A double blind comparative study of tegafur (FT) and UFT (a combination of Tegafur and uracil) in advanced breast cancer.

A double blind study to compare the efficacy of oral UFT (400 mg Tegafur (FT) plus 896 mg uracil/day) with that of oral FT (800 mg/day) on advanced breast cancer was performed between November, 1986, and November, 1989. Sixty patients were registered for the trial and fifty-six cases were evaluated (28 for UFT and 28 for FT). The primary end points in the study were response rate and time to relapse. There were no significant differences in patients' characteristics in either group. The objective response rates were 39% (11/28; 95% confidence interval (C.I.), 22-59%) in UFT and 21% (6/28; 95% C.I., 8-41%) in FT, without statistical significance (P = 0.25). For time to relapse, a trend was seen in favor of UFT, but this effect did not achieve statistical significance (P = 0.09). Both subjective and objective adverse effects were similar between the two treatments. The overall survivals were similar in both parts of the study. The size of the trial was too small for a definite conclusion to be drawn although, for both response rate and time to relapse, a trend was seen in favor of UFT. A large scale randomized study will be necessary to compare the drugs in the management of patients with advanced breast cancer.