In a nutshell
The authors aimed to determine the benefit of abiraterone acetate (Zytiga) plus prednisone (Deltasone) with hormone therapy in men with newly diagnosed, advanced prostate cancer.
The authors concluded that adding abiraterone acetate plus prednisone to hormone therapy significantly increased overall survival and progression-free survival in men with newly diagnosed, advanced prostate cancer.
Some background
Hormone therapy is a form of treatment that targets the male sex hormones active in prostate cancer, such as testosterone. There are different forms of hormone therapy, such as androgen-deprivation therapy (ADT). ADT is the standard of care for advanced prostate cancer (cancer that has spread beyond the prostate). ADT usually involves either surgical castration (surgical removal of the testicles) or medical castration (hormonal therapy), intended to reduce the production of androgens (male sex hormones such as testosterone), or inhibit their effect on cancer cell growth.
Abiraterone acetate is a hormone therapy drug that is usually used in combination with prednisone (corticosteroid that suppresses the immune system and inflammation) to treat advanced prostate cancer that has progressed after ADT. Further research is needed to determine the benefit of abiraterone acetate plus prednisone to hormone therapy in men with newly diagnosed advanced prostate cancer.
Methods & findings
The aim of this study is to determine the benefit of abiraterone acetate plus prednisone when added to hormone therapy in men with newly diagnosed, advanced prostate cancer.
1,199 patients were included in this study, with an average follow-up of 30.4 months. Patients were separated into two groups. Group 1 (597 patients) received ADT with abiraterone acetate plus prednisone. Group 2 (602 patients) received ADT plus placebos (inactive drugs used in the place of real drugs).
406 deaths occurred (28% in group 1 and 39% in group 2). Overall survival (time from treatment until death from any cause) was significantly improved in group 1 (not reached) compared to group 2 (34.7 months). Overall survival at three years was 66% in group 1. It was 49% in group 2.
Progression-free survival (time from treatment until disease progression) was 33 months in group 1 and 14.8 months in group 2. Secondary endpoints were significantly better in group 1, including follow-up treatment needed and pain progression.
Overall rates of severe side effects were similar between the two groups. Patients in group 1 were more likely to experience serious to severe high blood pressure (10 to 20%) compared to group 2 (0 to 0.2%).
The bottom line
The authors concluded that adding abiraterone acetate plus prednisone to hormone therapy significantly increased overall survival and progression-free survival in men with newly diagnosed, advanced prostate cancer.
Published By :
The New England Journal of Medicine
Date :
Jun 03, 2017