GeneCentric Therapeutics has entered the second phase of a diagnostic development collaboration with Jose Zevallos M.D., M.P.H., Chief of the Division of Head and Neck Oncologic Surgery in the Department of Otolaryngology at Washington University School of Medicine in St. Louis. The partnership is designed to develop a tumor subtyping, four-class molecular diagnostic test for patients with HPV-negative head and neck squamous cell carcinoma (HNSCC; pictured). [Sikora via Baylor College of Medicine]

A simple oral rinse may be able to detect patients at higher risk of head and neck cancer recurrence. CD44 levels in used rinse were triple the normal level in patients who recurred, according to a new study by researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. The study also generated early data on a rapid, point-of-care test to measure recurrence risk.

Their findings were published Aug. 15 in JAMA Otolaryngology – Head & Neck Surgery. The first author is Elizabeth Franzmann, MD, a head and neck surgeon at Sylvester.

“Our study suggests biomarker detection in saliva collected from an oral rinse after initial treatment offers potential to readily assess recurrence risk,” said Franzmann. “Elevated levels of either of two biomarkers were associated with disease return.” 

Head and neck cancer is usually treated first with surgery and radiation. Treatment can seriously impact speech, swallowing, and appearance. These effects can be even worse after recurrence, which is not always easy to catch. 

“It can be very difficult to determine if what you’re observing is just post-treatment changes or a cancer recurrence,” explained Joseph Califano III, MD, director of UC San Diego’s Hanna and Mark Gleiberman Head and Neck Cancer Center and the study’s co-corresponding author. “Good biomarkers could help remove some of the guesswork.”

Head and neck cancers account for nearly 4% of all cancers in the U.S. and are more commonly diagnosed in people over age 50, according to the National Cancer Institute. Men are more than twice as likely to be diagnosed with the disease.

Franzmann, emphasized the importance of early recurrence detection. “These patients suffer terribly,” she said. “The more we can minimize those effects by catching recurrence early, the better we can mitigate patient morbidity and mortality.”

Previously, Franzmann and her team found a link with two key biomarkers—CD44, a tumor-initiating molecule, and total protein levels—with a person’s risk for developing oral or oropharyngeal tumors, the most common types of head and neck cancers. 

In this new study, the researchers studied whether those two biomarkers could predict recurrence in already-diagnosed patients. Their clinical trial evaluated the effects of CD44 and total protein levels in 160-plus patients across multiple cancer centers. Patients were provided oral-rinse samples for use up to 18 months after their initial treatment.

To measure biomarker presence, the researchers used laboratory tests and experimental lateral-flow tests, technology similar to stick-based pregnancy and COVID-19 tests.

“Our laboratory assays showed an association between biomarker levels and later recurrence,” Franzmann said. “Compared to patients with normal protein levels three months after treatment, patients with about twice as much total protein had an estimated 65% greater risk of recurrence.”

“It would be really useful if we had a test that was inexpensive and could be performed and resulted while the patient was in the office,” said Franzmann. “That’s the area we are focusing on.”

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