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Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer

Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer
Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer
Purpose: We report the results of a prospectively randomized study that compared the combination of epirubicin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) (ECF) with the combination of mitomycin, cisplatin, and PVI 5-FU (MCF) in previously untreated patients with advanced esophagogastric cancer.
Patients and Methods: Five hundred eighty patients with adenocarcinoma, squamous carcinoma, or undifferentiated carcinoma were randomized to receive either ECF (epirubicin 50 mg/m2 every 3 weeks, cisplatin 60 mg/m2 every 3 weeks and PVI 5-FU 200 mg/m2/d) or MCF (mitomycin 7 mg/m2 every 6 weeks, cisplatin 60 mg/m2 every 3 weeks, and PVI 5-FU 300 mg/m2/d) and analyzed for survival, response, toxicity, and quality of life (QOL).
Results: The overall response rate was 42.4% (95% confidence interval [CI], 37% to 48%) with ECF and 44.1% (95% CI, 38% to 50%) with MCF (P = .692). Toxicity was tolerable, and there were only two toxic deaths. ECF resulted in more grade 3/4 neutropenia and grade 2 alopecia, but MCF caused more thrombocytopenia and plantar-palmar erythema. Median survival was 9.4 months with ECF and 8.7 months with MCF (P = .315); at 1 year, 40.2% (95% CI, 34% to 46%) of ECF and 32.7% (95% CI, 27% to 38%) of MCF patients were alive. Median failure-free survival was 7 months with both regimens. Global QOL scores were better with ECF at 3 and 6 months.
Conclusion: This study confirms response, survival, and QOL benefits of ECF observed in a previous randomized study. The equivalent efficacy of MCF was demonstrated, but QOL was superior with ECF. ECF remains one of the reference treatments for advanced esophagogastric cancer.
1527-7755
1996-2004
Ross, P.
5217656f-56ac-4818-9458-ee23467a1c6b
Nicolson, M.
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Cunningham, D.
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Valle, J.
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Seymour, M.
79cb91bf-b3e6-4222-82cf-c0072be29613
Harper, P.
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Price, T.
9cf30c20-8c59-45ba-98c7-50a758cc3f74
Anderson, H.
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Iveson, T.
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Hickish, T.
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Lofts, F.
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Norman, A.
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Ross, P.
5217656f-56ac-4818-9458-ee23467a1c6b
Nicolson, M.
293bfbb1-f76e-408e-a6e3-615dffb59acd
Cunningham, D.
02b4fd3a-f452-4419-96a7-f98f609f098d
Valle, J.
3ffb4abc-ceb8-4f43-bc0e-d4f19ede8434
Seymour, M.
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Harper, P.
93a9f992-d1de-4748-b77a-00917cf3e879
Price, T.
9cf30c20-8c59-45ba-98c7-50a758cc3f74
Anderson, H.
eeb72db9-1142-4ded-8565-4ed17821b9d0
Iveson, T.
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Hickish, T.
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Lofts, F.
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Norman, A.
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Ross, P., Nicolson, M., Cunningham, D., Valle, J., Seymour, M., Harper, P., Price, T., Anderson, H., Iveson, T., Hickish, T., Lofts, F. and Norman, A. (2002) Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. Journal of Clinical Oncology, 20 (8), 1996-2004. (doi:10.1200/JCO.2002.08.105).

Record type: Article

Abstract

Purpose: We report the results of a prospectively randomized study that compared the combination of epirubicin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) (ECF) with the combination of mitomycin, cisplatin, and PVI 5-FU (MCF) in previously untreated patients with advanced esophagogastric cancer.
Patients and Methods: Five hundred eighty patients with adenocarcinoma, squamous carcinoma, or undifferentiated carcinoma were randomized to receive either ECF (epirubicin 50 mg/m2 every 3 weeks, cisplatin 60 mg/m2 every 3 weeks and PVI 5-FU 200 mg/m2/d) or MCF (mitomycin 7 mg/m2 every 6 weeks, cisplatin 60 mg/m2 every 3 weeks, and PVI 5-FU 300 mg/m2/d) and analyzed for survival, response, toxicity, and quality of life (QOL).
Results: The overall response rate was 42.4% (95% confidence interval [CI], 37% to 48%) with ECF and 44.1% (95% CI, 38% to 50%) with MCF (P = .692). Toxicity was tolerable, and there were only two toxic deaths. ECF resulted in more grade 3/4 neutropenia and grade 2 alopecia, but MCF caused more thrombocytopenia and plantar-palmar erythema. Median survival was 9.4 months with ECF and 8.7 months with MCF (P = .315); at 1 year, 40.2% (95% CI, 34% to 46%) of ECF and 32.7% (95% CI, 27% to 38%) of MCF patients were alive. Median failure-free survival was 7 months with both regimens. Global QOL scores were better with ECF at 3 and 6 months.
Conclusion: This study confirms response, survival, and QOL benefits of ECF observed in a previous randomized study. The equivalent efficacy of MCF was demonstrated, but QOL was superior with ECF. ECF remains one of the reference treatments for advanced esophagogastric cancer.

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Published date: 2002

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Local EPrints ID: 26579
URI: http://eprints.soton.ac.uk/id/eprint/26579
ISSN: 1527-7755
PURE UUID: 4eb1b60e-fac3-46f8-abbf-ef93b120bf16

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Date deposited: 20 Apr 2006
Last modified: 16 Dec 2019 19:22

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Contributors

Author: P. Ross
Author: M. Nicolson
Author: D. Cunningham
Author: J. Valle
Author: M. Seymour
Author: P. Harper
Author: T. Price
Author: H. Anderson
Author: T. Iveson
Author: T. Hickish
Author: F. Lofts
Author: A. Norman

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