RANDOMIZED TRIAL OF EPIRUBICIN VERSUS FLUOROURACIL IN ADVANCED GASTRIC-CANCER - AN INTERNATIONAL-COLLABORATIVE-CANCER-GROUP (ICCG) STUDY

Background: It is not yet established whether doses of epirubicin equi toxic to adriamycin are more effective in the treatment of locally adv anced or metastatic gastric cancer. Patients and methods: Seventy pati ents with advanced gastric cancer were randomised to receive fluoroura cil (500 mg/m(2) days 1-5 every three weeks) or epirubicin (100 mg/m(2 ) every three weeks), with doses escalating to a maximum dose of 700 m g/m(2) of fluorouracil or 140 mg/m(2) of epirubicin. Results: No patie nts attained complete response. Partial response was seen in 3 patient s in the epirubicin arm (8%) compared with 2 patients in the fluoroura cil arm (6%). No statistically significant difference between the two treatments was seen in either response or survival. Severe side effect s, particularly alopecia, and nausea and vomiting were more common in the epirubicin arm (45% and 37%, respectively) compared with the fluor ouracil arm (12% and 8%, respectively). Conclusions: Our trial demonst rates that fluorouracil and epirubicin as single agents have comparabl e but insufficient activity in advanced gastric cancer.