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 aninfusion rate of 10 mg/m²/min may be more effective than thestandard 30-min infusion of Gemcitabine (GEM). Patients and methods:Thirty-four patients with histologicallyverified locally unresectable and/or metastatic pancreatic carcinoma receivedGEM at the dose of 1,500 mg/m² with an infusion rate of 10mg/m²/min, associated to 5-fluorouracil (5-FU) at the dose of 600mg/m². Both drugs were administered weekly for two consecutiveweeks out of every three weeks. Results:One complete and five partial responses have beenobserved for an overall response rate of 17% (95% CI:3%–27%). The time to progression was 3.7 months with amedian survival of 5.7 months. A clinical benefit was obtained in 5 of 29patients (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 thestandard 30-min infusion schedule in advanced pancreatic cancer.