TOTAL ANDROGEN BLOCKADE - THE UNITED-STATES EXPERIENCE

Maximal androgen blockade may improve the effectiveness of treatment o f prostate cancer. To test this hypothesis we conducted a randomized, double-blind trial in patients with disseminated and previously untrea ted prostate cancer (stage D2). All patients (n = 603) received leupro lide, 1 mg/day s.c. in combination with either placebo (n = 300) or fl utamide 250 mg p.o. t.i.d. (n = 303). The median progression-free surv ival times were estimated at 14 months for the leuprolide plus placebo group and 17 months for leuprolide plus flutamide patients: median ti mes for overall survival were 29 vs. 35 months, respectively. Patients with minimal disease and good performance status did particularly wel l on combination therapy. Median progression-free survival for this su bgroup was 19 months for leuprolide plus placebo patients vs. 48 month s for patients on combined therapy (p = 0.035) Flutamide appeared to r educe the disease flare associated with leuprolide-monotherapy. Combin ed androgen blockade with leuprolide and flutamide is superior to leup rolide treatment alone in patients with disseminated prostate cancer.