INTRODUCTION AND OBJECTIVES: The role of monotherapy with pure antiandrogens in pts with advanced prostate ca is still controversial. The purposes of the present study were: I) To evaluate the efficacy of B monotherapy as compared to total androgen deprivation; 2} to compare the toxicity of B versus that of F. METHODS: From March, 1993 until September, 1996, 220 pts with hystologically proven, locally advanced or metastatic prostate ca were randomly allocated to receive either B monotherapy, 150 mg daily (no=108) or F, 750 mg daily, plus G dpt, 3.6 mg every 4 weeks (no=l 12) until disease progression or toxicity. Pts characteristics: group B: median age, 74 (48-82); median PS (ECOG), 0 (0-2); stage C (AUS), 45%; stage D, 55%; G1-G2, 64%; median initial PSA level, 52 ng/ml (0.6-780); group F+G: median age, 74 (55-88); median PS, 0 (0-2); stage C, 38%; stage D, 62%; G1-G2, 54%; median initial PSA level, 75.5 ng/ml (1-6641). RESULTS: At a median f.u. time of 20 mos (1-40) overall 88 pts progressed (B: 42; F+G: 46) and 50 pts died (B: 21; F+G: 29). Median PFS in mos: all pts: B, 24; F+G, 23: n.s.; stage D: B, 19; F+G, 19: n.s.. Median S: all pts: B, not reached; F+G, 34 mos: n.s.. PSA normalized in 79% of pts in group B and in 86% in group F+G: n.s.. Diarrhea and hot flushes were more common in group F+G (p=0.000 both ones), while gynecomastia was more common in group B (p=0.001). Treatment was discontinued in 2% of pts receiving B and in 16.5% of pts receiving F (p=0.000). 20/52 pts maintained normal erections in group B as compared to 5/60 in group F+G (p=0.000). CONCLUSIONS: 1) B monotherapy was safe and as effective as total androgen deprivation, independently of disease stage; 2) B was better tolerated than F and used as monotherapy allowed a better quality of life.
|Number of pages||1|
|Journal||British Journal of Urology|
|Issue number||SUPPL. 2|
|Publication status||Published - 1997|
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