A combination of a fixed dose rate infusion of gemcitabine associated to a bolus 5-fluorouracil in advanced pancreatic cancer, a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD)

Background: Laboratory evidences suggest the possibility that an infusion rate of 10 mg/m(2)/min may be more effective than the standard 30-min infusion of Gemcitabine (GEM). Patients and methods: Thirty-four patients with histologically verified locally unresectable and/or metastatic pancreatic carcinoma received GEM at the dose of 1,500 mg/m(2) with an infusion rate of 10 mg/m(2)/min, associated to 5-fluorouracil (5-FU) at the dose of 600 mg/m(2). Both drugs were administered weekly for two consecutive weeks out of every three weeks. Results: One complete and five partial responses have been observed for an overall response rate of 17% (95% CI: 3%-27%). The time to progression was 3.7 months with a median survival of 5.7 months. A clinical benefit was obtained in 5 of 29 patients (17%). Grade 3-4 WHO toxicities included neutropenia (35%) and thrombocytopenia (10%). Conclusion: It is unlikely that a fixed dose rate infusion of GEM, at least with this dose, can improve palliation in comparison with the standard 30-min infusion schedule in advanced pancreatic cancer.