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Annals of Oncology 13:150-156, 2002
© 2002 European Society for Medical Oncology

Gemcitabine in metastatic nasopharyngeal carcinoma of the undifferentiated type

K.-F. Foo1, E.-H. Tan1,+, S.-S. Leong1, J. T. S. Wee2, T. Tan2, K.-W. Fong2, L. Koh3, B.-C. Tai4, L.-G. Lian2,4 and D. Machin3,4

1Department of Medical Oncology, 2Department of Therapeutic Radiology, 3Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore; 4National Medical Research Council, Clinical Trials and Epidemiology Research Unit, Singapore

Received 10 April 2001; revised 3 August 2001; accepted 20 August 2001.

Background

We conducted two parallel phase II trials in chemonaïve and previously treated patients with metastatic nasopharyngeal carcinoma (NPC) to evaluate the tumour response, progression-free and overall survival, and toxicity of gemcitabine.

Patients and methods

Gemcitabine 1250 mg/m2 was given on days 1 and 8 of a 21-day cycle. Patients with an Eastern Cooperative Oncology Group performance status <2, adequate renal, hepatic and bone marrow function, and radiologically measurable NPC were eligible.

Results

Twenty-five chemonaïve and 27 previously treated patients were enrolled. The overall response rate was 28% [95% confidence interval (CI) 14% to 48%] for the chemonaïve and 48% (95% CI 31% to 66%) for previously treated patients. Toxicities greater than or equal to grade 3 occurred in 15 (60%) chemonaïve and 13 (48%) previously treated patients. Neutropenia was uncommon in chemonaïve patients, but occurred in 37% of previously treated patients. The median time to progression was 3.6 months (range 0.9–7.9) for chemonaïve and 5.1 months (0.9–13.1) for previously treated patients. Median overall survival time was 7.2 months (1.4–15.6) and 10.5 months (2.4–15.0) for chemonaïve and previously treated patients, respectively.

Conclusions

Gemcitabine has moderate activity in NPC with minimal toxicity, and is also an effective salvage agent for patients who have failed or progressed after treatment with other agents.

Key words: gemcitabine, metastatic nasopharyngeal carcinoma


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