title: Phase II trial of the use of gemcitabine and 5-fluorouracil in the treatment of advanced pancreatic and biliary tract cancer.
abstract: In this phase II trial, we used the combination of gemcitabine and 5-fluorouracil (5-FU) to treat 26 patients: 17 (65%) with advanced pancreatic adenocarcinoma and 9 (35%) with advanced biliary tract adenocarcinoma (10 locally advanced and 16 metastatic); 15 (57.7%) male and 11 (42.3%) female; median age 58 (range, 39-68); median performance status 2 (range, 1-3). A total of 102 cycles were administered (median, 4 per patient). There were 8 objective responses, plus 1 complete response not confirmed by second-look laparotomy, thus the overall objective response rate was 30.7% (95% CI 12%-47%). Among the patients with biliary tract carcinoma, 33% (3/9) had PR. Six (23%) patients had stable disease (SD). All 8 responders and 3 of the patients with SD experienced clinical benefit (42%). The median overall survival was 9 months (range, 6-38), and the 1-year survival rate was 30%. The regimen was very well tolerated. One patient developed reversible World Health Organization grade IV febrile neutropenia. We observed grade III neutropenia in 11 (11%) cycles; grade III thrombocytopenia in 7 (7%) cycles; grade III mucositis in 7 (7%) cycles; and grade III diarrhea in 10 (10%) cycles. Asthenia grades I and II occurred in 30% of cycles and flulike syndrome grade II in 11 (11%) cycles. The combination of gemcitabine and 5-FU in patients with advanced pancreatic or biliary tract cancer produces promising activity and tolerability with the added potential for clinical benefit, and thus warrants further investigation.
authors.affiliation: Oncology Section, Hospital das Clínicas da Universidade Federal de Minas Gerais, Rua Piauí, 150 - 30150-320, Belo Horizonte, MG, Brazil. murad@pib.com.br
authors.forename: Andre M
authors.initials: AM
authors.lastname: Murad
authors.forename: Rodrigo C
authors.initials: RC
authors.lastname: Guimarães
authors.forename: Bruno C
authors.initials: BC
authors.lastname: Aragão
authors.forename: Víctor H
authors.initials: VH
authors.lastname: Rodrigues
authors.forename: Antonio O
authors.initials: AO
authors.lastname: Scalabrini-Neto
authors.forename: Charles A J
authors.initials: CA
authors.lastname: Padua
authors.forename: Flavio C
authors.initials: FC
authors.lastname: Moore
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine