In a nutshell
This study evaluated patient-reported outcomes in men with non-metastatic castration-resistant prostate cancer (CRPC) when treated with either enzalutamide (Xtandi) or a placebo. The data showed that enzalutamide treatment delayed the time until pain progression and improved the quality of life of patients compared to a placebo.
Non-metastatic castration-resistant prostate cancer (CRPC) is an aggressive form of prostate cancer that has not spread beyond the prostate gland and is no longer responsive to hormonal therapy such as androgen-deprivation therapy (ADT). ADT reduces the production of androgens (male sex hormones such as testosterone). Reducing these androgens prevents cancer cell growth.
Enzalutamide is an anti-androgen medication. It blocks testosterone from reaching PC cells. It is used for the treatment of CRPC. Enzalutamide plus ADT has been shown to improve clinical outcomes like overall survival and lowering the risk of disease progression and spread in men with CRPC. However, whether enzalutamide also influences patient-related outcomes such as pain and quality of life in patients with non-metastatic CRPC is still unknown.
Methods & findings
This study involved 1401 patients with non-metastatic CRPC. The patients were randomly assigned into two groups. Group 1 included 933 patients who received enzalutamide and group 2 included 433 patients who received a placebo. The average follow-up period was 18.5 months in the enzalutamide group and 15.1 months in the placebo group. Pain progression and the quality of life related to the patients' health were measured by patient questionnaires.
At the beginning of the study, both groups had similar quality of life scores. The time it took for patients to experience severe pain was 25% longer with enzalutamide compared to placebo. The time it took for patients to experience worsening of their urinary and bowel symptoms was 28-42% longer with enzalutamide compared to the placebo.
The bottom line
This study concluded that treating patients with enzalutamide delayed the time until pain progression, worsening of their pain, and improved the quality of life compared to a placebo in men with non-metastatic CRPC.
The fine print
This study was funded by Astellas, the manufacturer of enzalutamide.
Published By :
The Lancet. Oncology
Feb 12, 2019