Elizabeth Franzmann, MD, Associate Professor at the University of Miami, Sylvester Comprehensive Cancer Center in the Department of Otolaryngology and Chief Scientific Officer at Vigilant Biosciences talks about a new test to help detect signs of a patients risk for developing oral cancer.
Interview conducted by Ivanhoe Broadcast News in July 2017.
Tell me about the kind of patients you see and treat so we have a better understanding of what you do?
Dr. Franzmann: I’m a head and neck surgeon, the patients that I see primarily have tumors in the mouth, throat, voice box, thyroid … They can have salivary gland tumors as well. But the tumor that we struggle with the most is what we call oral cancer. When I refer to oral cancer I’m talking about tumors involving the mouth and the throat.
When it comes to oral cancer a lot of people don’t think about it or even think that they might be at risk. Is it very prevalent and do you see it a lot?
Dr. Franzmann: Unfortunately we’re seeing more and more of it. The reason behind that is because of the HPV virus which is becoming more and more common and so now we have an epidemic of this particular disease. A number of years ago the disease was actually decreasing in incidence in the United States because we are having quite a bit of success in getting people to stop smoking. But that’s now plateaued to a little less; twenty percent of Americans are still smoking, that’s plateaued over the years so the drop in oral cancer has stopped from that standpoint. Instead what we’re seeing is more of the HPV-related disease. That’s increasing particularly in white males but in other groups too. The reason for that is probably a change in sexual behaviors that we’ve had over recent decades.
Does HPV put you at greater risk? What else can put you at risk for oral cancer?
Dr. Franzmann: Yes. Still the same traditional factors; smoking, alcohol use; which some people don’t realize is an independent risk factor for head and neck cancer. HPV is the big one and again because of HPV the cancers of the throat are one of the only cancers in the United States that’s continuing to increase in incidence at this point. Most cancers are plateauing or decreasing, so in addition to that there’s some association with hereditary issues. If you have a family member you’re more likely to get the cancer as well. And there’s some question about other viruses having a role. There are a number of different things; immunosuppression also puts you at higher risk for head and neck cancer.
Up until this point has there been a screening tool for this? Are people being screened for oral cancer?
Dr. Franzmann: A number of national organizations and international quite frankly have recommended screening for oral cancer, particularly in populations who are known to be at risk. Unfortunately with the HPV epidemic there’s not really a great screening tool for that and most people are at risk. What we have been doing across the world and across the country has been screening by oral exam. If the lesion is identified, biopsying it and that’s how we diagnose the disease. There are also some adjuncts that are available that have been available for some time. But they haven’t really proven to decrease the number of deaths due to this disease. We are in need of better screening tools for the disease that are simple and inexpensive.
What are some of the symptoms that a person might have early on and is it something that can be caught early?
Dr. Franzmann: It can be caught early, particularly with physical exam. There have been studies in India showing that physical exam can actually reduce mortality. Those studies haven’t been replicated in the United States or other countries, but in India that has been shown in a very large multi-institutional trial.
Why haven’t they done that?
Dr. Franzmann: As far as the symptoms that we’re looking for it’s really any sore, red or white spots in the mouth, it may be ulcerated it may not be ulcerated, it may be raised or it may not. It may hurt it, may not, it may bleed it, may not. But any lesion inside the mouth that’s been there for three weeks or more is a concern. If it doesn’t go away then that’s something that we should be concerned about. It could be just from chronic biting or some other issue, but it’s something that should be looked at. Other symptoms are sometimes patients will complain of ear pain on one side, which is really more of a referred pain like you would get with a heart attack; how the pain can go down the shoulder. When you have cancer in the throat you can feel pain going up to the ear. Some people will have difficulty with speech, or pain with swallowing. All of those things can be early signs.
Can sore throat be a sign or not?
Dr. Franzmann: Yeah, sore throat can be a sign. But generally again that will resolve with treatment for being whatever is causing the sore throat. If it doesn’t then that would be a concern.
So in most cases is this being caught early when it’s treatable?
Dr. Franzmann: No. It’s frustrating because it seems like we should be able to because the mouth is right there and you should be able to see lesions and like you said you have sore throat. A lot of things can cause a sore throat and cancer can masquerade as a lot of other things. Unfortunately still two thirds of cases are caught in late stage, stage three or four when we don’t have as good a chance as curing them.
So screening is key? What have you guys found in your studies?
Dr. Franzmann: Yeah, the challenge with physical exam is that you really need someone who is trained in order to do it. They use the white light; they need to know what to look for. Often times there can be these lesions that may or not be cancer that need to then be further worked up. It’s been a challenge to do this in the United States and many other countries because it’s a fairly rare disease and there are so many people at risk. When I was working at Jackson Memorial Hospital, I took care of a lot of patients that didn’t have a whole lot of economic support. They would come in with very advanced disease. It was very frustrating because we can often times still cut the tumor out, but they would be left often very debilitated. We can reconstruct them, we can give them radiation and chemo. Sometimes they wouldn’t even make it through the treatment before the tumor comes back. And if those few people that we were able to cure that came in with such advanced disease; they still have to live with speech and swallowing problems for the rest of their lives. It is very frustrating, something needs to be done but it needs to be very simple, inexpensive and non-invasive. And it needs to not require someone that knows exactly what to look for because that’s time and a lot of expense and variability. I’ve been doing research for many, many years and interested in the mechanisms of cancer and so I’ve worked on a particular molecule called CD44 and we heard that it could be released into soluble form. So we started testing it in saliva and then in 2005 we published a paper that showed, sure enough, the levels in cancer patients were elevated compared to controls. Since then we’ve done more and more studies looking at larger and larger number of patients and more carefully controlling for different diseases and their risk factors and demographics and so forth. What we found is CD44 and another molecule or another marker which is total protein very simple and inexpensive as well. When they’re in combination we can accurately distinguish between patients that have cancer and patients that don’t have cancer. And antidotally we’ve even seen some patients that had high levels go on to develop a cancer even though at the time of collection they didn’t have anything. It’s exciting and we want to be able to offer this to patients as a way to identify when a patient is having a problem sooner.
How would patients be able to use this or how would doctors or dentists be able to use this to screen patients?
Dr. Franzmann: What we ended up with was we’d have patients take a tablespoon of normal saline, just ocean water basically, put it in their mouth they rinse for five seconds, gargle for five seconds then spit in a cup. Initially when we first started the experiment it would go to a lab and we would test it using some very simple and standardized tests. Then with those tests we would get a number and we were able to develop cut points determining what number was more worrisome than another number. That’s kind of the background science behind how we developed the test. Now we have a few products that are available. In Europe we had a kit that’s very similar to the lab tests that I just described, but it’s for commercial use. And then Vigilant Bioscience has also converted that technology into a point of care test that can be done right in the office. It’s simple, it looks kind of like a pregnancy test and then there’s another part of it that looks like a urine dip stick. They’re together in a simple device, the same collection method. They stick the device in, wait twenty minutes, and the results are available. That is available in Europe right now. In the United States we have a laboratory base test that’s available as well.
Is it something that a patient would rinse and spit?
Dr. Franzmann: Yes, and then it gets tested. Either the point of care, which is not available in the United States yet, or the laboratory-based test.
Judging by the patients’ level of CD44 that moment, would tell you whether or not…?
Dr. Franzmann: It’s the protein marker, and then with the lab test they also will capture information about demographics and whether or not they have a smoking history. That helps, it adds information that gives us a more accurate result of the likelihood of that person having the cancer or not. But all of these tests are aids in diagnosis, and not supposed to be used to make a diagnosis of oral cancer. It’s supposed to be used with first see the physicans interpretation, and the physicans examination and clinical judgment.
It could tell if a person might develop it later, so that’s a wonderful thing to be able to do that. What could the person then do, are there preventative measures?
Dr. Franzmann: Yeah. For the current tests that we have, that information was more antidotal, it’s a few patients. We do think that in the future we’ll be able to show that. What we do recommend though for a patient that was to have elevated levels, there are things that you can do that we know will decrease your risk. Such as decreasing tobacco use, responsible drinking, nutritious diet with lots of fruits and vegetables, particularly green leafy vegetables and good oral health. You want to make sure that they’re going to their dentist and taking the best care of their teeth as possible.
You said there are several different products, is there a name?
Dr. Franzmann: Yeah, we have the OncAlert lab test and OncAlert rapid test. The rapid tests are available in Europe and the lab test is available in United States.
What’s the next step?
Dr. Franzmann: In Europe the tests are CE marked and ready to go. As for the FDA we are just in the process of opening that trial and hope to have it completed soon.
The trial would be to test with patients?
Dr. Franzmann: Yes, in the United States with the aim of getting approval for use in the United States.
What would be your hope, would it be to have this available for patients for screening in like every dentist office?
Dr. Franzmann: Ultimately that’s what we would like to see. But first we have to get the FDA approval and we will be selling it to the appropriate market. Ultimately we want it to go to all dentists once we have the proper approvals.
In other words it would be easy because the patient who is being seen would actually have access to this screening which would be great.
Dr. Franzmann: Yeah.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Nicole Chimenti
Nicole.chimenti@vigilantbiosciences.com
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