Phase III data on Xtandi in Prostate Cancer published in Lancet Oncology-Astellas

Xtandi (enzalutamide), from Astellas, reduces the risk of skeletal-related events compared with placebo, as well as reducing pain and increasing quality of life in men with metastatic castration-resistant Prostate Cancer (mCRPC) according to new results from the Phase III AFFIRM study published in Lancet Oncology. Prospective analyses of secondary endpoints in the Phase III AFFIRM trial examined first skeletal-related events and investigated several measures of pain control and patient-reported health related quality of life (HRQoL).

Researchers found that enzalutamide reduced the risk of skeletal-related events (such as radiation treatment to the bone and spinal cord compression) by 31% versus placebo. The time to first skeletal-related event was significantly longer for patients on enzalutamide compared to placebo (16�7 months vs. 13�3 months). Enzalutamide signifcantly improved both pain severity and interference from baseline to week 13 compared with placebo, as well as reducing the risk of pain progression.

Compared to the placebo group, a signifcantly higher percentage of patients on enzalutamide reported improvements in quality of life measured by a wellbeing questionnaire used in prostate cancer studies. Patients in the enzalutamide group had a significantly longer time to HRQoL deterioration than those in the placebo group (9�0 months vs. 3�7 months). The drug was generally well tolerated. See: "Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial." Fizazi K, et al. Lancet Oncology, Volume 15, Issue 10. Pages 1147-1156, September 2014. doi:10.1016/S1470-2045(14)70303-1