國家衛生研究院 NHRI:Item 3990099045/8528
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/8528


    Title: A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer
    Authors: Chen, JS;Hsu, C;Chiang, NJ;Tsai, CS;Tsou, HH;Huang, SF;Bai, LY;Chang, IC;Shiah, HS;Ho, CL;Yen, CJ;Lee, KD;Chiu, CF;Rau, KM;Yu, MS;Yang, Y;Hsieh, RK;Chang, JY;Shan, YS;Chao, Y;Chen, LT
    Contributors: National Institute of Cancer Research;Division of Biostatistics and Bioinformatics;Institute of Molecular and Genomic Medicine
    Abstract: BACKGROUND: Previous clinical trials have not proved that adding epidermal growth factor receptor inhibitors to chemotherapy confers a survival benefit for patients with advanced biliary tract cancer (ABTC). Whether the KRAS mutation status of tumor cells confounded the results of past studies is unknown. PATIENTS AND METHODS: ABTC patients stratified by KRAS status, Eastern Cooperative Oncology Group performance status, and primary tumor location were randomized 1:1 to receive GEMOX (800 mg/m2 gemcitabine and 85 mg/m2 oxaliplatin) or C-GEMOX (500 mg/m2 cetuximab plus GEMOX) every 2 weeks. The primary endpoint was objective response rate (ORR). RESULTS: The study enrolled 122 patients between December 2010 and May 2012 (62 treated with C-GEMOX and 60 with GEMOX). Compared to GEMOX alone, C-GEMOX was associated with trend to better ORR (27% vs. 15%; p=0.12) and progression-free survival (PFS, 6.7 vs. 4.1 months; p=0.05), but not overall survival (OS, 10.6 vs. 9.8 months; p=0.91). KRAS mutations, which were detected in 36% of tumor samples, did not affect the trends of difference in ORR and PFS between C-GEMOX and GEMOX. The two treatment arms had similar adverse events, except that more patients had skin rashes, allergic reactions, and neutropenia in the C-GEMOX arm. Of patients with C-GEMOX, the presence of a grade 2 or 3 skin rash was associated with significantly better ORR, PFS, and OS. CONCLUSIONS: Addition of cetuximab did not significantly improve the ORR of GEMOX chemotherapy in ABTC, although a trend of PFS improvement was observed. The trend of improvement did not correlate with KRAS mutation status.
    Date: 2015-05
    Relation: Annals of Oncology. 2015 May;26(5):943-949.
    Link to: http://dx.doi.org/10.1093/annonc/mdv035
    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:000353830000017
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84929091392
    Appears in Collections:[Li-Tzong Chen] Periodical Articles
    [Jang-Yang Chang] Periodical Articles
    [Nai-Jung Chiang] Periodical Articles
    [Hsiao-Hui Sophie Tsou] Periodical Articles
    [Shiu-Feng Kathy Huang] Periodical Articles

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