Randomised 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 equitoxic to adriamycin are more effective in the treatment of locally advanced or metastatic gastric cancer.

Patients And Methods: Seventy patients with advanced gastric cancer were randomised to receive fluorouracil (500 mg/m2 days 1-5 every three weeks) or epirubicin (100 mg/m2 every three weeks), with doses escalating to a maximum dose of 700 mg/m2 of fluorouracil or 140 mg/m2 of epirubicin.

Results: No patients attained complete response. Partial response was seen in 3 patients in the epirubicin arm (8%) compared with 2 patients in the fluorouracil arm (6%). No statistically significant difference between the two treatments was seen in either response or survival. Severe side effects, particularly alopecia, and nausea and vomiting were more common in the epirubicin arm (45% and 37%, respectively) compared with the fluorouracil arm (12% and 8%, respectively).

Conclusions: Our trial demonstrates that fluorouracil and epirubicin as single agents have comparable but insufficient activity in advanced gastric cancer.