By: Charlotte Schubert, Ph.D. |

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A simple, mouthwash-based test has the potential to help physicians predict recurrence of head and neck cancer, suggests a new study.

The clinical study analyzed two biomarkers in saliva collected via an oral rinse. The findings show that elevated levels of either biomarker after initial treatment are associated with the return of disease.

The approach may lead to new tests to readily assess the risk for recurrence, said study first author Elizabeth Franzmann, M.D., a researcher at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine.

Initial treatments like surgery and radiation can affect speech, swallowing and appearance, diminishing a patient’s quality of life. The effects can be even worse upon recurrence.

“These patients suffer terribly,” said Dr. Franzmann. “The more we can minimize those effects by catching recurrence of the disease early, the better we can mitigate patient morbidity as well as mortality.”

Recurrence is not always easy to catch, added Dr. Franzmann, who is a professor of otolaryngology and director of head and neck research at the Miller School.

“It can be very difficult to determine if what you’re observing is just post-treatment changes or if you’re looking at a recurrence,” said Dr. Franzmann.

Good biomarkers could help take out some of the guesswork.

The study was conducted in collaboration with researchers at several institutions, including Joseph Califano III at the University of California, San Diego, who led the investigation. Thanks is extended to Vigilant Biosciences for its contribution to this work. The findings were published in JAMA Otolaryngology–Head & Neck Surgery.

In a previous study, Dr. Franzmann and her team assessed how biomarkers in oral rinses can assess an individual’s risk for initially developing oral or oropharyngeal tumors, the most common types of head and neck cancer. They found a link to disease with two key biomarkers, CD44, a tumor-initiating molecule, and total protein levels.

In the new study, the researchers studied whether these two biomarkers could predict recurrence in already-diagnosed patients. The study evaluated CD44 and total protein levels in more than 160 patients across multiple cancer centers. Patients were provided mouth-rinse samples for up to 18 months after their treatment.

The presence of the biomarkers was assessed in laboratory assays and in experimental lateral-flow tests, a type of test similar to stick-based pregnancy and COVID-19 tests.

Assessment of the samples in laboratory assays showed an association of biomarker levels with later recurrence. Compared to a patient with normal total protein levels at three months post-treatment, a patient with about twice as much total protein had an estimated 65% greater risk of recurrence. A patient with CD44 levels triple that of normal had an estimated 62% greater risk of recurrence.

The researchers also generated early data on a rapid, point-of-care test measuring the biomarkers. The findings will be used to improve the easy-to-use test.

“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 Dr. Franzmann. “That’s the area we are focusing on.”

The use of biomarkers holds promise for refining risk prediction in patients with head and neck cancer.

Better risk prediction, in turn, has the potential to save lives by reducing the need for harsh, invasive treatments. Only about half of head and neck cancer patients worldwide live to five years after their diagnosis, and there has been little change in mortality rates in the past few decades.