國家衛生研究院 NHRI:Item 3990099045/11759
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    题名: TCOG T1308 study: The final results of a phase II trial of modified gemcitabine plus S-1 combination as the first-line treatment in patients with advanced biliary tract cancer
    作者: Chiang, NJ;Chen, LT;Chen, JS;Yang, SH;Hsu, C;Shan, YS;Yen, CJ;Chen, MH;Tsou, HH
    贡献者: Institute of Population Health Sciences;National Institute of Cancer Research
    摘要: Background: Gemcitabine and platinum-based regimen is the standard regimen for advanced biliary tract cancer (ABTC) nowadays. A phase II study, JCOG0805 showed that gemcitabine plus S-1 was more promising than S-1 alone in ABTC, and a recently reported phase III JCOG1113 showed gemcitabine plus S-1 (GS) is non-inferiority to gemcitabine plus cisplatin (GC) in overall survival (OS). Herein, we report the results of a single arm phase II of modified GS in Taiwanese ABTC patients, NCT02425137. Methods: Patients with chemo-naïve ABTC were eligible to receive 800mg/m2 gemcitabine with 10 mg/m2/min infusion, on day 1 plus daily 80/100/120 mg of S-1 (based on BSA) days 1-10, in a 2-week cycle (modified GS). With Optimal Simon’s two-stage design and (p0=0.4, p1=0.6) for 12-week disease control rate (proportion of patients with complete or partial response [CR/PR] or stable disease ≥12 weeks [SD≥12weeks]) and given error probabilities (alpha=0.05, beta=0.2), the null hypothesis (p0) would be rejected if 24 or more patients with CR/PR/SD≥12weeks were observed among 46 accruals. Tumor response was assessed by CT/MRI every 6 weeks according to RECIST v1.1. Results: Between May 2015 and April 2016, totally 46 evaluable patients were enrolled with median treatment duration of 4.7 months (95% CI, 4.4-7.3). On May 31, 2017 of data lock, 11 (23.9%) patients achieved PR and additional 21 (45.7%) had SD>12weeks. The median progression-free survival and OS was 5.6 (95% CI, 5.0-6.2) and 14.5 (95% CI, 8.8-20.3) months, respectively. All grade 3 treatment-related adverse events were <5%. The dose intensity of S-1 and gemcitabine were both around 95%. Conclusions: By the observation of 32 patients with PR/SD≥12weeks, the null hypothesis was rejected. Modified GS is an active regimen with excellent safety profiles and deserves further investigation for the management of Asian ABTC patients.
    日期: 2018-11
    關聯: Annals of Oncology. 2018 Nov;29(Suppl. 9):50.
    Link to: https://doi.org/10.1093/annonc/mdy432.008
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000458082200202
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081656164
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