Dr Freedland on Implications of Treatment Suspension on HRQOL in High-Risk nmHSPC

Stephen J. Freedland, MD, director, the Center for Integrated Research in Cancer and Lifestyle, associate director, Training and Education, Samuel Oschin Comprehensive Cancer Institute; the Warschaw, Robertson, Law Families Chair in Prostate Cancer, professor, Department of Urology, at Cedars-Sinai, discusses the clinical implications of investigating the role treatment suspensionplays in health-related quality of life (HRQOL) in patients with high-risk, biochemically recurrent nonmetastatic hormone-sensitive prostate cancer (nmHSPC) who were enrolled on the phase 3 EMBARK trial (NCT02319837).

Notably, EMBARK evaluated enzalutamide (Xtandi) with or without leuprolide vs leuprolide plus placebo in this patient population. HRQOL data from this trial were shared at the 2024 ASCO Annual Meeting. HRQOL data through week 109 showed that treatment suspension did not cause clinically meaningful changes in most patient-reported outcome domains, indicating that these aspects were not significantly affected by the treatment initially. Additionally, hormonal treatment-related symptoms rapidly improved in all groups after treatment suspension but worsened after week 97, indicating that, despite the presence of symptoms, enzalutamide with or without leuprolide can delay metastasis or improve survival without worsening HRQOL during or after treatment.

Freedland notes that when treatment was stopped, hormonal-related symptoms, such as hot flashes, improved, highlighting the importance of considering patients’ overall treatment experiences, he says. It’s reassuring that the treatment doesn’t worsen these symptoms, but there are still adverse effects to manage, Freedland emphasizes. This is where holistic advice comes in, such as ensuring patients get enough sleep, exercise regularly, and eat well to maintain their energy levels and combat fatigue, which were observed across all 3 treatment groups, he reports.

Overall, EMBARK is an interesting and complicated study that still has a lot of work to come, Freedland says. Investigators will be mining the data from this trial for years to come, and although investigators are currently focusing on the most clinically relevant questions, Freedland says that there will be much to learn about prostate cancer through this study.