Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer.

摘要: A phase III randomised study, comparing treatment with fluorouracil, epidoxorubicin and methotrexate (FEMTX) the best supportive care, was conducted in patients unresectable or metastatic gastric cancer. During period from July 1986 to June 1992, 41 were receive FEMTX care. MTX given a dose of 1500 mg m-2 intravenously (i.v.) followed after 1 h by 5-FU i.v. on day 1; leucovorin rescue started 24 (30 orally every 6 for 48 h) 60 administered 15. In addition both groups received tablets containing vitamins E. Response rates as follows: complete response (CR), 19% (4/21); partial (PR), 10% (2/21); no change (NC), 33% (7/21); progressive disease (PD), 24% (5/21). control group were: NC, 20% (4/20); PD, 80% (16/20). Increased pain observed one patient treated 11 within first 2 months. WHO grade III/IV toxicity chemotherapy nausea/vomiting 40%, diarrhoea 10%, stomatitis 15%, leucopenia 50% thrombocytopenia 10%. One possible treatment-related death due sepsis. The median time progression 5.4 months [95% confidence interval (CI) 3.1-11.7 months], but only 1.7 (95% CI 1.2-2.7 months) (P = 0.0013). Similarly, displayed significantly 0.0006) prolonged survival compared group, i.e. 12.3 7.1-15.6 vs 3.1 1.6-4.6 months). conclusion, combined vitamin E is fairly well-tolerated treatment, giving rate 29% advanced cancer, also prolonging patients' survival. It can be used reference testing new investigational combinations.