HPV

Mayo Clinic Q and A: Throat cancer symptoms

Source: newsnetwork.mayoclinic.org
Author: Dr. Eric Moore, Otorhinolaryngology, Mayo Clinic

DEAR MAYO CLINIC: Are there early signs of throat cancer, or is it typically not found until its late stages? How is it treated?

ANSWER: The throat includes several important structures that are relied on every minute of the day and night to breathe, swallow and speak. Unfortunately, cancer can involve any, and sometimes all, of these structures. The symptoms of cancer, how early these symptoms are recognized and how the cancer is treated depend on which structures are involved.

All of the passageway between your tongue and your esophagus can be considered the throat. It includes three main areas. The first is the base of your tongue and tonsils. These, along with the soft palate and upper side walls of the pharynx, are called the oropharynx. Second is the voice box, or larynx. It consists of the epiglottis — a cartilage flap that helps to close your windpipe, or trachea, when you swallow — and the vocal cords. Third is the hypopharynx. That includes the bottom sidewalls and the back of the throat before the opening of the esophagus.

Tumors that occur in these three areas have different symptoms, behave differently and often are treated differently. That’s why the areas of the throat are subdivided into separate sections by the head and neck surgeons who diagnose and treat them.

For example, in the oropharynx, most tumors are squamous cell carcinoma. Most are caused by HPV, although smoking and alcohol can play a role in causing some of these tumors. Cancer that occurs in this area, particularly when caused by HPV, grows slowly ─ usually over a number of months. It often does not cause pain, interfere with swallowing or speaking, or have many other symptoms.

Most people discover cancer in the oropharynx when they notice a mass in their neck that’s a result of the cancer spreading to a lymph node. Eighty percent of people with cancer that affects the tonsils and base of tongue are not diagnosed until the cancer moves into the lymph nodes.

This type of cancer responds well to therapy, however, and is highly treatable even in an advanced stage. At Mayo Clinic, most tonsil and base of tongue cancers are treated by removing the cancer and affected lymph nodes with robotic surgery, followed by radiation therapy. This treatment attains excellent outcomes without sacrificing a person’s ability to swallow.

When cancer affects the voice box, it often affects speech. People usually notice hoarseness in their voice soon after the cancer starts. Because of that, many cases of this cancer are detected at an early stage. People with hoarseness that lasts for six weeks should get an exam by an otolaryngologist who specializes in head and neck cancer treatment, as early treatment of voice box cancer is much more effective than treatment in the later stages.

Early voice box cancer is treated with surgery — often laser surgery — or radiation therapy. Both are highly effective. If left untreated, voice box cancer can grow and destroy more of the larynx. At that point, treatment usually includes major surgery, along with radiation and chemotherapy ─ often at great cost to speech and swallowing function.

Finally, cancer of the hypopharynx usually involves symptoms such as pain when swallowing and difficulty swallowing solid food. It is most common in people with a long history of tobacco smoking and daily alcohol consumption. This cancer almost always presents in an advanced stage. Treatment is usually a combination of surgery, chemotherapy and radiation therapy.

If you are concerned about the possibility of any of these cancers, or if you notice symptoms that affect your speech or swallowing, make an appointment for an evaluation. The earlier cancer is diagnosed, the better the chances for successful treatment. — Dr. Eric Moore, Otorhinolaryngology, Mayo Clinic, Rochester, Minnesota

HPV Vaccination Linked to Decreased Oral HPV Infections

Author: NCI Staff
Date: June 5th, 2017
Source: www.cancer.org

New study results suggest that vaccination against the human papillomavirus (HPV) may sharply reduce oral HPV infections that are a major risk factor for oropharyngeal cancer, a type of head and neck cancer.

The study of more than 2,600 young adults in the United States found that the prevalence of oral infection with four HPV types, including two high-risk, or cancer-causing, types, was 88% lower in those who reported receiving at least one dose of an HPV vaccine than in those who said they were not vaccinated.

About 70% of oropharyngeal cancers are caused by high-risk HPV infection, and the incidence of HPV-positive oropharyngeal cancer has been increasing in the United States in recent decades. In the United States, more than half of oropharyngeal cancers are linked to a single high-risk HPV type, HPV 16, which is one of the types covered by Food and Drug Administration (FDA)-approved HPV vaccines.

“In an unvaccinated population, we would estimate that about a million young adults would have an oral HPV infection by one of these vaccine HPV types. If they had all been vaccinated, we could have prevented almost 900,000 of those infections,” said senior study author Maura Gillison, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center.

Dr. Gillison presented the new findings at a May 17 press briefing ahead of the 2017 annual American Society of Clinical Oncology (ASCO) meeting, held June 2–6 in Chicago.

A Rapidly Rising Cancer

Oropharyngeal cancer “is the fastest-rising cancer among young white men in the United States,” said Dr. Gillison, who was at Ohio State University when she conducted the study.

“The HPV types that cause oropharyngeal cancers are primarily transmitted through sexual contact,” explained lead study author Anil Chaturvedi, Ph.D., of NCI’s Division of Cancer Epidemiology and Genetics. The increased incidence of oropharyngeal cancers in white men has been linked to changes in sexual behaviors from the 1950s through the 1970s, he said. The exact reasons for the greater increase in oropharynx cancer incidence in men versus women are still unclear, Dr. Chaturvedi added.

Clinical trials have shown that FDA-approved HPV vaccines can prevent anogenital HPV infections and precancerous lesions that lead to HPV-associated cancers, including cervical and anal cancer. However, Dr. Gillison said, the potential impact of current HPV vaccines on oral HPV infections that lead to cancer has not yet been rigorously tested in clinical trials, and thus the vaccines are not specifically approved for preventing cancers of the oropharynx.

From 2006 through 2014, most HPV-vaccinated individuals in the United States received Gardasil®, an HPV vaccine that protects against infection with HPV types 6, 11, 16, and 18. In January 2015, FDA approved an updated HPV vaccine, Gardasil 9®, that protects against five additional HPV types.

Looking for a Link

To investigate the relationship between HPV vaccination and oral HPV infection, the researchers analyzed data for 2,627 young adults who participated in NHANES, a national survey that assesses the health of a representative slice of the US population.

Drs. Gillison, Chaturvedi, and their colleagues restricted their analysis to NHANES data from 2011 to 2014, focusing on 18- to 33-year-old men and women “because they were the first group [in the United States] to receive the vaccine,” Dr. Gillison said.

In the United States, routine vaccination against HPV, which causes nearly all cervical cancers, has been recommended since mid-2006 for 11- to 12-year-old girls and for females up to age 26 who have not previously been vaccinated. HPV vaccination has been recommended for males ages 9–26 since 2009.

The researchers analyzed mouth rinse samples (containing oral cells) from all study participants for the presence of 37 HPV types, including types 6, 11, 16, and 18, which are covered by Gardasil, Dr. Gillison said.

The prevalence of oral infections with these four HPV types was 1.61% in unvaccinated young adults versus 0.11% in vaccinated young adults—an 88% reduction in HPV prevalence with vaccination. Among men, the prevalence of oral infection with the four HPV types was 2.1% in unvaccinated individuals and 0.0% in vaccinated individuals.

By contrast, the prevalence of oral infection with 33 HPV types not covered by the vaccine was 4.0% in vaccinated groups and 4.7% in non-vaccinated groups, the researchers found, a difference that was not considered to be statistically meaningful.

Vaccination rates were low overall, with only 29.2% of women and 6.9% of men in the study population reporting having received at least one dose of an HPV vaccine before age 26.

Prevention Potential

Although the self-reported vaccination rates in this study were low, Dr. Gillison said, “there is considerable optimism because more recent data indicate that [roughly] 60% of girls and 50% of boys under age 18 have received more than one HPV vaccine dose.”

“HPV vaccines are already strongly recommended for cancer prevention,” Dr. Gillison continued. “Parents who choose to have their children vaccinated against HPV should realize that the vaccine may provide additional benefits, such as preventing oral HPV infections linked to oral cancers.”

However, she and Dr. Chaturvedi noted, only a randomized clinical trial that follows people over time could definitively show a cause and effect relationship between HPV vaccination and a lasting reduction of high-risk oral HPV infections, which experts agree is a more meaningful indicator of vaccine effectiveness.

In July 2013, NCI researchers and their collaborators reported findings from the NCI-sponsored HPV Vaccine Trial in Costa Rica that suggested that HPV vaccination can reduce oral HPV infections in women.

“Our study builds on those results by showing a reduction in oral HPV prevalence in vaccinated men, the group that bears the greatest burden of HPV-associated oropharynx cancers,” Dr. Chaturvedi said.

June, 2017|Oral Cancer News|

Novel vaccine therapy can generate immune responses in patients with HPV-related head and neck cancer

Source: www.news-medical.net
Author: staff

A novel vaccine therapy can generate immune responses in patients with head and neck squamous cell carcinoma (HNSCCa), according to researchers at the Abramson Cancer Center of the University of Pennsylvania. The treatment specifically targets human papillomavirus (HPV), which is frequently associated with HNSCCa, to trigger the immune response. Researchers will present the results of their pilot study during the 2017 American Society of Clinical Oncology Annual Meeting in Chicago (Abstract #6073).

HNSCCa is a cancer that develops in the mucous membranes of the mouth, and throat. While smoking and tobacco use are known causes, the number of cases related to HPV infection – a sexually transmitted infection that is so common, the Centers for Disease Control says almost all sexually active adults will contract it at some point in their lifetimes – is on the rise. The CDC now estimates 70 percent of all throat cancers in the United States are HPV-related. Sixty percent are caused by the subtype known as HPV 16/18.

“This is the subtype we target with this new therapy, and we’re the only site in the country to demonstrate immune activation with this DNA based immunotherapeutic vaccine for HPV 16/18 associated head and neck cancer,” said the study’s lead author Charu Aggarwal, MD, MPH, an assistant professor of Hematology Oncology in the Perelman School of Medicine at the University of Pennsylvania.

The vaccine is delivered as an injection of antigens – which leads the immune system to start producing antibodies and activate immune cells. At the time of injection, physicians use a special device to deliver a pulse of electricity to the area, which stimulates the muscles and speeds the intake of the antigens. Aggarwal noted that this study represents a multidisciplinary approach involving the lab and the clinic.

“This is truly bench-to-bedside and shows the value of translational medicine within an academic medical center,” Aggarwal said.

Penn researchers treated 22 patients with the vaccine. All of the patients had already received therapy that was intended to be curative – either surgery or chemotherapy and radiation. When doctors followed up an average of 16 months later, 18 of those patients showed elevated T cell activity that was specific to HPV 16/18. All of the patients in the study are still alive, and none reported any serious side effects.

“The data show the therapy is targeted and specific, but also safe and well-tolerated,” Aggarwal said.

Because of the positive activity, Aggarwal says the next step is to try this therapy in patients with metastatic disease. A multi-site trial will open soon that combines the vaccine with PD-L1 inhibitors, which target a protein that weakens the body’s immune response by suppressing T-cell production.

More patients presenting with HPV-associated oral cancers in Lubbock, TX

Source: lubbockonline.com
Author: Ellysa Harris

Detecting oral cancers in patients in their 50s and 60s has never been uncommon. But local dentists and doctors say finding it in younger patient populations has become a new norm.

Oral cancers driven by Human Papillomavirus are now the fastest growing oral and oropharyngeal cancers, according to the Oral Cancer Foundation website. And local health officials say they’ve seen a few more cases than usual.

Dr. Joehassin Cordero, FACS, professor, chairman and program director ofTexas Tech’s Health Sciences Center Department of Otolaryngology-Head & Neck Surgery, said less people are smoking and that has contributed to the decrease in the number of cases of oral cancers in the past two decades.

“In that same period, we have seen an increase in the HPV oropharyngeal cancer,” he said. “And oropharyngeal cancer — what it means it’s affecting the base of your tongue and tonsils.”

Dr. Brian Herring, a Lubbock dentist, chalks the increase up to increased awareness.

“I’m assuming probably for years and years and years it has affected the mouth but we didn’t know that,” he said. “As we get better at cellular diagnostics and molecular diagnostics, things like that, we’re finding that there is a large portion of cancers that do have an HPV component.”

What’s more alarming, said Dr. Ryan Higley, oral surgeon with West Texas Oral Facial Surgery, is it’s being diagnosed in younger people.

Higley said oral cancers are generally diagnosed between the ages of 55 and 65, mostly in women.

“With HPV-associated cancers, we see those four to 10 years before that,” he said. “It’s a younger patient population.”

Cordero said the oral cancers are often caused by exposure to HPV from years before.It starts with exposure to the HPV infection. One in four people in the United States are currently infected, according to the Centers for Disease Control and Prevention website.

“It’s truly considered a sexually transmitted disease,” Cordero said. “It has to do with not so much kissing, but oral sex.”

It’s passed on when somebody with an active lesion engages in sexual activities with another person, he said.

Nine out of 10 infections will disappear on their own, according to the CDC, but infections that linger for longer than about two years can lead to cancer.

“That doesn’t mean they’ll have cancer next week,” Cordero said.

Researchers are still trying to figure out why and how long after HPV exposure it takes for cancer to develop, he said.

“We don’t know the true mechanism because most of these people were not exposed a year ago,” he said. “They were not exposed six months ago. They were exposed a long time before that.”

When it does present, he said, there generally aren’t any noticeable symptoms.Because of that, it’s often diagnosed in later stages, Herring said.

“What we’re finding is because the demographic is changing, they’re not getting diagnosed as early because they’re not expecting to have this problem,” he said.

Screenings for oral HPV exist.

“The gold standard examination is your typical dental exam,” Herring said. If your dentist detects something unusual that might need further examination, he or she will make a referral to an oral surgeon.

Higley said oral HPV cancer presents as a lesion that looks like a kanker that won’t heal.

“However, cancerous lesions can have multiple presentations so that’s not exclusive,” he said. “So oftentimes, we’ll have a patient present with a hard nodule underneath their jaw line or in their neck. Sometimes they’ll just have red or white lesions within the mouth, hoarseness in their voice or difficulty swallowing. All those are things that need to be checked.”

The cancer seems to be more treatable, he said, but it’s hard to pinpoint why.

“We really don’t know if they’re more responsive to treatment because we’re treating a little bit younger patient population who is overall more healthy or if it’s inherant in the tumor itself,” Higley said.

Cordero said he hopes the HPV vaccine, which is recommended for both girls and boys 11 or 12 years old and people up to 26 years old, provides a measure of protection against the infection.

“We’re hoping in the next 10 to 20 years that head and neck cancer caused by HPV will be completely gone,” he said.

Symptoms of throat cancer depend on which throat structures are affected

Source: tribunecontentagency.com
Author: Eric Moore, M.D.

Dear Mayo Clinic: Are there early signs of throat cancer, or is it typically not found until its late stages? How is it treated?

Answer: The throat includes several important structures that are relied on every minute of the day and night to breathe, swallow and speak. Unfortunately, cancer can involve any, and sometimes all, of these structures. The symptoms of cancer, how early these symptoms are recognized and how the cancer is treated depend on which structures are involved.

All of the passageway between your tongue and your esophagus can be considered the throat. It includes three main areas. The first is the base of your tongue and tonsils. These, along with the soft palate and upper side walls of the pharynx, are called the oropharynx. Second is the voice box, or larynx. It consists of the epiglottis — a cartilage flap that helps to close your windpipe, or trachea, when you swallow — and the vocal cords. Third is the hypopharynx. That includes the bottom sidewalls and the back of the throat before the opening of the esophagus.

Tumors that occur in these three areas have different symptoms, behave differently and often are treated differently. That’s why the areas of the throat are subdivided into separate sections by the head and neck surgeons who diagnose and treat them.

For example, in the oropharynx, most tumors are squamous cell carcinoma. Most are caused by HPV, although smoking and alcohol can play a role in causing some of these tumors. Cancer that occurs in this area, particularly when caused by HPV, grows slowly usually over a number of months. It often does not cause pain, interfere with swallowing or speaking, or have many other symptoms.

Most people discover cancer in the oropharynx when they notice a mass in their neck that’s a result of the cancer spreading to a lymph node. Eighty percent of people with cancer that affects the tonsils and base of tongue are not diagnosed until the cancer moves into the lymph nodes.

This type of cancer responds well to therapy, however, and is highly treatable even in an advanced stage. At Mayo Clinic, most tonsil and base of tongue cancers are treated by removing the cancer and affected lymph nodes with robotic surgery, followed by radiation therapy. This treatment attains excellent outcomes without sacrificing a person’s ability to swallow.

When cancer affects the voice box, it often affects speech. People usually notice hoarseness in their voice soon after the cancer starts. Because of that, many cases of this cancer are detected at an early stage. People with hoarseness that lasts for six weeks should get an exam by an otolaryngologist who specializes in head and neck cancer treatment, as early treatment of voice box cancer is much more effective than treatment in the later stages.

Early voice box cancer is treated with surgery — often laser surgery — or radiation therapy. Both are highly effective. If left untreated, voice box cancer can grow and destroy more of the larynx. At that point, treatment usually includes major surgery, along with radiation and chemotherapy — often at great cost to speech and swallowing function.

Finally, cancer of the hypopharynx usually involves symptoms such as pain when swallowing and difficulty swallowing solid food. It is most common in people with a long history of tobacco smoking and daily alcohol consumption. This cancer almost always presents in an advanced stage. Treatment is usually a combination of surgery, chemotherapy and radiation therapy.

If you are concerned about the possibility of any of these cancers, or if you notice symptoms that affect your speech or swallowing, make an appointment for an evaluation. The earlier cancer is diagnosed, the better the chances for successful treatment. — Eric Moore, M.D., Otorhinolaryngology, Mayo Clinic, Rochester, Minn.

Note: For information, visit www.mayoclinic.org

First long-term study on HPV claims the vaccine is 100% effective at protecting men from cancer caused by the STI

Source: www.dailymail.co.uk
Author: Cheyenne Roundtree

The first long-term study conducted into the HPV vaccine confirm it is almost 100 percent effective at protecting men from developing oral cancer.

The treatment was approved to the market in 2006 to prevent women from getting cervical cancer but experts haven’t been able to fully examine its effect over time. Now, the results are in from a three-year study on the effects – the longest investigation ever on HPV.

It confirmed that there was no trace of cancer-linked strains of HPV among men who received the vaccine – whereas two percent of untreated men had a potentially cancerous strain.

Another study, also released today, found the jab makes it next to impossible for vaccinated children to develop genital warts from the STI in their late teens and 20s.

Despite a multitude of interest and research, these are the first substantial studies to confirm the vaccine’s ability to protect people from the STI and diseases that can stem from it.

Human papillomavirus (HPV) is the most common sexually-transmitted disease in the US, with approximately 80 million people currently infected.

Although most infections disappear on their own, without even displaying symptoms, some strains can lead to genital warts and even cancers, including prostate, throat, head and neck, rectum and cervical cancer. Approximately 28,000 cases of cancer caused by HPV are diagnosed annually – most of which would have preventable with the vaccine, the CDC says.

The vaccine was first introduced with the main goal to prevent cervical cancer in women, but only about half of those eligible are getting the shots.

The study on HPV vaccines leading to oral cancer in men was led by Dr. Maura Gillison of the University of Texas MD Anderson Cancer Center. It was the first research done on whether the vaccine might prevent oral HPV infections in young men, and the results suggest it can.

The data were compiled from 2,627 men and women ages 18 to 33 years in a national health study from 2011 to 2014. The results in men were striking – no infections in the vaccinated group versus 2.13 percent of the others.

The two-dose vaccine study on genital warts was conducted by medical experts at the Boston University School of Medicine and examined the number of shots given to patients. They concluded that girls given two or three jabs prevented better against genital warts compared to those given one or no jabs.

There were similar results in the two and three jab test subjects, which experts concluding two counts of the vaccine were enough.

Rebecca Perkins, an obstetrician and the lead author of the Boston study, said: ‘This study validates the new recommendations and allows us to confidently move forward with the two dose schedule for the prevention of genital warts.’

American Dental Association and The University of Texas MD Anderson Cancer Center announce collaboration

Source: www.prnewswire.com
Author: press release

The American Dental Association (ADA) and The University of Texas MD Anderson Cancer Center today announced a joint effort to improve patient outcomes through programs aimed at dental and medical professionals and the public to increase human papillomavirus (HPV) vaccinations and tobacco cessation for oral cancer prevention.

“ADA member dentists promise to put patients first, and as a profession we look for innovative ways to treat and prevent disease, and promote wellness,” said ADA President Gary Roberts, D.D.S. “Together with MD Anderson, one of the most respected cancer centers in the world, we are excited to pioneer new programs to help our patients live healthy and disease-free lives.”

Both organizations agree that increasing the percentage of children and young adults vaccinated for HPV is critical to improving their health and reducing risk of several related cancers, including those of the oropharynx (the part of the throat just behind the mouth which includes the back third of the tongue; the back part of the roof of the mouth, also known as the soft palate; the tonsils, and the side and back wall of the throat). In addition, programs aimed at preventing children and young adults from starting to smoke while encouraging current smokers to quit are another key component of the collaboration.

“MD Anderson is pleased to partner with the ADA to develop innovative educational programs that will increase awareness about the prevention and early detection of oral cancers,” said Marshall E. Hicks, M.D., president ad interim, MD Anderson. “Tobacco use and HPV infection remain the leading causes of oral cancers. Through this collaboration, we have a significant opportunity to inform care providers and the public about the associated risks, and we can make a difference in the fight to end cancer.”

According to the American Cancer Society, an estimated 50,000 cancers of the oral cavity and pharynx will be diagnosed this year in the U.S., and rates in men are more than twice as high as in women. These cancers are often not diagnosed until late stages, when treatment is less effective.

Tobacco use remains the leading preventable cause of cancers in the U.S., responsible for roughly one-third of all cases. HPV infections are responsible for approximately 70 percent of all oropharyngeal cancers, about 9,000 annually, as well as the majority of cervical, anal and genital cancers. HPV-related oropharyngeal cancers are four times more common in men than women, and the incidence rate of these cancers has risen significantly in recent years.

About the American Dental Association
The not-for-profit ADA is the nation’s largest dental association, representing more than 161,000 dentist members. The premier source of oral health information, the ADA has advocated for the public’s health and promoted the art and science of dentistry since 1859. The ADA’s state-of-the-art research facilities develop and test dental products and materials that have advanced the practice of dentistry and made the patient experience more positive. The ADA Seal of Acceptance long has been a valuable and respected guide to consumer dental care products. The monthly The Journal of the American Dental Association (JADA) is the ADA’s flagship publication and the best-read scientific journal in dentistry. For more information about the ADA, visit ADA.org. For more information on oral health, including prevention, care and treatment of dental disease, visit the ADA’s consumer website MouthHealthy.org.

About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 47 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report’s “Best Hospitals” survey. It has ranked as one of the nation’s top two hospitals since the survey began in 1990, and has ranked first for nine of the past 10 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy

Source: pipelinereview.com
Author: Bristol-Myers Squibb

Bristol-Myers Squibb Company today announced that the European Commission (EC) has approved Opdivo (nivolumab) as monotherapy for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. Opdivo is the first and only Immuno-Oncology (I-O) treatment that demonstrated in a Phase 3 trial a significant improvement in overall survival (OS) for these patients.

“Adult patients with squamous cell cancer of the head and neck that progresses on or after platinum-based therapy are fighting a debilitating and hard-to-treat disease that is associated with a very poor prognosis,” said Kevin Harrington, M.D., Ph.D., professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust in London. “As an oncologist who helps patients deal with this terrible disease, I hope that nivolumab will now be made available as widely as possible, offering this group of patients a new treatment option that can potentially improve their overall survival.”

The approval was based on results from CheckMate -141, a global Phase 3, open-label, randomized trial, first published in The New England Journal of Medicine last October, which evaluated Opdivo versus investigator’s choice of therapy in patients aged 18 years and above with recurrent or metastatic, platinum-refractory SCCHN who had tumor progression during or within six months of receiving platinum-based therapy administered in the adjuvant, neo-adjuvant, primary or metastatic setting. Investigator’s choice of therapy included methotrexate, docetaxel, or cetuximab. The primary endpoint was OS. The trial’s secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).

“The European Commission’s approval of Opdivo marks not only the first new treatment option in 10 years for patients with advanced cancers of the head and neck, but also the first Immuno-Oncology treatment for SCCHN,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Bristol-Myers Squibb remains committed to redefining survival for patients with cancer, and now that Opdivo is approved in Europe, we will work collaboratively with EU health authorities to ensure it is available for these patients as quickly as possible.”

In the interim analysis of the pivotal trial, Opdivo demonstrated statistically significant improvement in OS with a 30% reduction in the risk of death (HR=0.70 [95% CI: 0.53-0.92; p=0.0101]), and a median OS of 7.5 months (95% CI: 5.5-9.1) for Opdivo compared with 5.1 months (95% CI: 4.0-6.0) for the investigator’s choice arm. There were no statistically significant differences between the two arms for PFS (HR=0.89; 95% CI: 0.70, 1.13) or ORR (13.3% [95% CI: 9.3, 18.3] vs 5.8% [95% CI: 2.4, 11.6] for Opdivo and investigator’s choice, respectively. The EC approval was based on updated study results, which will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO).

Patient reported outcomes (PROs) were evaluated using the following European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Assessment: EORTC QLQ-C30, EORTC QLQ-H&N35, and 3-level EQ-5D instruments. Patients treated with Opdivo exhibited stable PROs, while those assigned to investigator’s choice therapy exhibited significant declines in functioning (e.g., physical, role, social) and health status as well as increased symptomatology (e.g., fatigue, dyspnoea, appetite loss, pain and sensory problems).

The safety profile of Opdivo in CheckMate -141 was consistent with prior studies in patients with melanoma and non-small cell lung cancer. Serious adverse reactions occurred in 49% of patients receiving Opdivo. The most frequent serious adverse reactions reported in at least 2% of patients receiving Opdivo were pneumonia, dyspnea, aspiration pneumonia, respiratory failure, respiratory tract infection, and sepsis.

About Head & Neck Cancer
Cancers that are known as head and neck cancers usually begin in the squamous cells that line the moist mucosal surfaces inside the head and neck, such as inside the mouth, the nose and the throat. Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4% for metastatic Stage IV disease. Squamous cell cancer of the head and neck (SCCHN) accounts for approximately 90% of all head and neck cancers with global incidence expected to increase by 17% between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol consumption. Human Papilloma Virus (HPV) infection is also a risk factor leading to rapid increase in oropharyngeal SCCHN in Europe and North America.

About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U. S. FDA approved indications for Opdivo
Opdivo® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Opdivo® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Opdivo® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Opdivo® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Opdivo® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Opdivo® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Opdivo® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

Opdivo® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

April, 2017|Oral Cancer News|

Overwhelming support from GPs & dentists for boys to receive the HPV vaccination

Date: 4/24/2017
Source: http://www.hpvaction.org

  • 97% of dentists and 94% of GPs would have their own sons vaccinated against the Human Papillomavirus (HPV), in a new survey published ahead of World Immunisation Week 24th-28th April.
  • 97% of dentists and 94% of GPs believe that the national HPV vaccination programme should cover both boys and girls.

95% of GPs and dentists together said if they had a son they would want him to receive the HPV vaccination. The findings come as the Government’s vaccination advisory committee (JCVI) moves towards a decision on whether boys should be given the HPV vaccination.

BRITISH MEDICAL ASSOCIATION

Dr Andrew Green, a member of the BMA’s General Practitioners Committee (GPC), said: “If we want to see an end to some of the most aggressive and hard to treat cancers such as throat, head, neck and anal cancer, boys as well as girls must be given the HPV vaccination. It is ridiculous that people are still dying from these cancers when their life could have easily been saved by a simple injection.”

BRITISH DENTAL ASSOCIATION

Mick Armstrong, Chair of the BDA’s Principal Executive Committee, said: “HPV is the leading cause of oro-pharyngeal cancers and men are just as likely to develop it as women so where is the logic – or fairness – in targeting protection to one section of the population? It is morally indefensible to allow people to contract cancer when prevention – the new NHS mantra – could be so cheap and easy. Cancers affecting the mouth and throat have a huge impact on the quality of people’s lives, so it’s frustrating for dentists, who are often the first to detect them, knowing how easily they could have been prevented.”

LETTER TO JEREMY HUNT

Parliamentarians from all parties have signed an open letter to the Health Secretary, Jeremy Hunt MP, urging him to ensure that the UK doesn’t miss this opportunity to eradicate some of the fastest rising cancers in the developed world.
Up to 80% of sexually active people will be infected by HPV at some point in their lives. 5% of all cancers are caused by HPV and some of these, notably oral cancers, are now rising sharply in incidence. HPV-related cancers such as anal cancer are also among the hardest to diagnose and treat.

THE COST-EFFECTIVE ARGUMENT

Many doctors, dentists, scientists and professional and patient organisations who support the vaccination of both sexes are concerned that the JCVI will reject universal coverage on the grounds of cost despite the vaccination’s ability to protect against 5% of all cancers and the huge cost of treating HPV-related cancers and other diseases caused by HPV (genital warts and recurrent respiratory papillomatosis).

It is estimated that vaccinating boys would cost £20-22m a year at most – a figure that is dwarfed by the cost of treating HPV-related cancers and warts. An estimated £57.1 million is spent treating head and neck cancer (in England), almost £7 million on treating men with anal cancer and an estimated £58.44 million a year treating anogenital warts.

Newly-published research by Favato G, Easton T, Vecchiato R, Noikokyris E. “Ecological validity of cost-effectiveness models of universal HPV vaccination: a systematic literature review” casts doubt on hitherto published cost-effectiveness modelling and highlights the uncertainties in the process.

The authors comment: “Our findings indicate that the selective immunisation of prepubertal girls is likely to fail to achieve the expected level of herd immunity at population level. A relatively small (15–20%) overestimation of QALY-gained with selective immunisation programmes could induce a significant error in the estimate of the cost-effectiveness of universal immunisation, making the option of vaccinating boys [wrongly appear to be] cost-ineffective.”

WHY GIRLS NOT BOYS?

As well as cost, the main argument deployed against vaccinating boys is that the girls’ programme indirectly protects boys. However, this has been widely dismissed because it fails to take into account men who have sex with unvaccinated women (from the UK and other countries) or men who have sex with men.

LEADING CAMPAIGNER 

One of the key voices in the campaign, Tristan Almada, HPV & Anal Cancer Foundation, said: “The UK government cannot ignore the overwhelming support from GPs, dentists and MPs who want boys to have the HPV vaccination. With every year that passes, almost 400,000 more boys go unvaccinated and are therefore at
risk of developing a HPV-related cancer later in life. The government must roll out gender-neutral vaccination nationally as soon as possible.”

THE GLOBAL VIEW

Australia, USA, Brazil, Bermuda, New Zealand, Austria, Israel, Italy, Switzerland and Canada all recommend that boys are vaccinated as well as girls.

HPV ACTION

Peter Baker, HPV Action Campaign Director, said: “HPV affects men and women equally and both sexes therefore deserve equal protection though a national vaccination programme. It is now time for the Government’s vaccination advisory committee to look up from its financial spreadsheets and act to end the suffering of those men and women affected by easily-preventable diseases caused by HPV.”

The survey was carried out by HPV Action with the support of the HPV and Anal Cancer Foundation and its other members. HPV Action is asking people, especially the parents of boys, to sign an online petition demanding gender-neutral vaccination: and will be calling on all political parties to commit themselves to gender-neutral HPV vaccination during the forthcoming General Election campaign.

April, 2017|Oral Cancer News|

HPV vaccine; cancer prevention

Source: www.nujournal.com
Author: staff

Human papillomavirus (HPV) is a sexually transmitted infection, of several strains, most associated with cervical cancers. The virus is so common that nearly all males and females have been infected at some time in their life. One in four is currently infected in the nation.

Signs and symptoms of HPV are variable. Most will recover from the virus within two years without ever knowing they were infected, making HPV easy to spread. Occasionally, the virus lasts much longer in the body which can cause cells to change and lead to cancer. Fortunately, we have a vaccine to prevent cancer caused by HPV.

The Food and Drug Administration (FDA) has approved three vaccines for HPV; Cervarix, Gardasil, and Gardasil 9. These vaccines are tested and proven to be safe and effective.

Prevention is important with HPV. The vaccine should be administered before exposure to the virus for stronger protection against cervical, vaginal, vulvar, penile, and some mouth or throat cancers. (Gardasil and Gardasil 9 also prevent genital warts and anal cancer.) The best age to obtain maximum potential of the vaccine is at 11 or 12 years old. At this age, the body’s immune system is the most receptive to the vaccination’s virus-like particles and the body produces higher amounts of antibodies in defense, protecting the adolescent for his or her future. Both girls and boys should get the HPV vaccine. For ages 9-14, two doses – six to twelve months apart, are recommended. For 15-26 year olds, three doses are recommended. Side effects may include brief soreness, or redness or swelling at the injection site.

The HPV vaccine does prevent cancer, limiting biopsies and invasive procedures thus cutting potential health care costs. Most private insurance companies cover preventive vaccinations, it is best to call your carrier for more information. The HPV vaccine is covered by Minnesota Health Plans. Uninsured individuals may be eligible to get the vaccine at their local public health office.

Schedule your adolescent’s annual health exam today and ask which HPV vaccine is best for the child in your life.

“Every year in the United States, HPV causes 30,700 cancers in men and women. HPV vaccination can prevent most of the cancers (about 28,000) from occurring.” (CDC, December, 2016)

Learn more at www.cdc.gov/hpv or www.cancer.gov

April, 2017|Oral Cancer News|