• Jpn. J. Clin. Oncol. · Sep 2015

    Multicenter Study

    Gemcitabine plus cisplatin for patients with recurrent or metastatic nasopharyngeal carcinoma in Taiwan: a multicenter prospective Phase II trial.

    • Jason Chia-Hsun Hsieh, Cheng-Lung Hsu, Shu-Hang Ng, Cheng-Hsu Wang, Kuan-Der Lee, Chang-Hsien Lu, Yi-Fang Chang, Ruey-Kuen Hsieh, Kun-Huei Yeh, Chi-Huang Hsiao, Sheng-Yu Chen, Cheng-Ying Shiau, and Hung-Ming Wang.
    • Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan Department of Chemical and Materials Engineering, Chang Gung University, Taoyuan.
    • Jpn. J. Clin. Oncol. 2015 Sep 1; 45 (9): 819-27.

    ObjectiveThis multicenter Phase II trial evaluated the toxicity/efficacy of gemcitabine plus cisplatin as first-line chemotherapy in patients with recurrent/metastatic nasopharyngeal carcinoma.MethodsGemcitabine 1250 mg/m(2) on Days 1 and 8 and cisplatin 75 mg/m(2) on Day 1 were administered at a 3-week interval. The primary endpoint was the response rate. Secondary endpoints included progression-free survival, overall survival, response duration and safety.ResultsFifty-two patients were recruited between 2004 and 2008. The response rate was 51.9% (complete remission rate, 9.6%) in the intent-to-treat group. The median progression-free and overall survivals were 9.8 and 14.6 months, respectively. The major Grade III/IV adverse event was leucopenia (61.6%). The mean number of cycles was 6.63 ± 0.40. The regimen was well-tolerated, although one treatment-related death occurred after severe sepsis from aspiration pneumonia.ConclusionsGemcitabine plus cisplatin is an effective, well-tolerated regimen as a first-line treatment for recurrent/metastatic nasopharyngeal carcinoma.© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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