Dr Hwang on Considering AEs Associated With FDA-Approved Agents in Nonmetastatic Prostate Cancer

Clara Hwang, MD, medical oncologist, senior staff physician, Henry Ford Health System, clinical assistant professor, Wayne State University School of Medicine, discusses adverse effects (AEs) associated with FDA-approved agents for patients with nonmetastatic prostate cancer.

In an OncLive^® State of the Science Summit™, Hwang and colleagues from the Henry Ford Health System each gave presentations on topics spanning prostate cancer care. Hwang shares that one of the main takeaways from her presentation was to give a review to her colleagues of the 3 FDA-approved agents in the treatment of patients with nonmetastatic prostate cancer: apalutamide (Erleada), enzalutamide (Xtandi), and darolutamide (Nubeqa). These 3 agents were all granted approvals by the FDA based on respective phase 3 trial data. Apalutamide was approved in 2018 based on data from the SPARTAN trial (NCT01946204). Enzalutamide was approved in 2018, and this regulatory decision was supported by outcomes from the PROSPER trial (NCT02003924). Darolutamide was granted approval in 2019 based on findings from the ARAMIS study (NCT02200614). Notably, these agents were all granted approvals because they are associated with overall survival benefits vs treatment with placebo.

Moreover, Hwang continues that she aimed to impart a review of some of the toxicities and key AEs associated with these 3 agents. In terms of clinical decision making, because these are toxic drugs for patients, it is vital to take these potential toxicities into consideration when deciding which patients need treatment with these agents, Hwang emphasizes. Notably, the pivotal SPARTAN, PROSPER, and ARAMIS trials all had clear enrollment criteria, Hwang says. These trials required a prostate-specific antigen doubling time of less than 10 months, she adds. Therefore, to optimize risk benefit, adhering to the entry criteria of these trials when determining which patients are eligible for apalutamide, enzalutamide, and darolutamide is in the best interest of patients, Hwang concludes.