Oral Cancer News

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.’

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Health Beat: Hunting head and neck cancer cells

Source: www.wfmz.com
Author: Melanie Falcon

Leonard Monteith led a healthy lifestyle. That’s why sudden problems with his mouth caught his attention.

“I noticed that when I would stick my tongue out, it would deviate to one side, and I thought that’s not right,” said Monteith, 66.

Doctors found an inch-wide tumor at the base of Monteith’s tongue. He was diagnosed with HPV positive cancer.

“The traditional treatment for head and neck cancer is really toxic and exhaustive and leads to side-effects that are very significant,” said Dr. Nabil Saba, a medical oncologist at Emory University Winship Cancer Institute in Atlanta.

After treatment, Monteith’s cancer went away for six months, but then it came back in his lungs.

Saba is a nationally-known expert in the treatment of head and neck cancers. He thought Monteith would be a good candidate for a new therapy.

“Immunotherapy is really, I think, a complete game changer,” said Saba.

Saba said two separate immunotherapy drugs are showing real promise. A drug called Nivolumab blocks the cancer receptors, allowing the body’s immune system to fight the cancer. Another drug, Pembrolizumab, also works in a similar way.

Because the trials are ongoing, Saba can’t say which specific drug Monteith was on.

“He had very good response to the treatment, to the point where we could not see any more lung lesions on the scan,” Saba said.

Monteith has been improving for three years, but he knows his condition could change without warning.

“I just live my life as I think I would have anyway,” said Monteith.

Doctors say the survival rates for patients who continued on Nivolumab were twice of those who did not take the immunotherapy drug. Twenty percent of the patients on the drug had their tumors shrink.

Research Summary: Hunting head and neck cancer cells (pdf format)

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Large Study Shows Reduced Oral HPV Infections With Vaccine

Author: Kate Johnson
Date: May 18, 2017
Source: http://www.medscape.com/viewarticle/880184#vp_1

Human papillomavirus (HPV) vaccination is associated with an 88% reduction in rates of oral HPV infection according to one of the first studies to investigate this association.

The findings, reported in a premeeting presscast for the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting, suggest that HPV vaccination may play an important role in the prevention of oropharyngeal cancer.

“Our data indicate that HPV vaccines have tremendous potential to prevent oral infections,” said senior study author Maura L. Gillison, MD, PhD, who conducted the research at Ohio State University and is now a professor of medicine at the University of Texas MD Anderson Cancer Center in Houston.

But she emphasized that although more than 90% of oropharangeal cancers are caused by HPV-16 ― one of the types for which HPV vaccines are currently available ― the vaccine is only indicated for the prevention of cervical and anogenital infections and associated cancers.

“There haven’t been any clinical trials evaluating whether the currently approved HPV vaccines can prevent oral infections that lead to cancer, so that is not currently an indication,” she explained.

In the absence of randomized trials, Dr Gillison and colleagues carried out a cross-sectional study using data from the National Health and Nutrition Examination Survey (NHANES) survey collected from 2627 young adults aged 18 to 33 years during the period 2011-2014.

This study was conducted by the National Center for Health Statistics and was designed to assess the health and wellness of the US population. Since 2009, Dr Gillison and colleagues have collaborated with NHANES to study oral HPV infections and have analyzed oral rinse samples collected by mobile health facilities.

Comparing individuals who had received the HPV vaccine (29.2% of women and 6.9% of men; P < .001) to those who had not, the analysis found the prevalence of oral HPV infections covered by the vaccine (HPV-16, -18, -6, and -11) was significantly lower in the vaccinated group (0.11% vs 1.61%; P = .008).

The most significant reduction was seen in men. None of those who had been vaccinated had an HPV infection of the types for which vaccinations were available, compared to 2.1% of unvaccinated men (P = .007).

“We were particularly interested in infections among men because the burden of HPV caused by head and neck cancer is largely borne by men, and the rates are rising most dramatically among men,” she said. The prevalence of HPV-positive oropharyngeal cancer is increasing faster than that of any other cancer among young, white, American men, she added.

“Using thse data, we estimated in an unvaccinated population about a million young adults would have oral HPV infection by one of these types, and if vaccines were universally accepted, we could have prevented perhaps over 900,000 of those,” she said.

HPV vaccines are recommended by a number of organizations, including the Centers for Disease Control and Prevention, the National Comprehensive Cancer Network, and ASCO, as well as a coalition of the top US cancer centers.

They were approved by the US Food and Drug Administration in 2006 for female patients aged 9 to 26 years; in 2011, they were approved for male patients aged 9 to 21 years (for men who have sex with men, they were approved to the age of 26 years).

However, in the 2011-2014 survey, only 18.3% of this population reported being vaccinated (6.9% of men and 29.2% of women).

Given this low uptake, the researchers estimated that “only 17% of potentially preventable infections have been prevented, 25% in women and a modest 7% in men,” said Dr Gillison.

Despite this, there is “considerable optimism,” she added.

“Recent data indicate that in individuals under the age of 18, 60% of girls have received more than one vaccine and 40% of boys – so vaccine uptake is higher now,” she added.

Dr Gillison warned against concluding on the basis of this study that there is a causal relationship between vaccination and prevention, because this was not a prospective trial. “Nevertheless, we can conclude that HPV vaccination may have additional benefits beyond prevention of anogenital cancers,” she said.

“The HPV vaccine has the potential to be one of the most significant cancer prevention tools ever developed, and it’s already reducing the world’s burden of cervical cancers,” said ASCO President-elect Bruce E. Johnson, MD, from the Dana-Farber Cancer Institute​ in Boston, Massachusetts.

“The hope is that vaccination will also curb rising rates of HPV-related oral and genital cancers, which are hard to treat. This study confirms that the HPV vaccine can prevent oral HPV infections, but we know it only works if it’s used.”

Approached for comment, Carole Fakhry, MD, from Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, said the results are promising, but further work is necessary.

“There have been no prospective studies to date that evaluate the impact of the vaccine on oral HPV infection,” Dr Fakhry told Medscape Medical News. “It is reassuring to see that the vaccine helps reduce oral HPV infections ― that was previously largely unknown ― [but] we can’t extrapolate from anogenital HPV [data].”

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May, 2017|Oral Cancer News|

Is the HPV vaccine safe?

Author: Linda Carroll
Date: May 15, 2017
Source: http://www.today.com/health/hpv-vaccine-who-should-get-it-t110710

There is so much confusion around the human papillomavirus, or HPV: what it is, what causes it, how you can prevent it, and most commonly, whether or not the HPV vaccine is actually safe.

Here are the basics: According to the Centers for Disease Control and Prevention, HPV is a group of more than 150 related viruses. It’s transmitted through intimate skin-to-skin contact, and you can get it by having vaginal, anal or oral sex with someone else who has the virus. It is very common: A recent report found 42 percent of Americans are infected with HPV.

That may sound alarming, but in most cases, HPV goes away without any signs and doesn’t lead to health issues. When HPV doesn’t go away, it can lead to genital warts and cancer. It’s important to note 25 percent of men and 20 percent of women between the ages of 18 and 59 are infected with the cancer-causing strains.

So what can you do? The best way to prevent these harmful types of HPV is to get the HPV vaccine, which was first recommended in 2006, but people are still wary of it.

“This is the only vaccine we have that prevents cancer,” said Dr. Donnica Moore, president of the Sapphire Women’s Health Group. The HPV vaccine protects against strains of the virus that have been shown to cause cervical, vaginal, vulvar and penile cancer, as well as certain cancers of the mouth and throat.

The most common cancer in women related to HPV is cervical cancer. In men, the head and neck are most commonly involved. A high-profile reminder of this hazard was Michael Douglas’s HPV-related throat cancer, which was found and treated in 2010.

The HPV vaccine is safe and effective: According to the CDC, the vaccine provides close to 100 percent protection against cervical pre-cancers and genital warts.

Currently, the vaccine is recommended for girls and young women between the ages of 9 and 26, said Dr. Melissa Simon, vice chair of clinical research in the department of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine. It’s also recommended for boys and men between 9 and 21, she added.

For children between 9 and 14, the recommendation is two doses, six months apart. If started later than 14, the recommendation is three doses.

Many parents are worried that vaccinating kids against a sexually transmitted disease will make them promiscuous, but experts say that’s not true.

“It doesn’t make them want more sex,” Simon said. If that concern is what’s holding you back, just tell your children they’re getting the vaccine to prevent cancer, Moore said.

While kids are the most likely to develop new infections with HPV, increasing numbers of women in their 50s are testing positive for it, Moore said. That’s most likely tied to new sexual activity after divorce, she explained.

For women older than 26 and men older than 21, the best way to prevent infection is with barrier protection, such as condoms.

If you’re older than 26 and want to be vaccinated, you can talk to your doctor about it. “Doctors can prescribe any FDA-approved drug or vaccine for anything they determine is appropriate, however you may have to pay for it,” Moore said. That’s because the labeling says it’s for women under age 27 and men under age 22, and many insurance companies won’t pay for a treatment that is not listed.

You’ll have a better case with the insurance company if you haven’t had sex yet, Moore said. The current age restrictions are in place partly because younger people are less likely to have been exposed to the virus. There’s no point in getting vaccinated if you’ve already been exposed, but your doctor can tell you if it’s beneficial for you get the vaccine.

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May, 2017|Oral Cancer News|

Changing definition of margin status for oral cancer

Source: www.medpagetoday.com
Author: staff

Data cast doubt on 5-mm standard, use of frozen sections

A commonly used metric for defining a close surgical margin for resected oral-cavity tumors failed to identify adequately the patients at increased risk of recurrence, a retrospective review of 432 cases showed.

The analysis showed an inverse relationship with increasing distance between invasive tumor and inked main specimen margin on the main specimen, but results of a receiver operating characteristic curve analysis identified a cutoff of < 1 mm as most appropriate for classifying patients as having a high risk of local recurrence, as opposed to the more commonly used cutoff of 5 mm.

The analysis also showed that resection of tissue beyond 1 mm on intraoperative frozen section did not improve local disease control, as reported online in JAMA Otolaryngology-Head and Neck Cancer.

“The commonly used cutoff of 5 mm for a close margin lacks an evidential basis in predicting local recurrence,” Steven M. Sperry, MD, of the University of Iowa in Iowa City, and colleagues concluded. “Invasive tumor within 1 mm of the permanent specimen margin is associated with a significantly higher local recurrence risk, though there is no significant difference for greater distances.

“This study suggests that a cutoff of less than 1 mm identifies patients at increased local recurrence risk who may benefit from additional treatment. Analysis of the tumor specimen, rather than the tumor bed, is necessary for this determination.”

The results add to a growing volume of evidence that margins <5 mm can still be curative, said Michael Burkey, MD, of the Cleveland Clinic, who was not involved in the study. The data also add to evidence that the margins calculated from the main specimen are more predictive than frozen-section margins that many head and neck surgeons have used for years.

“This doesn’t change the fact that clearly getting all the tumor out and clearing margins microscopically are still critical to curative surgery,” Burkey told MedPage Today. “The study provided good data to show that when they got positive margins, even if they subsequently treated with radiation therapy, that led to no improvement in local recurrence.”

“A second key point is that the way we determine the adequacy of surgery is changing,” he added. “We used to say 5 mm, and now it’s probably 1 to 2 mm. More and more we’re finding that the best way to look at margins is off the main specimen, not by taking frozen sections from the tumor bed.”

Despite widespread use in surgical management of head and neck cancers, interpretation of margin status and associated prognostic implications remain imprecise. A survey of head and neck surgeons showed that 83% of respondents considered carcinoma in situ as a positive margin and 17% included dysplasia in the definition. Additionally, 69% of the surgeons used a cutoff of <5 mm between invasive tumor and resection margin to a close margin, consistent with multiple reports in the literature. However, other literature suggested a smaller-distance cutoff is adequate, Sperry’s group noted.

To continue an investigation of the clinical significance and impact of surgical margins in oral-cavity cancer, the authors retrospectively reviewed results in 432 consecutive patients with primary oral-cavity squamous cell carcinoma treated at the University of Iowa from 2005 to 2014. Patients with recurrent disease were excluded from the analysis. The primary outcome was local recurrence as determined by minimum distance in millimeters between invasive tumor and inked main specimen margin.

The patients had a median age of 62, and men accounted for 58% of the study population. T-stage distribution consisted of T1 disease in 45% of patients, T2 in 21%, and T3/4 in 34%. Subsite location was tongue in 45%, alveolus in 21%, floor of the mouth in 18%, and other in 15%.

Rates of local recurrence by margin status were:
44% for microscopic positive margins
28% for margins <1 mm
17% for 1-mm margins
13% for 2-mm and 3-mm margins
14% for 4-mm margins
11% for ≥5-mm margins

“These data demonstrated an exponential inverse relationship between distance and local recurrence, with no appreciable difference in local recurrence for distances greater than 1 mm,” the authors reported.

Local recurrence also was determined on the basis of intraoperative frozen section assessment from tumor bed sampling. The analysis showed similar recurrence rates for close-margin distances between patients with involved and negative frozen sections. Among patients with a positive main specimen margin, those with an involved frozen margin had the highest local recurrence rate at 54%, as compared with 36% for patients with a negative frozen margin.

The authors analyzed the results on the basis of whether additional tissue was resected to achieve a negative margin after initial frozen section indicated cancer. The analysis incorporated collapsed margins of ≥5 mm, 1 to 5 mm, <1 mm, and positive. Success was defined as a final margin uninvolved with either invasive carcinoma or carcinoma in situ after further resection. For patients with a positive main specimen margin, successful additional resection did not improve local control.

“For patients with final margin distances grater than 0 millimeter, the local recurrence rate appeared to be the same whether a successful additional resection of the margin was performed or note,” the authors reported.

Finally, Sperry’s group analyzed local recurrence according to whether patients received adjuvant radiation therapy. For patients with a positive main specimen margin, radiotherapy did not improve local control, and the recurrence rate was the same for the other main-specimen margin categories, regardless of whether radiation therapy was administered.
Study limitations included a relatively small group of surgeons performing the majority of surgical procedures, and the inability to compare results based on different methods of intraoperative margin evaluation, such as tumor bed versus main specimen sampling, the authors noted.

Reviewed by:
Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Primary Source:
JAMA Otolaryngology-Head and Neck Surgery

Source Reference: Tasche KK, et al “Definition of ‘close margin’ in oral cancer surgery and association of margin distance with local recurrence rate” JAMA Otolaryngol Head Neck Surg 2017; DOI:10.1001/jamaoto.2017.0548.

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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).

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Swallowing exercises can improve quality of life for head and neck cancer patients

Source: www.targetedonc.com
Author: Gina Columbus

While patients with head and neck cancer are likely to experience difficulty swallowing after undergoing intesity-modulated radiation therapy (IMRT), Lynn Acton, MS, CCC (SLP) says the use of swallowing exercises can drastically improve muscle movement for these patients both during and after radiation therapy (RT).

In a study conducted by researchers at Dana-Farber Cancer Institute and Brigham Women’s Hospital, patients with head and neck cancer who underwent RT in a 2-year period were evaluated for swallowing difficulty with a video swallow to score stricture and aspiration. Of the 96 patients evaluated who received IMRT once daily, 32% had some aspiration after therapy, while 37% had evidence of stricture following RT.

Studies are currently ongoing to explore the utility of swallowing modalities for these patients. For example, an interventional, randomized, multicenter phase III trial is comparing early-active swallowing therapy versus nonspecific swallowing management (NCT02892487). Researchers are conducting the study to determine that early-active swallowing therapy can improve the quality of life of patients undergoing RT for head and neck cancer.

Additionally, a behavioral questionnaire is evaluating adherence to preventative swallowing exercises and the reasons why patients choose not to follow them (NCT03010150). Patients will complete the questionnaire at baseline and again at 6 months following RT that will discuss adherence to swallowing exercises.

Acton, a lecturer in surgery (otolaryngology) and speech pathologist at Yale School of Medicine, discussed the significance of swallowing modalities for patients with head and neck cancer during and after RT in an interview with Targeted Oncology.

Targeted Oncology: What is the benefit of doing these swallowing exercises for this patient population?

Acton: I spoke about prophylactic exercises for swallowing for patients with head and neck cancer who are undergoing RT. We have found that if we keep the muscles mobile during the treatment, there is less fibrosis of the muscles. If the patients don’t have fibrosis, they are able to move better and have better swallowing function. During the treatment, patients will have some pain. We try to manage that and do things like a mouthwash to numb the area before they do these exercises.

It is more important to keep the muscles mobile because, when a joint like your jaw becomes immobile, the cartilage becomes thinner and the joints becomes inflamed and painful. If we keep the muscles moving, then the function is much greater. We like to [continue] to do the exercises after treatment, because RT can continue to contract the muscles over time. Therefore, patients do the exercises several times during the day and after treatment, too.

Targeted Oncology: Have there been any advancements in this field that have increased the quality of life for these patients even further?

Acton: It is basically a lifelong thing at this point. For young patients, they say they feel relief after doing the exercises. Some of them [are simple] neck exercises, [such as] neck rolls. I do try to tag it in with something that they are already doing during the day. On their smartphone, I’ll put an [alarm] that reminds them to do their exercises on the way to work, or maybe [while] they are reading a newspaper. I [put the written exercises] in the memos section [of their phone] to explain the exercises. Doing those things makes it a positive result. For the patients who do the exercises, we notice that they’re able to maintain their oral opening. Normally, you should be able to put 3 fingers in your mouth.

When I started, I was seeing patients after RT because we didn’t know it was important to keep these muscles mobile [during treatment]. They would be at a 1-finger opening and then we would have to work to stretch the muscles. I’ve also talked to patients after completing their [swallowing exercises] and they no longer have food sticking in their throat. They do work.

Targeted Oncology: What impact does prophylactic swallowing exercises have on patients?

Acton: Well, not everybody is compliant, so we tell them what the negative effects are of not doing the exercises. Some patients have to get a feeding tube because they are not maintaining hydration.

If you do the exercises, you can maintain good swallowing function and [function of the] muscles not only for swallowing. [They also help for] speech; some of the patients will have radiation and have very hoarse voices. I will have to counsel them on how to talk without straining. Their vocal chords become swollen during RT. We teach them how to talk gently so they don’t do further damage to the chords.

Targeted Oncology: How should specialists handle adherence to these exercises?

Acton: It is most important for patients to do the exercises when they least feel like doing them. We want you to take the mouthwash, do the exercises, and if I see the patients I explain to them that this is a very intensive treatment. This [radiation] treatment works, but if you don’t do the things I am going to ask you to do, you are going to have disability after the treatment is done and we want to prevent that.

You have to see the patient frequently. [Seeing] them during RT and after the treatment would be ideal, because patients get a lot of encouragement. I will explain to them that I have seen [other] patients and evaluated their swallowing, and [if it is] perfect and it is because they did the exercises. I also let them know that before we do the exercises, patients will have to increase the oral opening.

Targeted Oncology: Are there any other types of exercises in addition to prophylactic swallowing that are worth mentioning?

Acton: We start with the mouth opening. Today, we are seeing a different population of people versus in the late 80s—it was a lot of type A-personality men and they sometimes found that [these exercises] were hard and [thought that] it was going to be better. It was the complete opposite.

We watch them do the exercises to move the muscles in the neck. Even just a simple, hard swallow can be done every time they eat or drink something, gargling, extreme-yawn positions, and moving the back of the tongue.

The head and neck area is a very narrow area, so I do tailor the exercises to the patient and [explain to them] what they might expect. What can you do if you feel the food sticking in your throat? You can swallow hard; you can swallow twice. I do explain to them the specific things they should do if these things happen. Generally, for anyone who is having RT [in this area] you want them to be able to move their neck and swallow—the RT the beams hit various points.

Targeted Oncology: What are the main points you hope the community oncologists took away from your lecture and what does the future hold?

Acton: In the future, I hope that patients will be able to see these professionals more frequently. It is just important that we see these patients and that they are treated. These exercises are very easy to do; [patients should] not be afraid of doing them.

Reference:
Caglar HB, Tishler RB, Othus M, et al. Dose to larynx predicts for swallowing complications after intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2008;72(4):1110-1118. doi:10.1016/j.ijrobp.2008.02.048.

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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.

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April, 2017|Oral Cancer News|

‘Happy Days’ star Erin Moran’s Husband Reveals Tragic Details about Cancer

Author: Marah Alindogan
Source: www.aol.com
Date: Apr 25th 2017

Erin Moran’s husband, Steve Fleischmann, revealed heartbreaking details about the months leading up to her death in a Facebook post on Tuesday.

New evidence from the Harrison County Sheriff’s Office on Monday suggested that the actress likely died due to complications from stage 4 cancer. The open letter, which was posted on Scott Baio’s official Facebook page, confirmed the report.

“Erin and I met 4/22/1992 and parted ways 4/22/2017,” her husband began the letter.

He recalled that Erin “woke up and had about a dime size blood stain on her pillowcase” right after they got back from a trip to celebrate their wedding anniversary in November of last year. After a couple of days, they kept on finding more blood.

“I get a flashlight and say let me look. It was not her tongue it was her tonsil on the left side. I thought it was tonsillitis,” wrote Fleischmann.

After getting a biopsy, doctors confirmed she had squamous cell carcinoma — a common form of cancer. Shortly after, she started radiation and chemo — five days a week on radiation and chemo only on Thursdays.

However, Erin’s condition slowly deteriorated: “It got so bad so fast. By the middle of February, Erin could no longer speak or eat or drink.”

Despite her poor health, the actress remained in good spirits.

“She was still happy, she was active, she texted people on her phone all day,” Steve added.

The day before her death, April 21, she had trouble breathing. And the next day, Steve claimed she wasn’t 100 percent.

“I laid down next to her held her right hand in my left. I feel asleep woke up about a hour later still holding her hand and she was gone, she was just gone …”

Steve revealed Norton Cancer Institute, where his wife received treatments, “never said how bad it was.”

“The coroner told me it was really really bad. It had spread to her spleen, she had alot of fluid in her lungs and part of her brain was infected,” he shared. “The coroner said even if she was in the hospital being pumped full of antibiotics she still would not of made it. He said it was the best that she was with me and went in her sleep.”

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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.

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April, 2017|Oral Cancer News|