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

摘要: PURPOSE: To compare the efficacy and tolerability of etoposide, leucovorin, bolus fluorouracil (ELF) or infusional plus cisplatin (FUP) with that reference protocol fluorouracil, doxorubicin, methotrexate (FAMTX) in advanced gastric cancer. PATIENTS AND METHODS: A total 399 patients adenocarcinoma stomach were randomized analyzed for toxicity, tumor response, progression-free overall survival. Only reviewed confirmed responses considered. The analysis remission was based on assessable documented measurable lesions. intent-to-treat principle, log-rank test, Cox regression model used statistical time-to-event end points. RESULTS: response rate 245 eligible disease 9% ELF, 20% FUP, 12% FAMTX, no significant differences. One hundred twelve assessable, nonmeasurable disease. No ch...