title: A multicentre, randomised phase III trial comparing protracted venous infusion (PVI) 5-fluorouracil (5-FU) with PVI 5-FU plus mitomycin C in patients with inoperable oesophago-gastric cancer.
abstract: BACKGROUND
  This randomised study compared protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin C (MMC) in patients with advanced oesophago-gastric cancer.
  
  
  METHODS
  Two hundred and fifty-four patients with adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma involving the oesophagus, oesophago-gastric junction or the stomach were randomised. The major end points were tumour response, survival, toxicity and quality of life.
  
  
  RESULTS
  The median age of patients treated was 72 years and the two arms were well-balanced for baseline demographic factors. The overall response rate was 16.1% [95% confidence interval (CI) 9.5% to 22.7%] in patients treated with PVI 5-FU alone compared with 19.1% (95% CI 12.0% to 26.0%) for those treated with PVI 5-FU plus MMC (P = 0.555). Median time to treatment failure was 3.9 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC (P = 0.195). Median survival was 6.3 months for PVI 5-FU and 5.3 months for PVI 5-FU plus MMC (P = 1.0). Toxicity was mild for both treatments. Symptomatic benefit measured by improvement in pain control, weight loss, dysphagia and oesophageal reflux was observed in over 64% of patients in each arm. Quality of life scores were comparable in each arm.
  
  
  CONCLUSIONS
  PVI 5-FU is a safe, effective form of palliation for patients with advanced oesophago-gastric cancer although the addition of MMC adds little extra benefit.
authors.affiliation: Royal Marsden Hospital, London and Surrey, UK.
authors.forename: N C
authors.initials: NC
authors.lastname: Tebbutt
authors.forename: A
authors.initials: A
authors.lastname: Norman
authors.forename: D
authors.initials: D
authors.lastname: Cunningham
authors.forename: T
authors.initials: T
authors.lastname: Iveson
authors.forename: M
authors.initials: M
authors.lastname: Seymour
authors.forename: T
authors.initials: T
authors.lastname: Hickish
authors.forename: P
authors.initials: P
authors.lastname: Harper
authors.forename: N
authors.initials: N
authors.lastname: Maisey
authors.forename: K
authors.initials: K
authors.lastname: Mochlinski
authors.forename: Y
authors.initials: Y
authors.lastname: Prior
authors.forename: M
authors.initials: M
authors.lastname: Hill
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000494:pharmacology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000494:pharmacology*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000494:pharmacology; D010146:Pain; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013534:Survival; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D000964:Antimetabolites, Antineoplastic; D016685:Mitomycin; D005472:Fluorouracil