Japanese Journal of Clinical Oncology 31:18-24 (2001)
© 2001 Foundation for Promotion of Cancer Research
Prospective and Randomized Comparison of Combined Androgen Blockade Versus Combination with Oral UFT as an Initial Treatment for Prostate Cancer

1Tsurumi Nishiguchi Hospital, Yokohama, Kanagawa, 2Department of Urology, Gifu University School of Medicine, Gifu, 3Department of Urology, Nagoya University School of Medicine, Nagoya, 4Department of Pathology, Kanazawa Medical University, Kanazawa, and 5Department of Public Health, Gifu University School of Medicine, Gifu, Japan
Objective: This prospective and randomized clinical study was initiated to compare the efficacy and safety of combined androgen blockade with combination with UFT in patients with untreated prostate cancer.
Methods: A total of 142 patients were entered in this study between April 1990 and December 1992. All patients received bilateral orchiectomy and 200 mg/day of diethylstilbestrol diphosphate. Of these patients, 70 patients were administered an additional 400 mg/day of UFT after randomization. Either treatment was continued for at least 1 year or until objective progression occurred if the initial response was equal to or better than no change. The endpoints of this study were progression-free survival, cancer-specific survival and change of QOL scores.
Results: A total of 136 patients were evaluable and 131 patients (96.3%) could be followed up with a median follow-up period of 1469 days. Both groups showed similar initial treatment response at 12 weeks, adverse effect and change of quality of life score during the first year after initiation of the treatment. There was a significantly longer progression-free survival and better but not significant cancer-specific survival in the endocrine chemotherapy group. The patients with earlier stage and initial serum prostate-specific antigen values <40 ng/ml showed a good indication for this endocrine chemotherapy.
Conclusion: This endocrine chemotherapy was confirmed to be tolerable and significantly effective in the delay of disease progression, which leads to longer survival in patients with prostate cancer.
+ For reprints and all correspondence: Manabu Kuriyama, Tsurumi Nishiguchi Hospital, 11231 Tsurumi, Tsurumi-ku, Yokohama 230-0063, Japan E-mail: mkuriyama@mtg.biglobe.ne.jp
Abbreviations: CAP, prostate cancer; EC, endocrine chemotherapy; E, endocrine; PS, performance status; PSA, prostate-specific antigen; QOL, quality of life; NC, no change
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