title: Phase II study of gemcitabine, UFT and leucovorin in patients with advanced pancreatic cancer.
abstract: The combination of gemcitabine with protracted 5-fluorouracil (5-FU) in the treatment of metastatic pancreatic cancer has shown activity with tolerable toxicity. The administration of UFT may simulate the effects of a protracted infusion of 5-FU. Patients with previously untreated metastatic or unresectable measurable pancreatic adenocarcinoma received gemcitabine (800 mg/m2 i.v., administered as an 80-min infusion on days 1, 8 and 15), UFT (200 mg/m2/day, on days 1 to 21), and oral leucovorin (90 mg/day, on days 1 to 21). Thirty patients were enrolled in this study. Five patients had partial responses, with an overall response rate of 17% (5/30), using the intent-to-treat principle (95% confidence interval (CI), 3-30%). Nine out of 25 (36%) patients experienced clinical benefit responses (95% CI; 17-55%). The median time to progression was 3.0 months, and the median overall survival was 7.2 months. The principal adverse event was neutropenia. The combination of gemcitabine, UFT, plus oral leucovorin shows significant antitumor activity and a beneficial clinical effect with an acceptable level of toxicity.
authors.affiliation: Section of Hematology-Oncology, Department of Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. twkimmd@amc.seoul.kr
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Kim
authors.forename: Hae Jin
authors.initials: HJ
authors.lastname: Kang
authors.forename: Jin Hee
authors.initials: JH
authors.lastname: Ahn
authors.forename: Keehyun
authors.initials: K
authors.lastname: Lee
authors.forename: Heung Moon
authors.initials: HM
authors.lastname: Chang
authors.forename: Yoon Koo
authors.initials: YK
authors.lastname: Kang
authors.forename: Jung Shin
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage; D014498:Uracil / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D005641:Tegafur; D014498:Uracil; D002955:Leucovorin; D000093542:Gemcitabine