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Cancer Chemotherapy and Pharmacology

, Volume 61, Issue 1, pp 33–38 | Cite as

Phase II clinical study of gemcitabine in the treatment of patients with advanced nasopharyngeal carcinoma after the failure of platinum-based chemotherapy

  • Li ZhangEmail author
  • Yang Zhang
  • Pei-Yu Huang
  • Fei Xu
  • Pei-Jian Peng
  • Zhong-Zhen Guan
Original Article

Abstract

Purpose

This study was designed to evaluate the anti-tumor activity and toxicity profile of gemcitabine in the treatment of patients with advanced nasopharyngeal carcinoma (NPC) who had been pretreated with platinum-based chemotherapy.

Method

This is an open label, single arm phase II trial. All patients were treated with single agent of gemcitabine. Gemcitabine was given in the dosage of 1.0 g/m2 on days 1, 8, 15, each cycle repeated every 4 weeks. Gemcitabine was added to 100 ml normal saline infused over 30 min.

Result

About 32 patients were enrolled in this trial. Thirty patients were assessable for response to treatment. Fourteen patients had a partial response (PR), giving an overall response rate of 43.8% (14/32); 9 patients had stable disease (28.1%) and 7 progressed disease (21.9%). The median time to progression was 5.1 months and median survival time was 16 months, 1 year survival rate was 67%, 2 year overall survival rate was 12%. A total of 11 patients (34.4%) experienced grade 3 and 4 toxicity and the main toxicity was myelosuppression. the non-hematology toxicity was minimal.

Conclusion

The effectiveness of gemcitabine was higher and side effects were minimal in advanced NPC patients after platinum-based chemotherapy failed.

Keywords

Gemcitabine Nasopharyngeal carcinoma 

Notes

Acknowledgments

We thank Eli Lilly Corporation for providing free samples of gemcitabine for our study. We also thank all patients and their families for their willingness to take part in this study.

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Copyright information

© Springer-Verlag 2007

Authors and Affiliations

  • Li Zhang
    • 1
    Email author
  • Yang Zhang
    • 1
  • Pei-Yu Huang
    • 1
  • Fei Xu
    • 1
  • Pei-Jian Peng
    • 1
  • Zhong-Zhen Guan
    • 1
  1. 1.Department of Medical OncologyCancer Center of Sun Yat-Sen UniversityGuangzhouPeople’s Republic of China

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