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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.

April, 2017|Oral Cancer News|

Epigenetic modification discovered in adult throat cancers

Source: www.specialtypharmacytimes.com
Author: Lauren Santye, Assistant Editor

An epigenetic modification may be the cause of 15% of adult head and neck cancers that are linked to tobacco and alcohol use, according to a study published in Nature Genetics.

Although the body is made up of a large number of different types of cells––neurons, skins cells, fat cells, immune cells–– they all have the same DNA or genome. It was not until recently that scientists discovered their differences can be explained by epigenetics.

“This discovery was absolutely unexpected since it seemed highly improbable that the kind of alterations of the epigenome that we had previously found in other types of tumors in children and young adults could also target an epithelial tumor like throat cancer that occurs only in adults,” said Dr Nada Jabado.

There are already some promising drug molecules currently on the market for other diseases that could be tested for head and neck cancers, as well as other cancer types, according to the study. Additionally, the investigators hope that the findings could help in developing treatments for pediatric patients.

“Now that we’ve identified this cohort of patients, we can move quite quickly since the case of adults, as opposed to children, there are more patients and lots of clinical trials,” Dr Jabado said. “The medicines could then be tested on children afterward.”

Dr Jabado’s work focuses on epigenetics in pediatric cancers, particularly on the mutations of the histone H3 protein. In particular, the investigators were interested in a 2015 publication by the Tumor Cancer Genome Atlas Consortium on head and neck cancer that included 1 of the genes that regulates H3.

“We made use of the same data but took a completely different approach,” said principal study author Dr Jacek Majewski. “Instead of concentrating on genetic mutations, we looked at the effect of these mutations on histone H3 proteins. That’s when we discovered that the histone H3 protein was abnormal or incorrectly modified in about 15% of patients with head and neck cancer. The data were there, but this fact had gone unnoticed.”

An essential part of the study was collaboration between scientists and access to the vast genomic databases of patients around the globe, according to the investigators.

“It’s crucial to have access to public data, because it allows us to advance faster and go further in our analyses,” Dr Jabado said. “In our case, this discovery revealed a sub group of patients who might benefit from a therapy that targets the epigenome. This could improve the treatment of more than 1 in 5 patients suffering from devastating oropharyngeal cancer. We are currently collaborating with 2 big groups specializing in head and neck cancer with the goal of finding treatments.”

The investigators are hopeful that the results of the study will open a variety of treatment options in the future.

January, 2017|Oral Cancer News|

Genetic variants are associated with susceptibility to mouth and throat cancer

Source: www.eurekalert.org
Author: news release

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

December, 2016|Oral Cancer News|

Mouth cancer rates soar over 20 years

Source: www.sciencedaily.com
Author: staff

A new Cancer Research UK analysis reveals that rates of mouth (oral) cancer have jumped by 68 per cent1 in the UK over the last 20 years. The figures — released during Mouth Cancer Action Month — reveal the cancer is on the rise for men and women, young and old, climbing from eight to 13 cases per 100,000 people over the last two decades.

For men under 50, the rate has jumped by 67 per cent in the last 20 years2 — going up from around 340 cases to around 640 cases each year. For men aged 50 and over, rates have increased by 59 per cent climbing from around 2,100 cases to around 4,400 cases annually.

Oral cancer is more common in men, but there have been similar increases women3.

In women under 50, oral cancer rates have risen by 71 per cent in the last 20 years, with annual cases climbing from around 160 to around 300. Rates for women over 50 have also gone up by 71 per cent, with cases increasing from around 1,100 to around 2,200.

Around nine in 10 cases are linked to lifestyle and other risk factors. Smoking is the biggest avoidable risk factor, linked to an estimated 65 per cent of cases. Other risk factors include alcohol, diets low in fruit and vegetables, and infections with the Human Papilloma Virus (HPV).

Oral cancers include cancer of the lips, tongue, mouth (gums and palate), tonsils and the middle part of the throat (oropharynx)4.

Cancer Research UK — working with the British Dental Association — has developed an oral cancer toolkit5 to help GPs, dentists, nurses and hygienists spot the disease and refer suspected cases sooner.

Jessica Kirby, Cancer Research UK’s senior health information manager, said: “It’s worrying that oral cancer has become more common. It’s important to get to know your body and what’s normal for you, to help spot the disease as early as possible. An ulcer or sore in your mouth or tongue that won’t go away, a lump on your lip or in your mouth, a red or red and white patch in your mouth or an unexplained lump in your neck are all things to look out for. Speak to your GP or dentist about any changes that are unusual or don’t go away.

“Healthy lifestyles can help reduce the risk of developing the disease in the first place. Not smoking, drinking less alcohol and eating plenty of fruit and vegetables can all help to cut our risk of mouth cancer. HPV vaccination could help protect against oral HPV infections, and it can prevent a range of cancers associated with the HPV virus, so it’s a good idea to get the vaccine if you are offered it.”

With smoking being the biggest preventable cause of oral cancer, Cancer Research UK is also calling on the public and local councillors to help protect vital Stop Smoking Services. These specialist services are the most successful way for people to quit smoking.

Andrea Fearon, 47 from Newbury, was diagnosed in 2013 with mouth cancer after a routine checkup by her dentist.

Andrea said: “I had thought that most people with mouth cancer are heavy smokers over the age of 50, so I completely shocked when I was diagnosed with the disease. I’m proof that this type of cancer isn’t limited to a particular age or sex. I thought seeing the dentist was about looking after your teeth — but it can save your life. It’s thanks to my dentist that the mouth cancer was caught early — that’s why I feel so lucky to be alive.”

Notes:
1. Based on oral cancer incidence rates for all ages, persons, from 8 cases per 100,000 people between 1993-1995 to 13 cases per 100,000 people between 2012-2014.

2. Based on oral cancer incidence rates, for males aged 0-49, the rise is from two cases per 100,000 males between 1993-1995 to three cases per 100,000 males between 2012-2014. For men aged 50 and over, this rise is from 26 cases per 100,000 between 1993-1995 to 41 cases per 100,000 men between 2012-2014.

3. Based on oral cancer incidence rates, for females aged 0-49 years, the rise is from one case per 100,000 females between 1993-1995 to two cases per 100,000 females between 2012-2014.

For women aged 50 and over, the rise is from 11 cases per 100,000 women between 1993-1995 to 18 cases per 100,000 women between 2012-2014.

Cases are based on the number of new diagnoses between 1993-1995 and between 2012-2014.

4. Oral cancer includes ICD-10 C00-C06, C09-C10 and C12-C14 (which include the lip, tongue, mouth, oropharynx, piriform sinus, hypopharynx and other and ill-defined sites of the lip, oral cavity and pharynx).

For the latest oral cancer statistics visit the Cancer Research UK statistics webpage http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/oral-cancer

5. The toolkit covers the signs to look out for, how to respond, as well as possible risk factors for oral cancer. The toolkit also features a detailed image library, a referral guide, case studies, examination videos and a CPD accredited quiz.

Story Source:
Materials provided by Cancer Research UK. Note: Content may be edited for style and length.

November, 2016|Oral Cancer News|

For this cancer, ‘stage 4’ isn’t as bad as it sounds

Source: www.omaha.com
Author: Steve Hendrix – The Washington Post

Hearing the word “cancer” in a doctor’s office is bad enough. Hearing “stage 4” invokes even more dread. When I learned I had stage 4 HPV-related oral cancer, I didn’t know exactly what it meant, but I knew there wasn’t a stage 5.

Doctors use the standardized staging system to describe the location, size and extent of a cancer and its spread throughout the body. Using data on the treatment and survivability of each particular kind of cancer, clinicians combine these factors to produce a number from stage 1 (a small tumor confined to one spot) to stage 4 (a cancer that has spread, either to a single adjacent lymph node or to distant organs).

My cancer was stage 4A, a small tumor at the base of my tongue that had spread to a single lymph node in my neck.

My doctor immediately tried to soften the blow. There were problems with the staging rules as they applied to this kind of cancer, he said. HPV oropharyngeal cancers, while potentially fatal, were far more treatable than other oral cancers, particularly the ones related to tobacco and alcohol use that were used to define the staging standards.

He was right. A study published in the Lancet early this year found that the current guidelines lead to needless panic for the newly diagnosed. “At the present time, most patients with HPV+ oropharyngeal cancer are told they have (stage 4) disease, but the reality is that their outlook is similar to that of patients with the most curable malignant diseases,” the study authors wrote.

This month, the American Joint Committee on Cancer is releasing new guidelines for HPV-positive oropharyngeal cancer staging that will ease patient fears and make it easier for doctors to offer less-invasive treatment options.

“It’s remarkable,” said my own physician, Arjun Joshi of George Washington University. “Under the new system, you would only be a stage 1.”

November, 2016|Oral Cancer News|

HPV and mouth cancer

Source: www.hippocraticpost.com
Author: Thea Jourdan

hpv

Mouth cancer kills nearly 2000 people in the UK each year. The Human Papilloma Virus (HPV) of which there are over 100 different types, is more commonly associated with cervical cancer and genital warts, but it can also cause oral cancer, particularly of the back of the tongue and tonsils. The virus incorporates itself into the cell’s DNA and causes the cell to multiply out of control, leading to cancer.

In Britain, the number of mouth and throat cancers have increased by 40 per cent in just a decade, to 6,200 cases a year. According to Cancer Research UK, the HPV virus, which is transmitted to the mouth region from the genitals during oral sex, may be key to the ‘rapid rise’. Statistics also show that the more sexual partners you have the greater your chance of acquiring mouth cancer.

“There is now scientific evidence that a proportion of mouth and throat cancers are linked to HPV infection,” says Hazel Nunn, head of health information at Cancer Research UK. “We know that HPV is found in the mouth but we do not yet know how it gets there – whether through oral sex or otherwise. HPV virus has been found on the fingers and elsewhere on the body. It is possible that oral sex is having an impact but more research needs to be done into the kinds of behaviour that leads to this infection.”

“HPV has been causing mouth cancer for decades but the link is only now becoming clear. HPV is a hardy virus that likes sitting in lymphoid tissue wherever it is in the body,” explains Professor Mark McGurk, a senior consultant ENT surgeon based at London Bridge Hospital in London. That means it thrives in the lymphoid tissue in the mouth, including that of the tonsils and at the base of the tongue. For the same reason, it settles in the cervix, the vulva and around the anus.

For many people, HPV won’t cause any problems at all. “In fact, we know that 80 per cent of women and men will have the HPV infection at some time in their lives and clear it themselves without any symptoms,” explains Mr Mike Bowen, a consultant obstetrician and gynacologist based at St John and St Elizabeth Hospital in London. “But for a few it can cause cellular changes that lead to cancer.”

Professor McGurk says that over the last 30 years, he has seen a rise in oropharyngeal cancer, which typically affects sexually active men in their 50s and 60s. “They may have been infected with the virus for some time and ,” he explains. The cancer reveals itself as growths on the tonsils and back of the tongue.

Many patients are only diagnosed at the late stage of their disease. Michael Douglas, the actor, already had stage 4 cancer when his cancer was recognized. Fortunately, oral cancer caused by HPV is very treatable, even when it is very advanced, using radiotherapy. “We used to do surgery on these cases, but we don’t need to anymore. In many cases, the cancer simply melts away with radiotherapy,” explains Professor McGurk. Patients with stage 1 and 2 Oral cancer caused by HPV have an 85 per cent chance of surviving for 5 years after treatment, and patients with stage 4 disease have a 60 per cent chance of surviving five years – impressive compared to the survival rates for other types of oral cancer where overall survival is 50 per cent over 5 years. [Cancer Research UK]

Cancer research UK is pushing for all mouth tumors to be tested to see if they are HPV positive, to assist with effective treatment of patients. “At the moment, it varies massively depending on what hospital you are in. We think it should be standard,” says Hazel Nunn.

Professor McGurk believes there is a simple explanation why men are more likely to have HPV in their mouths than women. “Women harbor the virus in their genitalia which provides a hospitable environment while the male penile area is a relatively hostile area for the virus to settle.”

One way to try and turn the tide would be to introduce a HPV vaccination for boys and girls before they become sexually active. Girls from the age of 12 in the UK have been offered vaccinations since 2008 against the two most common strains of HPV -16 and 18- which are linked to cervical cancer.

Boys are not offered the vaccine, but this should change, according to Professor Margaret Stanley, a virologist based at Cambridge University who believes that boys must be given the vaccine for HPV too from the age of 12 or 13.

‘Obviously cervical cancer is the big one but the other cancers – cancers of the anus and increasingly the tonsil and tongue – there is no screening for them and no way of detecting them until they are proper cancers and they are more common in men than in women.’

Hazel Nunn of Cancer Research UK points out that there is no evidence that vaccinating boys will help protect them from oral cancer. “It is theoretically possible but there have been no trials that had this as an end point. There is a danger that we get too far ahead of ourselves without evidence-based medicine.”

She insists that although HPV is a worrying factor, by far the most significant risks associated with mouth and throat cancers of all types are smoking and alcohol. “

November, 2016|Oral Cancer News|

The startling rise in oral cancer in men, and what it says about our changing sexual habits

Source: www.washingtonpost.com
Author: Ariana Eunjung Cha

Oral cancer is on the rise in American men, with health insurance claims for the condition jumping 61 percent from 2011 to 2015, according to a new analysis.

oc2

The most dramatic increases were in throat cancer and tongue cancer, and the data show that claims were nearly three times as common in men as in women during that same period with a split of 74 percent to 26 percent.

The startling numbers — published in a report on Tuesday by FAIR Health an independent nonprofit — are based on a database of more than 21 billion privately billed medical and dental claims. They illustrate both the cascading effect of human papillomavirus (HPV) in the United States and our changing sexual practices.

The American Cancer Society estimates that nearly 50,000 Americans will be infected this year, with 9,500 dying from the disease. In past generations, oral cancer was mostly linked to smoking, alcohol use or a combination of the two. But even as smoking rates have fallen, oral cancer rates have remained about the same, and researchers have documented in recent studies that this may be caused by HPV.

HPV infects cells of the skin and the membranes that lines areas such as the mouth, throat, tongue, tonsils, rectum and sexual organs. Transmission can occur when these areas come into contact with the virus. HPV is a leading cause of cervical, vaginal and penile cancers.

Surveys have shown that younger men are more likely to perform oral sex than their older counterparts and have a tendency to engage with more partners.

“These differences in sexual behavior across age cohorts explain the differences that we see in oral HPV prevalence and in HPV-related oropharyngeal cancer across the generations and why the rate of this cancer is increasing,” Gypsyamber D’Souza, an associate professor in the Viral Oncology and Cancer Prevention and Control Program at the Johns Hopkins Bloomberg School of Public Health, said at the time. The work was published in the Journal of Infectious Diseases.

In February, researchers at the American Association for the Advancement of Science meeting reported that men are not only more likely to be infected with oral HPV than women but are less likely to clear the infection. It’s not known why oral HPV is more aggressive in men.

oc1

HPV is an extremely common virus that has infected nearly 80 million, or one in four, people in the United States. Fortunately, the risk of contracting HPV can be greatly reduced by a vaccine. HPV has become a public health priority in recent years with dozens of countries recommending universal vaccination. The Centers for Disease Control and Prevention recommends that children get it at the age of 11 or 12, although they may get vaccinated as early as 9 years old. The CDC said earlier this month that young people who get it before the age of 15 need two doses rather than the typical three.

A CDC study has found that although fewer teenagers and young adults are having sex than in previous years, more are engaging in oral sex than vaginal intercourse under the assumption that it’s safer.

“However, young people, particularly those who have oral sex before their first vaginal intercourse, may still be placing themselves at risk of STIs or HIV before they are ever at risk of pregnancy,” the researchers wrote in the 2012 report.

October, 2016|Oral Cancer News|

Forgotten patients: New guidelines help those with head-and-neck cancers

Source: www.fredhutch.org
Author: Diane Mapes and Sabrina Richards

Stigma, isolation and medical complexity may keep patients from getting all the care they need; recommendations aim to change that.

Like many cancer patients, Jennifer Giesel has side effects from treatment.

There’s the neuropathy in her hands, a holdover from chemo. There’s jaw stiffness from her multiple surgeries: an emergency intubation when she couldn’t breathe due to the golf ball-sized tumor on her larynx and two follow-up surgeries to remove the cancer. And then there’s hypothyroidism and xerostomia, or dry mouth, a result of the 35 radiation treatments that beat back the cancer but destroyed her salivary glands and thyroid.

“I went to my primary care doctor a couple of times and mentioned the side effects,” said the 41-year-old laryngeal cancer patient from Cleveland, who was diagnosed two years ago. “She was great but she didn’t seem too knowledgeable about what I was telling her. She was like, ‘Oh really?’ It was more like she was learning from me.”

Patients like Giesel should have an easier time communicating their unique treatment side effects to health care providers with the recent release of new head-and-neck cancer survivorship guidelines. Created by a team of experts in oncology, primary care, dentistry, psychology, speech pathology, physical therapy and rehabilitation (with input from patients and nurses), the guidelines are designed to help primary care physicians and other health practitioners without expertise in head-and-neck cancer better understand the common side effects resulting from its treatment. The goal is that they’ll then be able to better make referrals or offer a holistic plan for patients to get the support they need.

“Head-and-neck cancer survivors can have enormous aftereffects from the disease and treatment by virtue of the location of the primary tumor,” said Dr. Gary Lyman, a public health researcher with Fred Hutchinson Cancer Research Center who helped create the guidelines. “There are functional interruptions, like losing the ability to talk, eat or taste. And some of the surgeries can be disfiguring.

“I’m really glad the American Cancer Society decided to take this on,” he said. “These guidelines are sorely needed, long overdue and will serve cancer patients who are incredibly affected — both physically and emotionally.”

Currently, there are more than 430,000 head-and-neck cancer, or HNC, survivors in the U.S., accounting for around 3 percent of the cancer patient population.

As with many other cancers, HNC is an umbrella term for a number of different malignancies, including cancers that develop in or around the mouth, tongue, throat, nose, sinuses or larynx. Brain, thyroid and esophageal cancer are not considered head-and-neck cancers.

HNC has traditionally been linked to tobacco and alcohol use, and about 75 percent of HNC are related to these risk factors. Increasingly, though, human papillomavirus, or HPV, is causing a significant number of head-and-neck cancers (another reason why the HPV vaccine is such an important prevention tool).

An isolating group of diseases
For some patients with HNC, there can be a certain amount of stigma and isolation, due to its association with drinking and smoking. Treatment can also isolate patients since it sometimes mars a person’s appearance or alters their speech.

Some patients, literally, have no voice.

HNC’s complicated nature — it’s not one disease but several, all of which behave and respond to treatment differently — also results in very small patient populations, which can hinder research.

“Head-and-neck cancer patients have historically been somewhat ignored,” said Lyman, an oncologist with Seattle Cancer Care Alliance, Fred Hutch’s treatment arm. “Many view this as a lifestyle-associated cancer, like lung cancer, heavily influenced by tobacco exposure and [drinking] alcohol to excess. And people may have difficulty dealing with the appearance of some of the more severely affected patients.”

t’s a sentiment echoed by Dr. Eduardo Méndez, a Fred Hutch clinical researcher and head-and-neck cancer surgeon at SCCA.

“It’s in a location that affects your appearance, it affects your ability to speak and to swallow, and those are all things that you need to interact with others,” he said. “It can have an effect of shutting you down from the rest of society. Even the treatment for head-and-neck cancer can have consequences that affect those very same things that the tumor was affecting — swallowing, speech, appearance.”

Not surprisingly, many HNC survivors suffer from depression and/or body image and self-esteem issues after diagnosis and treatment.

“I struggle with body image issues every day,” said Beci Steelman, a 42-year-old court clerk from Bushnell, Illinois, who went through radiation and eight surgeries, including a total right maxillectomy (a surgery of the upper jaw), after being diagnosed with a rare head and neck tumor in 2010.

“You can see that my eye looks like someone’s pulling it halfway down my cheek,” she said. ”My mom and I just call it my googly eye and joke that I have ‘really good face days’ and others that are just ‘face days.’ Clearly something’s not right. When I smile, you can see a bit of metal from the obturator, this weird rubbery dental piece that plugs the hole in the roof of my mouth. Some days I just feel like I’m so ugly.”

Holistic approach benefits patients
There is good news with these cancers: most patients are diagnosed with HNC in its early, most curable stages.

“The majority will be completely functional and normal [after treatment],” said Dr. Christina Rodriguez, the medical oncologist who oversees the majority of HNC patient care at SCCA.

According to the National Comprehensive Cancer Network, around 80 to 90 percent of early stage patients (stage 1 and 2) go into remission after receiving surgery or radiation. Advanced stage patients (stage 3 and 4) receive more aggressive treatment and have lower cure rates, with the exception of patients with HPV-related head-and-neck cancers. Their 5-year cure rates are close to 90 percent.

But even those who go into remission may have to contend with a constellation of difficult side effects.

The head and neck area is “like a fine-tuned machine,” said Dr. Keith Eaton, a medical oncologist at SCCA and Fred Hutch who specializes in lung cancer and HNC. “There are so many dedicated structures that we can’t do without. If you get rid of half your liver, not a problem. If your epiglottis doesn’t work, you aspirate.”

In addition to trouble with swallowing and speech, stiffness in the jaw and problems with shoulder and neck mobility, HNC patients can be left with hypothyroidism, hearing loss, taste issues, periodontitis and lymphedema, the swelling that comes after lymph nodes are surgically removed, a common step in cancer treatment. Because of this complexity, patients need a holistic approach, said Méndez.

Steelman’s cancer extended to the orbital floor of her right eye which meant she had to undergo extensive surgery to her face including the removal of four back teeth, an incision to the roof of her mouth and the shortening of a jaw muscle.

“They got the tumor out and then put me back together,” she said. “I feel like Humpty Dumpty.”

She now wears a prosthetic (which requires daily maintenance) and has had injectable fillers to help with the atrophy around her right eye (an implant in the area became infected and had to be removed). She’s lost hearing in her right ear, her speech is sometimes “a little marble-y,” she has dry mouth from damage to her salivary glands and her jaw will not open as wide as it once did.

Steelman tapped a number of specialists to help her deal with these issues, including an otolaryngologist (ear, nose and throat doctor), speech pathologist, a prosthodontist (an expert in the restoration and replacement of teeth) and a plastic surgeon.

“You have to be your own advocate,” she said. “You learn that very quickly.”

Get help early
Physical therapists, speech pathologists, dietitians and providers with expertise in palliative and pain care (also called supportive care) can improve survivors’ quality of life enormously, especially when therapy is started early.

“Careful — and early — attention to side effects and treatment-related complications can help optimize survivors’ quality of life,” said Eaton, the SCCA oncologist.

Dr. Elisabeth Tomere, a physical therapist at SCCA, said she and her colleagues prescribe exercises that help patients regain strength, range of motion and tissue flexibility that surgery and/or radiation may have diminished. Some patients, for instance, need help building up their trapezius muscle to improve shoulder function they have lost after neck surgery. Others need to learn movements that strengthen the front of their necks and the muscles needed to maintain posture.

Patients with lymphedema in the face and neck — a common side effect from HNC treatments — can also benefit from early intervention by a physical therapist, said Tomere.

“These issues are all helpful to address as quickly as possible so they’re not ongoing,” she said, adding that it may take up to two years for patients to mentally and physically recover from treatment.

“We try to give people a realistic timeline,” she said.

The new ACS guidelines should help providers without expertise in head-and-neck cancers find the right specialists for their patients, she said.

Cancer physical therapy, while new, is becoming more standard. Both the American Physical Therapy Association and the Lymphology Association of North America allow providers or patients to search for specialized physical therapists near them — a boon to primary care providers who are not “connected to that world,” said Tomere.

Dietitians can play a key role, too, since many HNC patients struggle to eat. Treatments can cause dry mouth, taste changes or make chewing difficult. Food can become unappetizing or difficult to ingest.

“There’s an emotional component. Food becomes medicine,” said Linda Kasser, an SCCA dietitian and specialist in oncology nutrition. Patients must eat to keep their weight up, “but it can become exhausting … Sometimes they need to force themselves to eat. They feel pressured, which can contribute to family tensions and even food aversions.”

Dietitians can offer approaches to help patients maintain their weight and strength, from using new cooking strategies to make food more palatable to recommending temporary feeding tubes inserted into the stomach that help patients avoid the pain of chewing and swallowing altogether. They also help alleviate patients’ worries about food and separate “nutrition fallacy from fact,” said Kasser.

Not surprisingly, communication is strongly emphasized in the guidelines.

“We wanted to make sure that there is open communication between the providers and caregivers,” said Lyman. “That there’s a care plan that the patient understands and the caregiver understands. All the different specialists involved in the care should be on the same page.”

The new guidelines also emphasize lifestyle choices that will help to reduce the risk of HNC recurrence and secondary cancers: smoking cessation, limiting use of alcohol, regular exercise and good oral hygiene.

Exciting new research
Chemotherapy, radiation and surgery remain the standard of care for HNC — and drive many of the side effects covered by the new ACS care guidelines — but recent advances are making researchers like Méndez very optimistic for future care.

Thanks to advances in genomics, researchers now know that the mutations found in head and neck tumors vary widely.

“One size will not fit all,” said Méndez. “Treatment will have to be individualized.”

Méndez is leading efforts at Fred Hutch to develop tailored therapies based on the cancer’s genomic mutations, zeroing in on cancer cells’ “Achilles heels” — molecular pathways that tumor cells rely on to survive but that normal cells can do without. The approach is already paying dividends: Méndez is currently leading a clinical trial of a drug he and his team identified that exploits a vulnerability unique to head and neck tumors missing a key gene called p53.

“Once we understand the genotype driving tumor growth, strategies [for treatment] can become more targeted, more effective and less toxic,” he said.

New robotic-assisted surgery has also transformed the procedure for certain patients with tumors in the larynx and at the base of the tongue, allowing surgeons to perform fewer incisions and better preserve functions like swallowing and speech, he said.

Immunotherapy also looks like a very promising path to better HNC treatments.

“New immunotherapy drugs are getting FDA approval for head and neck cancer,” said Méndez. “I think in the next few years we will see it moving to a first-line therapy. It’s a very exciting time for head and neck cancer.”

For patients like Steelman and Giesel, that’s great news.

“I had a social worker who helped me get through the thick of [treatment], but nobody talked about what it would be like when treatment was over,” said Giesel, who had to teach herself how to swallow food a new way (she no longer has an epiglottis). “I thought I’d be returned to myself and I’d be fine, but it was not like that in any way.”

These new guidelines, she said, will help patients like her get the help they truly need.

“Primary care doctors need to know about the physical and emotional effects,” she said. ”I have a lot of good support and know how to ask for help, but I can’t imagine how [patients] who don’t know how to ask for help explain how they’re feeling.”

Do you or someone you love have a head-and-neck cancer? Join the conversation about treatment challenges and how the new guidelines might help on our Facebook page.

About the authors:
Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor and patient advocate, she writes the breast cancer blog doublewhammied.com and tweets @double_whammied. Reach her at dmapes@fredhutch.org.

Sabrina Richards is a staff writer at Fred Hutchinson Cancer Research Center. She has written about scientific research and the environment for The Scientist and OnEarth Magazine. She has a Ph.D. in immunology from the University of Washington, an M.A. in journalism and an advanced certificate from the Science, Health and Environmental Reporting Program at New York University. Reach her at srichar2@fredhutch.org.

Note:
1. Original article available at: http://www.fredhutch.org/en/news/center-news/2016/04/new-survivorship-guidelines-spotlight-head-and-neck-cancers.html

April, 2016|Oral Cancer News|

A small revolution in cancer treatment by Belarusian and U.S. scientists

Source: http://eng.belta.by/
Author: Igor Belotserkovsky

Scientists from Belarus and the United States have developed a new method for detecting residual cancer cells. This method also contributes to their destruction. This is done with the help of nanobubbles generated in some cancer cells. The method was successfully tested on laboratory mice with implanted head and neck cancer cells. Although scientists are only at the beginning of the road, they call their discovery a small revolution in the fight against cancer.

The results of the research titled “Intraoperative diagnostics and elimination of residual microtumors with plasmonic nanobubbles” was published in the prestigious science journal Nature Nanotechnology on 15 February. To learn more about the successes of oncologists, BelTA talked to Igor Belotserkovsky, PhD in Medical Sciences, one of the authors of the research, the leader of the head and neck tumor research team at the Aleksandrov National Cancer Center.

Mr Belotserkovsky, what is the share of head and neck tumors in the structure of other localizations?
In the total structure of oncological morbidity, the share of head and neck tumors is 3-4% (excluding skin cancer). Larynx and oral cavity cancer are diagnosed most frequently. For example, in 2014 laryngeal cancer was detected in 604 Belarusians, oro-pharyngo-laryngeal cancer in 1,338 people. Men fall ill ten times more often.

Despite the fact that head and neck cancers are categorized as tumors of outside localization, many patients with cancer have their disease diagnosed when it has already reached an advanced stage. This is due to the social aspect. In most cases cancer patients are alcohol and smoking abusers. In 2014, 50% of laryngeal cancer cases were found at an early stage, as was 30% of cases of oral cavity cancer.

Why has it been decided to test the new method specifically on head and neck tumors?
Head and neck account for 9% of the total body surface area. Yet, this is where many important organs are located. If one of these organs is affected by cancer, oncologists have to work in a small body region. When removing a tumor, a surgeon cannot cut out much of the normal tissue surrounding it. He has to remove the parts affected by cancer and ensure no damage is done to vitally important structures.

For this reason, the radicality of head and neck cancer surgeries is strongly debated. Some reputable specialists believe that many head and neck surgeries are conditionally radical. We remove the visible tumor, and some unnoticed microscopic metastatic cancer cells may remain in the body. These cells cause cancer recurrences that are more difficult to treat, because they are more resistant to drugs, chemotherapy, and radiation therapy.

What is special about this new treatment method?
Its breakthrough nature is seen in our ability to spot and eliminate residual cancer cells during the surgery, right after the removal of the visible tumor. Today there is no fast, accurate and safe method for detection of individual cancer cells and microtumors in the tumor removal zone to be used during the surgery.

The method is based on the utilization of gold nanoparticles and laser radiation to generate nanobubbles inside tumor cells. The nanobubbles, in turn, are detected with an acoustic probe. For this purpose, the gold nanoparticles are decorated with special antibodies that identify cancer cells and gather in clusters only around the tumor, thereby ensuring no damage is done to healthy tissue.

The approach has been successfully tested on lab mice. The animals of the research and control groups underwent the same operations to remove implanted head and neck tumors. With additional minimal surgery conducted after detection of residual cancer cells with plasmonic nanobubbles, the survival rate in the research group was 100%. Meanwhile, the control group mice underwent only a standard surgery and died of progressing tumor. By the way, nanobubbles helped eliminate inoperable microtumors.

The idea is to reduce the frequency of tumor recurrence. The procedure is as follows: a patient gets an injection with gold nanoparticles before the surgery. After the tumor is removed, the tumor bed is treated with laser which activates nanobubbles that quickly expand and burst, ripping apart the residual cancer cells.

We expect that the new method will help reduce the number of local recurrences. It will allow a maximum radical removal of tumors. Oncologists will be able to eliminate cancer cells, which may cause recurrences, at the microlevel.

When do you plan clinical tests?
We are ready to conduct the tests, here in Belarus. Our center has a high level of credibility in research. Foreign companies annually run nearly 30-40 clinical tests in the Aleksandrov National Cancer Center.

However, it is still early to talk about the date for clinical testing of the new method. There is a certain algorithm to follow. It can take up 3 to 4 years from research to the final product.

What are the prospects for the plasmonic nanobubbles technology?
Proceeding from the results of the experiment, we can say it is a small victory over cancer. However, I would like to reiterate that in interpreting our successes we do not go beyond the framework of the experiment. In the future this technology can be used to treat other types of cancer.

How long did the research take? Who financed the studies?
This is a Belarusian-U.S. project launched some three years ago. Dmitry Lapotko, head of laser science at medical nanotechnology group Masimo Corporation, is the leading researcher. The project was financed by Gillson Langenbough Foundation, Houston, TX and the National Science Foundation of the United States.

Thank you for the interview. We wish you every success with this important project.

February, 2016|Oral Cancer News|

Rodeo Insider: Cowboy takes it on himself to ride home a message

Source: www.star-telegram.com
Author: Brett Hoffman
 
0125 rodeoBronc rider Cody Kiser is trying to encourage cowboys to abstain from tobacco. Richard W. Rodriguez Star-Telegram

 

In a day when rodeo riders are approaching the sport from an athletic standpoint more than ever, there’s a heavier emphasis on physical fitness and many competitors are taking a closer look at abstaining from substances such as alcohol and tobacco.

One cowboy attempting to send a message about abstaining from frequent tobacco consumption is bareback bronc rider Cody Kiser.

“A lot of these cowboys don’t smoke or chew, and if they do, it’s really rare,” Kiser said. “A lot of the guys consider themselves as athletes. So they want to keep their bodies at an optimum performance and they don’t want to do anything that would break them down.”

When the Fort Worth Stock Show conducted the opening performance of its 16-day Professional Rodeo Cowboys Association show on Friday, Kiser turned in a bareback score of 80, the highest marking of the night.

As he competed in the renowned rodeo, Kiser wore a patch on his shirt that said: “Oral Cancer Foundation.”

The foundation’s website lists Kiser and a spokesman and states: “The western/rodeo environment has had a long-term relationship with tobacco, and until 2009 the PRCA had a lengthy history of tobacco sponsorship money. While that has ended, tobacco use, and smokeless/spit tobaccos still thrive in the sport. While adults have the right to make any lifestyle choice, they inadvertently expose impressionable young people to what are sometimes harmful habits though poor examples like the use of tobacco products. This is particularly harmful as kids look up to athletes.”

Kiser, 25, who is from Carson City, Nev., aspires to set a great example.

“My message is for the younger generation, to expand the sport of rodeo and help it become more mainstream,” he said. “Rodeo can be like NASCAR. When NASCAR started getting rid of most of their alcohol and tobacco sponsors and then started bringing in sponsors such as Tide and Kellogg, which are more family oriented, then the sport exploded. Today, there’s so much more money in NASCAR and it can become the same for rodeo.”

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