Document Detail

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.
MedLine Citation:
PMID:  12377644     Owner:  NLM     Status:  MEDLINE    
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. PATIENTS AND 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.
N C Tebbutt; A Norman; D Cunningham; T Iveson; M Seymour; T Hickish; P Harper; N Maisey; K Mochlinski; Y Prior; M Hill
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  13     ISSN:  0923-7534     ISO Abbreviation:  Ann. Oncol.     Publication Date:  2002 Oct 
Date Detail:
Created Date:  2002-10-14     Completed Date:  2003-04-18     Revised Date:  2009-11-03    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1568-75     Citation Subset:  IM    
Royal Marsden Hospital, London and Surrey, UK.
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MeSH Terms
Aged, 80 and over
Antimetabolites, Antineoplastic / administration & dosage*,  pharmacology*
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Esophageal Neoplasms / drug therapy*,  pathology
Fluorouracil / administration & dosage*,  pharmacology*
Infusions, Intravenous
Middle Aged
Mitomycin / administration & dosage,  pharmacology
Quality of Life
Stomach Neoplasms / drug therapy*,  pathology
Treatment Outcome
Weight Loss
Reg. No./Substance:
0/Antimetabolites, Antineoplastic; 50-07-7/Mitomycin; 51-21-8/Fluorouracil

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