Prospective Data Establishing the Clinical Utility of Testing All Biomarkers in Advanced Bladder Cancer is Still Needed, Says Expert


With the increasing clinical use of circulating tumor DNA biomarker testing among community urologists, an expert from Tisch Cancer Institute at Mount Sinai in New York City suggests that more prospective data are needed to make the best decisions among patients with bladder cancer.

Additional data from prospective studies are necessary for establishing the clinical utility of testing for all circulating tumor DNA (ctDNA) biomarkers among patients with advanced urothelial cancer, according to Matthew Galsky, MD, director of Genitourinary Medical Oncology, professor of medicine, and co-director of the Bladder Cancer Center of Excellence at Tisch Cancer Institute at Mount Sinai in New York City.

During the 2022 Society for Urologic Oncology (SUO) Annual Meeting, CancerNetwork® spoke with Galsky about his presentation on the use of adjuvant immunotherapy following radical surgery in the treatment of urothelial cancer, which is a type of bladder cancer.

According to Galsky, the use of ctDNA biomarker testing for urothelial cancers has become more frequent in the clinical setting. However, he emphasized to other community urologists that the frequent use of biomarker testing needs to be supplemented with prospective data to comfortably make the right treatment decisions among patients.

“Just because there's a biomarker that's available to test, [that] doesn't mean we actually have prospective data to establish clinical utility,” he said.


Probably the most important thing to know is that adjuvant immune checkpoint blockade is approved by the FDA. Adjuvant nivolumab, based on a phase 3 international study, met its co-primary end points. The second [thing] is that circulating tumor DNA testing is here. It's being used in the clinic, but it's very important with any new biomarker that we be as rigorous with biomarker testing as we are with drug development. And just because there's a biomarker that's available to test, [that] doesn't mean we actually have prospective data to establish clinical utility. And that's really what we need to be able to feel comfortable, that we're making the best decisions with our patients. That will take prospective studies to establish clinical utility.

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