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, Hung Ming Wang

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11 Citations (Scopus)

Abstract

Objective: This multicenter Phase II trial evaluated the toxicity/efficacy of gemcitabine plus cisplatin as first-line chemotherapy in patients with recurrent/metastatic nasopharyngeal carcinoma. Methods: Gemcitabine 1250 mg/m2 on Days 1 and 8 and cisplatin 75 mg/m2 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. Results: Fifty-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 cycleswas 6.63 ± 0.40. The regimenwaswell-tolerated, although one treatment-related death occurred after severe sepsis from aspiration pneumonia. Conclusions: Gemcitabine plus cisplatin is an effective, well-tolerated regimen as a first-line treatment for recurrent/metastatic nasopharyngeal carcinoma.

Original languageEnglish
Article numberhyv083
Pages (from-to)819-827
Number of pages9
JournalJapanese Journal of Clinical Oncology
Volume45
Issue number9
DOIs
Publication statusPublished - Sep 1 2015
Externally publishedYes

Keywords

  • Chemo-phase I-II-III
  • Clinical trials
  • H & N-Med
  • Head and neck
  • Palliative care
  • Supportive care

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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    Hsieh, J. C. H., Hsu, C. L., Ng, S. H., Wang, C. H., Lee, K. D., Lu, C. H., Chang, Y. F., Hsieh, R. K., Yeh, K. H., Hsiao, C. H., Chen, S. Y., Shiau, C. Y., & Wang, H. M. (2015). Gemcitabine plus cisplatin for patients with recurrent or metastatic nasopharyngeal carcinoma in Taiwan: A multicenter prospective Phase II trial. Japanese Journal of Clinical Oncology, 45(9), 819-827. [hyv083]. https://doi.org/10.1093/jjco/hyv083