Phase III study of 5-FU and carmustine versus 5-FU, carmustine, and doxorubicin in advanced gastric cancer.

Seventy-seven patients with advanced gastric carcinoma were prospectively randomized to receive 5-FU and carmustine (FB) with or without doxorubicin (FAB). Thirty-five patients were evaluable for response. Neither the response rates (partial remission, 11% for FB and 24% for FAB) nor survival times (median, 4.0 months for FB and 5.5 months for FAB) were statistically different. The median survival of patients with partial remission (7.8 months) and those with no change (7.4 months) was significantly prolonged compared to patients with progressive disease (4.5 months). The side effects of both regimens after the first treatment cycle (except alopecia in FAB) were low. After the second cycle more pronounced myelosuppression in the FAB arm was observed.