Monthly Archives: June 2019

HPV vaccine benefits ‘exceed expectations,’ may lead to elimination of cervical cancer

Source: NBC News
Date: June 27, 2019
Author: Katie Sullivan

A new study suggests that the benefits of the vaccine extend to people who aren’t vaccinated — meaning the more people who are vaccinated, the better.

The HPV vaccine is far more effective than expected, with benefits extending beyond those who receive the vaccine, a study published Wednesday finds.

The new study, published in The Lancet, suggests that the more people who receive the vaccine, the better. That’s because vaccination not only reduces rates of HPV infection and the presence of precancerous cells in the cervix in people who receive the vaccine, it also reduces rates of HPV-related diseases in people who were not vaccinated.

The findings come as a U.S. federal advisory panel recommended Wednesday that the HPV vaccine be given to both men and women up to age 26.

HPV, or human papillomavirus, is the leading cause of cervical cancer. The virus can also cause other cancers, including cancers of the penis, head and neck, as well as conditions like genital warts.

The HPV vaccine was first introduced in 2006. Since then, more than 115 countries and territories have implemented it in their vaccination programs. The World Health Organization recommends that girls ages 9 to 13 receive two doses of the vaccine.

“The impact of the HPV vaccination has actually exceeded expectations,” said Lauri Markowitz, associate director of science for HPV at the Centers for Disease Control and Prevention, who worked on the study. “The trials showed that HPV vaccines are very effective, and data from the real world has confirmed that.”

Indeed, the reductions in HPV infections and precancerous cells “are a first sign that vaccination could eventually lead to the elimination of cervical cancer as a public health problem,” the study’s lead author, Mélanie Drolet, an epidemiologist at Laval University in Canada, said in a statement.

The Lancet study expanded upon a 2015 meta-analysis that had looked at the real-world effects of the vaccine. The new analysis was updated to include a total of 65 studies, which spanned eight years and included more than 60 million people living in 14 countries. Each study measured either changes in the number of new HPV infections, genital warts diagnoses or cases of abnormal cells associated with cervical cancer in countries before and after they adopted routine HPV vaccination in girls. (Two countries included in the analysis, the U.S. and Australia, also recommend the vaccine for boys.)

The impact of the HPV vaccination has actually exceeded expectations.

The researchers found that, in these countries, there was a significant decrease in the prevalence of two strains of HPV that cause 70 percent of cervical cancers, HPV 16 and 18. (There are more than 100 strains of HPV, 14 of which are known to cause cancer. The HPV vaccine protects against up to 9 strains.) In addition, there was a decrease in the prevalence of precancerous cells in the cervix, which can develop into cancer.

What’s more, in countries where at least half the population that was targeted for vaccination had actually received the vaccine, researchers saw evidence of herd immunity, meaning there was a decrease in the prevalence of HPV-related diseases even among those who weren’t vaccinated. This is because vaccination leads to fewer HPV hosts.

These countries also saw a decrease in genital warts diagnoses among unvaccinated boys and older women. And among girls within the age groups targeted for vaccination, there were fewer diagnoses of three HPV strains that the vaccine does not specifically protect against, a phenomenon called cross-protection. Countries in which people in multiple age groups received the vaccine also saw a greater decrease in HPV-related disease.

“This paper shows that with a broader age range that’s targeted, you’ll find greater impact in your vaccination program,” Markowitz told NBC News.

Lagging vaccination rates

Despite the widespread benefits of the vaccine, however, HPV vaccination rates in the U.S. are still lagging behind those of other adolescent immunizations. The U.S. was the first country to implement HPV vaccination for both genders, but the CDC has found that many parents and health care providers don’t yet see a need to vaccinate boys. Parents have also expressed concerns about the vaccine and its costs, the CDC found.

According to Debbie Saslow, managing director of HPV and gynecological cancers at the American Cancer Society, the lagging rates are not entirely because parents are against vaccinating their kids; rather, the way some doctors are presenting the vaccine also plays a role.

Two required vaccinations, for tetanus and meningitis, are administered at the same time as HPV, around age 12. Saslow said HPV is usually presented as an optional third vaccine at that time, and one that patients can delay another year.

“Providers often think they’re recommending all three vaccines, but they’re actually making the third, the HPV vaccine, optional,” Saslow told NBC News. “They’re just suggesting it or doctors are setting it apart from the other two in some way.”

The fact that HPV is a sexually transmitted infection could also be a hard concept for parents to come to terms with. Saslow said beliefs about sex may be a factor that deters parents from opting to have their children vaccinated against HPV.

“Despite all that, vaccination rates are continuing to grow,” she said.

Indeed, the number of adolescents in the U.S. who received at least one dose of the HPV vaccine has increased by 5 percent each year since 2013. The CDC recommendseveryone receive the first dose by age 12. Though adults up to age 45 can still be vaccinated, the vaccine may be less effective. And while the WHO does recommend that girls 9 to 13 get vaccinated against HPV, it does not yet recommend that all genders receive the vaccination. That could change in response to study results that continue to show the vaccine has substantial impact on public health.

Cancer prevention

That impact on public health is cancer prevention. Ultimately, that’s the “main goal of the HPV vaccination program,” Markowitz said. “We’re seeing an impact on one of the HPV outcomes that is close to a cancer outcome.” (Because cervical cancer can take decades to develop, it’s not yet possible to study the effects of the vaccine on cervical cancer rates, Drolet noted in the statement.)

In particular, the study found the HPV vaccine led to a reduction in the rates of abnormal pap smear findings. Pap smears are used to detect abnormal cells in the cervix that can sometimes develop into cancer. Five to nine years after a population was vaccinated against HPV, the researchers found a more than 50 percent reduction in cases of these pre-cancerous cells in girls 15 to 19. In vaccinated women 20 to 24, there were one-third fewer cases of these cells.

A separate study, published in April in The BMJ, found a 90 percent reduction in cases of pre-cancerous cells in young women in Scotland within the first decade of introducing the HPV vaccine.

But vaccination is only one piece of cervical cancer prevention; screening is also necessary.

Whether or not a person has received the HPV vaccine, getting cervical cells regularly tested — through Pap tests and HPV screening — is still a crucial to reducing cases of cervical cancer and early detection, said Diane Harper, senior associate director of the Michigan Institute for Clinical and Health Research. Rates of invasive cervical cancer dropped significantly in the U.S. when cancer screening was introduced in the 1940s, and there were less than half the number of cases in 2007 that there were in 1973, largely due to screening.

“Vaccination and screening together make a program,” Harper told NBC News. “Very few HPV cases progress into cancer, but the only way we’re going to find those that do is through the screening program.”

June, 2019|Oral Cancer News|

British Association of Oral and Maxillofacial Surgeons praise HPV vaccination study

Source: www.nationalhealthexecutive.com
Author: staff

The British Association of Oral and Maxillofacial Surgeons (BAOMS) has welcomed new study findings from the two-year Cancer Research study in Scotland that the HPV vaccination for boys may substantially reduce head and neck cancer. BAOMS had been involved in successfully lobbying for the extension to the HPV to boys last year in England and Northern Ireland.

Life-threatening HPV-related cancers can develop during middle age, but boys had been excluded from the national HPV vaccination programme. Currently the cost of treating HPV-driven mouth and throat cancer to the NHS is approximately £30m a year.

Since the UK-wide immunisation scheme for girls aged 12 and 13 was introduced in 2008, data shows a reduction of up to 90% of pre-cancerous cells in the smear tests among women aged 20.

BAOMS Chair, Patrick Magennis, said: “Between 2010 and 2012 nearly 2,000 men had HPV-related head and neck cancer.

Over half of these oropharyngeal cancers are caused by HPV, and in the last decade alone the incidence of these cancers has doubled in the UK population.

“Current evidence suggests that vaccination of boys in their teenage years will prevent them from developing HPV-related cancers in middle age, so the introduction of male vaccination is timely.”

He welcomed the publication of the new study, which found that, over two years, in the 235 male patients in Scotland with head and neck cancer, HPV was present in 60% of cases. The findings follow an earlier report, which suggested routine vaccination of schoolgirls in Scotland with HPV had led to a dramatic reduction in cervical disease in later life.

Oral and maxillofacial cancer surgeons’ specialist skills include removing mouth, jaw and tongue cancer and replacing the missing parts with flesh and bone borrowed from the leg, hip or arm. They say that effective and timely cancer treatment for HPV-positive oropharyngeal cancer has excellent survival results. But patients frequently have serious and debilitating life-long side-effects from treatment that have a profound impact on the quality of life of the cancer survivors.

How dental professionals can help patients with xerostomia

Source: www.dentistryiq.com
Author: Jennifer Pettit, CRDH

Xerostomia affects up to 65% of the population, according to the American Academy of Oral Medicine.1 Many patients might experience dry mouth and accept it as a part of their life without seeking treatment or mentioning it to a health-care professional. It is important to recognize the signs of xerostomia to help reduce patients’ symptoms and prevent the consequences it carries.

Xerostomia is the reduction of salivary flow. The majority of saliva is produced by the parotid gland, followed by the lingual and submandibular glands. Saliva plays multiple roles in the oral cavity. It carries enzymes to help us digest food. It moistens food to create a bolus for easy passage through the esophagus. It also carries buffering agents to neutralize the pH of the oral environment, which can help prevent demineralization of tooth structure and caries lesions. It protects the oral mucosa and tongue from irritants such as bacteria and fungus. Lastly, it cleanses the teeth of small food particles.1

Hyposalivation is associated with many factors. According to the American Dental Association, more than 400 medications cause dry mouth as a side effect.2 The most well-known prescriptions to cause dry mouth are antipsychotics, anticonvulsants, bronchodilators, and certain hypertension medications.2 Other factors contributing to low saliva flow are aging, smoking, radiation therapy to the neck and head, and some diseases and conditions such as HIV/AIDS, diabetes, rheumatoid arthritis, thyroid dysfunctions, and Sjögren’s syndrome, just to mention a few.2

Oral manifestations of xerostomia include dry or chapped lips, mouth sores, fissured tongue and mucosa, salivary threads while talking, enamel erosion, and rampant caries. Symptoms described by patients are a burning or tingling sensation of the mucosa and tongue, difficulty swallowing dry foods, bad breath, altered taste buds, thirst, and cotton mouth.3

Once you have reviewed a patient’s medical history and medication list, there are many products you can recommend. To start off, a wide variety of over-the-counter medications can treat the symptoms of xerostomia. The most popular brands are Biotene (GSK), Act, Colgate, and TheraBreath, and they are available as mouthwashes, lozenges, xylitol mints and gums, gels, and sprays. Most over-the-counter products help to stimulate salivary flow or are used as a saliva substitute. These are typically used as needed throughout the day.

Prescription saliva substitutes, such as Caphosol (Eusa Pharma), NeutraSal (OraPharma), and SalivaMax (Forward Science), are available as well. The FDA has approved two systemic medications that need to be prescribed by a medical professional.2 One of them is pilocarpine, known by its brand name Salagen, which is a tablet to treat oral dryness associated with radiation therapy. The second is cevimeline, also known by its brand name Evoxac, a pill used to treat oral dryness associated with Sjögren’s syndrome. The newest prescription spray available on the market is 3M Xerostomia Relief Spray, which is the only lipid-based solution that coats the mucosa, throat, and tongue to prevent water loss and restore elasticity. All medications, both over-the-counter and prescription, should be taken with caution, as they may have their own side effects and contraindications.

Patients should be encouraged to receive an in-office application of 5% fluoride varnish. Home care should include a prescription-strength fluoride toothpaste, such as Colgate Prevident 5000 or 3M Clinpro 5000. GC America also offers two at-home treatments: GC Dry Mouth Gel to lessen symptoms and MI Paste to be applied as a topical tooth cream after brushing and flossing. MI Paste contains calcium, phosphate, and fluoride to remineralize teeth. A formula without fluoride is also available. Other recommendations you can make include using lip balm, sipping on water or licking ice cubes, and avoiding tobacco, alcohol, and salty or spicy foods.3

Dental professionals should keep an eye out for dry mouth signs as a preventive measure and guide patients through the many options available to reduce their symptoms. Over-the-counter medications might not be a cookie-cutter solution for everyone, and some trial and error might be necessary for patients to find the best product to treat their symptoms without causing any additional side effects.

References

1. Sankar V, Rhodus N; AAOM Web Writing Group. Xerostomia. American Academy of Oral Medicine website. https://www.aaom.com/index.php%3Foption=com_content&view=article&id=107:xerostomia&catid=22:patient-condition-information&Itemid=120. Updated October 15, 2015.

2.Center for Scientific Information; American Dental Association Science Institute. Xerostomia (Dry Mouth). American Dental Association website. https://www.ada.org/en/member-center/oral-health-topics/xerostomia. Updated August 27, 2018.

3Sankar V, Rhodus N; AAOM Web Writing Group. Dry Mouth. American Academy of Oral Medicine website. https://www.aaom.com/dry-mouth. Updated October 15, 2015.

Author:
Jennifer Pettit, CRDH, is a full-time dental hygienist at HQ Dontics, a prosthodontics office in Miami, Florida. She graduated from Miami Dade College in 2010 and has always had a passion for dental health. She takes pride in educating patients to prevent disease and finding the best solutions to suit their needs.

Meet the New York couple donating millions to the anti-vax movement

Source: The Washington Post
Date: June 19th, 2019
Authors: Lana H. Sun & Amy Brittain

A wealthy Manhattan couple has emerged as significant financiers of the anti-vaccine movement, contributing more than $3 million in recent years to groups that stoke fears about immunizations online and at live events — including two forums this year at the epicenter of measles outbreaks in New York’s ultra-Orthodox Jewish community.

Hedge fund manager and philanthropist Bernard Selz and his wife, Lisa, have long donated to organizations focused on the arts, culture, education and the environment. But seven years ago, their private foundation embraced a very different cause: groups that question the safety and effectiveness of vaccines.

How the Selzes came to support anti-vaccine ideas is unknown, but their financial impact has been enormous. Their money has gone to a handful of determined individuals who have played an outsize role in spreading doubt and misinformation about vaccines and the diseases they prevent. The groups’ false claims linking vaccines to autism and other ailments, while downplaying the risks of measles, have led growing numbers of parents to shun the shots. As a result, health officials have said, the potentially deadly disease has surged to at least 1,044 cases this year, the highest number in nearly three decades.

The Selz Foundation provides roughly three-fourths of the funding for the Informed Consent Action Network, a three-year-old charity that describes its mission as promoting drug and vaccine safety and parental choice in vaccine decisions.

Lisa Selz serves as the group’s president, but its public face and chief executive is Del Bigtree, a former daytime television show producer who draws big crowds to public events. Bigtree has no medical credentials but holds himself out as an expert on vaccine safety and promotes the idea that government officials have colluded with the pharmaceutical industry to cover up grievous harms from the drugs. In recent weeks, Bigtree has headlined forums in ultra-Orthodox Jewish communities in Brooklyn and Rockland County, N.Y., both areas confronting large measles outbreaks.

“They should be allowed to have the measles if they want the measles,” Bigtree told reporters outside the Brooklyn meeting on June 4. “It’s crazy that there’s this level of intensity around a trivial childhood illness.”

Thanks largely to the Selzes’ donations, ICAN is now the best-funded among a trio of organizations that have amplified concerns about vaccines. ICAN brought in $1.4 million in revenue in 2017, with just over $1 million supplied by the Selz Foundation, according to tax filings.

The Selzes and the groups they support are hardly the only purveyors of anti-vaccine ideas. Environmental attorney Robert F. Kennedy Jr., a nephew of the late president, runs the Children’s Health Defense, a charity that promotes a similar agenda; it brought in $727,000 in 2017, according to tax filings. Barbara Loe Fisher, who says her son was injured by vaccines, runs a Virginia-based nonprofit that fights legislative efforts to tighten vaccine requirements. Her group, the National Vaccine Information Center, brings in about $1 million a year, according to its 2018 tax documents.

Though they are separately organized, the three groups reinforce one another’s efforts. Kennedy and Bigtree often appear together at public events, while ICAN’s website includes a link to Fisher’s group. Bigtree’s weekly live stream broadcast, which ICAN promotes, frequently features Kennedy.

New York City Health Commissioner Oxiris Barbot, who has battled the nation’s single worst measles outbreak since October, said she never heard of the Selzes. “But I do know the science and the science is clear — the MMR vaccine prevents measles,” she said, using the common acronym for the vaccine that prevents measles, mumps and rubella. “Any suggestion to the contrary is a threat to the health and well-being of New Yorkers.”

The Selzes did not respond to emails or phone messages. A woman who answered the telephone at the couple’s home on Manhattan’s Upper East Side declined to identify herself. “There’s nothing to say,” she said before hanging up.

Bernard Selz, 79, has more than 40 years experience in the securities industry and runs Selz Capital, a hedge fund that holds a portfolio valued at more than $500 million, according to recent filings from the Securities and Exchange Commission.

Lisa Pagliaro Selz, 68, worked for Manufacturers Hanover Trust and Tiffany and Co. Since 1993, she has helped manage the Selz Foundation “with a focus on humanitarian, educational, geriatric, homeopathic, animal causes and the arts,” according to a news release issued by LaGuardia Community College Foundation, where she was a board memberfrom 2011 to 2016.

The Selzes’ sons — both young adults — declined to comment. Friends and family members reached by The Washington Post said they were unable to shed light on the Selzes’ philanthropic choices.

“This is a topic we don’t discuss,” said Marilyn Skony Stamm, a business executive and close friend of Lisa Selz. “We have differing opinions.” Stamm declined to elaborate, except to say that she values her friendship with the Selzes, whom she called “an incredibly philanthropic family.”

Support for a key figure

Tax filings for the couple’s charitable foundation show they began supporting the movement in 2012, when they gave $200,000 to a legal fund for Andrew Wakefield, one of the most important figures in the anti-vaccine movement.

Wakefield, a former gastroenterologist, rose to fame in 1998 after publishing a paper in the Lancet, a respected British medical journal, that linked the MMR vaccine to autism in eight children. An investigation by Britain’s General Medical Council, which regulates doctors, found Wakefield guilty of professional misconduct in 2010 and revoked his license. The panel concluded that Wakefield had financial and ethical conflicts of interest, and had acted “dishonestly and irresponsibly.” Twelve years after the study’s publication, the Lancet retracted it.

Wakefield declined to comment for this report. He has repeatedly denied wrongdoing and said he was motivated by children’s suffering.

“You have probably heard in the newspapers and elsewhere that I am guilty of scientific fraud,” Wakefield said via Skype to a forum this spring in Rockland, N.Y. “And I want to reassure you that I have never been involved in scientific fraud. What happened to me is what happens to doctors who threaten the bottom line of the pharmaceutical companies.”

By 2012, Wakefield had moved to Austin, where supporters began raising money for the Dr. Wakefield Justice Fund, an effort to sue the journalists who had questioned Wakefield’s findings. The fund was “established by friends and supporters . . . to respond to false claims made against Dr. Wakefield; expose the corrupting influence of special interest groups behind these allegations and protect Dr. Wakefield’s work from both profit- and politically-motivated censorship and retribution,” an archived version of the fund’s website says.

Wakefield’s lawsuit was unsuccessful, but the Selz Foundation found other ways to support his work. After he launched two nonprofits in 2014, the Selz Foundation donated $1.6 million to the groups over the next several years, according to tax records. One, the AMC Foundation, was registered as a public charity to fund documentaries about public health issues. The other was a Texas nonprofit corporation.

Wakefield used the money to help fund a documentary film called “Vaxxed,” which details his allegations about a government coverup of vaccine dangers. After filming, he and other producers traveled the country in a black “Vaxxed” bus that stopped at churches, libraries and chiropractors’ offices to record interviews with parents who believe their children had been injured by vaccines.

“Virtually every dollar in this film to date has been donated by a handful of brave parents and philanthropists,” the “Vaxxed” website says. In the credits, the film lists the Selz Foundation first among 16 donors who financed the production.

The film also introduced a new face to the anti-vax movement: Bigtree. Once a television producer of “The Doctors,” a daytime talk show filmed in Hollywood, Bigtree signed on to co-produce the film, which was released in 2016.

Tara Smith, an infectious disease expert at Kent State University who hasresearchedthe anti-vaccine movement, called the film “an effective piece of propaganda” that uses “heart-wrenching stories of children supposedly harmed by vaccination.”

For example, one mother featured in the filmsaid her son developed autism after he was inadvertently given a double dose of the MMR vaccine. Filmmakers provided no medical documentation to support the claim, and the mother has said publiclythat her son’s medical records were stolen from her apartment.

The stories in the film “frequently fall apart when scrutinized,” Smith said.

Bigtree said the film’s critics are “spreading misinformation” unless they “have proof that the exact stories of vaccine injury by the parents that appear in ‘Vaxxed’ are false.”

Since the publication of Wakefield’s Lancet paper, 21 studies have investigated vaccines and autism. None has found evidence of a link. The latest and largest study published this spring involved 657,461 Danish childrenborn between 1999 and 2010. Experts note the first symptoms of autism often appear when children are about 12 months old — the same age they receive their first MMR shot — leading many parents to blame vaccines.

Last year, Wakefield dissolved the two nonprofits, according to Texas business filings and Wakefield’s co-founder, Polly Tommey. During its brief life, the AMC Foundation doled out grants exclusively to Autism Media Channel LLC, a private company that was also run by Wakefield, Tommey and a third partner, according to tax filings.

According to the filings, the grants supported an educational film project.

Attorney Marc Owens, a former head of the IRS division responsible for monitoring tax-exempt organizations, said the arrangement is “a very suspicious transaction.”

“They transferred all of their income, it appears — with the exception of a small amount — to, basically, themselves,” Owens said. “It is extremely unusual to see this sort of expenditure from a public charity.”

In an interview, Tommey defended the transactions.

“Everything was cleared legally, and we stuck to our mission,” she said.

Tommey said she is now focused on the upcoming release of a sequel to “Vaxxed” that will include information about Gardasil, a vaccine that protects against several strains of the human papillomavirus. Wakefield, meanwhile, has launched another public charity to fund educational film projects, according to tax filings.

The same year “Vaxxed” was released, Bigtree established the Informed Consent Action Network. The Selz Foundation donated $100,000 that first year — 83 percent of the charity’s funding, according to tax records.

June, 2019|Oral Cancer News|

Merck’s Keytruda wins FDA approval to treat head and neck cancer

Source: Reuters
Date: June 11, 2019
Author: Reporting by Aakash Jagadeesh Babu; Editing by Shailesh Kuber

(Reuters) – Merck & Co Inc said on Tuesday its blockbuster cancer drug Keytruda won approval from the U.S. Food and Drug Administration to treat a type of head and neck cancer.

The drug was approved for use as a monotherapy, as well as in combination with a common chemotherapy regimen, to treat previously untreated patients with head and neck squamous cell carcinoma, Merck said.

The approval is based on results from a late-stage trial, where Keytruda showed a significant improvement in overall survival in cancer patients, Merck said.

Keytruda, a type of immunotherapy called a PD-1 inhibitor, is already an approved treatment for several forms of cancer, including lung and skin cancers.

Head and neck cancer includes tumors in the mouth, tongue, nose, sinuses, throat and lymph nodes in the neck.

Merck estimates that there will be more than 65,000 new cases of head and neck cancer diagnosed in 2019 in the United States.

Keytruda works by increasing the ability of patients’ immune system to help detect and fight tumor cells.

The drug has been amassing approvals as a standalone therapy and in combination with other drugs to treat several forms of cancer. It is the leading immunotherapy for treating lung cancer, ahead of rival drugs from Bristol-Myers Squibb, Roche and AstraZeneca.

Keytruda, first approved for advanced melanoma in 2014, is Merck’s most important growth driver. It has overtaken Bristol’s Opdivo as the industry’s immuno-oncology leader with sales expected to top $10 billion this year and $20 billion in 2024, according to IBES data from Refinitiv.

Keytruda brought in revenue of $7.17 billion for Merck in 2018, while Bristol’s Opdivo earned $6.74 billion.

June, 2019|Oral Cancer News|

Merck’s Keytruda wins FDA approval to treat head and neck cancer

Source: www.pharmalive.com
Author: staff, Reuters Health

Merck & Co Inc said on Tuesday its blockbuster cancer drug Keytruda won approval from the U.S. Food and Drug Administration to treat a type of head and neck cancer.

The drug was approved for use as a monotherapy, as well as in combination with a common chemotherapy regimen, to treat previously untreated patients with head and neck squamous cell carcinoma, Merck said.

The approval is based on results from a late-stage trial, where Keytruda showed a significant improvement in overall survival in cancer patients, Merck said.

Keytruda, a type of immunotherapy called a PD-1 inhibitor, is already an approved treatment for several forms of cancer, including lung and skin cancers.

Head and neck cancer includes tumors in the mouth, tongue, nose, sinuses, throat and lymph nodes in the neck.

Merck estimates that there will be more than 65,000 new cases of head and neck cancer diagnosed in 2019 in the United States.

Keytruda works by increasing the ability of patients’ immune system to help detect and fight tumor cells.

The drug has been amassing approvals as a standalone therapy and in combination with other drugs to treat several forms of cancer. It is the leading immunotherapy for treating lung cancer, ahead of rival drugs from Bristol-Myers Squibb, Roche and AstraZeneca.

Keytruda, first approved for advanced melanoma in 2014, is Merck’s most important growth driver. It has overtaken Bristol’s Opdivo as the industry’s immuno-oncology leader with sales expected to top $10 billion this year and $20 billion in 2024, according to IBES data from Refinitiv.

Keytruda brought in revenue of $7.17 billion for Merck in 2018, while Bristol’s Opdivo earned $6.74 billion.

Antibodies against HPV16 can develop up to 40 years before throat cancer is diagnosed

Source: www.eurekalert.org
Author: news release

An international group of researchers has found that antibodies to the human papilloma virus type 16 (HPV16) develop in the body between six to 40 years prior to a clinical diagnosis of throat cancer, and their presence indicates a strong increased risk of the disease.

The study, which is published in the leading cancer journal Annals of Oncology [1] today (Wednesday), also found that having HPV16 antibodies increased the risk of throat cancer far more in white people than in black: nearly 100-fold in white people, but 17-fold in black people.

Patients with HPV-associated throat cancer tend to respond better to treatment than those whose cancer is not associated with the infection; the researchers say this may partly explain the worse survival rates among black patients.

The main causes of throat cancer (known as oropharyngeal squamous cell carcinoma, OPSCC) are smoking, alcohol use and infection with HPV16. In the USA the proportion of OPSCCs attributable to HPV16 is around 70%; in some European countries a similar proportion is caused by HPV16, although this varies from country to country. [2]

Dr Mattias Johansson, a cancer epidemiologist at the International Agency for Research on Cancer (IARC) in Lyon, France, who led the research, said: “Importantly, the proportion of throat cancers caused by HPV16 has been increasing over the past few decades, particularly in men, and in some countries the overwhelming majority are now caused by the virus.

“Investigating the range in time prior to diagnosis in which HPV antibodies develop is important to understand how many years an individual who tested positive would be at increased risk, and also gives important insight into the natural history of the disease. In this study we found that antibodies can, in some cases, develop several decades prior to diagnosis of cancer. If rates of throat cancer continue to rise in the future, this biomarker could provide one means to identify individuals at very high risk of the disease who may benefit from specific preventive measures.”

The researchers from Europe, North America and Australia, who were part of the HPV Cancer Cohort Consortium, looked at 743 patients with throat cancer and compared them with 5,814 people without cancer who were the control group [3]. In the years before any diagnosis of cancer, all patients provided at least one blood sample, which was tested for antibodies against the HPV16 cancer-causing E6 protein, and 111 patients provided multiple samples over a period of up to 40 years. The median (average) time between first blood sample collection and a diagnosis of OPSCC was just over 11 years.

Specifically, they found that HPV antibodies were present in only 0.4% of people in the control group (22 out of 5814), but were detected in 26.2% of OPSCC patients (195 out of 743). Antibodies were present in 27.2% of white people before diagnosis with OPSCC (191 of 701) and in 7.7% of black people (3 of 39). This means that the presence of HPV16 antibodies was associated with a 98.2-fold increase in the risk of OPSCC in white people and a 17.2-fold increase in black people.

The first author of the study, Dr Aimée Kreimer, senior investigator at the Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, USA, said: “We also found that people diagnosed in more recent calendar years were more likely to have HPV antibodies, which is consistent with what we know about the increase in the proportion of throat cancers that are due to HPV16. Although there were some people with HPV antibodies detected prior to 1995, this was relatively rare.”

The researchers found that HPV16 antibodies tended to appear in people aged between about 40 to 80 years old – the median age at which antibodies were detected was 52 years, while the median age of diagnosis with OPSCC was 62. As there is no suitable, evidence-based way to test for OPSCC before symptoms appear, more research will be needed before HPV16 antibodies could be used to detect OPSCC in its early, pre-symptomatic stages.

Dr Kreimer said: “Although HPV16 antibodies could be a way to identify people at very high risk of cancer, we are currently missing the critical next steps in the screening process. Also, even though the antibody marker was very good at discriminating between those who would develop cancer and the controls who would not, with such a rare cancer, many people would still be likely to have a false-positive results.”

Dr Johansson concluded: “Future studies will focus on the most appropriate way to follow-up individuals who test positive for HPV16 antibodies and whether there is a way to identify pre-malignant lesions, as well as alternative ways of reducing the risk of eventually developing OPSCC. In other words, there is a long way to go before this biomarker can be used in clinical practice. While vaccination against HPV holds promise in preventing HPV-related cancers, we will not see a resulting reduction in throat cancers for several decades.”

Reasons why HPV16-driven throat cancer has increased in recent decades include changes in sexual practices that started in the middle of the 20th century and a decrease in tonsillectomy rates, which results in more tissue being available for infection by the virus.

The main limitation of the study is the difference between the groups of patients who took part in the study. For example, the group with the longest period of time between first collection of blood and diagnosis of OPSCC came from Norway, while other patient groups tended to have fewer blood samples collected over shorter timescales.

The research was carried out in collaboration with Dr Tim Waterboer, Head of Infection and Cancer Epidemiology, at the German Cancer Research Centre (DKFZ) in Heidelberg, Germany, who developed the HPV16 antibody test.

Notes:
[1] “Timing of HPV16-E6 antibody seroconversion before OPSCC: findings from the HPVC3 consortium”, by A.R. Kreimer et al. Annals of Oncology. doi:10.1093/annonc/mdz0138

[2] Oropharyngeal cancer starts inside the throat directly behind the nose, and can include the base of the tongue and tonsils. It is still a relatively rare cancer. Worldwide there are approximately 500,000 cases of head and neck cancers, of which OPSCC is one type. It is twice as common in men as in women.

[3] Of the 743 OSCC patients, 66% were from Europe, 30% from North America and 4% from Australia.

Researchers zero in on new class of oral cancer drugs

Source: UT Health San Antonio
Date: June 3, 2019
Author: Rosanne Fohn

SAN ANTONIO (June 3, 2019) ― Researchers at UT Health San Antonio have identified a potent new class of anti-cancer drugs that target oral cancer cells while leaving other cells unharmed. The new drug class also has shown promise in stopping other types of cancer.

In two recent papers, a research team led by Cara Gonzales, D.D.S., Ph.D., developed a new class of drugs broadly referred to as capsazepine analogs and tested them against oral and other types of cancers in preclinical and animal studies.

Low survival rate for advanced and recurrent oral cancer

“Our main goal was to develop cancer-targeting drugs to effectively treat advanced and recurrent oral cancer,” said Dr. Gonzales, an associate professor in the School of Dentistry’sDepartment of Comprehensive Dentistry. “This is important because oral cancer is a deadly disease with a five-year survival rate of only 40 percent,” she said. “Oral cancer is rarely diagnosed in its earliest stages when it can be cured. About 75 percent of patients come to the clinic with advanced disease, dramatically lowering their chance of survival,” she said.

The team’s previous research showed that capsazepine is a potent cancer killer. Capsazepine is a synthetic cousin of capsaicin, the substance in chili peppers that gives them their heat. While studying oral cancer pain, Dr. Gonzales’ team discovered that capsazepine has significant cancer-fighting activity through a cancer-selective mechanism of action. In collaboration with the Center for Innovative Drug Discovery, a partnership of UT Health San Antonio and The University of Texas at San Antonio, more potent capsazepine analogs were developed with significantly stronger anti-cancer efficacy in mouse models of oral cancer and no adverse effects on healthy tissue.

Two papers show progress

In a paper published in Bioorganic & Medicinal Chemistry in November, Dr. Gonzales’ team describes their work synthesizing 30 new compounds whose chemical structures were based on the parent compound, capsazepine. The compounds were then screened based on their ability to kill oral cancer cells in culture. Lead compounds CIDD24, CIDD99 and CIDD111 were validated in mouse models of human cancer.

This data informed additional preclinical and animal work outlined in the second paper, published in March in the Journal of Oral Pathology & Medicine. These studies zeroed in on the most effective lead compound, CIDD99. This compound eradicated the tumors while leaving normal healthy tissue unaffected. An added benefit was that CIDD99 also sensitized oral cancer cells to traditional chemotherapies, meaning that much lower doses of chemotherapy could be used with dramatically greater effectiveness and fewer side effects.

Drugs effective against other types of cancer

CIDD99 was also effective against a panel of other cancer types and therefore may provide a new therapy for multiple cancers with fewer side effects than traditional chemotherapies. “As we got further into our research, we found that CIDD99 also is effective against non-small-cell lung cancer, triple-negative breast cancer and prostate cancer cells,” Dr. Gonzales said.

“These results are very exciting because no new drugs have been developed in over 40 years to treat oral cancer. While immunotherapy works very well, it is only effective in a small group of patients. Our compounds may provide a new class of drugs that may be effective for all oral cancer patients,” she added.

Patents filed on three drugs

UT Health San Antonio and UTSA have a patent on the three drugs through the Office of Technology Commercialization, which serves both universities as a catalyst for stimulating innovation and entrepreneurship among faculty, staff and students and industry partners through the UT System.

Researchers working toward human clinical trials

The research team is now working with venture capital companies to apply for Small Business Technology Transfer grants and an American Cancer Society Mission Boost Phase 1 grant to conduct additional preclinical studies that are required before applying to the U.S. Food and Drug Administration for an Investigational New Drug (IND) status. An IND designation authorizes the administration of an experimental agent in humans enabling future clinical trials.

“These grants will help us generate additional data regarding safety, toxicity and how they work in the body that will get us ready to submit our FDA application for human trials,” Dr. Gonzales said.

The research was supported by an Institute for Integration of Medicine and Science Clinical and Translational Science Pilot Award and a San Antonio Life Science Sciences InstituteCenter for Innovative Drug Discoveries Pilot Grant.

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The University of Texas Health Science Center at San Antonio, now called UT Health San Antonio®, is one of the country’s leading health sciences universities. With missions of teaching, research, healing and community engagement, its schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced 36,500 alumni who are leading change, advancing their fields and renewing hope for patients and their families throughout South Texas and the world. To learn about the many ways “We make lives better®,” visit www.uthscsa.edu.

June, 2019|Oral Cancer News|

Robotic surgery for oropharyngeal cancer not better than radiation therapy, study finds

Source: News Medical
Date: June 7, 2019
Author: Reviewed by James Ives, M.Psych (Editor)

In 2012, scientists at Lawson Health Research Institute launched the world’s first clinical trial comparing robotic surgery to radiation therapy for the treatment of oropharyngeal cancer (cancer at the back of the throat). The team is now reporting findings from the seven-year study which challenges beliefs that surgery leads to better swallowing outcomes, suggesting instead that radiation results in better quality of life for patients.

For Betty Ostrander, an operating room nurse from Tillsonburg, Ontario, a throat cancer diagnosis was life-changing. Betty was 59 when she discovered a small lump on the right side of her neck. After seeking medical care and testing, she was told she had oropharyngeal cancer.

“I remember thinking ‘I’m healthy, I eat right and I exercise; this can’t be happening to me.’ But it was, and it was scary,” recalls Betty. “One of the first questions I asked was whether there were any clinical trials available.”

Betty was one of 68 research participants in the ORATOR trial. The study included six centres from across Canada and Australia, including London Health Sciences Centre’s (LHSC) London Regional Cancer Program. Participants were randomized to receive either precision radiation therapy, often combined with chemotherapy, or transoral robotic surgery (TORS).

TORS is a surgical method for treating throat cancer which uses a small 3D camera and miniature robotic instruments to remove tumors. LHSC was the first center in Canada to offer TORS in 2011.

“Early studies suggested TORS might reduce the risk of swallowing problems historically associated with radiation and it therefore rose quickly in popularity,” explains Dr. Anthony Nichols, Associate Scientist at Lawson and Head and Neck Cancer Surgeon at LHSC. “But there was no randomized trial to compare patients’ swallowing outcomes. As the first center in Canada to offer TORS, we decided to tackle this problem through the ORATOR trial.”

The research team found no difference in survival between the two groups but, surprisingly, participants in the radiation group experienced better swallowing outcomes. A mild decline in swallowing function was observed in 40 per cent of the surgery participants compared to 26 per cent of radiation participants. All participants were able eat a full diet after treatment but 16 per cent from the surgery group said they needed to specially prepare their food.

Our findings challenge the notion that TORS leads to better swallowing outcomes. While radiation was previously associated with poor swallowing outcomes, treatments have advanced considerably and are now much more precise, which may be leading to better patient outcomes.”

Dr. David Palma, Associate Scientist at Lawson and Radiation Oncologist at LHSC

Patients in the surgery group were also at risk for dangerous bleeding during surgery. One year after treatment, patients in the surgery group were more likely to experience pain (22 per cent versus eight per cent in the radiation group), use painkillers (45 per cent versus 15 per cent), have issues with their teeth (12 per cent versus one per cent), and experience shoulder impairment.

The team found that patients in the radiation group experienced more short-term constipation and a temporary drop in blood counts. They also experienced an increased risk of tinnitus (ringing in the ears) and high frequency hearing loss when receiving chemotherapy, with some needing hearing aids.

“Each therapy has its different potential side effects but our findings suggest that TORS is not superior to modern radiation,” says Dr. Nichols. “We hope this research can be used by patients and their oncologists to help inform treatment decisions.”

Cases of oropharyngeal cancer have more than doubled since the 1990s. While throat cancer was more common in elderly patients with a history of heavy smoking or drinking, physicians have seen a dramatic rise in cases caused by human papilloma virus (HPV).

There is fortunately a high survival rate in patients with HPV-related throat cancer, leading researchers to study quality of life after treatment.

Drs. Nichols and Palma recently launched the ORATOR 2 trial which will further compare TORS against radiation and chemotherapy. The goal is to reduce the intensity of radiation and chemotherapy to improve quality of life while maintaining survival rates. The team aims to recruit 140 participants.

Results from the ORATOR trial were shared by Dr. Nichols at the American Society of Clinical Oncology’s Annual Meeting on May 31, 2019. The study was funded by the Canadian Cancer Society.

June, 2019|Oral Cancer News|

Researchers training AI mobile app to detect early signs of oral cancer

Source: www.beckershospitalreview.com
Author: Andrea Park

Computer scientists have secured funding to develop artificial intelligence that can automatically identify signs of early-stage oral cancer using an existing screening app.

The project will build upon Cancer Research Malaysia’s Mobile Mouth Screening Anywhere (MeMoSA) app, which is currently used to capture images of the oral cavity for remote interpretation by oral medicine and surgical specialists. Researchers from the U.K.’s Kingston University and Malaysia’s University of Malaya will train a deep learning system to distinguish between thousands of photos with and without signs of oral cancer, then integrate that system into the app.

“Our challenge is to develop deep learning models that demonstrate a high accuracy and prediction of disease,” said lead researcher Sarah Barman, PhD, a professor of computer vision at Kingston. “If we find this approach is reliable enough, artificial intelligence could be used for other forms of disease screening with a wide range of possible applications in the field of medical diagnostics.”