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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/12704


    Title: Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study
    Authors: Chiang, NJ;Chen, MH;Yang, SH;Hsu, C;Yen, CJ;Tsou, HH;Su, YY;Chen, JS;Shan, YS;Chen, LT
    Contributors: National Institute of Cancer Research;Institute of Population Health Sciences
    Abstract: BACKGROUND & AIMS: Gemcitabine plus cisplatin (GC) remains the standard, frontline therapy for advanced biliary tract cancer (ABTC). The JCOG1113 study suggested that the median overall survival and incidence of significant neutropenia after gemcitabine plus S-1 (GS) and GC treatments were comparable. This study evaluates the efficacy and safety of the modified GS regimen. METHODS: The eligible patients with chemonaive, measurable ABTC received 800 mg/m(2) of gemcitabine on day 1 and 80 mg/m(2) /day of S-1 (80/100/120 mg for patients with body surface <1.25/ ≥1.25 and <1.5/ ≥1.5m(2) , respectively). The primary endpoint (PE) was the 12-week disease control rate (12-week DCR: objective response and stable disease ≥12 weeks). Per the p0=40% and p1=60% (a/b=0.05/0.2) assumption, Simon's optimal 2-stage design indicated 12-week DCR in ≥24 of 46 evaluable patients for significant activity. Tumour responses were assessed every 6 weeks. RESULTS: Fifty-one patients were enrolled and most of them had intrahepatic cholangiocarcinoma (64.7%), metastatic disease (84.3%) and disease-related symptoms (82.4%). On intention-to-treat analysis, 11 (21.6%) patients showed partial response, whereas 21 (41.2%) showed stable disease ≥12 weeks. The progression-free and overall survival of 5.4 months (95% confidence interval [CI]: 3.5-7.0), and 12.7 months (95% CI: 6.1-15.6), respectively. The study met its PE with a 12-week DCR of 69.6% in 46 evaluable patients. Grade 3/4 treatment-related adverse events occurred in <6% of patients. The mean dose intensities of S-1 and gemcitabine were 87.1% and 92.5%, respectively. CONCLUSIONS: Modified GS showed moderate efficacy with a favourable safety profile in ABTC patients, thus mandating further assessment.
    Date: 2020-10
    Relation: Liver International. 2020 Oct;40(10):2535-2543.
    Link to: http://dx.doi.org/10.1111/liv.14538
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1478-3223&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000539016900001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85086172033
    Appears in Collections:[陳立宗] 期刊論文
    [姜乃榕] 期刊論文
    [鄒小蕙] 期刊論文
    [蘇勇曄] 期刊論文

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