Prospective evaluation of efficacy and toxicity of 5-fu and folinic acid (Mayo Clinic regimen) in patients with advanced cancer of the gallbladder.

We evaluated the efficacy and toxicity of 5-fluorouracil (5-FU) and folinic acid (Mayo Clinic regimen) in previously untreated patients with advanced gallbladder cancer. Thirty patients with histologically confirmed adenocarcinoma of gallbladder were enrolled on this trial. All were symptomatic and had stage IV disease. Patients received 5-FU 425 mg/m2 daily for 5 consecutive days preceded by folinic acid 20 mg/m2/d. Treatment cycles were repeated every 28 days. Only two patients (7%) achieved an objective response to therapy. Another 10 (33%) had stable disease. Median time to progression was 4.7 months, and median overall survival was 14.8 months. Toxicity was moderate, and one treatment-related death occurred. In conclusion, 5-FU and folinic acid (Mayo Clinic regimen) is ineffective in the management of patients with advanced gallbladder cancer, and further trials with this regimen are not recommended.