Multicenter phase II study of pre-administrated uracil/tegafur (UFT) plus gemcitabine for unresectable/recurrent pancreatic cancer

Abstract

4152 Background: Gemcitabine (GEM) remains the standard of care for advanced pancreatic cancer. The rationale to develop the pretreatment of 5-fluorouracil (5-FU) and GEM combination in pancreatic cancer is based on that 5-FU is a major mediator of GEM uptake. Our objective was to evaluate the efficacy and toxicity of pre-administration of UFT (uracil/tegafur: prodrug of 5-FU) and GEM combination therapy for unresectable/recurrent pancreatic cancer in outpatient setting. Methods: Major eligibility criteria: histologically or cytologically proven pancreatic adenocarcinoma, measurable disease, age 20–80 yrs, good performance status (50 -100 in KPS), normal renal, liver, and bone marrow function, capable oral intake, and written informed consent. UFT (250 mg/ m2/day) was orally administrated from day 1 through day 6 and from day 8 through 13, and GEM (800 mg/m2, div/30min) was administrated on day 7 and 14, and one week rest every 3 weeks based on the result of the previous phase I study. Results: 36 pts (24 male, 12 female) were enrolled (median age, 63.8 yrs). 24 pts were considered to be unresectable (15: liver metastasis, 2: lymph node, 7: locally advanced). 12 pts were recurrent pancreatic cancer after curative surgery (7: liver metastasis, 3: lung metastasis, 2: local reccuremce). 32 pts were evaluable for efficacy and were treated at outpatient clinic. Median KPS was 90 (range 100 - 50). Median number of courses administrated was 4 (range 1–20). There were 8 partial responses (25%), 18 pts (56%) had stable disease, and 6 pts (19%) had a progression. Reduced CA19–9 level less than a half of that at starting time was observed in 11 pts (34%). Median progression-free survival time was 6.7 months (range 1–21). Median survival time was 8.3 months (range 1.5–26). Grade 3 toxicities were leucopenia (19%), neutropenia (12%), thoronbocytopenia (3%), nausea (3%), and liver dysfunctions (3%). There was no Grade 4 toxiciety. Conclusion: Pre-administrated UFT plus GM is a promising treatment for unresectable/recurrent pancreatic cancer due to a favorable prognosis and less toxicity in outpatient setting. No significant financial relationships to disclose.