Oxaliplatin, 5-FU, and leucovorin (FOLFOX) in advanced biliary tract cancer.

4106 Background: There is no standard palliative chemotherapy regimen in biliary tract cancers (BTC). Fluoropyrimidine or gemcitabine, with or without platinum, are most frequently used. The purpose of this prospective multicenter phase II study was to evaluate the efficacy and safety of FOLFOX-6(5-FU/LV plus oxaliplatin) combination chemotherapy in patients with advanced BTC. Methods: Eligible criteria included pathologically or cytologically confirmed biliary adenocarcinoma, unresectable or metastatic BTCs with at least one measurable lesion, no previous palliative chemotherapy, age ≥ 18, performance status ≤ 2, adequate organ function and no clinically significant cardiovascular disease. 89.8% patients had metastatic disease. All patients received FOLFOX-6 (oxaliplatin 85mg/m2 and folinic acid 400 mg/m2 on day 1 follwed by a 5-FU bolus 400 mg/m2 and 46-h infusion 2400 mg/m2 every 2 weeks) until progression of disease or unacceptable toxicities. Tumor response was evaluated each after four treatment cyc...