In a nutshell
The authors aimed to determine the effectiveness of apalutamide before or after treatment with abiraterone acetate (Zytiga) and prednisone (Deltasone) in men with advanced, hormone-resistant prostate cancer.
The authors concluded that apalutamide was a safe treatment option and demonstrated effectiveness against advanced, hormone-resistant prostate cancer in men who received treatment for 6 months or longer.
Some background
Advanced prostate cancer is cancer that has spread outside of the prostate gland into other organs. In some cases, advanced cancer can become resistant to treatments, such as hormone therapy (treatment that targets the male sex hormones, such as testosterone). This is known as hormone-resistant prostate cancer.
Treatments available for advanced, hormone-resistant cancer include abiraterone acetate (prevents the production of enzymes needed for cancer cell growth) and prednisone (used to treat patients with low levels of corticosteroids by replacing steroids naturally made by the body). These treatments are often used in combination. Apalutamide (ARN-509) is an emerging treatment in advanced prostate cancer that prevents the production of hormones that increase tumor growth.
Methods & findings
The aim of this study is to determine the benefit of apalutamide when used before or after abiraterone acetate and prednisone treatment in men with advanced, hormone-resistant prostate cancer.
46 patients were used in this study and were separated into two groups. 25 patients in group 1 received apalutamide only and did not receive abiraterone acetate and prednisone (AAP). 21 patients in group 2 received AAP for at least 6 months followed by apalutamide. Prostate specific antigen (PSA – protein in the blood elevated in the presence of prostate cancer) response rates were tested at 12 weeks. The PSA response rate was defined as a 50% or more reduction in PSA levels over 12 weeks.
The 12-week PSA response rate was 88% for group 1. It was 22% for group 2. In group 1, 80% of patients received apalutamide treatment for more than 6 months and and 64% of patients for more than 12 months. In group 2, 43% of patients received apalutamide treatment for more than 6 months and 10% of patients received apalutamide treatment for more than 12 months.
The average time to PSA progression was 18.2 months in group 1 and 3.7 months in group 2. The most common side effects experienced in group 1 was fatigue, nausea, and stomach pain. The most common in group 2 were fatigue, diarrhea, and nausea.
The bottom line
The authors concluded that apalutamide was a safe treatment option and demonstrated effectiveness against advanced, hormone-resistant prostate cancer in men treated for 6 months or longer.
Published By :
Clinical Cancer Research
Date :
Feb 17, 2017
