Mouthwash test could detect risk for recurrence of head and neck cancer
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A mouthwash-based biomarker test has demonstrated efficacy for detecting risk of head and neck cancer recurrence, according to results of a nonrandomized clinical trial.
A multi-institutional team of researchers evaluated the ability of two salivary biomarkers — CD44 and total protein — to monitor for head and neck cancer recurrence.
They collected saliva samples through an oral rinse provided to 172 patients with newly diagnosed, untreated oral cavity and oropharyngeal cancer.
The investigators collected oral rinse samples from study participants s at baseline and at 3, 6, 12 and 18 months after treatment completion.
Researchers assessed the samples for the two biomarkers in laboratory and lateral flow tests. They also followed participants for 3 years to track disease status.
Multivariate-adjusted analysis showed associations between recurrence risk and higher CD44 (HR = 1.13; 95% CI, 1.04-1.22) and total protein (HR = 3.51; 95% CI, 1.24-9.98).
“Ideally, this would be something we can use in the clinic to identify those patients we need to watch more carefully for recurrence,” Elizabeth J. Franzmann, MD, FACS, professor of otolaryngology and director of head and neck cancer research at University of Miami Sylvester Comprehensive Cancer Center, told Healio. “It may trigger earlier diagnostic testing or other, more intensive physical exams. It’s not yet FDA approved, so we have a bit of work to do before that can happen.”
Healio spoke with Franzmann about the motivation for developing the test, its efficacy for predicting recurrence, and next steps in research.
Healio: How difficult is it to detect recurrence of head and neck cancer?
Franzmann: It’s been quite a challenge because treatment usually involves surgery or combinations of surgery, radiation and chemotherapy. These treatments cause changes to the anatomy, and to the appearance of the lining of the mouth and throat. There’s scarring and redness, and these can be signs of cancer recurrence. It can be very difficult to distinguish between post-treatment changes and actual recurrence of the cancer.
Healio: How did you develop the test and how does it work?
Franzmann: It’s been in the development process for decades. We started with mechanistic studies involving the key marker that we use in our test, which is a cancer stem cell marker. It detects the very earliest changes, and it becomes detectable in oral rinses. It appears early in the process of cancer development.
We were trying to develop a test that would be easy, inexpensive and tolerable for the patient and also easy for clinicians to use.
We thought it was time for a test like this to be developed, and we thought oral rinses would be easy. With some of the saliva collection methods available, you have to sit and spit into a cup and wait for 15 minutes. That adds time to the clinic visit.
Our test uses 5 ccs of saline that the patient rinses in their mouth for 5 seconds, gargles for 5 seconds, and then spits into a cup. That can be done in seconds as opposed to waiting 15 minutes. Then it can be evaluated in a laboratory.
In our most recent paper, we looked at a point-of-care test, but that needs a little bit more development. However, the laboratory- based test did show promise for identifying patients at risk for recurrence.
Healio: How did you evaluate its efficacy?
Franzmann: This was a joint effort led by Joseph Califano, MD, of University of California, San Diego. He coordinated five different sites where this research was performed. We followed these patients over time and took measurements of their oral rinses at each of the time points. After the study was done, we analyzed patients who recurred versus those who didn’t. We found associations with recurrence for the CD44 and total protein marker. For example, the patients who have CD44 levels at about 1 standard deviation above normal had over a 60% higher chance of recurrence compared with those who didn’t have elevated levels.
Healio: What are the next steps in this research?
Franzmann: We want to develop a point-of-care test. This will be most useful and will distinguish it from other available tests. We will be able to do it right there in the clinic without making the patient wait for weeks.
Healio: Is there anything else you’d like to mention?
Franzmann: Head and neck cancer is increasing in incidence, largely due to an increase in oropharyngeal cancer related to the human papillomavirus. This disease affects the parts of a person that often make them feel the most human. It affects speech, and it can affect cosmesis. Inability to swallow could affect the ability to enjoy a meal with family or friends. It’s important that we try to prevent this disease in the first place, and also prevent recurrence.
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For more information:
Elizabeth J. Franzmann, MD, FACS, can be reached at efranzman@med.miami.edu.
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