The University of Southampton
University of Southampton Institutional Repository

Multicenter randomized phase III trial comparing protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin in inoperable pancreatic cancer

Multicenter randomized phase III trial comparing protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin in inoperable pancreatic cancer
Multicenter randomized phase III trial comparing protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin in inoperable pancreatic cancer
Purpose: To compare protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin (MMC) in patients with advanced pancreatic cancer in a multicenter, prospectively randomized study.
Patients and Methods: Two hundred eight patients were randomized to PVI 5-FU (300 mg/m2/d for a maximum of 24 weeks) or PVI 5-FU plus MMC (7 mg/m2 every 6 weeks for four courses). The major end points were tumor response, survival, toxicity, and quality of life (QOL).
Results: The two treatment groups were balanced for baseline demographic factors, and 62% had metastatic disease. The overall response rate was 8.4% (95% confidence interval [CI]) 3.2% to 13.7% for patients treated with PVI 5-FU alone compared with 17.6%; 95% CI 10.3% to 25.1% for PVI 5-FU plus MMC (P = .04). Median failure-free survival was 2.8 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC (P = .14). Median survival was 5.1 months for PVI 5-FU and 6.5 months for PVI 5-FU plus MMC (P = .34). Toxicities in both arms were mild. There was an increased incidence of neutropenia in the 5-FU plus MMC arm (P < .01), although no differences in infection were seen. No patients developed hemolytic uremic syndrome. Global QOL improved significantly after 24 weeks of treatment compared with baseline for patients receiving 5-FU plus MMC, although there was no statistically significant difference in QOL between arms.
Conclusion: PVI 5-FU plus MMC resulted in a superior response rate in comparison with PVI 5-FU alone in advanced pancreatic cancer, but this did not translate into a survival advantage. These results emphasize the importance of chemotherapy in this setting and the continuing value of the fluoropyrimidines in pancreatic cancer.
1527-7755
3130-3136
Maisey, Nick
728c18c6-48f5-4d75-aee2-5b2ce6027728
Chau, Ian
77e24001-6045-49ff-99c5-a49f708ba5da
Cunningham, David
c40c8fe4-7eac-4b98-aaa5-b866da1e32ab
Norman, Andrew
cc3c1a3a-2880-449e-bfff-09d21a18b11f
Seymour, Matt
44cf10cf-eb59-4e1b-8bc3-87159d82c25e
Hickish, Tamas
585e80ad-7670-4fcd-9448-a454744ed486
Iveson, Tim
867cb6c5-ea9a-4521-a4cc-4cd4d2503b3a
O'Brien, Mary
938635fb-ffe7-475e-b454-f0315e0b9b47
Tebbutt, Niall
ac50285d-d798-4a7b-a3b8-e770c2a2d255
Harrington, Angela
fbc8df5d-a992-4de4-9610-e584fb840c24
Hill, Mark
1dc95e98-aa1a-4b7c-a452-40d69477e414
Maisey, Nick
728c18c6-48f5-4d75-aee2-5b2ce6027728
Chau, Ian
77e24001-6045-49ff-99c5-a49f708ba5da
Cunningham, David
c40c8fe4-7eac-4b98-aaa5-b866da1e32ab
Norman, Andrew
cc3c1a3a-2880-449e-bfff-09d21a18b11f
Seymour, Matt
44cf10cf-eb59-4e1b-8bc3-87159d82c25e
Hickish, Tamas
585e80ad-7670-4fcd-9448-a454744ed486
Iveson, Tim
867cb6c5-ea9a-4521-a4cc-4cd4d2503b3a
O'Brien, Mary
938635fb-ffe7-475e-b454-f0315e0b9b47
Tebbutt, Niall
ac50285d-d798-4a7b-a3b8-e770c2a2d255
Harrington, Angela
fbc8df5d-a992-4de4-9610-e584fb840c24
Hill, Mark
1dc95e98-aa1a-4b7c-a452-40d69477e414

Maisey, Nick, Chau, Ian, Cunningham, David, Norman, Andrew, Seymour, Matt, Hickish, Tamas, Iveson, Tim, O'Brien, Mary, Tebbutt, Niall, Harrington, Angela and Hill, Mark (2002) Multicenter randomized phase III trial comparing protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin in inoperable pancreatic cancer. Journal of Clinical Oncology, 20 (14), 3130-3136. (doi:10.1200/JCO.2002.09.029).

Record type: Article

Abstract

Purpose: To compare protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin (MMC) in patients with advanced pancreatic cancer in a multicenter, prospectively randomized study.
Patients and Methods: Two hundred eight patients were randomized to PVI 5-FU (300 mg/m2/d for a maximum of 24 weeks) or PVI 5-FU plus MMC (7 mg/m2 every 6 weeks for four courses). The major end points were tumor response, survival, toxicity, and quality of life (QOL).
Results: The two treatment groups were balanced for baseline demographic factors, and 62% had metastatic disease. The overall response rate was 8.4% (95% confidence interval [CI]) 3.2% to 13.7% for patients treated with PVI 5-FU alone compared with 17.6%; 95% CI 10.3% to 25.1% for PVI 5-FU plus MMC (P = .04). Median failure-free survival was 2.8 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC (P = .14). Median survival was 5.1 months for PVI 5-FU and 6.5 months for PVI 5-FU plus MMC (P = .34). Toxicities in both arms were mild. There was an increased incidence of neutropenia in the 5-FU plus MMC arm (P < .01), although no differences in infection were seen. No patients developed hemolytic uremic syndrome. Global QOL improved significantly after 24 weeks of treatment compared with baseline for patients receiving 5-FU plus MMC, although there was no statistically significant difference in QOL between arms.
Conclusion: PVI 5-FU plus MMC resulted in a superior response rate in comparison with PVI 5-FU alone in advanced pancreatic cancer, but this did not translate into a survival advantage. These results emphasize the importance of chemotherapy in this setting and the continuing value of the fluoropyrimidines in pancreatic cancer.

Text
26454.pdf - Version of Record
Restricted to Repository staff only
Request a copy

More information

Published date: 2002

Identifiers

Local EPrints ID: 26454
URI: http://eprints.soton.ac.uk/id/eprint/26454
ISSN: 1527-7755
PURE UUID: 33dc935a-5fe2-40e9-a498-af938536ae40
ORCID for Tim Iveson: ORCID iD orcid.org/0000-0002-4681-2712

Catalogue record

Date deposited: 21 Apr 2006
Last modified: 16 Mar 2024 02:58

Export record

Altmetrics

Contributors

Author: Nick Maisey
Author: Ian Chau
Author: David Cunningham
Author: Andrew Norman
Author: Matt Seymour
Author: Tamas Hickish
Author: Tim Iveson ORCID iD
Author: Mary O'Brien
Author: Niall Tebbutt
Author: Angela Harrington
Author: Mark Hill

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×