title: A phase II trial of gemcitabine and weekly high-dose 5-fluorouracil in a 48-hour continuous-infusion schedule in patients with advanced pancreatic carcinoma. A study of the Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD).
abstract: OBJECTIVE
  A multi-centred, open-labelled, phase 11 study containing 46 patients was conducted to evaluate the clinical benefit of gemcitabine (1,400 mg/m(2)) combined with 5-FU (3 g/m(2)) in a 48 h continuous infusion (CI).
  
  
  METHODS
  Both drugs were administered on days 1, 8 and 15 of every 4 week cycle in chemotherapy-naïve patients with locally advanced unresectable metastatic pancreatic carcinoma. The minimum follow-up was 6 months.
  
  
  RESULTS
  Clinical benefit response was the primary endpoint and this was achieved by 24.4% of the patients. Quality of life (QoL) improved in 16.6% of patients. Objective response was observed in 7% of the patients. The median progression-free survival (PFS) was 14.4 weeks and the median overall survival (OS) time was 22.7 weeks. One-year survival was 25%. The most frequent grade 3-4 toxicities were neutropenia (45%), mucositis (7.5%) and hyperbilirubinaemia (10.5%).
  
  
  CONCLUSIONS
  This schedule was not superior in terms of clinical benefit, response rate, PFS and OS than standard gemcitabine treatment
authors.affiliation: Departamento de Oncología Médica, Hospital Clínic, Barcelona, Spain.
authors.forename: Joan Maurel
authors.initials: JM
authors.lastname: Santasusana
authors.forename: José Luis
authors.initials: JL
authors.lastname: García López
authors.forename: Juan José
authors.initials: JJ
authors.lastname: García
authors.forename: Ana Isabel León
authors.initials: AI
authors.lastname: Carbonero
authors.forename: Javier Gallego
authors.initials: JG
authors.lastname: Plazas
authors.forename: Pedro Sánchez
authors.initials: PS
authors.lastname: Rovira
authors.forename: Carlos Fernández
authors.initials: CF
authors.lastname: Martos
authors.forename: M Carmen Galán
authors.initials: MC
authors.lastname: Guzmán
authors.forename: Jesús Florián
authors.initials: JF
authors.lastname: Jericó
authors.forename: Francisco Javier Dorta
authors.initials: FJ
authors.lastname: Delgado
authors.forename: Javier Casinello
authors.initials: JC
authors.lastname: Espinosa
authors.forename: Marta Llanos
authors.initials: ML
authors.lastname: Muñoz
authors.forename: Enrique Aranda
authors.initials: EA
authors.lastname: Aguilar
authors.forename: Javier Sastre
authors.initials: JS
authors.lastname: Valera
authors.forename: Ignacio
authors.initials: I
authors.lastname: García Ribas
authors.forename: Alfredo Carrato
authors.initials: AC
authors.lastname: Mena
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D006932:Hyperbilirubinemia / Q000139:chemically induced; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010349:Patient Compliance; D011788:Quality of Life; D013030:Spain; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine