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Leaders in Dentistry: Dr. Ezra Cohen

Source: Dr. Bicuspid
By: Donna Domino, Features Editor
Date: July 17, 2013

Ezra Cohen, MD, University of Chicago.
May 21, 2013 — DrBicuspid.com is pleased to present the next installment of Leaders in Dentistry, a series of interviews with researchers, practitioners, and opinion leaders who are influencing the practice of dentistry.

We spoke with Ezra Cohen, MD, an associate professor of medicine and the co-director of the head and neck cancer program at the University of Chicago, and the associate director for education at the university’s Comprehensive Cancer Center. Dr. Cohen specializes in head and neck, thyroid, and salivary gland cancers, and is an expert in novel cancer therapies who has conducted extensive research in molecularly targeted agents in the treatment of these cancers.

His research interests include discovering how cancers become resistant to existing treatments and overcoming these mechanisms and ways to combine radiotherapy with novel agents. Here Dr. Cohen discusses trends in the incidence, detection, and treatment of oral and head and neck cancers.

DrBicuspid.com: What’s the significance of your recent finding that there may be five distinct subgroups of the human papillomavirus (HPV)?

Dr. Cohen: The purpose of the research was trying to define molecular subgroups of head and neck cancer (HNC) to inform therapy and outcomes a lot more than we do now as defined by stage and anatomic site. We were taking advantage of a cohort of patients that we treated in a similar fashion at the University of Chicago with a chemotherapy regimen that we commonly use here. The patients had tumors banked and the specimens were carefully clinically annotated, so we had information on response, outcome, and toxicity.

Because many of these patients had participated in clinical trials, we could draw upon all this clinical data and begin to coordinate the data with molecular profiling. We noticed that five subgroups served the classification best. If we went to more subgroups, it did not help to differentiate the patients with respect to outcome; if we went to fewer subgroups, we were leaving out important categories.

What really made us stop and realize that this was real was that HPV-positive patients and HPV-negative patients segregated into their own groups quite nicely. We of course validated the entire algorithm on different datasets, and we showed that, indeed, on other datasets the five subgroups still held and the outcomes were still different between those subgroups. So we felt reassured that this wasn’t just a spurious finding based on a limited number of samples and limited datasets, that these subgroups are real.

When we looked at specific genes or groups of genes that made up the subgroups, we were then able to see some very important patterns. The predominantly HPV-negative subgroup looked like they classified into one that was driven by hypoxia, one that was driven by stem cell or mesenchymal type of features that we are calling basal, and one that was driven by cell cycle or epidermal growth factor receptor (EGFR)-related genes that we are calling the classical HNC.

HPV positives segregated primarily into two subgroups: one that appeared to express a lot of immune-related genes and one that was actually similar to the basal HPV-negative group. What is interesting is that the latter HPV group actually did worse and was closer in terms of outcome to the basal subgroup in the predominantly HPV-negative group. We have known that obviously not all HPV-positive patients do well. So maybe here is a classifier that we can apply prospectively to begin to segregate patients into groups of those that will do well and those that may be amenable to specific therapies such as EGFR inhibitions, hypoxia modulations, or immune modulation, depending on the subgroup.

A report published in January in the Journal of the National Cancer Institute noted that the rate of HPV-related oropharyngeal cancers is rising, but there is no etiological data on what’s causing the increase. What do you think is causing the increase?

We are still trying to figure that out, but there are some things we can be confident about and some things we have to surmise. We can be confident that the number of HPV-positive and tobacco-unrelated cancer patients are definitely increasing. Also, no doubt these are sexually transmitted entities and that HPV oropharynx cancer is a sexually transmitted disease. The epidemiology strongly favors that and there likely is an immune-host component to this — the ability to eliminate the virus completely versus allowing the virus to integrate into DNA. What we do not know is why. Why are we seeing an increase in the incidence? Why do people not clear the virus? And in the subgroup of those patients, do they eventually develop cancer?

There is a parallel with oral herpes infections and the rise of HPV oropharynx cancer. There is a parallel with a change in sexual practices to more oral sexual activity versus other forms of sexual activity. And there is a parallel to a younger age of sexual activity where, because of concerns about contraception and sexually transmitted diseases, oral sexual activity may be preferred in younger individuals versus older people who are having sex to conceive.

Those may be demographic factors that are beginning to favor the emergence of HPV-positive cases. And, of course, these are things that have been going on for decades, not just now, because the virus takes 20 to 30 years to produce cancer. These are exposures that happened 20 years ago. They are trends that would parallel what we are seeing in terms of hosts that are not clearing the virus.

There may be modulating factors. We know that males are more likely to harbor the infection than females and that males have a much higher incidence — a 3-to-1 ratio — of HPV-related oropharynx cancer than females. There may be something hormone-related or differences in the immune systems that somehow protects females from developing oropharynx cancer. There may be an interaction with smoking, and some have cited an interaction with marijuana and the development of this cancer. How those may play a role in the ability of the immune system to clear this virus we still have to elucidate. But clearly there are host factors that in some individuals do not allow clearance of this virus, and we do not understand those completely.

Are you seeing more HNC and oral cancer cases in your facility? If so, why?

We are definitely seeing more oropharynx cancers. It could be a combination of factors. We are a tertiary care center that has an interest in HNC and the numbers are truly rising. We are seeing more young patients with tongue cancer who do not have the typical risk factors. That is a disease that worries us quite a bit, not only because we really cannot explain the biology, but our data indicate these patients have worse outcomes.

Researchers have found that parts of the genome are missing in cancer patients. Has there been any information related to oral cancer patients? A recent study of head and neck cancer patients showed that in one patient, 5,000 genes had at least one mutation, and 1,300 had at least two. But the researchers said most were “passengers” — that is, mutations alongside another mutation that acts as a “driver.” What do you think is the significance of these findings?

Without doubt it is true. When we sequence cancers, including oral and HNC, we can see a lot of mutations. The challenge is trying to figure out which ones are important. We call those drivers because they affect the biology of the cancer. So the presumption is if you inhibit a driver, you will have a therapeutic effect on the cancer. If you modify a passenger, you are unlikely to see a therapeutic benefit.

It is certainly true in oral and HNC. We think one gene that is commonly mutated in tobacco-related HNC is p53. We think that is an important gene in the biology of these cancers because it is a common mutation in 50% to 60% of these cancers, and because it is a gene that affects so many critical pathways in the carcinogenic process. It tends to happen very early; even before cancers develop, we see evidence of p53 mutations. That is an example of a gene we think is indeed a driver. On the other hand, there are mutations in many other genes, but we are just not sure how important they are.

What is the greatest challenge in successfully treating head and neck cancers?

Head and neck cancer is an important disease in the way we view cancer and our approaches to it because of two factors. It is a disease in which in a majority of patients we are at least going to consider curative therapy. That does not apply to lung, pancreatic, esophageal cancer, and most cancers that we treat.

The other thing is if you think about what defines us as human beings, especially social animals, so much of it occurs above the clavicle. They involve structures that are profoundly affected not only by the disease but by the treatment. So when you think about it in that context, HNC becomes a cancer that most affects quality of life and that has the greatest financial and social implications of any cancer we know of. So choosing the appropriate therapy on an individual basis for HNC really becomes critical. I cannot overemphasize that. This is a cancer in which the patient has to be cognizant of where they are going for treatment, what type of treatment they will get, and the experience of the center because cure and function are at stake.

A study compared outcomes in patients treated in multidisciplinary centers and with collaboration prior to therapy, and the differences were dramatic. There is evidence that outcomes are better. I think it is a critical component. Not just having multidisciplinary conferences — the content of the conference is important, but one surrogate of that is likely the experience of the center. A radiation oncologist, medical oncologist, and surgeon who treat five of these a year is likely to be much different than somebody who treats hundreds of these a year.

Where do you think we will see the next big breakthrough for oral cancer, in treatment or prevention?

I think the next wave of breakthroughs will be predicated on what we are learning in the molecular biology of this disease. That will lead to the development of agents specifically for HNC and the molecular alterations, which will lead to better patient selection for therapies and, ultimately, better outcomes. But screening and prevention are critical, especially for oral cancer because this is a disease we should be able to screen for quite readily. For cancers of the oropharynx, hypopharynx, and larynx, those are a little bit more difficult to screen for, but for oral cancer, screening and prevention are very important.

There are also ongoing efforts for different compounds that hopefully try to prevent a second cancer from developing or a preneoplastic lesion from turning into a cancer. Nothing has been approved yet, but there are a lot of efforts going on around the country.

What role can dental professionals play in improving the detection of oral cancer?

It is the hygienist who often spends more time with patients, so we have to train those individuals, as well as primary care physicians, to implement oral cancer screening. But clearly the dental office is a key component, and it really should be the individual that spends the most time with a patient, and for most practices that is probably the hygienist.

What kinds of research are you doing now?

Research naturally flows out of the classification. We are developing protocols specifically for HP- positive versus HPV-negative patients. We will look at this classification in a prospective manner to see if it is validated. We are of course integrating novel agents based on what we understand about the molecular biology. We feel very strongly that the PI3 kinase is an important pathway in many cancers, and we think it is a very important pathway in HPV-positive cancers. We are developing and have ongoing clinical trials that specifically target that pathway to see if indeed these agents will be effective.

We also have a large chemoprevention effort using an approach that was developed at the University of Chicago to inhibit early blood vessel growth in preneoplastic lesions using the drug vandetanib, which is commercially available. We are very encouraged by the preclinical data, and hopefully we’ll have something to offer patients to actually prevent the cancer from occurring in the first place.
* This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

July, 2013|Oral Cancer News|

Nutrition and cancer

Source: insciences.org
Author:

Relatively recently, researchers have become keenly interested in exploring which food compounds are beneficial in treating and preventing serious diseases such as cancer and osteoporosis.

Omer Kucuk, MD, is one of those researchers. Kucuk, a professor of hematology and medical oncology at Emory Winship Cancer Institute, studies specific food compounds and their effect on cancer prevention and treatment. Evidence indicates that some food compounds, such as soy isoflavones and curcumin, can increase the effectiveness of chemotherapy and radiation therapy.

To listen to Kucuk’s own words about which food compounds affect cancer prevention and treatment, access Emory’s new Sound Science podcast at http://whsc.emory.edu/soundscience/.

Kucuk conducted the first clinical trials to show the benefits of soy and lycopene supplements in prostate cancer treatment.

“In our preclinical studies we have observed that taking soy isoflavones during chemotherapy and radiation for advanced prostate cancer can improve the efficacy of the treatments,” says Kucuk. “The compounds sensitize the cancer cells to chemotherapy and radiation while at the same time they protect the normal tissues from side effects.”

Most nutritional compounds used for therapy or disease prevention can be taken as part of a routine diet and have little if any side effects, Kucuk says. “People can get enough lycopene by eating tomato paste and tomato sauce, which is very rich in lycopene. So, if people ate a couple of ounces of tomato paste a day as part of a regular diet, they would eat enough to get all the benefits,” he says.

Kucuk and his colleagues are currently exploring how soy isoflavones make chemotherapy and radiation more effective. “These are pleiotropic agents. That means they affect multiple pathways in cancer cells as well as other cells,” Kucuk says. “This is actually good, because a lot of the drugs that are developed target one pathway, and they’re usually very toxic. But because nontoxic nutritional compounds work with multiple pathways they have mild side effects making them very attractive for treatment.”

Kucuk recently joined Emory Winship from the Karmanos Cancer Center at Wayne State University in Detroit, where he was a professor and co-leader of the population sciences and prevention program and a member of genitourinary and head and neck cancer multidisciplinary groups.

He is on the editorial boards of publications including Cancer Detection and Prevention and Cancer Epidemiology, Biomarkers and Prevention.

###

The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research, health care and public service. Its components include schools of medicine, nursing, and public health; the Yerkes National Primate Research Center; the Emory Winship Cancer Institute; and Emory Healthcare, the largest, most comprehensive health system in Georgia. The Woodruff Health Sciences Center has a $2.3 billion budget, 17,000 employees, 2,300 full-time and 1,900 affiliated faculty, 4,300 students and trainees, and a $4.9 billion economic impact on metro Atlanta.

May, 2009|Oral Cancer News|

Zila might file Chapter 11 after cutting costs

Source: MSN Money

Zila Inc.’s worsening financial situation might force the company to file for Chapter 11 bankruptcy, despite a number of cost-saving measures, according to financial statements filed March 17.

Despite cost-reduction strategies, the company’s revenue and cash continue to decline, according to its quarterly filing with the U.S. Securities and Exchange Commission.

Scottsdale-based Zila’s cash and cash equivalents dropped to $2.5 million as of Jan. 31, compared with $3.2 million on Oct. 31 and $4.5 million on July 31.

“In order to continue as a going concern and fund our current level of operations over the next 12 months, we will require additional funds and need to restructure our senior secured convertible notes,” the company stated in its filing.

Company officials question whether Zila (Nasdaq: ZILA) has sufficient cash available to pay future quarterly interest payments due under those notes. Chapter 11 would allow the company to restructure its debts while continuing operations.

For the six months ended Jan. 31, Zila reported a net loss of $28 million on $18.2 million in revenue. That compares with a $9.6 million net loss on revenue of $21 million during the same period in 2008.

The oral cancer diagnostic company’s stock closed Wednesday at 14 cents a share, close to its 52-week low of 13 cents a share. Its 52-week high is $3.57.

Last year, Nasdaq warned Zila that its stock was in danger of being delisted if it didn’t keep its price over $1 per share for 10 consecutive business days. In a last-ditch effort to prevent delisting, Zila issued a 1-for-7 reverse stock split Sept. 17, which enabled it to regain compliance under Marketplace Rule 4450(a)(5).

Zila continues to market its ViziLite Plus, which detects oral abnormalities that could lead to cancer, to dentists nationwide and in many other countries. Most recently, ViziLite sales expanded to India.

In an effort to lower Zila’s operating loss, company officials implemented salary reductions for some management personnel and eliminated 15 percent of its field sales force. It also eliminated the employee stock purchase plan and furloughed certain manufacturing production personnel.

The company recently moved its headquarters from Phoenix to Scottsdale, signing a two-year lease that costs $26,000 monthly.

Company officials continue to seek funding from financial and strategic investors as well as with the holders of the notes.

All potential investors Zila officials have talked to required as a condition of their investment that the notes be repaid from the funds provided by the investors. Investors also wanted the repayment to be at a substantial discount from the $12 million outstanding principal to reflect the current market value of those notes, according to the filing.

However, the holders of the notes have been unwilling to agree to an amount to extinguish this debt, the filing states.

Zila didn’t make its Jan. 31 interest payment, which puts the company in default of its notes.

Zila officials could not be reached for comment.

Copyright 2009 bizjournals.com

March, 2009|Oral Cancer News|

Dental van offers seniors free care

Source: Wicked Local Marlborough.com

By Catherine Buday

MARLBOROUGH

The problem:
Health experts say that seniors, squeezed by limited budgets and declining dental coverage, often neglect their teeth. “What I’ve been hearing is that people haven’t been to the dentist in years, mainly because of the high cost of care,” said Nancy Fernandez, a nurse for Marlborough’s Council on Aging. “Many do everything else for the rest of their bodies, but the teeth are the last thing.” 

Michael Henry of the Massachusetts Dental Society sees the same problem. “Many say, ‘why should I spend $5,000 to get dental work done when I might die tomorrow?,’” he says. “They would rather leave the money to their kids. They don’t realize that it lowers their quality of life if they can’t chew properly or if their mouth gets infected.”

One solution:
Early this month, the Massachusetts Dental Society van brought free dental care to the Marlborough Senior Center. The van traditionally serves disadvantaged children and only recently expanded its services to seniors in Marlborough, Waltham and Natick. On March 6, 14 Marlborough seniors received free checkups and screenings for oral cancer and other problems from dentists John Giordano, of Worcester, and Linda Drennen, of Milford. A grant from the Marlborough-based office of Boston Scientific helped pay for the visit.
“We’re seeing things like broken fillings or crowns that they’ve had for a long time,” said Dr. Giordano. “Seniors need professional cleanings at least every six months, or there can be problems with gum bleeding and other issues.”

What’s next:
The dental van will return to Marlborough on April 10. Marlborough seniors can call Nancy Fernandez at 508-485-6492, Ext. 15 to sign up. “It’s a great way for seniors with low income to get free cleanings, oral cancer screenings and a referral to local dentists for other issues,” Fernandez said.
“Our ultimate goal,” said Henry, “is to find them a dental ‘home’ within their community, either with a dentist who takes Mass Health (the state-run program for those who can’t afford health insurance) or with a dentist who does pro-bono work for the community.” According to Henry, the Dental Society has a network of dentists who will provide care for free for some patients who can’t afford it.

March, 2009|Oral Cancer News|

Prognostic Factors for Survival After Salvage Reirradiation of Head and Neck Cancer

Source: Journal of Clinical Oncology

Writer: Tawee Tanvetyanon, Tapan Padhya, Judith McCaffrey, Weiwei Zhu, David Boulware, Ronald DeConti, and Andrea Trotti From the Head and Neck and Thoracic Programs, and the Statistic Core, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.

Purpose: Patients who develop recurrent or new primary head and neck cancer in a previously irradiated site have poor prognosis. Reirradiation is a treatment option, although it is associated with substantial toxicities. We investigated potential prognostic factors, including comorbidity and pre-existing organ dysfunction, for survival after reirradiation.

Methods: Institutional electronic records of patients treated with reirradiation between January 1998 and 2008 were reviewed. Comorbidity was assessed by Charlson index and Adult Comorbidity Evaluation-27 (ACE-27) grading. Organ dysfunction was defined as feeding tube dependency, functioningtracheostomy, or soft tissue defect.

Results: There were 103 patients, including 46 patients who underwent salvage surgery before reirradiation. Median progression-free and overall survivals were 12.1 months (95% CI, 9.7 to 16.6) and 19.3 months (95% CI, 13.9 to 29.9), respectively. Significant comorbidity was present in 36% of patients by Charlson index and 24% by ACE-27. Baseline organ dysfunction was present in 37% of patients. Median overall survivals were 5.5 months among those with both organ dysfunction and comorbidity per Charlson index, and 4.9 months per ACE-27, compared with 59.6 and 44.2 months, respectively, among the patients with neither organ dysfunction nor comorbidity (P) .001 and < .001). Other independent prognostic factors were interval from previous radiation, recurrent tumor stage, tumor bulk at reirradiation, and reirradiation dose. A nomogram to predict the probability of death within 24 months after reirradiationwas developed (concordance index = 0.75).

Conclusion:: Comorbidity and pre-existing organ dysfunction are among several important prognostic factors for patients undergoing reirradiation. For those with both comorbidity and organ dysfunction, reirradiation largely serves as a palliative therapy.

March, 2009|Oral Cancer News|

First DNA Test for Two Types of Human Papillomavirus Approved by FDA

Source: FDA News

The first DNA test that identifies the two types of human papillomavirus (HPV) causing the majority of cervical cancers among women in the United States is approved by the U.S. Food and Drug Administration.

The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient’s risk of subsequently developing cervical cancer. 

A positive Cervista 16/18 test result indicates whether HPV type 16, 18 or both types are present in the cervical sample. 

The FDA also approved yesterday the Cervista HPV HR test, which is the second DNA test that detects essentially all of the high-risk HPV types in cervical cell samples. The Cervista HPV HR test uses a method similar to the Cervista HPV 16/18 test to detect the DNA sequences of these HPV types. 

In women age 30 and older or women with borderline cytology, the Cervista HPV 16/18 test can be used together with cytology and the Cervista HPV HR test to assess risk of cervical disease. 
“Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. 

HPV is the most common sexually transmitted infection in the United States. The U.S. Centers for Disease Control and Prevention estimates that more than 6 million Americans become infected with genital HPV each year and that more than half of all sexually active women and men become infected at some time in their lives. 

For most women, the body’s own defense system clears the virus and infected women do not develop related health problems. However, some HPV types can cause cell abnormalities on the lining of the cervix that later can become malignant. While there are many different types of HPV, types 16 and 18 cause about 70 percent of all cervical cancers. 

Cervista HPV 16/18 and Cervista HPV HR are manufactured by Madison, Wis.-based Third Wave Technologies

March, 2009|Oral Cancer News|

Chewing tobacco use surges among boys

Source: Reuters

Reporter: Will Dunham

WASHINGTON (Reuters) – Use of snuff and chewing tobacco by U.S. adolescent boys, particularly in rural areas, has surged this decade, a federal agency said in a report on Thursday that raised concern among tobacco control advocates.

The use of such smokeless tobacco products increases the risk of oral cancer as well as heart disease and stroke. It leads to nicotine addiction just like cigarette smoking.

The report by the U.S. Substance Abuse and Mental Health Services Administration showed a 30 percent increase in the rate of smokeless tobacco use among boys aged 12 to 17 from 2002 to 2007. Use by adults remained stable.

In 2007, the report estimated that 566,000 boys in that age group had used chewing tobacco or snuff.

“This trend toward more smokeless tobacco use by kids is of great concern,” Danny McGoldrick, vice president for research at the Campaign for Tobacco-Free Kids advocacy group, said in a telephone interview.

“This is an industry that has a history of targeting kids because they know that’s when everybody starts,” he added.

Among adolescent boys, the rate of use of smokeless tobacco rose from 3.4 percent in 2002 to 4.4 percent in 2007, according to the report.

McGoldrick said the increase occurred as smokeless tobacco companies greatly increased their spending on marketing and introduced a new range of products.

The findings reiterated the need for the U.S. Food and Drug Administration to have the power to regulate tobacco products, as legislation being considered by U.S. lawmakers would do, McGoldrick said.

Use of smokeless tobacco products was most common in rural areas, particularly in the South and Midwest, SAMHSA statistician Jim Colliver said in a telephone interview.

The findings were based on government surveys in which about 68,000 people nationwide were questioned annually. Among health and substance use questions, they were asked whether they had used snuff or chewing tobacco in the previous month.

An estimated 7.8 million Americans overall used smokeless tobacco during 2007, according to the report. Men were about 15 times more likely to use it than women.

More than half of the adolescent smokeless tobacco users also were current cigarette smokers, and the figure jumped to two-thirds in ages 18 to 25, according to the report.

March, 2009|Oral Cancer News|

The selling of tobacco to children

              

Source: Examiner.com

Writer: Jan Potter

 Recent news articles have complained of recent marketing trends by the tobacco marketing women and girls. The cigarettes come packaged in an attractive and enticing pink package. This is not new, but every year, it appears that tobacco companies spend more and more money trying to draw in new smokers with these attractive packages. 

For years, many people were upset by candy cigarettes that were sold to children as “pretend.” These have almost disappeared in many markets, but there is a new problem though and that is the marketing of tobacco “drops” or other products that look exactly like candy. Parent may not even realize that the package contains a tobacco product because of its appearance. The marketing of this “candy” and other related products is considered very dangerous for children because of the friendly appeal of the packaging. This kind of product comes as small “candy” sized pieces, as “film” strips, or as toothpick sized sticks.

Another product that has been around for several years is the tobacco “snus” (which rhymes with goose). Snus generally contain more nicotine than a cigarette but some consider them safer because they are not inhaled. They are, however, addictive. The snus is a small packet of tobacco powder meant to be put under the tongue. It is believed that they are dangerous because of the impact of the tobacco on the body. It might not mean lung cancer, but there is the danger of cancer of the mouth, tongue, or palate.

Tobacco is the number one preventable cause of death in the world.

March, 2009|Oral Cancer News|

VELscope System Called the World’s Leading Oral Cancer Screening System

Source: LED Dental Inc

Writer: John Pohl

WHITE ROCK, British Columbia—February 27, 2009—LED Dental Inc. claimed today that its VELscope system is used for more oral cancer examinations than any other adjunctive technology in the world.

Impressive Milestones Passed

According to Dr. Ralph Green, president and CEO of LED Dental’s parent, LED Medical Diagnostics, “Since our mid-2006 launch, we have sold over 4,000 VELscope systems worldwide. Based on an independent survey of VELscope users, we estimate that these devices have been used to conduct over 4 million VELscope exams to date.” Dr. Green added, “What’s more, we estimate that over 3 million additional VELscope exams will be conducted in 2009 alone. Based on sales information reported by our leading competitor, it is clear that their product is currently being used for a much lower number of exams.”

Powerful Supporting Research

The tissue fluorescence visualization technology platform on which the VELscope system is based is the culmination of over $50 million in research funded by the National Institutes of Health and other respected institutions and conducted by such leading organizations as the British Columbia Cancer Agency and the University of Texas’s M.D. Anderson Cancer Center. Translating this highly sophisticated, breakthrough technology for use in an efficacious device to examine the oral mucosa was the brainchild of LED Dental and the British Columbia Cancer Agency. Launched in 2006 as the first tissue fluorescence device made commercially available to the dental community, the VELscope system revolutionized the dental practitioner’s ability to visualize the oral mucosal environment. A second-generation device featuring a more powerful lamp and several other advancements was introduced in 2008. The VELscope system remains the first and only device in widespread use that is cleared by the FDA and Health Canada to help dental practitioners discover tissue changes, including dysplasia and cancer, that might not be apparent to the naked eye, and to help surgeons determine the appropriate surgical margin when excising cancerous lesions.

The VELscope system’s regulatory clearances were based in part on three clinical studies conducted by researchers at the British Columbia Cancer Agency. The first, “Simple Device for the Direct Visualization of Oral Cavity Fluorescence,” was published in the Journal of Biomedical Optics in 2006. The second, “Fluorescence Visualization Detection of Field Alterations in Tumor Margins of Oral Cancer Patients,” was published in the prestigious Clinical Cancer Research journal in 2006. The third, “Direct Fluorescence Visualization of Clinically Occult High-Risk Oral Premalignant Disease Using a Simple Hand-Held Device,” was published in the equally prestigious Head & Neck journal in early 2007.

Since these original publications, the clinical research community has continued to show intense interest in clinical application of the VELscope fluorescence visualization system and its role in oral disease and oral cancer management. The British Columbia Cancer Agency has presented very exciting results on the performance of VELscope’s fluorescence visualization technology in helping detect oral cancer and pre cancer as part of a longitudinal study involving over 500 dysplasia patients. They also remain very strong proponents of the technology as a tool to help surgeons determine lesion margins and recently presented new data indicating that patients who underwent fluorescence-assisted lesion surgery have considerably fewer high risk lesions present at follow-up than a control group.

In addition, extensive clinical studies of the VELscope system are currently underway at such respected institutions as the University of Washington, the University of Chicago, Ohio State University, the Baylor College of Dentistry, Kings College in London and the University of Cologne.

Speaking about a recently completed but yet-to-be-published study at the University of Washington, Dr. Edmond Truelove, Chair of Oral Medicine at the university, disclosed to the New York Times that the VELscope system discovered 100% of the cases of moderate-to-severe dysplasia, versus only 68% for a conventional visual exam.

Outstanding Clinical Experiences Reported by Dentists

“While we are quite proud of the milestones we have achieved,” said Dr. Ralph Green, president and CEO of LED Dental’s parent, LED Medical Diagnostics, “we have just scratched the surface of the VELscope system’s potential.” Dr. Green added, “We know from user surveys that the VELscope exam is easy to administer, takes only two to three minutes, and is financially attractive for the practice. What’s more, patients find it very affordable and love the fact that no distasteful rinses or messy stains are required. Most important, clinicians are telling us that it’s helping them discover abnormal tissue that they otherwise would have missed. When you look at these simple facts, there is absolutely no reason why every dental practice should not have a VELscope system.”

Clinicians give the VELscope system high marks for the relative ease with which it can incorporated into dental practices. Said Dr. Green, “We believe that a big part of this is the fact that dentists can easily photo-document any suspect areas that need to be referred to a specialist for further observation and possible surgical biopsy.” In fact, the latest generation of the VELscope system comes with an adapter kit that makes it easy for the clinician to attach a digital camera to the VELscope hand-piece. No existing competitive products, including a new low-powered device now being introduced to the market, have this capability.

Dental Practices: The First Line of Defense

One hundred Americans develop oral cancer every day, and one American dies of the disease every hour of every day. Despite the fact that tobacco usage is declining, the rate of occurrence of oral cancer is actually increasing. This increase is widely attributed in large part to the spread of HPV-16, a strain of the sexually transmitted human papilloma virus strongly associated with oropharyngeal cancers. This has led many health experts to recommend that anyone old enough to have sex should receive an oral cancer exam at least once a year.

The need for regular exams is further supported by studies showing that the majority of oral cancers are discovered in late stages, when the five-year survival rate is 20-to-30%. When discovered in early stages, however, the survival rate leaps to 80-to-90%.

In the words of Brian Hill, founder of the widely-respected Oral Cancer Foundation, “Simply stated, early detection is the key to higher survival rates. And the only way that can possibly happen is if dental practices step up and start making opportunistic, comprehensive oral cancer exams a mandatory part of their annual and even semi-annual exams.” According to Mr. Hill, “The most essential step is a visual and tactile exam. When this exam is augmented by an adjunctive exam utilizing tissue fluorescence visualization, the opportunity for early discovery is increased. The conventional and adjunctive exams combined should take only six minutes or so, which is little to ask when you consider the potentially life-saving benefit provided to the patient.”

About LED Dental

LED Dental Inc. is a wholly-owned subsidiary of LED Medical Diagnostics Inc., which was founded in 2003 and is headquartered in White Rock, British Columbia, Canada. For more information, call +1 604 541-4614, or visit www.VELscope.com.

February, 2009|OCF In The News, Oral Cancer News|

Drink a day increases cancer risk

Source: BBC News

A glass of wine each evening is enough to increase your risk of developing cancer, women are being warned.

Consuming just one drink a day causes an extra 7,000 cancer cases – mostly breast cancer – in UK women each year, Cancer Research UK scientists say.

The risk goes up the more you drink, whether spirits, wine or beer, the data on over a million women suggests.

Overall, alcohol is to blame for about 13% of breast, liver, rectum, mouth and throat cancers, the researchers say.

They estimate that about 5,000 cases of breast cancer in the UK – 11% of the 45,000 cases diagnosed each year – can be attributed to women’s consumption of alcohol.

The study looked specifically at women who consumed low to moderate levels of alcohol – defined as three drinks a day or fewer.

Over the seven years of the study, published in the Journal of the National Cancer Institute, a quarter of the 1.3 million women reported drinking no alcohol.

Of those who did drink, virtually all consumed fewer than 21 drinks per week, and an average of 10g of alcohol per day, which is equivalent to just over one unit of alcohol found in half a pint of lager, a 125ml glass of wine or a single measure of spirits.

Nearly 70,000 of the middle-aged women developed cancer and a pattern emerged with alcohol consumption.

One too many?

Consuming one drink a day increased the risk of all types of cancer by 6% in women up to the age of 75.

The rates for individual cancers varied, with one drink a day causing a 12% rise in the risk of breast cancer, a 10% rise in rectal cancer, a 22% rise in gullet cancer, a 29% rise in mouth cancer and a 44% rise in throat cancer. On a population scale, this would mean 15 extra cases of these cancers diagnosed for every 1,000 women – comprising 11 breast, one mouth, one rectal cancer and 0.7 each for cancers of the gullet, throat and liver.

The government says no amount of alcohol is fully safe, but recommends women should drink no more than two to three units per day on a regular basis to have a lower risk of any harm to health.

For men the recommended limit is no more than three to four units per day.

Mixed messages

Lead author Dr Naomi Allen from the University of Oxford said her work would help the government assess whether the limits should be changed, although the study did not look at men.

“The findings of this report show quite strongly that even low levels of drinking that were regarded to be safe do increase cancer risk.

“About 5% of all cancers in the UK are due to drinking something in the order of one alcoholic drink a day.”

She said there was confusion about how much people should drink. Research has shown a daily tipple can be good for the heart. And factors other than alcohol pose a bigger risk for certain cancers.

“It is up to individual people to make their own decision. All of us to some extent have to weigh up the risks and take some responsibility for our health,” said Dr Allen.

A Department of Health spokesman said: “We keep our guidance on sensible drinking under review. We currently advise on a lower risk drinking limit and that drinking above this level could be harmful.

“There is no completely safe level of drinking but this lower level reflects the known risks including breast cancer, which is partly why there is a lower drinking limit for women.

“We look forward to examining this research in more detail.”

Dr Sarah Cant of Breakthrough Breast Cancer said: “We already know that drinking alcohol can increase your risk of breast cancer.

“This study suggests that for women over 50 even drinking moderate amounts of any type of alcohol can have many health consequences, including a greater chance of developing breast cancer.

“Around 80% of breast cancer cases are diagnosed in women aged over 50, so limiting how much you drink is one step you can take to try to reduce your risk of developing the disease.”

Breast cancer is now the most common cancer in the UK. Each year almost 45,000 women are diagnosed with breast cancer. A woman’s lifetime risk for breast cancer in the UK is one in nine.

February, 2009|Oral Cancer News|