[Multicenter phase II study of pre-administered uracil/tegafur (UFT) plus gemcitabine for unresectable/recurrent...

Our objective was to evaluate the efficacy and toxicity of the pre-administration of UFT (uracil/tegafur: prodrug of 5-FU) and GEM combination therapy for unresectable/recurrent pancreatic cancer in the outpatient setting. UFT (250mg/m(2)/day) was orally administered from day 1 through day 6 and from day 8 through 13, and GEM (800mg/m(2), div/30 min) was administered on day 7 and 14, with a one-week rest every 3 weeks based on results of the previous phase I study. Thirty-six pts (24 male, 12 female) were enrolled (median age, 63.8 yrs). There were 8 partial responses (25%). Eighteen pts (56%) had stable disease, and 6 pts (19%) had a progression. The median survival time was 7. 0 months( range 1.5 -66). Grade 3 toxicities were leucopenia (17%), thrombocytopenia (3%), nausea (3%), and liver dysfunctions(3%). There were no Grade 4 toxicities. Pre-administered UFT plus GM is a promising treatment for unresectable/recurrent pancreatic cancer in the outpatient setting.