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

Purpose: We report the results of a prospectively ran-domized study that compared the combination of epiru-bicin, cisplatin, and protracted venous infusion fluoro-uracil (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 pa-tients with adenocarcinoma or undifferentiated carci-noma were randomized and analyzed for survival, tu-mor response, toxicity, and quality of life (QL). Results: The overall response rate was 45 % (95 % con-fidence interval [CI], 36 % to 54%) with ECF and 21 % (95% Cl, 13 % to 29%) with FAMTX (P =.0002). Toxicity was tolerable and there were only three toxic deaths. Th