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Journal of Clinical Oncology, Vol 15, 261-267, Copyright © 1997 by American Society of Clinical Oncology

ARTICLES

Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer

A Webb, D Cunningham, JH Scarffe, P Harper, A Norman, JK Joffe, M Hughes, J Mansi, M Findlay, A Hill, J Oates, M Nicolson, T Hickish, M O'Brien, T Iveson, M Watson, C Underhill, A Wardley and M Meehan
Cancer Research Campaign (CRC) Section of Medicine, Royal Marsden Hospital, Sutton, Surrey, United Kingdom.

PURPOSE: We report the results of a prospectively randomized study that compared the combination of epirubicin, cisplatin, and protracted venous infusion fluorouracil (5-FU) (ECF regimen) with the standard combination of 5-FU, doxorubicin, and methotrexate (FAMTX) in previously untreated patients with advanced esophagogastric cancer. PATIENTS AND METHODS: Two hundred seventy-four patients with adenocarcinoma or undifferentiated carcinoma were randomized and analyzed for survival, tumor response, toxicity, and quality of life (QL). RESULTS: The overall response rate was 45% (95% confidence interval [CI], 36% to 54%) with ECF and 21% (95% CI, 13% to 29%) with FAMTX (P = .0002). Toxicity was tolerable and there were only three toxic deaths. The FAMTX regimen caused more hematologic toxicity and serious infections, but ECF caused more emesis and alopecia. The median survival duration was 8.9 months with ECF and 5.7 months with FAMTX (P = .0009); at 1 year, 36% (95% CI, 27% to 45%) of ECF and 21% (95% CI, 14% to 29%) of FAMTX patients were alive. The median failure-free survival duration was 7.4 months with ECF and 3.4 months with FAMTX (P = .00006). The global QL scores were better for ECF at 24 weeks, but the remaining QL data showed no differences between either arm of the study. Hospital-based cost analysis on a subset of patients was similar for each arm and translated into an increment cost of $975 per life- year gained. CONCLUSION: The ECF regimen results in a survival and response advantage, tolerable toxicity, better QL and cost- effectiveness compared with FAMTX chemotherapy. This regimen should now be considered the standard treatment for advanced esophagogastric cancer.
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Cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) is more active than 5-fluorouracil, doxorubicin and methotrexate (FAMTX) in advanced gastric carcinoma
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Chemotherapy in gastric cancer: a never ending saga
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Randomized Phase III Trial of Fluorouracil Alone Versus Fluorouracil Plus Cisplatin Versus Uracil and Tegafur Plus Mitomycin in Patients With Unresectable, Advanced Gastric Cancer: The Japan Clinical Oncology Group Study (JCOG9205)
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T. W. Kim, Y. K. Kang, J. H. Ahn, H. M. Chang, J. H. Yook, S. T. Oh, B. S. Kim, and J. S. Lee
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Phase II Study of Oxaliplatin, Fluorouracil, and Folinic Acid in Locally Advanced or Metastatic Gastric Cancer Patients
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C.M.F. Kruijtzer, J.H. Beijnen, and J.H.M. Schellens
Improvement of Oral Drug Treatment by Temporary Inhibition of Drug Transporters and/or Cytochrome P450 in the Gastrointestinal Tract and Liver: An Overview
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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
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G. D. Leonard, S. H. Zhuang, J. L. Grem, P. J. Ross, and D. Cunningham
Epirubicin, Cisplatin, and Protracted Venous-Infusion Fluorouracil in Advanced Esophagogastric Cancer
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T. R. J. Evans, G. Pentheroudakis, J. Paul, A. McInnes, R. Blackie, N. Raby, R. Morrison, G. M. Fullarton, M. Soukop, and A. C. McDonald
A phase I and pharmacokinetic study of capecitabine in combination with epirubicin and cisplatin in patients with inoperable oesophago-gastric adenocarcinoma
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M. Rowe, J. W Valle, R. Swindell, L. Fitzsimmons, and R. D James
New face for a familiar friend: the deGramont regimen in the treatment of metastatic colorectal cancer given as an outpatient: a feasibility study
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W H Allum, S M Griffin, A Watson, and D Colin-Jones
Guidelines for the management of oesophageal and gastric cancer
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D. H. Ilson
Epirubicin, Cisplatin, and Fluorouracil in Gastric and Esophageal Cancer: A Step Ahead?
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P. Ross, M. Nicolson, D. Cunningham, J. Valle, M. Seymour, P. Harper, T. Price, H. Anderson, T. Iveson, T. Hickish, et al.
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
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D. Rischin, J. Corry, J. Smith, J. Stewart, P. Hughes, and L. Peters
Excellent Disease Control and Survival in Patients With Advanced Nasopharyngeal Cancer Treated With Chemoradiation
J. Clin. Oncol., April 1, 2002; 20(7): 1845 - 1852.
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E. Van Cutsem, D. Cunningham, J. Maroun, A. Cervantes, and B. Glimelius
Raltitrexed: current clinical status and future directions
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Abstracts
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[PDF]

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N. C. Tebbutt, A. Norman, M. Hill, D. Cunningham, and J. A. Ajani
Standard Chemotherapy for Gastric Carcinoma: Is It a Myth?
J. Clin. Oncol., May 15, 2001; 19(10): 2765 - 2767.
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J. A. Ajani, H. Wilke, U. Vanhoefer, P. Rougier, B. Nordlinger, E. Van Cutsem, J. A. Wils, and B. Baron
Standard Chemotherapy for Gastric Carcinoma: Is It a Myth?
J. Clin. Oncol., December 1, 2000; 18(23): 4001 - 4003.
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P. J. Ross, M. E. Hill, A. Norman, and D. Cunningham
ECF in Gastric Cancer
J. Clin. Oncol., November 15, 2000; 18(22): 3874 - 3875.
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M R BORGAONKAR and E J IRVINE
Quality of life measurement in gastrointestinal and liver disorders
Gut, September 1, 2000; 47(3): 444 - 454.
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M. H. Kulke
The Treatment of Advanced Gastric Cancer: In Search of the Right Combination
J. Clin. Oncol., July 14, 2000; 18(14): 2645 - 2647.
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U. Vanhoefer, P. Rougier, H. Wilke, M. P. Ducreux, A. J. Lacave, E. Van Cutsem, M. Planker, J. G. D. Santos, P. Piedbois, B. Paillot, et al.
Final Results of a Randomized Phase III Trial of Sequential High-Dose Methotrexate, Fluorouracil, and Doxorubicin Versus Etoposide, Leucovorin, and Fluorouracil Versus Infusional Fluorouracil and Cisplatin in Advanced Gastric Cancer: A Trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group
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A L Thomas, K O'Byrne, and W P Steward
Chemotherapy for upper gastrointestinal tumours
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A. Bamias and N. Pavlidis
Systemic Chemotherapy in Gastric Cancer: Where Do We Stand Today?
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