Beer T.M., Armstrong A.J., Rathkopf D.E., Loriot Y., Sternberg C.N., Higano C.S., Iversen P., Bhattacharya S., Carles J., Chowdhury S., Davis I.D., De Bono J.S., Evans C.P., Fizazi K., Joshua A.M., Kim C.-S., Kimura G., Mainwaring P., Mansbach H., Miller K., Noonberg S.B., Perabo F., Phung D., Saad F., Scher H.I., Taplin M.-E., Venner P.M., Tombal B.
New England Journal of Medicine 2014 371:5 (424-433)
BACKGROUND: Enzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy. New treatment options are needed for patients with metastatic prostate cancer who have not received chemotherapy, in whom the disease has progressed despite androgen-deprivation therapy. METHODS: In this double-blind, phase 3 study, we randomly assigned 1717 patients to receive either enzalutamide (at a dose of 160 mg) or placebo once daily. The coprimary end points were radiographic progression-free survival and overall survival. RESULTS: The study was stopped after a planned interim analysis, conducted when 540 deaths had been reported, showed a benefit of the active treatment. The rate of radiographic progression-free survival at 12 months was 65% among patients treated with enzalutamide…(ver más)