國家衛生研究院 NHRI:Item 3990099045/6907
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    題名: Randomised clinical trial: Comparison of two everolimus dosing schedules in patients with advanced hepatocellular carcinoma
    作者: Shiah, HS;Chen, CY;Dai, CY;Hsiao, CF;Lin, YJ;Su, WC;Chang, JY;Whang-Peng, J;Lin, PW;Huang, JD;Chen, LT
    貢獻者: National Institute of Cancer Research;Division of Clinical Trial Statistics
    摘要: Background: Deregulation of mammalian target of rapamycin (mTOR) signalling is common in human hepatocellular carcinoma (HCC). Aim: To determine the maximum tolerated dose (MTD) of the oral mTOR inhibitor everolimus in advanced HCC patients. Methods: Patients with locally advanced or metastatic HCC (Child-Pugh class A or B) were enrolled in an open-label phase 1 study and randomly assigned to daily (2.5–10 mg) or weekly (20–70 mg) everolimus in a standard 3 + 3 dose-escalation design. MTD was based on the rate of dose-limiting toxicities (DLTs). Secondary endpoints included safety, pharmacokinetics and tumour response. In a post hoc analysis, serum hepatitis B virus (HBV) DNA levels were quantified. Results: Thirty-nine patients were enrolled. DLTs occurred in five of 21 patients in the daily and two of 19 patients in the weekly cohort. Daily and weekly MTDs were 7.5 mg and 70 mg respectively. Grade 3/4 adverse events with a ≥10% incidence were thrombocytopenia, hypophosphataemia and alanine transaminase (ALT) elevation. In four hepatitis B surface antigen (HBsAg)-seropositive patients, grade 3/4 ALT elevations were accompanied by significant (>1 log) increases in serum HBV levels. The incidence of hepatitis flare (defined as ALT increase >100 IU/mL from baseline) in HBsAg-seropositive patients with and without detectable serum HBV DNA before treatment was 46.2% and 7.1% respectively (P < 0.01, Fisher exact test). Disease control rates in the daily and weekly cohorts were 71.4% and 44.4% respectively. Conclusions: The recommended everolimus dosing schedule for future hepatocellular carcinoma studies is 7.5 mg daily. Prophylactic anti-viral therapy should be mandatory for HBsAg-seropositive patients.
    日期: 2013-01
    關聯: Alimentary Pharmacology and Therapeutics. 2013 Jan;37(1):62-73.
    Link to: http://dx.doi.org/10.1111/apt.12132
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0269-2813&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000312160400006
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84870609803
    顯示於類別:[陳立宗] 期刊論文
    [夏和雄(1996-2012)] 期刊論文
    [彭汪嘉康(1996-2007)] 期刊論文
    [張俊彥] 期刊論文
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