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

Abstract

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.

• Authors: A Webb, D Cunningham, J H Scarffe, P Harper, A Norman, J K 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, M Meehan
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 15 Issue 1 Pg. 261-7 (Jan 1997) ISSN: 0732-183X [Print] United States
• PMID: 8996151 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Epirubicin
• Doxorubicin
• Cisplatin
• Fluorouracil
• Methotrexate

Topics

• Adenocarcinoma (drug therapy)
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (economics, therapeutic use)
• Carcinoma (drug therapy)
• Cisplatin (administration & dosage, economics)
• Costs and Cost Analysis
• Doxorubicin (administration & dosage, economics)
• Drug Costs
• Epirubicin (administration & dosage, economics)
• Esophageal Neoplasms (drug therapy)
• Female
• Fluorouracil (administration & dosage, economics)
• Humans
• Male
• Methotrexate (administration & dosage, economics)
• Middle Aged
• Prospective Studies
• Quality of Life
• Stomach Neoplasms (drug therapy)
• Survival Rate