Activity of gemcitabine and continuous infusion fluorouracil in advanced pancreatic cancer

Background/Objectives: Gemcitabine has been shown to improve survival and q uality of life parameters compared to fluorouracil alone in advanced pancre atic cancer [J Clin Oncol 1997;15:2403-2413]. However, fluorouracil was giv en as a weekly bolus in that study and other administration schedules might be more effective. The objective of this trial was to determine the activi ty and toxicity of gemcitabine in combination with continuous infusion (CI) fluorouracil in advanced pancreatic cancer. Patients and Methods: Chemothe rapy-naive patients with measurable advanced adenocarcinoma of the pancreas were treated with gemcitabine 1,000 mg/m(2) intravenously weekly x 3 follo wed by 1 week of rest every 4 weeks and 200 mg/m(2)/day CI fluorouracil unt il disease progression or limiting toxicity. Results: Twenty-five patients were evaluable for response and toxicity. Objective partial responses were documented in 5 patients (20%; 95% confidence interval 6.8-40.7%) and disea se stabilization or minor responses in 13 patients (52%; 31.3-72.2%). Toxic ity was mild with grade 2/3 leucopenia in 26%, stomatitis in 15%, nausea in 6%, diarrhea in 3%, and hand-foot syndrome in 2% of the treatment cycles. In 3 patients a catheter thrombus occurred and in 1 patient the treatment h ad to be stopped due to asthenia. The performance status improved in 39% of the patients and 65% benefitted in terms of a decrease in pain intensity o r consumption of analgesics. Conclusion: This phase II trial confirms a sig nificant antitumor activity and a beneficial clinical effect of gemcitabine plus CI fluorouracil in advanced pancreatic cancer. The combination is wel l tolerated and it will have to be shown whether oral fluoropyrimidines can increase the practicability of this treatment without impairing efficacy. Copyright (C) 2001 S. Karger AG, Basel.