Pierce Brosnan demands image is removed from Indian ad after cancer link

Source: www.aol.co.uk
Author: Emily Sheridan

Actor Pierce Brosnan has demanded his image is removed from an Indian advertising campaign after the featured product was linked to cancer. The former James Bond star, 63, appeared in TV commercials and newspaper front pages endorsing Pan Bahar breath freshener. However, the product – otherwise known as pan masala – may contain ingredients which can cause mouth and throat cancers.

Cancer is an issue close to the actor’s heart after he lost his first wife Cassandra Harris and their daughter Charlotte to the disease in 1991 and 2013 respectively.

In a statement to People magazine, Brosnan said he was “deeply shocked and saddened” to learn of the association with Pan Bahar and claimed the product was presented to him as “all-natural containing neither tobacco, supari, nor any other harmful ingredient”.

Apologized profusely to his fans
He added: “As a man who has spent decades championing women’s healthcare and environmental protection, I was distressed to learn of Pan Bahar’s unauthorised and deceptive use of my image to endorse their range of pan masala products.

“I would never have entered into an agreement to promote a product in India that is dangerous to one’s health.”

Brosnan apologized profusely to his fans and Indian consumers, accusing Pan Bahar of having “grossly manipulated” his image and wrongly portraying him as a brand ambassador.

When contacted by the BBC, Ashok & Co. the company that produces Pan Bahar, was unavailable for comment. Its website is currently “under maintenance”.

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October, 2016|Oral Cancer News|

This Is Why Your Drug Prescriptions Cost So Damn Much

Source: www.motherjones.com
Author: Stuart Silverstein



When the Republican-controlled Congress approved a landmark program in 2003 to help seniors buy prescription drugs, it slapped on an unusual restriction: The federal government was barred from negotiating cheaper prices for those medicines. Instead, the job of holding down costs was outsourced to the insurance companies delivering the subsidized new coverage, known as Medicare Part D.

The ban on government price bargaining, justified by supporters on free-market grounds, has been derided by critics as a giant gift to the drug industry. Democratic lawmakers began introducing bills to free the government to use its vast purchasing power to negotiate better deals even before former President George W. Bush signed the Part D law, known as the Medicare Modernization Act.

All those measures over the last 13 years have failed, almost always without ever even getting a hearing, much less being brought up for a vote. That’s happened even though surveys have shown broad public support for the idea. For example, a Kaiser Family Foundation poll found last year that 93 percent of Democrats and 74 percent of Republicans favor letting the government negotiate Part D prescription drug prices.

“I mean, how in the world can one explain that the government actually passed a law saying that you can’t negotiate prices?”

It seems an anomaly in a democracy that an idea that is immensely popular—and calculated to save money for seniors, people with disabilities, and taxpayers—gets no traction. But critics say it’s no mystery, given the enormous financial influence of the drug industry, which rivals the insurance industry as the top-spending lobbying machine in Washington. It has funneled $1.96 billion into lobbying in the nation’s capital since the beginning of 2003 and, in just 2015 and the first half of 2016, has spent the equivalent of $468,108 per member of Congress. The industry also is a major contributor to House and Senate campaigns.

“It’s Exhibit A in how crony capitalism works,” said Rep. Peter Welch (D-Vt.), who has sponsored or co-sponsored at least six bills since 2007 to allow Part D drug price negotiations. “I mean,” he added, “how in the world can one explain that the government actually passed a law saying that you can’t negotiate prices? Well, campaign contributions and lobbying obviously had a big part in making that upside-down outcome occur.”

Wendell Potter, co-author of a book about the influence of money in politics, Nation on the Take, likened the drug industry’s defiance of public opinion to the gun lobby’s success in fending off tougher federal firearms controls and the big banks’ ability to escape stronger regulation despite their role in the Great Recession.

“They are able to pretty much call the shots,” Potter said, referring to the drug industry along with its allies in the insurance industry. “It doesn’t matter what the public will is or what public opinion polls are showing. As long as we have a system that enables industries, big corporations, to spend pretty much whatever it takes to influence the elections and public policy, we’re going to wind up with this situation.”

While Part D is only one of the issues the drug industry pushes in Washington, it is a blockbuster program. According to a report from the trustees of the Medicare system, this year Part D is expected to spend $103 billion to serve an estimated 43 million Americans.

A paper released in August by Harvard Medical School researchers cited the size of the program and its lack of government negotiating clout as among the reasons why Americans pay the highest prices in the world for prescription drugs. A co-author of that paper, Ameet Sarpatwari, estimates that Part D accounts for nearly 30 percent of the nation’s spending on prescription drugs.

What’s more, Part D often pays far more for drugs than do Medicaid or the Veterans Health Administration—which, unlike Part D, mandate government measures to hold down prices. One report found that Part D pays 80 percent more for medicines than the VHA and 73 percent more than Medicaid. While researchers aren’t unanimous in their views, an array of experts have concluded that federal negotiating power—if backed up by other cost controls—would bring Part D drug costs more in line.

The drug industry and its allies acknowledge that, at least in the short term, federal intervention in the marketplace could bring lower drug prices. Yet the industry says such a step would also kill incentives to develop new medicines.

In addition, industry officials and many analysts say substantial cost reductions will come only if the Part D program refuses to pay for drugs that it considers overpriced, possibly reducing seniors’ access to some medicines. They point to the way the VHA strengthens its negotiating leverage by rejecting some expensive medicines. Instead, the veterans’ health care system limits its purchases to a list of approved drugs known as a formulary.

“If you want to have lower prices, you’re going to have fewer medicines,” said Kirsten Axelsen, a vice president at Pfizer, a pharmaceutical giant that leads all drug companies in spending on lobbying and political campaigns at the federal level.

It took intense maneuvering by the Bush White House and GOP leaders to get Part D through Congress in November 2003, when the House and the Senate were under Republican control. The measure came up for a vote in the House at 3 a.m. on the Saturday before Thanksgiving, as lawmakers were trying to finish business before the holiday. But when the bill appeared headed to a narrow defeat after the normal 15 minutes allowed for voting, Republican leaders kept the vote open for an extraordinary stretch of nearly three hours, described in a 2004 scholarly paper as by far the longest known roll-call vote in the history of the House.

With the help of pre-dawn phone calls from Bush and a custom-defying visit to the House floor by Tommy Thompson, then secretary of health and human services, enough members were coaxed to switch their votes to pass the bill, 220-215, shortly before 6 a.m.

Part D was conceived at a time when rapidly rising US drug costs were alarming seniors, prompting some to head to Canada and Mexico to buy medicines at dramatically lower prices. With the 2004 presidential election campaign coming up, Republican leaders saw “an opportunity to steal a long-standing issue from the Democrats,” said Thomas R. Oliver, a health policy expert at the University of Wisconsin-Madison and the lead author of the 2004 paper about the adoption of Part D.

Last year the drug industry retained 894 lobbyists to influence the 535 members of Congress, staffers, and regulators.

A key aim of Part D proponents, Oliver said, was to cover seniors “in a Republican, pro-market kind of way.” That meant including “as much private sector involvement as possible,” which led to insurance companies managing the program. At the same time, it excluded federal price controls, which were anathema to the drug industry.

Today, the program remains subject to the pervasive influence of the drug industry. An analysis by FairWarning, based on spending data provided by the Center for Responsive Politics, a nonprofit and nonpartisan research group, has found:

— There are far more lobbyists in Washington working for drug manufacturers and wholesalers than there are members of Congress. Last year the industry retained 894 lobbyists to influence the 535 members of Congress, along with staffers and regulators. From 2007 through 2009, there were more than two drug industry lobbyists for every member of Congress.

— For each of the last 13 years, more than 60 percent of the industry’s drug lobbyists have been “revolvers”—that is, lobbyists who previously served in Congress or who worked as congressional aides or in other government jobs. That raises suspicions that lawmakers and regulators will go easy on the industry to avoid jeopardizing their chances of landing lucrative lobbying work after they leave office.

Probably the most notorious example was the Louisiana Republican Billy Tauzin. He helped shape the Part D legislation while serving as chairman of the House Energy and Commerce Committee. In January 2005, just days after he retired from the House, he became the drug industry’s top lobbyist as president of a powerful trade group, the Pharmaceutical Research and Manufacturers of America, or PhRMA. He remained in that job—which reportedly paid him $2 million a year—until 2010.

“It was pretty blatant but an accurate reflection of the way pharma plays the game, through campaign contributions and, in Billy’s case, way more than that,” said US Rep. Jan Schakowsky, an Illinois Democrat who has been a leading proponent of government price negotiations.

— Since January 2003, drug manufacturers and wholesalers have given $147.5 million in federal political contributions to presidential and congressional candidates, party committees, leadership PACs and other political advocacy groups. Of the total, 62 percent has gone to Republican or conservative causes.

Over the period, four Republican lawmakers from the 2015-16 Congress received more than $1 million in contributions from drug companies. (One of them, former House Speaker John Boehner, R-Ohio, resigned last October.) In all, 518 members of the current Congress—every member of the Senate and more than 95 percent of the House—have received drug industry money since 2003.

Pfizer said that since the beginning of 2003 through the middle of this year it has spent, at the federal level, $145.9 million on lobbying as well as $12.2 million on political contributions through its PACs. In a written statement, the company said, “Our political contributions are led by two guiding principles—preserve and further the incentives for innovation, and protect and expand access for the patients we serve.”

— The big money goes to top congressional leaders as well as chairs and other members of key committees and subcommittees.

The House Energy and Commerce Health Subcommittee, repeatedly a graveyard for Part D price negotiation bills, underscores the pattern. The 16 Republican members have received an average of $340,219 since the beginning of 2003.

The drug industry “knows that you really only need, in many cases, just a small number of influential members to do their bidding. That’s why you see contributions flowing to committee chairs, regardless of who is in power. They flow to Democrats as well as Republicans,” Potter said.

Proponents of negotiations say some economic and political currents may turn the tide in their favor. The main factor: After years of relatively modest price rises for prescription drugs, cost increases have begun to escalate. That’s partly because of expensive new treatments for illnesses such as hepatitis C.

According to Medicare officials, Part D payments are expected to rise 6 percent annually over the coming decade per enrollee, up from only 2.5 percent annually over the last nine years. Already, cost increases are “putting wicked pressure on our hospitals, on our seniors, and on our state governments,” Welch said.

At the same time, both major presidential candidates, Hillary Clinton and Donald Trump, have called for Medicare drug price negotiation. So have doctor groups such as the American College of Physicians and an alliance of more than 100 oncologists, many nationally known, who last year garnered headlines with their plea for Medicare negotiations and other measures to fight skyrocketing costs for cancer drugs.

PhRMA, the trade group, wouldn’t comment for this story on lobbying or campaign spending. In a written statement, however, PhRMA spokeswoman Allyson Funk said, “There is significant price negotiation that already occurs within the Medicare prescription drug program.” Pointing to the private companies that run the program, Funk added, “Large, powerful purchasers negotiate discounts and rebates directly with manufacturers, saving money for both beneficiaries and taxpayers.”

Funk also pointed to skeptical assessments by the Congressional Budget Office about the potential additional savings from federal negotiations. Repeatedly—including in letters in 2004 and 2007—the CBO has said government officials likely could extract only modest savings, at best. The office’s reasoning is that costs already would be held down by bargaining pressure from insurance firms and by drug manufacturers’ fear of bad publicity if they are viewed as jacking up prices too high.

But many analysts, particularly amid recent controversies over skyrocketing costs for essential drugs and EpiPen injection devices, scoff at those CBO conclusions. They fault the CBO for not taking into account other price controls, such as those used by Medicaid and the VHA, that likely would be coupled with price negotiation.

“You would want Medicare to have the option to say, ‘Okay, this is our price, and you’re going to take it. And if you don’t take it, we’re not buying it.'”

What CBO officials “seem to be assuming is that Congress would change the law in a really foolish way,” said Dean Baker, a liberal think tank economist who has studied the Part D program. “It seems to me that if you got Congress to change the law, you would want Medicare to have the option to say, ‘Okay, this is our price, and you’re going to take it. And if you don’t take it, we’re not buying it.”

In fact, related bills proposed during the current Congress by two Illinois Democrats—Schakowsky and Richard J. Durbin, the Senate minority whip—go beyond requiring drug price negotiations. They both provide for federal officials to adopt “strategies similar to those used by other Federal purchasers of prescription drugs, and other strategies…to reduce the purchase cost of covered part D drugs.”

The potential to reduce prices is underscored by a 2015 paper by Carleton University of Ottawa, Canada, and the US advocacy group Public Citizen. It found that Medicare Part D on average pays 73 percent more than Medicaid and 80 percent more than the VHA for the same brand-name drugs. The VHA’s success in holding down costs helped inspire a measure on California’s November ballot, Proposition 61, that would restrict most state-run health programs from paying any more for prescription drugs than the veterans agency does.

Two studies by the inspector general of health and human services that compared drug expenditures under the Part D and Medicaid programs also concluded that Part D pays far more for the same medicines. The more recent inspector general study, released in April 2015, examined spending and rebates on 200 brand-name drugs. It found that, after taking rebates into account, Medicaid, which provides health care for low-income families with children, paid less than half of what Part D did for 110 of the drugs. Part D, on the other hand, paid less than Medicaid for only 5 of 200 drugs.

Those findings provide evidence that “the current reliance on private insurers that negotiate drug prices isn’t working that well,” said Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities, a Washington think tank.

Five Democrats who are leading opponents of the status quo—US Representatives Welch, Schakowsky, and Elijah E. Cummings of Maryland, along with Sens. Durbin and Amy Klobuchar of Minnesota—each have introduced price negotiation bills (HR 3061, HR 3261, HR 3513, S 31 and S 1884) during the current, 114th Congress. All the measures have stalled in committee.

Schakowsky, a House Democratic chief deputy whip, said under Republican control in her chamber, “I think it is virtually impossible for this to ever go to hearings and markups.”

Take, for example, the bill that Welch introduced in the House on July 14, 2015. Within a week, it was referred to two health subcommittees, where it has sat ever since.

The closest Welch ever came to success was in 2007. He was among 198 co-sponsors—all but one, Democrats—of a bill introduced by then-US Rep. John D. Dingell of Michigan. It was approved by the House but then blocked by Republicans from being taken up in the Senate.

“There’s a lot of industry opposition…It doesn’t mean, however, that industry is all-powerful.”

 Lawmakers on committees where Part D bills ordinarily go—the Finance Committee in the Senate, and the Energy and Commerce Committee as well as the Ways and Means Committee in the House—tend to be well funded by the drug industry.

For instance, Sen. Richard Burr (R-N.C.), who sits on the Finance Committee, has received more money from the industry since 2003 than anyone else currently in Congress, $1.3 million. Close behind is Senate Finance Chairman Orrin Hatch, (R-Utah), who has gotten $1.18 million. (The other members of the million-dollar club are Rep. Fred Upton (R-Mich.), House Energy and Commerce chairman, at $1 million, and former House Speaker Boehner, at $1.21 million.)

Burr also is the Senate leader so far in the 2015-16 political cycle, collecting $229,710 from the drug industry. In the House in the current cycle, John Shimkus (R-Ill.), a member of the Energy and Commerce health subcommittee, has snagged $189,000, trailing only Republican Majority Leader Kevin McCarthy ($292,550) and House Speaker Paul Ryan ($273,195). A Burr spokeswoman declined to comment. Hatch and Shimkus did not respond to repeated requests for comment.

Amid the EpiPen controversy and growing concerns about prescription drug prices, Park sees signs that more lawmakers are willing to buck industry opposition to government price negotiation. “There’s a lot of industry opposition. This would affect their bottom line,” Park said. “It doesn’t mean, however, that industry is all-powerful.”

But Baker, co-director of the Center for Economic and Policy Research in Washington, was skeptical about the prospects for reform. “I think it’s pretty clear what you’re seeing is, there’s an industry group that stands to lose a lot of money, and they’re basically using all of the political power they can to make sure that it doesn’t happen.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

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October, 2016|Oral Cancer News|

Pre-Teens need just two doses of HPV vaccine, not three: Feds

Source: www.nbcnews.com/health
Author: Maggie Fox

There’s good news for kids who haven’t received all their HPV vaccines yet – they only need two doses of the vaccine instead of three, federal government advisers said Wednesday. The new recommendations should make it easier to get more children vaccinated against the human papillomavirus (HPV), which causes a range of cancers including cervical cancer, throat cancer and mouth cancer, officials said.

“It’s not often you get a recommendation simplifying vaccine schedules,” said Dr. Nancy Messonnier, Director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention.

The CDC immediately accepted the recommendations from its Advisory Committee on Immunization Practices.

“Safe, effective, and long-lasting protection against HPV cancers with two visits instead of three means more Americans will be protected from cancer,” said CDC Director Dr. Tom Frieden. “This recommendation will make it simpler for parents to get their children protected in time.”

The CDC says every pre-teen boy and girl should get the vaccine, but fewer than a third have received all three doses.

Messonnier says the three-dose schedule was based on the earliest studies of the vaccine. New studies show that two doses protect people for decades from the cancer-causing virus. And studies also suggest that spacing the two doses a year apart is at least as effective, if not more effective than giving them more closely together – something that could also make it easier to get kids fully vaccinated.

Older teens who have not been vaccinated at all before age 15 should still get three doses, because there’s not enough evidence to show whether two doses fully protect them, ACIP said.

Adults can also get the HPV vaccine. “Young women can get HPV vaccine through age 26, and young men can get vaccinated through age 21,” the CDC says.

“The vaccine is also recommended for any man who has sex with men through age 26, and for men with compromised immune systems (including HIV) through age 26, if they did not get HPV vaccine when they were younger.”

HPV is extremely common, but rates of HPV-related disease have fallen among vaccinated people.

“About 14 million people, including teens, become infected with HPV each year. HPV infection can cause cervical,vaginal, and vulvar cancers in women; penile cancer in men; and anal cancer, cancer of the back of the throat (oropharynx), and genital warts in both men and women,” the CDC says.

The original two vaccines on the market protected against either two or four of the strains of HPV known to cause cancer. Now the only vaccine available in the U.S. is Merck’s Gardasil 9, which protect against 9 strains of HPV.

Messonnier says it’s too soon to say whether teens vaccinated with the older vaccines should get a top-up dose with the new formulation.

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October, 2016|Oral Cancer News|

Mouth, throat cancers caused by HPV on the rise, especially among Canadian men

Source: www.ctvnews.ca
Author: Sonja Puzic, CTVNews.ca Staff

Mouth and throat cancers caused by the human papilloma virus have been rising steadily over the past two decades, with a “dramatic” increase among Canadian men, according to a new report from the Canadian Cancer Society.

The special report on HPV-associated cancers, released Wednesday as part of the 2016 Canadian Cancer Statistics breakdown, says the rate of mouth and throat cancers in men is poised to surpass the rate of cervical cancer diagnoses in women.

Researchers and doctors have known for decades that certain strains of HPV – the most commonly sexually transmitted disease in Canada and the world — cause cervical cancer. But the latest Canadian cancer statistics show that only 35 per cent of HPV cancers are cervical, and that about 33 per cent of HPV cancers occur in males.

The latest data show that about one-third of all HPV cancers in Canada are found in the mouth and throat.

Between 1992 and 2012, the incidence of HPV-related mouth and throat cancers increased 56 per cent in males and 17 per cent in females. In 1992, the age-standardized incidence rate (or ASIR) of those cancers was 4.1 per 100,000 Canadian males. In 2012, it was 6.4 per 100,000 males. In females, the rate was 1.2 in 1992 and 1.4 in 2012.

‘I thought I was done’
Three years ago, Dan Antoniuk noticed a lump on his neck and initially thought that it was just a swollen gland. But when the Edmonton father went to see a doctor, he was diagnosed with Stage 4 throat cancer, caused by HPV.

“I was devastated. I thought I was done,” Antoniuk, 61, told CTV News. “It shattered me, it shattered my family and affected everybody sitting in the waiting room.”

Antoniuk said that until his diagnosis, he had never heard of HPV cancers in men. His doctors told him that, despite the late stage of his cancer, his prognosis was still good with the right treatment. He underwent surgery, radiation and chemotherapy and although the treatments took a toll on his body, he’s now doing well.

“The end result is I am here, I am healthy and I can do most of the same things I have done before,” he said. “The ultimate message is: Be aware of your body and be aware of the fact that this could be something more serious and there is hope now.”

Dr. Hadi Seikaly, a professor and oncology surgeon at the University of Alberta, said doctors are seeing more HPV-related cancers in both men and women.

“The surprising thing is that we’re just seeing the front end of the epidemic,” he told CTV News. “And it is an epidemic … cervical cancer rates are coming down and head, neck cancer rates are going up.”

Doctors say that oropharyngeal cancers (which include the back of the throat, the base of the tongue and the tonsils) and cancers of the mouth used to be mostly found in older patients who smoked, drank heavily or had other health issues. But it’s now more common to see HPV-related throat and mouth cancers in younger, otherwise healthy patients.

“HPV is without question driving the dramatic increase we are seeing in oropharyngeal squamous cell carcinoma (OPSCC),” Dr. Joseph Dort, the chief of otolaryngology head and neck surgery at the Foothills Medical Centre in Calgary, told CTV News.

“Our most recent data shows that about 70 per cent of our new cases of this cancer are HPV positive. Recent studies suggest that oropharyngeal cancer will become the most common HPV-associated malignancy by the year 2020, surpassing cancer of the cervix,” he said in an email.

The changing face of the disease
Jennifer Cicci was shocked to learn that she had oral cancer caused by HPV after a lump appeared on the side of her neck in the fall of 2013.

The dental hygienist and mother of four from Brampton, Ont., said she was an otherwise healthy woman in her 40s who didn’t have any of the typical risk factors associated with head and neck cancers.

Cicci’s surgeon removed a baseball-sized mass of tissue from the back of her throat and a section from the back of her tongue. She also underwent laser surgery and radiation, with painful side effects. Still, she feels she “got off easy,” despite the entire ordeal.

In some cases, mouth and neck cancer treatments can have devastating effects on a patient’s ability to speak and eat. Some patients have had parts of their tongues and even their voice boxes removed.

The good news, doctors say, is that HPV-related cancers seem to be more treatable. More than 80 per cent of patients will survive if the cancer is caught in time.

“I felt like having this gave me an opportunity to raise awareness of something that I felt was becoming an epidemic,” Cicci said.

Dr. Brian O’Sullivan, a head and neck cancer specialist at Princess Margaret Hospital in Toronto, said that HPV infections in the throat and mouth are largely linked to sexual contact, but he has also seen patients who have had very few sexual partners and little experience with oral sex.

Calls for more widespread HPV immunization
The Canadian Cancer Society estimates that nearly 4,400 Canadians will be diagnosed with an HPV-caused cancer (that can include cervical, vaginal, anal and oral) and about 1,200 will die from it in 2016.

The society is focusing its messaging on cancer prevention and informing the public about the HPV vaccine. The two HPV vaccines approved by Health Canada are Gardasil and Cervarix.

HPV immunization is already available through publicly-funded school programs across the country, starting between Grades 4 and 7, up to age 13. But while the vaccine is offered to girls in all provinces and territories, only six provinces — Alberta, Manitoba, Nova Scotia, Ontario, Prince Edward Island and Quebec – also offer it to boys.

The Canadian Cancer Society is calling on the remaining provinces and territories to expand HPV immunization to boys.

Robert Nuttall, the society’s assistant director of health policy, also said that adults should talk to their doctors to see whether they can benefit from the HPV vaccine. However, there is currently no scientific evidence showing the benefits of HPV vaccines in older adults.

In Canada, Gardasil is approved for use in females aged 9 to 45, and males aged 9 to 26. Cervarix is approved for use in females between the ages of 10 and 25, but is currently not approved for boys and young men.

The vaccine works best in people who have not been exposed to HPV. That’s why it is given to school-aged children and teens as a preventative measure.

It will be a while before scientists can conclusively determine whether HPV vaccines can prevent throat and neck cancers, since it can take many years for an HPV infection to cause malignancies.

In the meantime, Dr. Seikaly says it’s important for Canadians to understand this disease could happen to anybody, because the modes of HPV transmission aren’t fully understood.

“They need to understand the signs and symptoms of it. And those include pain in your throat, difficulty swallowing, neck masses, ulcers in your mouth and throat,” he said. “And they need to make sure during their physical that doctors do look in their mouth and their throat.”

Early symptoms of mouth and throat cancers can often be vague, but they also include white or red patches inside the mouth or on the lips, persistent earaches and loose teeth.

As a dental hygienist who was also a cancer patient, Cicci urges regular exams of the mouth and throat during dental visits.

“What I try to do is to break down the stigma that is attached to (HPV),” she said. “The fact of the matter is, while most of the time it is still being sexually transmitted … we don’t know all the modes of transmission.”

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October, 2016|Oral Cancer News|

Oral cancer in the crosshairs at San Antonio Dental School

Source: tpr.org
Author: Wendy Rigby

San Antonio researchers are working on a new therapy for a stealthy killer: oral cancer. Visits to the dentist are your number one protection against the disease. In a lab at the University of Texas Health Science Center at San Antonio, dental researcher Cara Gonzales, DDS, Ph.D., shared promising news on a new approach to healing.

“It was very exciting,” Gonzales said. “These patients have not had any new therapeutic options in 40 years.”

The discovery of a new gene that’s turned on in oral cancers gave Gonzales and her colleagues a new target at which to aim. It’s a gene that’s also found in lung cancers.

So-called nude mice are used in the oral cancer experiments. Webdt Rigby / Texas Public Radio

So-called nude mice are used in the oral cancer experiments.
Wendy Rigby / Texas Public Radio

Gonzales works in a sprawling space filled with lab equipment and cell lines used in many molecular biology projects. One of her research assistants brought in a cage of lab animals with some strange lumps on their backs.

“These are called nude mice because they don’t have a complete immune system,” Gonzales explained.

These mice are at the center of a successful experiment. First, scientists used human oral cancer cells to grow large tumors on the animals. They tried one oral cancer drug already on the market. Not much action. Then, they tried a lung cancer drug, also already approved by the Food and Drug Administration. Not that effective on its own. Finally, they used a combination of two drugs. What happened made the medical profession take notice.

“When we combined the two, then we saw a 50 percent reduction in the tumor volumes after 14 days,” Gonzales described.

That kind of success could help thousands of patients whose cancers aren’t caught until the later stage, patients like Paige Lewis of San Antonio who was only 35 when she got the results of a biopsy from her doctor.

“I walked in and she said the words I’ll never forget,” Lewis recalled. “‘Sweetie, it’s cancer.’”

Lewis had tried for a year to get various doctors and her dentist to examine and biopsy the strange spot under her tongue. But no one really thought she was at risk for the disease.

“I was told it’s most likely nothing because I’m young. I was only 35 years old. I was a female non-smoker, non-drinker,” Lewis said.

While smoking, drinking and age are big risk factors for oral cancer, so is the presence of the human papillomavirus in the body. Some cases, like Lewis’, are simply unexplained.

Since her cancer was so advanced, Lewis, a single mother of three children, faced a massive surgery and weeks of radiation. Paige still bears scars on her arm from a major surgery where doctors removed her tumor and rebuilt her tongue.

“They removed half of my tongue,” she described. “They harvested part of my arm in order to place a flap in my mouth. And then a part of my leg to cover part of my arm.”

Lewis spent 20 days in the intensive care unit. If her cancer had been detected earlier, or if doctors had the ability to shrink her tumor, her ordeal would have been less painful and less risky. Only slightly more than half of all oral cancer patients are alive five years after their treatment. Lewis is four years out.

U.T. Health Science Center researchers are trying to secure funding for human trials which may take place in San Antonio. The pills used in this new combination target tumors specifically, so patients would not suffer as many side effects as they do with conventional chemotherapy, side effects like hair loss and gastrointestinal issues.

Dr. Cara Gonzales’ oral cancer paper was published in the journal Oral Oncology.
“If we can find something that would treat these advanced tumors, we could potentially increase the survival rate of approximately 25 percent of all oral cancer patients,” Gonzales stated.

Lewis is coping well with the side effects of surgery and radiation, but it hasn’t been easy. “Cancer takes over your life during that period of time. And it affects every single person you know,” Lewis said. “All of this could have been avoided with an early diagnosis.”

An oral cancer screening at the dentist only takes two minutes, and checking for oral cancer should be part of a regular dental screening. Like Lewis and thousands of others, though, you may have to insist the hygienist or dentist examine your mouth, tongue and gums in detail. Having a medical professional look for signs and symptoms of the disease is still the best defense against oral cancer which claims an average of one American life every hour.

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October, 2016|Oral Cancer News|

Merck KGaA, Pfizer and Transgene team up on cancer vaccine

Source: www.biopharmadive.com
Author: Joe Cantlupe

Dive Brief:

  • Transgene announced Tuesday it is teaming up with Merck KGaA of Darmstadt, Germany, and Pfizer to evaluate the possibilities of the combination of its human papillomavirus (HPV)-positive head and neck cancer vaccine TG40001 with big pharma’s avalumab in a Phase 1/2 study.
  • The incidence of HPV-related head and neck cancers has increased significantly, with one variation, HPV-16 accounting for 90% of all HPV-related head and neck cancers. HPV-16 is a subset of head and neck squamous cell carcinoma (HNSCC), a group of cancers that can affect the mouth and throat. Global spending on head and neck cancer indications amounted to $1 billion in 2010, according to the companies’ recent estimates.
  • Current treatments for the disease include surgical resection with radiotherapy or chemo-radiotherapy; the companies say they are exploring better options for advanced and metastatic HPV and HNSCC.

Dive Insight:
The current deal between the big pharma partners and Transgene highlights the industry’s efforts to create combination therapies to treat cancer. Virtually every company in the space has embraced the idea that using multiple modes of attack could be the only way to eventually find cures for the many forms of cancer; companies have been teaming up in hopes of finding that crucial pairing.

In previous clinical trials, TG4001 has demonstrated promising activity in terms of HPV viral clearance and was well tolerated, according to Transgene. TG4001 is one of the few drugs targeting HPV-associated cancers that can be combined with an immune checkpoint inhibitor such as avelumab.

TG4001 is an active immunotherapeutic designed by Transgene to express the coding sequences of the E6 and E7 tumor associate antigens of HPV-16, and the cytokine, L IL-2. Avelumab is an investigational fully human antibody specific for a protein found on tumor cells called PD-L1. It is considered to have a mechanism that may enable an immune system to locate an attack cancer cells. In 2014, Merck KGaA and Pfizer signed a strategic alliance to co-develop and commercialize avelumab.

“The preclinical and clinical data that have been generated with both TG4001 and avelumab individually suggest this combination could potentially demonstrate a synergistic effect, delivering a step up in therapy for HPV- positive HNSCC patients,” said Philippe Archinard, chairman and CEO of Transgene, in a statement.

Christophe Le Tourneau, the principal investigator of the study, said HPV-induced head and neck cancers are now treated with the same regimen as non-HPV-positive HNSCC tumors, and that is not enough. “Their different etiology clearly suggests that differentiated treatment approaches are needed for HPV-positive patients,” he said in a statement. “Targeting two distinct steps in the immune response could deliver improved efficacy for patients who have not responded to or have progressed after a first line of treatment,” added Le Tourneau, who is also head of the Early Phase Program at Institut Curie.

This trial is expected to begin in France, with the first patients expected to be recruited in the beginning of 2017, said Le Tourneau. The companies will seek to recruit patients with recurrent and/or metastatic virus-positive oropharyngeal squamous cell carcinoma that have progressed after definitive local treatment or chemotherapy, and cannot be treated with surgical resection and/or re-irradiation.

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October, 2016|Oral Cancer News|

Recognizing oral carcinoma

Source: nurse-practitioners-and-physician-assistants.advanceweb.com
Author: Amber Crossley, MSN, ARNP, FNP-BC

Oral carcinoma is identified as one of the top ten cancers worldwide, accounting for nearly 2% to 5% of all cancer cases.1, 2 In 2014, there were an estimated 42,440 new cases of oral and pharyngeal carcinoma.

Males have a greater risk of developing the disease compared to females.2 Black males in particular are amongst the highest at-risk group for developing oral carcinoma.2 Oral carcinoma typically develops after the age of 50, with the majority of cases occurring between the ages of 60 and 70.2 When initially diagnosed with oral carcinoma, more than 50% of people will have metastases.3

The most common causes of oral carcinoma are related to tobacco use and alcohol consumption.4 In fact, 75% of all cases of oral carcinoma may be caused by the combination of tobacco and alcohol use.4


However, it has also been extrapolated that chronic trauma to the oral mucosa, such as in the case of ill-fitting dentures or the consumption of high-temperature foods, is a leading modifiable risk factor for oral carcinoma.1,5 Dietary deficiencies of vitamins A, C, E, selenium, and folates may also contribute to the development of malignant cancerous lesions in the oral cavity.6

While cases of oral carcinoma have decreased over the last few years in the United States, oropharyngeal cancer is increasing in incidence.4 The rise in cases of oropharyngeal cancer may be related to viral and infectious diseases; however, the mechanisms are largely unclear. Some of these infections and viruses include human papilloma virus (HPV), periodontitis, candida albicans, syphilis and herpes simplex virus.7 However, for the purposes of this case presentation, only oral cavity cancer will be discussed.

A Non-Healing Oral Lesion
MC is an 82-year-old white female who visited her primary care provider’s office complaining of a mouth sore. The sore was present for approximately six months, and grew increasingly painful.

She has worn dentures for more than 10 years, and was accustomed to the typical soreness with irritation sometimes associated with everyday denture use. With this particular occurrence, the soreness lingered in the same area and lasted longer than any previous experience.

MC attempted to alleviate the soreness with an existing prescription for hydrocodone. This treatment proved unsuccessful. MC scheduled an appointment with her primary care provider, as she assumed the pain was the result of ill-fitting dentures.

At MC’s initial appointment, the provider noticed a 7mm erythematous lesion on the lower interior aspect of her right molar, and suggested it could be the result of her ill-fitting dentures. Because MC had exhausted her hydrocodone, the provider prescribed tramadol and a viscous lidocaine suspension for pain. She was told to follow-up with her dentist once the sore completely healed in order to be fitted with new dentures. She was instructed to refrain from denture use until the sore had resolved. There were no further follow-up instructions given.

One week after the initial visit, MC returned to the primary care provider’s office because of increasing pain and discomfort. During this visit, the provider noted the sore had ulcerated edges that were friable and showed little improvement. She was referred immediately to an otolaryngologist for the suspicion of carcinoma of the oral cavity.

Patient History
MC is an 82-year-old widow. She is a Medicare recipient living in government-subsidized housing for the elderly. MC smoked tobacco between the ages of 17 and 52 at a rate of 1.5 packs per day, or 53 pack years. During the same 35 year time frame, she drank 1 to 2 alcoholic beverages daily.

Over the past 10 years, she lost a total of 40 pounds without any lifestyle modifications to justify the weight loss. At the time of MC’s initial primary care visit, she weighed 91 pounds. Additional patient history included hypothyroidism, mitral stenosis, gastroesophageal reflux disease, coronary artery disease, arthritis and hypertension.

Clinical Features
Oral carcinoma is defined as cancer involving the floor of the mouth, hard palate, buccal mucosa, interior tongue, retromolar trigone, or alveolar ridge.8 Premalignant oral carcinoma may present as a painless white patch known as leukoplakia, or a painful reddened patch identified as erythroplakia.9 In addition to the aforementioned signs, the cervical lymph nodes may be enlarged.10 Any erythroplakia or leukoplakia lesions that appear to be non-healing in an older individual should be deemed suspicious.10

Differential Diagnosis

Refer to the table below to help you rule out other conditions.


Early identification of oral carcinoma offers patients the greatest chance for successful treatment and survival following diagnosis.5

An initial patient history that includes tobacco use, alcohol consumption, sexual practices, denture use, oral trauma, infections of the oral cavity and a history of present illness should be obtained.8 It is important to understand that patients complaining of ill-fitting dentures are four times more likely to develop an oral lesion that is cancerous.5

Oral lesions caused by trauma increase the likelihood of carcinogen absorption from tobacco and alcohol in the oral mucosa. This absorption may disrupt the deoxyribonucleic acid of the mucosal cells.1

Following a thorough history, the provider can perform a complete head and neck examination. During oral cavity inspection, a mirror and fiberoptic exam should also be performed.8 A combination of inspection and palpation for lumps or abnormalities within the tissue of the oral mucosa is the definitive mechanism used to screen for oral cancer as identified by the U.S. Preventive Services Task Force.4 In the presence of a potentially cancerous oral lesion, a surgical biopsy should be completed to confirm a diagnosis of oral carcinoma.9

Imaging studies can be used to detect and identify metastases of oral carcinoma. Computed tomography is the preferred imaging study performed at the site of the primary tumor.11 This study can identify the extent of the tumor, as well as lymph node involvement.10,12 Additionally, a chest x-ray is recommended in order to determine whether or not the oral carcinoma originated in the lungs or metastasized to the lungs. The lungs are the primary site for metastases of oral carcinoma.12 More than 90% of oral cavity cancers are considered to be squamous cell carcinoma.11

Laboratory studies should also be considered in addition to imaging studies. Serum ferritin, alpha anti-trypsin, and alpha-antiglycoprotein levels can be elevated in patients with advanced cancer of the head or neck region.12 Laboratory studies alone cannot determine the presence of oral carcinoma. However, they can aide in identifying the extent and progression of the cancer.12

Case Outcome
A surgical biopsy was performed in order to identify the causative organism. MC was diagnosed with stage IV malignant squamous cell carcinoma of the right retromolar trigone, as well as squamous cell carcinoma of the right middle and lower lobe of the lung. The patient had no lymph node involvement.

Because of her increased age and nutritional status, MC did not qualify for multimodal treatment. Instead, she is being treated with aggressive radiation therapy over a period of 12 weeks.

Understanding key factors related to MC’s case — increased age, history of tobacco and alcohol use, and ill-fitting dentures — is paramount when identifying the painful, non-healing, 7 mm lesion in her oral cavity as a potential diagnosis of oral carcinoma.

Implications for Practice
Due to the increase in oral health disparities, the Institute of Medicine released a report revealing a new demand for non-dental health care providers to perform screenings for oral diseases as well as offering prevention advice and referral to preventative services.13

Increasing interprofessional collaboration amongst dentists, nurse practitioners, physician assistants, physicians and medical students has shown to be effective in implementing the head, ears, eyes, nose, oral cavity, and throat (HEENOT) assessment into practice.14 While this is similar to the head, ears, eyes, nose and throat assessment, it allows for the integration of the oral cavity into the evaluation of the head and neck exam.

One study, conducted between 2008 and 2014 at New York University, revealed that the result of HEENOT implementation led to 500 patient referrals to dental clinics for suspicious oral lesions.14 Preventative measures at the primary care level should focus on the greatest risk factors (tobacco use, alcohol consumption and ill-fitting dentures).

Research has shown that due to the sometimes vague and misleading symptoms of early-onset oral carcinoma, a diagnosis may be prolonged by up to 6 months.12 Although screening for oral cancer in healthy individuals without risk factors may not be beneficial, evidence supports oral screenings by primary care providers for high-risk patients.3, 4, 15

Given the fact that only 30% of patients ages 65 years and older have dental insurance coverage, the primary care provider must screen patients who present with many risk factors for oral carcinoma.14,16 Because there are a greater number of primary care providers in comparison to dentists, they have the potential to increase awareness and detection of oral carcinoma.16

While the leading cause for oral carcinoma is tobacco use, it is recommended that the primary care provider encourage patients who use tobacco to employ smoking cessation products.4 Second, the primary care provider should educate patients on the harmful effects of daily alcohol use.12 Third, providers should stress to patients the importance of regular dental check-ups and denture fittings as an essential tool for maintaining good oral health.5

Amber Crossley practices as an advanced registered nurse practitioner in Jacksonville, Florida.

1. Piemonte ED, et al. Relationship between chronic trauma or the oral mucosa, oral potentially malignant disorders and oral cancer. J Oral Pathol Med. 2010;39(7):513-517.

2. National Cancer Institute. Stat fact sheets: oral cavity and pharynx cancer. http://seer.cancer.gov/statfacts/html/oralcav.html.

3. Rethman MP, et al. Evidence-based clinical recommendations regarding screening for oral squamous cell carcinoma. JADA. 2010;141(5):509-520.

4. U.S. Preventative Services Task Force. Oral cancer: screening. http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/oral-cancer-screening1

5. Manoharan S, et al. Ill-fitting dentures and oral cancer: a meta-analysis. Oral Oncol. 2014;50(11):1058-1061.

6. Freedman ND, et al. Fruit and vegetable intake and head and neck cancer risk in a large United States prospective cohort study. Int J Cancer. 2008;122(1):2330-2336.

7. Meurman JH. Infectious and dietary risk factors of oral cancer. Oral Oncol. 2010;46(6):411-413.

8. National Comprehensive Cancer Network. Head and neck cancers. http://oralcancerfoundation.org/treatment/pdf/head-and-neck.pdf

9. Jefferson GD. Adult with oral cavity lesion. AAO-HNSF Patient Month Program. 2011;40(5): 1-25.

10. Arya S, et al. Head and neck symposium: imaging in oral cancers. Indian J Radiol Imaging. 2012.22(3):195-208.

11. Akram S, et al. Emerging patterns in clinico-pathological spectrum of oral cancers. Pak J Med Sci. 2013;29(3):783-787.

12. Scully C. Cancers of the oral mucosa. Medscape. 2016. http://emedicine.medscape.com/article/1075729-overview

13. Institute of Medicine. Improving access to oral health care for vulnerable and underserved populations. https://www.iom.edu/Reports/2011/Improving-Access-to-Oral-Health-Care-for-Vulnerable-and-Underserved-Populations/Report-Brief.aspx.

14. Haber JH, et al. Putting the mouth back in the head: HEENT to HEENOT. Am J Public Health. 2015;105(3):437-441.

15. American Family Physician. Screening for the early detection and prevention of oral cancer. http://www.aafp.org/afp/2011/0501/p1047.html

16. Cohon LA. Expanding the physician’s role in addressing the oral health of adults. Am J Public Health. 2013;103(3);408-412.

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October, 2016|Oral Cancer News|

Immunotherapy drug a ‘gamechanger’ for head and neck cancer

Source: www.theguardian.com
Author: staff

An immunotherapy drug hailed as a potential gamechanger in the treatment of cancer could soon offer new hope to patients with currently untreatable forms of the disease.

Nivolumab outperformed chemotherapy significantly in keeping relapsed head and neck cancer patients alive. Photograph: Alamy

Nivolumab outperformed chemotherapy significantly in keeping relapsed head and neck cancer patients alive. Photograph: Alamy

Nivolumab was found to extend the lives of relapsed patients diagnosed with head and neck cancers who had run out of therapy options. After a year of treatment, 36% of trial patients treated with the drug were still alive compared with 17% of those given standard chemotherapy.

Trial participants treated with nivolumab typically survived for 7.5 months, and some for longer. Middle-range survival for patients on chemotherapy was 5.1 months. The phase-three study, the last stage in the testing process before a new treatment is licensed, provided the first evidence of a drug improving survival in this group of patients.

Prof Kevin Harrington, from the Institute of Cancer Research, London, who led the British arm of the international trial, said: “Nivolumab could be a real gamechanger for patients with advanced head and neck cancer. This trial found that it can greatly extend life among a group of patients who have no existing treatment options, without worsening quality of life.

“Once it has relapsed or spread, head and neck cancer is extremely difficult to treat. So it’s great news that these results indicate we now have a new treatment that can significantly extend life, and I’m keen to see it enter the clinic as soon as possible.”

Before it can be offered on the NHS, the treatment will have to be approved by the European Medicines Agency and the National Institute for Health and Care Excellence (Nice), which vets new therapies in England and Wales for cost-effectiveness.

Of the 361 patients enrolled in the trial, 240 were given nivolumab while the remaining 121 received one of three different chemotherapies. UK patients were assigned the chemotherapy drug docetaxel, the only treatment currently approved for advanced head and neck cancer by Nice.

Patients whose tumours tested positive for the HPV virus, which is linked to cervical cancer and may be spread by oral sex, did especially well. They typically survived for 9.1 months, compared with 4.4 months when treated with chemotherapy. More than half of patients relapse within three to five years.

Nivolumab is one of a new class of antibody drugs called checkpoint inhibitors that help the immune system fight cancer. It works by blocking signals from tumour cells that stop the immune system attacking.

The drug is already licensed for the treatment of advanced melanoma skin cancer and non-small-cell lung cancer in the UK. However while Nice has backed its use on the NHS for melanoma it has so far refused to recommend making the drug freely available to lung cancer patients.

Prof Paul Workman, chief executive of the Institute of Cancer Research, said: “Nivolumab is one of a new wave of immunotherapies that are beginning to have an impact across cancer treatment. This phase-three clinical trial expands the repertoire of nivolumab even further, showing that it is the first treatment to have significant benefits in relapsed head and neck cancer.

“We hope regulators can work with the manufacturer to avoid delays in getting this drug to patients who have no effective treatment options left to them.”

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October, 2016|Oral Cancer News|

Why Pierce Brosnan is causing a ‘spit storm’ in India

Source: www.bbc.com
Author: staff


Former Bond star Pierce Brosnan has left Indians both shaken and stirred after his appearance in an advertisement endorsing a product that many associate with a highly addictive and dangerous form of chewing tobacco, writes the BBC’s Ayeshea Perera.

The advertisement is a mixture of suave Bond “cool” mixed with the kind of superhuman action one generally associates with south Indian films, where heroes are known to take out entire gangs by just looking at them.

Armed with nothing but a bottle of Pan Bahar mouth freshener, Brosnan proceeds to take down an entire cartel, pausing once every so often to kiss the jar in his hand. The 60-second advertisement is nothing short of a mini film. It features hired thugs, a party, a woman who is actually a spy, and of course a face to face encounter with a dastardly villain.

But the reaction in India has been anything but positive.

Many have associated Pan Bahar with pan masala and gutka, a potent mixture of tobacco, crushed betel nut, lime, and clove among other ingredients. It is chewed (and subsequently expectorated in bright red streams) by millions of people, who get addicted to its mildly psychotropic effects.

Both pan masala and gutka have often been described as the scourge of the South Asian subcontinent, as it has been linked to serious illness like mouth cancer and tumours.

Many Indian states have, in fact, banned the open sale of the products and have run a series of campaigns designed to discourage people from buying them. And although the product Brosnan is endorsing is neither a pan masala or gutka, the reactions have ranged from anger to disappointment.

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October, 2016|Oral Cancer News|

Particular HPV strain linked to improved prognosis for throat cancer

Source: medicalxpress.com
Author: provided by University of North Carolina Health Care

When it comes to cancer-causing viruses like human papillomavirus, or HPV, researchers are continuing to find that infection with one strain may be better than another.

In an analysis of survival data for patients with a particular type of head and neck cancer, researchers from the University of North Carolina Lineberger Comprehensive Cancer Center confirmed findings that a particular strain of HPV, a virus linked to a number of cancers, resulted in better overall survival for patients with oropharyngeal cancer than patients with other strains of the virus in their tumors.

They believe their findings, reported in the journal Oral Oncology, are particularly important as physicians move to lessen treatment intensity for patients with HPV-linked oropharyngeal cancer in clinical trials to try to spare them negative side effects of radiation or drugs. They also found that a test used widely to determine patients’ HPV status may not be sensitive enough to select patients for de-intensification.

“What we demonstrate in this study is that the type of HPV can help us to better determine a patient’s prognosis,” said the study’s senior author Jose P. Zevallos, MD, MPH, an associate member of UNC Lineberger and an associate professor in the UNC School of Medicine. “We think this is important because HPV positive patients do so well generally, and there’s been a huge move nationally to take treatment down a couple notches to limit morbidity and side effects. The risk is that if you de-intensify too much, and you happen to have a high-risk tumor because you have a different type of HPV, then this could be harmful to patients who don’t warrant it.”

The UNC study was based on an analysis of survival data for 238 patients in North Carolina diagnosed between January 2002 and February 2006 with oropharyngeal cancer, a type of head and neck cancer in the throat at the back of the mouth, as part of the Carolina Head and Neck Cancer Study, or CHANCE. The Centers for Disease Control and Prevention estimates that more than 15,600 cases of HPV-associated oropharyngeal cancer are diagnosed in the United States each year.

Previous studies have shown that patients with HPV-linked oropharyngeal cancer have higher survival and lower recurrence rates compared to those with HPV-negative oropharyngeal cancer. As those patients tend to respond better to treatment, researchers are studying whether patients with HPV-linked oropharyngeal cancer can receive less intensive treatment with good outcomes. The researchers point out, however, that there has been limited research that tracks outcomes for oropharyngeal cancer based on the particular strain of HPV that patients have.

Zevallos and his colleagues confirmed earlier findings that patients with oropharyngeal cancer tumors infected with HPV16 had improved overall survival. They also determined that patients whose cancer was infected with other HPV strains had similar survival rates as patients whose cancer did not have HPV at all.

They found that 71.4 percent of patients with HPV16-linked oropharyngeal cancer lived at least five years. Meanwhile, the five-year survival-rates for patients with other strains of the virus in their tumors, and for patients who were HPV-negative, were lower: 57 percent for patients with other types of HPV and 50 percent for HPV-negative patients.

Zevallos said the finding of a lower survival rate for patients positive for HPV strains other than HPV16 is important in that it indicates that those patients may not be good candidates for treatment de-intensification.

“The finding that non-HPV16 types are closer to the HPV-negative group in terms of survival differences suggests that those patients should definitely not be considered for anything other than standard aggressive therapy,” he said.

The researchers noted that additional research needs to be done in a larger sample size to rule out the possibility that characteristics other than HPV status are driving survival differences, and to clarify whether the patients found to have other HPV strains were not false-positives.

The also cautioned that based on their findings, a commonly used clinical test that measures for the presence of the p16 protein may not be specific enough to identify HPV-linked oropharyngeal cancer patients who are good candidates for treatment de-intensification. To determine whether patients had HPV-positive tumors, they compared the results of the p16 test with results of a more specific genetic test.

They found that 4.3 percent of the patients were positive for p16, but negative for HPV according to the genetic test. Another approximately 11 percent of p16-positive cases had HPV strains other than HPV16, according to the genetic tests. Zevallos said this is an important finding because patients whose cancer was not infected with HPV16 had a lower 5-year survival rate, meaning they would not be good candidates for treatment de-escalation.

Yet the researchers report that many of the clinical trials that de-intensify treatment use p16 expression alone to determine if a patient’s cancer is HPV-positive, and whether they should be considered for treatment de-intensification.

“Even though we rely almost exclusively around the country on p16 positivity as a surrogate for HPV16 presence, this sheds some light on the fact that maybe we should be considering HPV genotyping because of the survival differences we saw here,” Zevallos said.

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September, 2016|Oral Cancer News|