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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

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
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
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.
5-fluorouracil, mitomycin C, oesophago-gastric cancer
0923-7534
1568-1575
Tebbutt, N.C.
6933086b-80e3-4747-99df-0b9ed380439d
Norman, A.
880800e2-eabd-4e44-847f-ca6f4321c5aa
Cunningham, D.
02b4fd3a-f452-4419-96a7-f98f609f098d
Iveson, T.
867cb6c5-ea9a-4521-a4cc-4cd4d2503b3a
Seymour, M.
79cb91bf-b3e6-4222-82cf-c0072be29613
Hickish, T.
d17bf903-3f13-4b46-9389-f0f458083442
Harper, P.
93a9f992-d1de-4748-b77a-00917cf3e879
Maisey, N.
4c2f7543-3d25-412d-ae38-183b75da3916
Mochlinski, K.
084af020-ec81-4ec2-8bbc-ccc6b8dc225b
Prior, Y.
124b2e90-4a34-4a09-89b2-6e044de29772
Hill, M.
c50e3b2f-2e91-488a-b89a-88f98d46661e
Tebbutt, N.C.
6933086b-80e3-4747-99df-0b9ed380439d
Norman, A.
880800e2-eabd-4e44-847f-ca6f4321c5aa
Cunningham, D.
02b4fd3a-f452-4419-96a7-f98f609f098d
Iveson, T.
867cb6c5-ea9a-4521-a4cc-4cd4d2503b3a
Seymour, M.
79cb91bf-b3e6-4222-82cf-c0072be29613
Hickish, T.
d17bf903-3f13-4b46-9389-f0f458083442
Harper, P.
93a9f992-d1de-4748-b77a-00917cf3e879
Maisey, N.
4c2f7543-3d25-412d-ae38-183b75da3916
Mochlinski, K.
084af020-ec81-4ec2-8bbc-ccc6b8dc225b
Prior, Y.
124b2e90-4a34-4a09-89b2-6e044de29772
Hill, M.
c50e3b2f-2e91-488a-b89a-88f98d46661e

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).

Record type: Article

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.
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.

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Published date: 2002
Keywords: 5-fluorouracil, mitomycin C, oesophago-gastric cancer
Organisations: Cancer Sciences

Identifiers

Local EPrints ID: 26634
URI: http://eprints.soton.ac.uk/id/eprint/26634
ISSN: 0923-7534
PURE UUID: da3c3a1f-af16-40ef-ba73-2eb48f0a6bc5

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Date deposited: 21 Apr 2006
Last modified: 15 Jul 2019 19:13

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Contributors

Author: N.C. Tebbutt
Author: A. Norman
Author: D. Cunningham
Author: T. Iveson
Author: M. Seymour
Author: T. Hickish
Author: P. Harper
Author: N. Maisey
Author: K. Mochlinski
Author: Y. Prior
Author: M. Hill

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