Yair Lotan, MD, explains how urine biomarker research needs to focus on how these markers can optimally fit into clinical algorithms for bladder cancer.
In this video, Yair Lotan, MD, University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center, explains what steps are needed to advance urine biomarker research to a level where these markers can be integrated further into clinical practice. At the Bladder Cancer Advocacy Network (BCAN) 2023 Think Tank, Lotan co-chaired the session, “What is the clinical utility and potential for urine biomarkers?”
Most of the urine marker development focuses on performance in terms of the marker, but doesn't focus on clinical algorithms. I think the next phase of studies really needs to say, “I have a clinical question. And how do I incorporate a marker into this [clinical setting] to answer this clinical question] and then compare it to standard of care?” And then examine how, if you had this added information that the urine marker provided, how did it change your clinical management. And it could be a fairly focused thing. For example, there’s an ongoing trial randomizing patients with intermediate low-grade bladder cancer to a urine marker vs cystoscopy; the study is alternating the marker with cystoscopy. So, that's a very focused question: Can you do less cystoscopy in low-grade patients. Another marker study from the company Pacific Edge is randomizing patients to standard of care vs a urine marker–based approach based on risk. Those are very clinically oriented trials. And that's really what we need to say is, “How do we want the urine markers to impact our care?” Where do we think that this would benefit either clinicians or patients or, hopefully, both? And so we need to try to work our way toward future trial designs where the prioritizations might be, “What do we think is the highest impact area [for these markers]?” And that's hopefully what we might be able to elicit from this discussion at BCAN. For this session, we’ll have people representing multiple institutions and stakeholders, and maybe we can get some impetus to actually launch some trials. It's a think tank but hopefully trials can get initiated, at least conceptually, and then people can take the next step later.
Transcript has been edited for clarity.