A pilot study evaluating the safety and toxicity of epirubicin, cisplatin, and UFT (ECU regimen) in advanced gastric carcinoma

Best response rates have been achieved with three-drug regimens containing 5-FU in the treatment of advanced gastric cancer (AGC) and oral fluoropyrimidines are the best alternatives as substitutes for infusional 5-FU. This study aimed to evaluate the safety and toxicity of epirubicin, cisplatin, and UFT (ECU regimen) regimens in AGC outpatients. Forty-one patients with AGC received epirubicin, cisplatin, and oral UFT plus leucovorin. Epirubicin 50 mg/m(2) and cisplatin 60mg/m(2) were administered on Day 1. Three hundreds (300) mg/m(2)/day UFT was administered with leucovorin at a fixed oral dose of 90 mg/day for 21 days, followed by a 7-day rest period. Cycles were repeated every 4 weeks. Performance status was either as 0 and 1. Among the 41 patients enrolled, complete and partial response was achieved in 7.3% and 36.6% of patients, respectively, with an overall response rate of 43.9%. Stable disease was observed in 34.1% of patients and 22% showed disease progression. Median time to progression was 5.2 months and median survival was 12.3 months. A median of 4 cycles (range: 1-6) of chemotherapy were administered. The main grade III-IV toxicities were nausea/vomiting (19.4%) and neutropenia (12.1%). Grade IV toxicities were gastric perforation and renal failure. ECU appears to be an effective regimen in the treatment of AGC, with acceptable tolerability and manageable toxicity. In three-drug regimens, substitution of infusional 5-FU by UFT offers the possibility of increased AGC outpatient compliance.