A randomized, comparative study of buserelin with DES/orchiectomy in the treatment of stage D2 prostatic cancer patients.

This multicenter, randomized study compared the LH-RH agonist buserelin with diethylstilbestrol (DES)/orchiectomy in the treatment of patients with stage D2 prostatic carcinoma. Subjects were randomized to treatment with buserelin or DES/orchiectomy in a 2:1 ratio. Data from 160 subjects were available for analysis: 105 buserelin subjects (89 s.c. and 16 i.n.), 41 DES-treated subjects, and 14 orchiectomized subjects. Either subcutaneous (200 micrograms q.d.) or intranasal (400 micrograms t.i.d.) maintenance doses of buserelin suppressed serum testosterone values to below castrate levels (less than 100 ng/dl) by week 3 and maintained suppression for over 24 months. Times to treatment failure for specific reasons were analyzed and compared between treatment groups. There was a significant difference between treatment groups in favor of buserelin in the time to treatment failure due to an adverse event (p less than or equal to 0.05). There were no statistically significant differences between the treatment groups in the progression-free survival, best response, and life survival analyses. In addition, buserelin treatment improved quality of life parameters such as pain, performance status, and genitourinary symptoms. With the exception of symptoms of androgen deficiency, few side effects were reported in the buserelin subjects and most were of a minor nature. The incidence of severe side effects was significantly higher among the DES/orchiectomy subjects.