Randomized comparison of 5-FU alone or combined with carmustine, doxorubicin, and mitomycin (BAFMi) in the treatment of advanced gastric cancer: a phase III trial of the Italian Clinical Research Oncology Group (GOIRC).

Eighty-two evaluable patients with advanced gastric carcinoma were randomized to receive either 5-FU alone or the combination of carmustine, doxorubicin, 5-FU, and mitomycin (BAFMi). Objective remissions were seen in 15% of the patients who received 5-FU alone and in 22% of the patients on the BAFMi regimen. The difference was not statistically significant. The median duration of objective remission (31 vs 40 weeks) was longer using BAFMi combination, and the median duration of survival, calculated in the 85 randomized patients, was slightly longer using 5-FU (28 vs 24 weeks). The differences were not statistically significant. It is concluded that there is no therapeutic advantage in using the BAFMi combination over 5-FU alone.