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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
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Cunningham, David
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Norman, Andrew
cc3c1a3a-2880-449e-bfff-09d21a18b11f
Seymour, Matt
44cf10cf-eb59-4e1b-8bc3-87159d82c25e
Hickish, Tamas
585e80ad-7670-4fcd-9448-a454744ed486
Iveson, Tim
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O'Brien, Mary
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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
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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.

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Published date: 2002

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Local EPrints ID: 26454
URI: http://eprints.soton.ac.uk/id/eprint/26454
ISSN: 1527-7755
PURE UUID: 33dc935a-5fe2-40e9-a498-af938536ae40

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Date deposited: 21 Apr 2006
Last modified: 06 Aug 2019 17:49

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Contributors

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

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