Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy.
Index Terms :
Abiraterone Acetate/administration & dosage; Abiraterone Acetate/adverse effects; Adult; Aged; Aged, 80 and over; Androgen Antagonists/administration & dosage; Androgen Antagonists/adverse effects; Antineoplastic Combined Chemotherapy Protocols/adverse effects; Antineoplastic Combined Chemotherapy Protocols/therapeutic use; Humans; Male; Middle Aged; Neoplasm Metastasis/drug therapy; Neoplasm Recurrence, Local/drug therapy; Prednisolone/administration & dosage; Prednisolone/adverse effects; Prostate-Specific Antigen/blood; Prostatic Neoplasms/drug therapy; Prostatic Neoplasms/mortality; Prostatic Neoplasms/radiotherapy; Prostatic Neoplasms/surgery; Steroid 17-alpha-Hydroxylase/antagonists & inhibitors; Survival Analysis
Dodane szczegóły :
de Bono, J.S.
Typ dokumentu :
Open access content. Open access content
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Pozostałe numery :
Źródło wspomagające :
UNIV DE LAUSANNE-LETTRES,HIST,SCI RELG
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Numer akcesji :
Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design. We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer). A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 i