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 cycles using the RECIST. Results: 49 patients were enrolled in this phase II study from May 2008 to Aug 2010. Medain age was 60.14 years (range 35-80), male/female=27/12, ECOG performance status 0/1/2 = 23/21/5. The primary tumor site was 14 patients in gallbladders, 28 patients in intrahepatic cholangiocarcinoma, and 7 patients in extrahepatic cholangiocarcinoma. 44 patients showed metastatic disease at baseline. Total chemotherapeutic cycles were 210 and 4.29 cycles were performed each person. Treatment related grade 3/4 toxicities included (number of cycles) diarrhea (2), neutropenia (10), neutropenic fever (2), anemia (1), thrombocytopenia (2), nausea (1) and pneumonia (1). Overall response rate was 16.3% and overall disease control rate was 61.7%. The median TTP was 3.83 months (95%CI, 3.45-5.68 months) and the overall survival was 10.77 months (95%CI, 7.92-13.62 months). No treatment related deaths occurred during the study. Conclusions: This results suggest that FOLFOX-6 would be an effective and well-tolerated chemotherapy regimen for Korean patients with advanced BTC.