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
Tebbutt, N.C., Norman, A., Cunningham, D., Iveson, T., Seymour, M., Hickish, T., Harper, P., Maisey, N., Mochlinski, K., Prior, Y. and Hill, M. (2002) 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. Annals of Oncology, 13, (10), 1568-1575. (doi:10.1093/annonc/mdf273).
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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.
|Keywords:||5-fluorouracil, mitomycin C, oesophago-gastric cancer|
|Subjects:||R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)|
|Divisions:||University Structure - Pre August 2011 > School of Medicine > Cancer Sciences
|Date Deposited:||21 Apr 2006|
|Last Modified:||01 Jun 2011 06:29|
|Contributors:||Tebbutt, N.C. (Author)
Norman, A. (Author)
Cunningham, D. (Author)
Iveson, T. (Author)
Seymour, M. (Author)
Hickish, T. (Author)
Harper, P. (Author)
Maisey, N. (Author)
Mochlinski, K. (Author)
Prior, Y. (Author)
Hill, M. (Author)
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