title: Weekly Gemcitabine plus Fluorouracil-Folinic Acid Given Weekly for Two Days in Patients with Advanced Pancreatic Cancer : A Phase II Study.
abstract: OBJECTIVE
  To investigate the efficacy and toxicity of gemcitabine administration followed by the combination of fluorouracil (5-FU) modulated by folinic acid in patients with advanced, symptomatic pancreatic cancer. The main objective was to estimate tumour response and any improvement in patients' quality of life.
  
  
  METHODS
  The study included 48 evaluable patients with metastatic disease with no prior chemotherapy. The study duration was 3 years.
  
  
  METHODS
  Gemcitabine 1000 mg/m(2) intravenously was given on days 1 and 8 followed by fluorouracil 350 mg/m(2) intravenously as a bolus biologically modulated by folinic acid 350 mg/m(2) intravenously given on days 1, 2, 8 and 9 in order to develop the conditions for any potential drug synergism. The regimen was administered every 3 weeks for 1 year or until disease progression.
  
  
  RESULTS
  Objective partial responses were documented in ten (21%) patients (95% CI 10.5, 35). Twenty-two (46%) patients had stable disease while 16 (33%) patients had progressive disease. The median response duration was 8 months (range 4-20). The median time to progression was 6 months (range 2-24), while the median survival of the group was 7 months (range 3-36) and the probability of surviving beyond 12 months was 20%. Of the 44 patients with tumour-related symptoms who were considered evaluable for clinical-benefit response, 28 (70%) patients had pain improvement, 25 (52%) patients had improvement of their performance status, and nine (28%) patients experienced weight gain during treatment. Serum concentrations of cancer antigen (Ca-19-9) were decreased by more than 50% in 14 (37%) of the 38 assessable patients. Chemotherapy was well tolerated, with mild myelotoxicity. Gastrointestinal toxicity was moderate with mild mucositis.
  
  
  CONCLUSIONS
  The regimen of gemcitabine and fluorouracil administered in this study was well tolerated and showed a moderate antitumour activity and a significant palliative effect on tumour-related symptoms. Because fluorouracil is a low toxicity combination agent for gemcitabine, other forms of the two-drug combination warrant further investigation.
authors.affiliation: Medical Oncology Unit, Laikon General Hospital, Athens University School of Medicine, Athens, Greece.
authors.forename: Aristides
authors.initials: A
authors.lastname: Polyzos
authors.forename: Nicholas
authors.initials: N
authors.lastname: Tsavaris
authors.forename: Christos
authors.initials: C
authors.lastname: Kosmas
authors.forename: Helen
authors.initials: H
authors.lastname: Gogas
authors.forename: George
authors.initials: G
authors.lastname: Koutinos
authors.forename: Nicholas I
authors.initials: NI
authors.lastname: Nikiteas
authors.forename: Evangelos
authors.initials: E
authors.lastname: Felekouras
authors.forename: Gregory
authors.initials: G
authors.lastname: Kouraklis
authors.forename: Othon
authors.initials: O
authors.lastname: Papadopoulos
authors.forename: Antonios
authors.initials: A
authors.lastname: Papachristodoulou
authors.forename: Demetrios
authors.initials: D
authors.lastname: Stamatiadis
authors.forename: Michael
authors.initials: M
authors.lastname: Safioleas
authors.forename: George
authors.initials: G
authors.lastname: Nikou