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Annals of Oncology 15:770-774, 2004
© 2004 European Society for Medical Oncology

Original Paper

Gemcitabine concurrent with continuous infusional 5-fluorouracil in advanced biliary cancers: a review of the Princess Margaret Hospital experience

Received 9 October 2003; revised 12 January 2004; accepted 14 January 2004

Background:

Unresectable biliary tract cancer has a very poor prognosis. A combination of weekly gemcitabine plus continuous infusional 5-fluorouracil (5-FU) (GEM/CVI 5-FU) was evaluated as therapy for this cancer.

Patients and methods:

The charts of 27 patients with advanced biliary tract adenocarcinoma treated with GEM/CVI 5-FU at the Princess Margaret Hospital were evaluated for response, survival and toxicity. The treatment consisted of a 30-min infusion of gemcitabine at 900 mg/m2 on days 1, 8 and 15 of a 28-day cycle plus 5-FU given via a peripherally inserted central line at 200 mg/m2/day continuously for 21 days, every 28 days.

Results:

Objective responses were observed in nine patients (33%; 95% confidence interval 17% to 54%). An additional eight patients (30%) achieved stable disease for a median of 4 months (range 2.3–11). Median time to progression and overall survival were 3.7 and 5.3 months, respectively. Direct chemotherapy-related toxicity was mild, with only 11% grade ≥3 myelosuppression. Central venous catheter complications were common (26%). There were no treatment-related deaths.

Conclusions:

This study shows that GEM/CVI 5-FU is active and well tolerated in advanced and metastatic biliary tract cancers.

J. J. Knox1,*, D. Hedley1, A. Oza1, L. L. Siu1, G. R. Pond2 and M. J. Moore1

1 Departments of Hematology and Medical Oncology, Princess Margaret Hospital/University Health Network, Toronto, Canada and Department of Medicine, University of Toronto, Toronto; 2 Department of Biostatistics, Princess Margaret Hospital/University Health Network, Toronto, Canada

Key words: biliary tract cancer, chemotherapy, 5-fluorouracil, gemcitabine


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