology. 2006 Nov;58(5):654-664.
    Link to: http://dx.doi.org/10.1007/s00280-006-0203-z
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0344-5704&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000239485000012
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84984535366
    Appears in Collections:[Tsang-Wu Liu] Periodical Articles
    [Her-Shyong Shiah(1996-2012)] Periodical Articles
    [Jang-Yang Chang] Periodical Articles
    [Jacqueline Whang-Peng(1996-2007)] Periodical Articles
    [Li-Tzong Chen] Periodical Articles
    [Others] Periodical Articles
    [Tzu-Chun Yao(1999-2002)] Periodical Articles

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