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 Tegaf ur (FT) plus 896 mg uracil/day) with that of oral FT (800 mg/day) on a dvanced breast cancer was performed between November, 1986, and Novemb er, 1989. Sixty patients were registered for the trial and fifty-six c ases 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 si gnificant differences in patients' characteristics in either group. Th e 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 st atistical significance (P=0.25). For time to relapse, a trend was seen in favor of UFT, but this effect did not achieve statistical signific ance (P=0.09). Both subjective and objective adverse effects were simi lar 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 def inite conclusion to be drawn although, for both response rate and time to relapse, a trend was seen in favor of UFT. A large scale randomize d study will be necessary to compare the drugs in the management of pa tients with advanced breast cancer.