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Journal of Clinical Oncology, Vol 20, Issue 8 (April), 2002: 1996-2004
© 2002 American Society for Clinical Oncology

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

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

From the Department of Medicine and Gastrointestinal Unit, Royal Marsden Hospital, London and Sutton, Surrey; Aberdeen Royal Infirmary, Aberdeen; Christie Hospital, Manchester; Cookridge Hospital, Leeds; Guy’s Hospital, and St George’s Hospital, London; Wythenshaw Hospital, Manchester; Salisbury District Hospital, Salisbury; and Royal Bournemouth and Poole Hospitals, Dorset, United Kingdom.

Address reprint to requests to D. Cunningham, MD, Department of Medicine, Royal Marsden Hospital, Downs Road, Sutton, Surrey, United Kingdom, SM2 5PT; email: david.cunningham{at}icr.ac.uk

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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