Dr. Freedland on Real-World Evidence Vs PREVAIL Trial in mCRPC

Stephen J. Freedland, MD, Warschaw Robertson Law Families Chair in Prostate Cancer, director of the Center for Integrated Research in Cancer and Lifestyle, co-director of the Cancer Genetics and Prevention Program, associate director of the Faculty Development Samuel Oschin Comprehensive Cancer Institute, and professor of surgery at Cedars-Sinai Medical Center, discusses how real-world evidence with the use of enzalutamide (Xtandi) in patients with metastatic castration-resistant prostate cancer (mCRPC) compares with data from the phase III PREVAIL trial.

Data from the phase III PREVAIL trial are in line with other real-world evidence observed with enzalutamide, says Freedland. Evidence shows that enzalutamide is a potent drug and works well in this patient population.

Real-world evidence showed prostate-specific antigen (PSA) declines of ≥50% and ≥90% in 55.0% and 23.8% of patients, respectively. Comparatively, the PREVAIL trial showed that a PSA decline of ≥50% and ≥90% in 78% and 47% of patients, respectively. Furthermore, the median time to PSA progression was 18.5 months (95% CI, 15.6-23.7) in the real-world setting compared with 11.2 months in the PREVAIL trial.

In the real-world analysis, investigators did not assess the adverse events associated with enzalutamide, but having that data in the real-world setting would be beneficial, according to Freedman, especially in patients who are not optimally healthy. However, toxicity information is difficult to obtain from a retrospective chart review, Freedland concludes.