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

Abstract
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.