Endocrine plus uracil/tegafur therapy for prostate cancer.

A prospective, randomized clinical trial was conducted to evaluate the efficacy of endocrine chemotherapy with uracil and tegafur (in a molar ratio of 4:1 [UFT]) in patients with prostate cancer. The study included two treatment arms: endocrine plus UFT vs endocrine-only therapy. Of the 136 patients with prostate cancer enrolled in this study from April 1990 to December 1992, 69 received endocrine plus UFT therapy and the remaining 67 received endocrine-only therapy. Among those receiving UFT therapy, eight patients had stage A2 and B prostate cancer, 11 had stage C disease, and 50 had stage D disease. In the endocrine-only group, 10 patients had stage A2 and B disease, seven had stage C disease, and 50 had stage D disease. Tumors were well differentiated in 20 patients, moderately differentiated in 38 patients, and poorly differentiated in 11 patients receiving UFT. The endocrine-only group included 29 patients with differentiated tumors, 26 with moderately differentiated tumors, and 12 with poorly differentiated carcinomas. After a mean follow-up period of 54.9 months for patients receiving endocrine plus UFT therapy and 47.8 months for patients receiving endocrine-only therapy, disease had not progressed in 53.0% of the UFT-treated patients and 43.8% of the endocrine-only-treated patients (P = .114). The 5-year cancer-specific survival rates were 67.4% for the UFT group and 49.5% for the endocrine-only group (P = .273). The 5-year survival rates were 47.4% for the UFT group and 35.4% for the endocrine-only group (P = .177). Adverse effects, such as bone marrow suppression, nausea, vomiting, and anorexia, occurred in 36 patients in the UFT group and 41 patients in the endocrine-only group. However, adverse effects were not specifically related to UFT use. It is concluded that endocrine chemotherapy plus UFT is a tolerable regimen that might be effective for patients with prostate cancer.