A phase II trial of gemcitabine in combination with 5-fluorouracil (24-hour) and folinic acid in patients with chemonaive advanced pancreatic cancer

Background: Gemcitabine (Gemzar(R)) and 5-fluorouracil (5-FU) plus folinic acid (FA) both have proven activity in the treatment of patients with advan ced pancreatic cancer. The present study was initiated to investigate the e fficacy of gemcitabine in combination with 5-FU-FA. Patients and methods: Thirty-eight patients, median age 60 years (range 34- 70) with inoperable, stage IV, pancreatic cancer were enrolled into the stu dy and treated on an outpatient basis. All except one patient received at l east one cycle of treatment with gemcitabine (1000 mg/m(2)), followed by FA (200 mg/m(2)) and 5-FU (750 mg/m(2)) administered as a 24-hour continuous infusion on days 1, 8, 15 and 22 of a 42-day schedule. No patient had recei ved prior chemotherapy or radiotherapy. All 38 patients were assessed for e fficacy, toxicity and time to progressive disease. Results: Two patients (5%), achieved a partial response and thirty-four pat ients (89%) achieved stable disease. There were two early deaths (less than or equal to4 weeks). The median time to progression was 7.1 months (range 0.4-18.1+; 95% confidence interval (95% CI): 5.3-7.9 months). Three patient s had a progression-free interval of greater than 12 months and 12 of 38 pa tients (32%) survived longer than 12 months. The median overall survival wa s 9.3 months (range 0.5-26.5; 95% CI: 7.3-13.0 months). The incidence of gr ade 3 and 4 toxicities was low. Conclusions: The combination of gemcitabine and 5-FU-FA is active and well tolerated and seems to offer an improvement in progression-free interval ov er both gemcitabine monotherapy and 5-FU-FA therapy.