1. Abiraterone and Increased Survival in Metastatic Prostate Cancer
- Author
-
de Bono, Johann S., Logothetis, Christopher J., Molina, Arturo, Fizazi, Karim, North, Scott, Chu, Luis, Chi, Kim N., Jones, Robert J., Goodman, Oscar B., Saad, Fred, Staffurth, John N., Mainwaring, Paul, Harland, Stephen, Flaig, Thomas W., Hutson, Thomas E., Cheng, Tina, Patterson, Helen, Hainsworth, John D., Ryan, Charles J., Sternberg, Cora N., Ellard, Susan L., Fléchon, Aude, Saleh, Mansoor, Scholz, Mark, Efstathiou, Eleni, Zivi, Andrea, Bianchini, Diletta, Loriot, Yohann, Chieffo, Nicole, Kheoh, Thian, Haqq, Christopher M., Scher, Howard I., COU-AA-301 Investigators, [missing], and Rottey, Sylvie
- Subjects
Male ,CASTRATION ,PLUS PREDNISONE ,Kaplan-Meier Estimate ,Antiandrogen ,Androgen deprivation therapy ,Prostate cancer ,chemistry.chemical_compound ,TESTOSTERONE ,Antineoplastic Combined Chemotherapy Protocols ,Medicine and Health Sciences ,Neoplasm Metastasis ,CYP17A1 Inhibitor ,Fatigue ,DOCETAXEL ,Androstenols ,Apalutamide ,Abiraterone acetate ,I CLINICAL-TRIAL ,Steroid 17-alpha-Hydroxylase ,General Medicine ,Middle Aged ,Treatment Outcome ,Androgens ,Disease Progression ,Hormonal therapy ,Androstenes ,medicine.medical_specialty ,medicine.drug_class ,Urology ,HUMAN CYTOCHROME P450(17-ALPHA) ,Article ,CYP17 ,Double-Blind Method ,ACETATE ,medicine ,Humans ,Orteronel ,Aged ,business.industry ,Prostatic Neoplasms ,Androgen Antagonists ,medicine.disease ,Survival Analysis ,Surgery ,chemistry ,Prednisone ,ANDROGEN-DEPRIVATION THERAPY ,business ,HORMONAL-THERAPY - Abstract
BACKGROUND Biosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy. METHODS We randomly assigned, in a 2: 1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate. RESULTS After a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate-prednisone group than in the placebo-prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P
- Published
- 2011
- Full Text
- View/download PDF