human papilloma virus

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. ”The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”

According to the CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the U.S. In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.

The FDA granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck, Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

October, 2018|Oral Cancer News|

Doctors push HPV vaccine, Merck asks FDA to expand Gardasil 9 age range

Source: www.drugwatch.com
Author: Michelle Llamas, Emily Miller (editor)

Doctors, national cancer organizations and 70 nationally recognized cancer centers banded together in June to increase HPV vaccinations and improve cervical cancer screening. But they’re not the only ones pushing for more vaccinations.

HPV vaccine maker Merck requested the FDA expand the recommended age range for Gardasil 9. Gardasil 9 is currently the only HPV vaccination available in the U.S.

Nearly 80 million Americans get HPV infections each year. Of those people, about 32,500 get HPV-related cancers, according to the CDC.

Studies show the HPV vaccine is effective in protecting against the human papilloma virus. The virus can lead to several cancers. These include cervical, vaginal, vulvar, anal, penile or throat cancers.

HPV vaccination rates in the U.S. remain low. Doctors and cancer centers say low vaccination rates are a public health threat.

“HPV vaccination is cancer prevention,” Dr. Deanna Kepka, assistant professor in the University of Utah’s College of Nursing, said in a statement. “It is our best defense in stopping HPV infection in our youth and preventing HPV-related cancers in our communities.”

Right now, the vaccination rate among teens ages 13 to 17 is 60 percent. Doctors are pushing for an 80 percent HPV vaccination rate in pre-teen boys and girls.

“[Vaccination] combined with continued screening and treatment for cervical pre-cancers … could see the elimination of cervical cancer in the U.S. within 40 years,” Dr. Richard Wender, chief cancer control officer for the American Cancer Society, said in a news release. “No cancer has been eliminated yet, but we believe if these conditions are met, the elimination of cervical cancer is a very real possibility.”

Gardasil 9 requires two to three doses to be complete. Only 43 percent of teens get all required doses.

Studies show the vaccine is safe for most people. The most common side effects are headache, nausea, vomiting and fever.

But, the HPV vaccine may cause rare but serious side effects. The FDA’s Vaccine Adverse Event Reporting System has reports of autoimmune diseases, deaths and premature ovarian failure linked to the vaccine.

The National Vaccine Injury Compensation Program (VICP) has paid out millions to a few people who said the vaccine injured them. Since 2006, VICP has paid out or settled 126 HPV claims and dismissed 157.

Current campaigns urge pre-teens and teens to get the HPV vaccine. Merck wants more adults to get the vaccine, too.

At the beginning of June, the FDA accepted Merck’s application to expand the age range for Gardasil 9. The agency granted it priority review. The FDA originally approved Gardasil 9 for people ages 9 to 26. But Merck wants that age range expanded to include adults ages 27 to 45.

“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases,” Dr. Alain Luxembourg, Merck Laboratories’ director of clinical research, said in a statement.

HPV is a group of about 150 related viruses. Gardasil 9 protects against nine strains. The FDA hopes to reach a decision on the application by Oct. 2, 2018.

Be your own advocate

Source: www.wvnews.com
Author: Mary McKinley

The importance of dental care goes beyond cavities — it’s also about preventing cancer. The week of April 8 is National Oral, Head and Neck Cancer Awareness Week, and your dentist or dental hygienist may be your first line of defense against oral cancer.

More than 50,000 Americans are expected to be diagnosed with oral or oropharyngeal cancer (cancer of the back of the throat, including the base of the tongue and the tonsils) in 2018, and 350 will be diagnosed in West Virginia alone.

Routine dental exams can detect cancer or pre-cancers during the early stages. If you notice a persistent sore or pain, swelling or changes in your mouth, or red or white patches on the gums, tongue, tonsils or lining of the mouth, visit a doctor or dentist so they can examine your mouth more closely.

Some people diagnosed with oral cancer have no risk factors, so it’s important for everyone to keep those dental appointments.

If you use tobacco, drink alcohol in excess, or have the human papillomavirus (HPV), you have an increased risk for oral cancer. Oral cancer is more common in older adults, particularly men, but oropharyngeal cancer is on the rise in middle-aged, nonsmoking white men between the ages of 35 and 55. The majority of these types of cancer cases are caused by HPV.

Take charge of your health and reduce your risk of oral cancer. If you smoke or chew tobacco, quit now (it’s never too late). Moderate your alcohol consumption to no more than one drink a day for women or two for men.

If you have children, make sure they receive the HPV vaccine, which is recommended for all girls and boys ages 11 and 12; a “catch-up” vaccine is also available for young women up to age 26 and most young men up to age 21.

You can be your own best advocate. Check the inside of your mouth in the mirror each month, and speak up to your dentist or dental hygienist if you notice any changes that concern you.

Ask about cancer screenings when making your dental appointments. And to learn more about cancer prevention, be sure to visit www.preventcancer.org.

April, 2018|Oral Cancer News|

Accurately identifying aggressive head and neck cancers

Source: www.eurekalert.org
Author: press release

The Case Western Reserve-led research team will analyze computerized images of tissue samples for patterns which could become “biomarkers,” or predictors, for determining relative risk for recurrence in one particularly common type of head and neck cancers.

Those tumors, known as oropharyngeal cancers, occur primarily at the base of the tongue and in the tonsils.

Currently, however, oncologists tend to treat all of these tumors with the same aggressive level of therapy. This is the case even though many of the oropharyngeal tumors which are caused by the human papilloma virus (HPV) tend to have favorable outcome-regardless of treatment-while another subset of the tumors progress and metastasize, or spread.

“Right now, it’s a one-size-fits-all therapy for all of these patients with HPV head and neck cancers,” said Anant Madabhushi, MD, the F. Alex Nason Professor II of Biomedical Engineering, founding director of the CCIPD at the Case School of Engineering and primary investigator in the new research.

“There are currently very few validated biomarkers and approaches that are accurate enough to be able to identify which of these cancers are more aggressive or which ones are less aggressive,” he said. “That has limited the ability of clinicians to even hold clinical trials to find out if they can de-escalate therapy for some of these patients-or who needs more aggressive therapy.”

The National Cancer Institute (NCI) recently awarded a $3.15 million, five-year academic-industry partnership grant to Madabhushi and his team to pursue the research and build toward establishing those clinical trials.

Co-primary investigator on the grant is Vanderbilt University’s James Lewis Jr., MD, whose specialty is head and neck pathology, while Cleveland Clinic’s Shlomo Koyfman, MD, and David Adelstein, MD, are co-investigators with expertise in radiation and medical oncology.

Additionally, Pingfu Fu, an associate professor of population and quantitative health statistics at Case Western Reserve, brings expertise in biostatistics. Cheng Lu, a senior research associate in CCIPD is also involved with the project.

Madabhushi’s team is again working with Mark Lloyd, MD, of industry partner Inspirata Inc., the Florida-based company also teaming up with the lab on studies of breast and lung cancer-work supported by more than $6.3 million in NCI funding.

The team presented its data at the 2018 United States and Canadian Association of Pathology (USCAP) meeting in Vancouver this month and has generated data to suggest that the approach could soon become a clinically actionable tool.

Initial results on almost 400 oropharyngeal cancer patients suggests that the technology is independently prognostic of disease progression-meaning that it could stand alone in helping clinicians figure out how aggressive the disease is and then make a more informed decision on how aggressively to treat the cancer.

“In those cancers, they’ve established whether you can modulate your therapy based on the risk profile for those tumors,” Madabhushi said. “But in head and neck, clinicians might have a sense that there are different risk profiles for different patients, but nobody knows for certain. We want to change that by giving them the risk stratification tools to better help the patient.”

March, 2018|Oral Cancer News|

Biofilms in tonsil crypts may explain HPV-related head and neck cancers

Source: www.genengnews.com
Author: staff

Human papilloma virus (HPV) encased in biofilms inside tonsil crypts (pictured) may explain why the roughly 5% of HPV-infected people who develop cancer of the mouth or throat are not protected by their immune systems. Tonsil crypts with HPV are shown in green; epithelial and biofilm layers are shown in red. [Katherine Rieth. M.D.]

How can human papilloma virus (HPV) be prevalent in otherwise healthy people not known to carry it? A just-published study concludes that the virus may be lurking in small pockets on the surface of their tonsils.

Researchers from University of Rochester Medical Center (URMC) found HPV encased in biofilms inside tonsil crypts, where HPV-related head and neck cancers often originate. HPV is shed from the tonsil during an active infection and gets trapped in the biofilm, where it may be protected from immune attack.

In the crypts, the virus likely lays in wait for an opportunity to reinstate infection or invade the tonsil tissue to develop cancer.

“The virus gains access to the basal layer of stratified squamous epithelium through structural breaks in the stratified epithelial superstructure,” the investigators reported in the study. “Tonsillar crypt reticulated epithelium itself has been shown to contain numerous small blood vessels and has a discontinuous basement membrane, which may facilitate this infection and reinfection process.”

The URMC researchers said their finding could help prevent oropharyngeal cancers that form on the tonsils and tongue—and may explain why the roughly 5% of HPV-infected people who develop cancer of the mouth or throat are not protected by their immune systems.

HPV 16 and 18, high-risk strains that are known to cause cervical cancer, also cause head and neck cancers. While verified tests can detect HPV in people before they develop cervical cancer, that’s not the case with head and neck cancers, which according to a 2016 study are expected to outnumber cervical cancer cases by 2020.

“Far-Reaching Implications”
“Given the lack of universal HPV immunization and the potential for the virus to evade the immune system, even in individuals with detectable HPV in their blood, our findings could have far-reaching implications for identifying people at risk of developing HPV-related head and neck cancers and ultimately preventing them,” Matthew Miller, M.D., associate professor of otolaryngology and neurosurgery at URMC, said in a statement.

Dr. Miller and six colleagues detailed their findings in “Prevalence of High-Risk Human Papillomavirus in Tonsil Tissue in Healthy Adults and Colocalization in Biofilm of Tonsillar Crypts,” published online January 25 in JAMA Otolaryngology-Head & Neck Surgery, and announced by URMC today. The study’s corresponding author is Katherine Reith, M.D., an otolaryngology resident at URMC.

The researchers carried out a retrospective, cross-sectional study using samples obtained from tonsils archived at a university hospital following elective nononcologic tonsillectomy from 2012 to 2015. The samples consisted of formalin-fixed, paraffin-embedded samples of tumor-free tonsil tissue from 102 adults who had elective tonsillectomies and were between ages 20 and 39. More than half the patients (55, or 53.9%) were female.

Five of the samples contained HPV and four contained HPV 16 and 18. In every case, HPV was found in tonsil crypts biofilms.

HPV status was assessed by polymerase chain reaction (PCR), and high-risk subtypes 16 and 18 were assessed with quantitative PCR assay. Samples that demonstrated presence of HPV were then analyzed by in situ hybridization to localize the viral capsid protein.

These samples were then stained with concanavalin A to establish biofilm presence and morphology and with 4′,6-diamidino-2-phenylindole (DAPI) to visualize location of the virus in relation to cell nuclei. Data was assembled for aggregate analysis to colocalize HPV in the biofilm of the tonsillar crypts, the URMC researchers reported.

The research team plans to develop topical antimicrobials designed to disrupt the biofilm and allow the immune system to clear the virus—part of their investigation of potential screening tools, such as an oral rinse, to detect HPV in the mouth and throat.

February, 2018|Oral Cancer News|

7 million American men carry cancer-causing HPV virus

Source: www.nytimes.com
Author: Nicholas Bakalar

The incidence of mouth and throat cancers caused by the human papilloma virus in men has now surpassed the incidence of HPV-related cervical cancers in women, researchers report.

The study, in the Annals of Internal Medicine, found that 11 million men and 3.2 million women in the United States had oral HPV infections. Among them, 7 million men and 1.4 million women had strains that can cause cancers of the throat, tongue and other areas of the head and neck.

The risk of infection was higher for smokers, for people who have had multiple sex partners, and for men who have sex with men. Frequent oral sex also increased the risk. The rate was higher among men who also had genital HPV. (Almost half of men aged 18 to 60 have a genital HPV infection, according to the Centers for Disease Control and Prevention.)

Neither age nor income made a difference in high-risk oral infection rates, but rates among non-Hispanic blacks were higher than other races and ethnicities.

HPV vaccination is recommended starting at age 11 or 12 and is effective, said the senior author, Ashish A. Deshmukh, an assistant professor at the University of Florida, and “it’s crucial that parents vaccinate boys as well as girls.”

The lead author, Kalyani Sonawane, also at the University of Florida, said that behavioral change is important, too, particularly smoking cessation. “The difference in oral HPV infection between smokers and nonsmokers is staggering,” she said.

October, 2017|Oral Cancer News|

Trans oral robotic surgery saves public Australian hospital patients from disfiguring procedure

Source: www.smh.com.au
Author: Kate Aubusson

The cancerous tumour growing at the back of Brian Hodge’s tongue was about as hard-to-reach as cancers get. The 73-year-old was told he’d need radical, invasive surgery to remove the 50¢-sized tumour. His surgeon would make an incision almost from ear-to-ear and split his jaw in two for the 10-12 hour surgery.

After five days in intensive care, another three weeks in hospital and four to six months recovery, re-learning how to eat and talk Mr Hodge would have been left with disfiguring scars, and a voice that he may not recognise as his own.

“My kids didn’t want me to have it,” Mr Hodge said. “But I’m not one to throw in the towel … Then the unbelievable happened,” he said.

Mr Hodge became one of the first public patients to undergo robotic surgery for head, neck and throat cancer at Nepean Hospital, the state’s only hospital offering the service to patients who can’t afford private healthcare.

Mr Hodge’s surgeon, Associate Professor Ronald Chin, performed the trans oral robotic surgery (TORS) by guiding the robot’s arm into his patient’s open mouth to remove the cancerous tumour.

“I went in on Monday morning for the surgery and I was discharged Tuesday night,” Mr Hodge said of his surgery performed on June 19.

“It’s just amazing. Two days compared to six months recovering.

“What’s got me is that before it was only available to people who could pay the big money. I’ve worked all my life, I’ve paid tax and I think, why can’t we people get this surgery as well,” he said.

TORS is available for private health patients in other NSW hospitals, but its use at a major tertiary hospital in Sydney’s west – surrounded by suburbs with some of the highest smoking rates and lowest private health insurance rates in Sydney – was significant.

“It’s an enormous step forward to be able to offer this state-of-the-art treatment with such obvious benefits both cost-wise and [avoiding] disfigurement-wise … to patients who may not have previously had the resources to access it,” Dr Chin said.

The da Vinci robot Dr Chin used was the same one Nepean Hospital’s urological surgeons use to perform prostatectomies on prostate cancers. The TORS procedure takes about 45 minutes.

“Traditionally surgery is incredibly invasive. We had to make very large incisions across the neck, then lift the skin well above the lower lip and cut the jaw open,” said the otolaryngology, head and neck surgeon.

“We’re talking about a massive operation. Then reconstruction is very difficult.

“Not only did people face a horrendously long operation, they had to deal with long post-operative recovery and rehabilitation to regain speech, language, voice and the ability to eat and drink.

“With TORS, patients can go home the next day [with minimal discomfort],” he said.

More than 400,000 cases of oropharyngeal squamous cell carcinomas are diagnosed each year worldwide. The five-year survival rate for head and neck cancer in Australia is 69 per cent, according to government estimates.

Nepean Hospital would see between 10 and 15 patients with head and neck cancers per year who would be suitable for TORS, Dr Chin said. The cancerous tumours, usually linked to smoking and excessive drinking as well as the human papilloma virus, were “extraordinarily difficult to access, almost impossible”, said Dr Chin.

Robotic surgery costs significantly more than traditional surgeries. But Dr Chin said TORS could save the public health system up to $100,000 per procedure, where patients no longer needed to spend days in ICU, costing more than $3000 per night, or weeks in hospital. The robotic surgery is primarily indicated for patients with oropharyngeal carcinomas of up to four centimetres in size. Roughly one-third of TORS patients will not need chemo and radiotherapy.

“The early evidence available on trans oral robotic surgery for oropharyngeal cancer is promising,” said Dr Tina Chen, medical and scientific adviser at the Cancer Institute NSW.

“However, higher-quality research is needed to definitively say whether it means better clinical outcomes for patients, compared to other treatments already available,” she said.

There was currently no high-quality evidence from randomised controlled trials comparing TORS to chemotherapy and radiotherapy for these types of cancers, a 2016 Cochrane review concluded. It noted “data are mounting”.

Mr Hodge will soon be able to swap the pureed food he has eaten since the day after his surgery for his favourite meal, barbecue chicken, and the avid karaoke singer is already planning his first post-surgery crooning set-list. First, Engelbert Humperdinck’s Please Release Me, and the song he has been singing to his wife for decades, Anne Murray’s Could I Have This Dance.

Genetic variants are associated with susceptibility to mouth and throat cancer

Source: www.eurekalert.org
Author: news release

A number of genetic variants associated with susceptibility to oral cavity and pharyngeal cancer have been described in an international study published in the journal Nature Genetics.

The most noteworthy finding was an association between cancer of the oropharynx and certain polymorphisms (alternative versions of a given DNA sequence) found in the human leukocyte antigen (HLA) genomic region. HLAs, proteins found on the surface of most cells in the body, play an important role in recognizing potential threats and triggering the immune response to foreign substances.

According to Eloiza Helena Tajara, a professor at the São José do Rio Preto Medical School (FAMERP) in São Paulo State, Brazil, and co-author of the article, a specific group of variants in this region, located on chromosome 6, is associated with enhanced protection against oropharyngeal cancer caused by human papilloma virus (HPV).

“Previous research showed that these same variants confer protection against cancer of the uterine cervix, which is known to be associated with HPV,” Tajara said. “Our findings suggest that the genes that control the immune system play a key role in predisposition to HPV-related tumors. This discovery points to the possibility of clarifying the mechanisms whereby such tumors develop and of designing methods for monitoring risk groups.”

The study was coordinated by the International Agency for Research on Cancer (IARC) and involved 40 research groups in Europe, the United States, and South America. The Brazilian participants are members of the Head & Neck Genome Project (GENCAPO), a consortium of scientists affiliated with several institutions.

In a recent study, GENCAPO evaluated more than 7 million genetic variants in samples from 6,034 patients with head and neck cancer. The cases comprised 2,990 oral cavity tumors, 2,641 oropharyngeal tumors, 305 tumors in the hypopharynx (the bottom part of the pharynx near the esophagus), and 168 tumors in other regions or more than one region concurrently. The study population also included samples from 6,585 people without cancer as controls.

The researchers detected eight loci (genomic sites) associated with susceptibility to these types of tumor. Seven had not previously been linked to mouth or throat cancer.

According to Tajara, the IARC set out to focus on analyzing oral cavity and oropharynx tumors because there are no genome-wide association studies of these two tumor types. Although these cancers are predominantly caused by tobacco and alcohol use, the importance of HPV, particularly HPV16, as a cause of oropharyngeal cancer has become more evident in recent years.

“The throat is the most affected area among head and neck cancer subsites, likely because its tissue is more receptive to the virus,” Tajara said.

In the article, the researchers note that the proportion of HPV-related oropharyngeal cancer cases is estimated to be approximately 60% in the US and 30% in Europe but lower in South America.

“One finding that was expected to some extent was the absence of HLA associations with oropharyngeal cancer, which may be due to the fact that the frequency of HPV-positive oropharyngeal cancer is less than 10% in South America,” Tajara said. “The same factor appears to account for the weak association between the variants identified and HPV-positive oral cavity cancer, which is also far less frequent than HPV-negative oral cavity cancer.”

In her view, the strong rise in cases linked to HPV in the US could be partly due to a change in sexual habits, especially regarding the practice of oral sex. “It’s possible that Brazil is still in a transition stage and that the habits that favor infection are only starting to become more common. If so, the effects will appear in a few years’ time,” she said.

Previous studies have already shown that HPV-associated head and neck cancers affect younger people and develop rapidly. By contrast, cases associated with tobacco and alcohol use as well as poor oral hygiene are more prevalent in those over fifty years old and progress more slowly but are harder to treat.

In addition to DNA in tissue samples taken from participants of the study, data were also collected on environmental and clinical factors possibly associated with the development of this type of cancer, such as smoking, alcohol consumption, and age.

According to Tajara, thanks to the joint efforts of 40 research groups it was possible to obtain data on a significant number of patients, thus enhancing the impact and reliability of the results. The GENCAPO team contributed some 1,000 samples from tumors for analysis.

“Based on these results, we can try to understand from the molecular standpoint how the observed polymorphisms interfere with the response to HPV infection,” Tajara said. “This may give us clues as to how to protect people and how to reduce the incidence of this type of tumor.”

December, 2016|Oral Cancer News|

Predicting throat cancer recurrence with a blood test

Source: knowridge.com
Author: from University of Michigan Health System

A new study suggests the possibility of predicting at its earliest stages when a type of head and neck cancer will come back.

Oropharyngeal cancer — which occurs in the throat, tonsils and back of the tongue — is frequently linked to the human papilloma virus. That’s good news, in a way, as HPV-related cancers are generally more responsive to treatment.

But for about 15 to 20 percent of these patients, the treatment won’t work and their cancer will return. There are no known biomarkers to predict when treatments are likely to fail.

In a new study in Clinical Cancer Research, researchers found that patients whose oropharyngeal cancer recurred had higher levels of antibodies for two proteins, E6 and E7, which are found in HPV-fueled cancers. The finding suggests a potential blood-based marker that could predict when cancer is likely to return.

For this study, researchers looked back at 52 patients with advanced oropharyngeal cancer who had enrolled in a prior study: 22 who had developed recurrence and 30 who had not. The two groups were similar in age, cancer classification and smoking status. All tumors were linked to the human papilloma virus.

On average, cancer recurred 13 months after a patient’s treatment ended. Serum was measured via a blood test at diagnosis or start of treatment, then repeated after treatment ended and about every three months after.

Initially, there was no difference in E6 and E7 antibody levels between those patients who recurred and those who didn’t. All patients showed a decline in their antibody levels three months after treatment.

That makes sense, says study author Matthew E. Spector, M.D., assistant professor of otolaryngology at the University of Michigan Health System. After three months, all or most of the cancer had been wiped out. Since oropharyngeal cancer almost never recurs three months after treatment, antibody levels declined in all the patients studied.

“Most patients recur within the first two years, so the window to catch it is two years after treatment. Everyone’s level goes down over time, but some start to go up a little — and those are the ones we have to focus on,” Spector says.

Finding answers in antibodies

When the researchers looked at E6 and E7 antibody levels over time, they found that in patients whose cancer recurred, the levels of E7 were not decreasing as quickly as patients who did not recur. And they could begin to detect that prior to the point when the recurrence was discovered.

“If we can monitor someone through blood markers, then instead of a patient coming for a clinic visit every two to three months, they could get blood drawn near home. If there’s evidence of high E7, we can tell the patient to come in for more evaluation,” Spector says.

The key is to look at the ratio of E7 antibodies. Every patient had a different baseline level, and the absolute level was not an indication.

“It’s very patient-specific,” Spector says. “Each patient will have different levels, but the question is what happens when you track it over time. If it rises, that suggests recurrence.”

Oropharyngeal cancer most commonly recurs in the throat, neck or lungs. If recurrence is caught early, surgery to remove the cancer in the throat or neck can eliminate the disease and is likely to be a cure. If the cancer spreads to the lungs, offering targeted therapies earlier might improve outcomes.

The test for E6 and E7 antibodies is a standard laboratory test that any cancer treatment facility could perform, so it would likely be inexpensive to implement.

More testing among a larger number of patients is needed. The U-M team has opened a phase II trial to assess the potential for E7 antibodies as a biomarker for recurrence. For information, call the U-M Cancer AnswerLine at 800-865-1125.

December, 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.”

October, 2016|Oral Cancer News|