RANDOMIZED COMPARISON OF FLUOROURACIL, EPIDOXORUBICIN AND METHOTREXATE (FEMTX) PLUS SUPPORTIVE CARE WITH SUPPORTIVE CARE ALONE IN PATIENTS WITH NONRESECTABLE GASTRIC-CANCER

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