Two-Week Combination Chemotherapy with Gemcitabine, High-Dose Folinic Acid and 5 Fluorouracil (GEMFUFOL) as First-Line Treatment of Metastatic Biliary Tract Cancers

Background: The aim of this study was to evaluate the efficacy and tolerability of a gemcitabine, 5-fluorouraciland leucovorin (GEMFUFOL) chemotherapy regimen as first line treatment of metastatic biliary tract cancer.Materials and
Methods: All patients received folinic acid 400 mg/m2 on day 1, 5-fluorouracil bolus 400 mg/m2 on day 1, IV infusion of 5-fluorouracil 2400 mg/m2 over 46 hours, and gemcitabine 1250 mg/m2 on day 1.
Results: A total of 29 patients with metastatic biliary tract cancer received GEMFUFOL regimen as the firstlinetreatment. The mean follow-up was 22.1 months (95%CI, 12.5-31.8). One patient (3.4%) achieved completeresponse, 5 (17.2%) had partial response, and 4 (13.8%) had stable disease. The median progression-free survivalwas 3.3 months (95%CI, 2.9-3.7), and the median overall survival was 8.8 months (95%CI, 3.5-14). The 1-yearand 2-year survival rates were 58.6% and 30%, respectively. Grade 3 and 4 toxicity included neutropenia in4 patients (13.7%), thrombocytopenia in 2 (6.8%), anemia in 2 (6.8%), and alopecia in 1 (3.4%). Two patients(6.8%) developed febrile neutropenia. A dose reduction was achieved in 8 patients (27.6%) while 5 patientshad extended-interval dosage (17.2%) for toxicity.
Conclusions: The GEMFUFOL chemotherapy regimen wasgenerally efficacious and tolerable as a first-line treatment of metastatic biliary tract cancer.