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    Testimony by otolaryngologists in defense of tobacco companies 2009–2014

    Fri, Jul 31, 2015

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    Source: www.onlinelibrary.wiley.com
    Author: Robert K. Jackler, MD
     

    Abstract

    Objectives/Hypothesis

    To examine expert testimony offered by otolaryngologists in defense of the tobacco industry and to assess whether opinions rendered were congruent with evidence in the scientific literature.

    Methods

    Data sources include publically available expert witness depositions and trial testimony of board-certified otolaryngologists employed by the tobacco industry in defense of lawsuits brought by smokers suffering from head and neck cancer. The cases, adjudicated in Florida between 2009 and 2014, focused on whether smoking caused the plaintiff’s cancer.

    Results

    The study includes nine legal cases of upper aerodigestive tract cancer involving six otolaryngologists serving as expert witnesses for the tobacco industry. Cancer sites included larynx (5), esophagus (2), mouth (1), and lung (1). Five of the six otolaryngologists consistently, over multiple cases, offered opinions that smoking did not cause the plaintiff’s cancer. By highlighting an exhaustive list of potential risk factors, such as human papillomavirus (HPV), alcohol, asbestos, diesel fumes, salted fish, mouthwash, and even urban living, they created doubt in the minds of the jurors as to the role of smoking in the plaintiff’s cancer. Evidence shows that this testimony, which was remarkably similar across cases, was part of a defense strategy shaped by tobacco’s law firms.

    Conclusions

    A small group of otolaryngologists regularly serve as experts on behalf of the tobacco industry. Examination of their opinions in relation to the scientific literature reveals a systematic bias in interpreting the data relating to the role played by smoking in head and neck cancer causation.

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

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    Mouth rinse could help predict recurrence of HPV-related oropharyngeal cancers

    Fri, Jul 31, 2015

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    Source: www.eurekalert.com
    Author: Barbara Benham of Johns Hopkins University Bloomberg School of Public Health

    In small study, patients with HPV traces post-treatment were more likely to have cancer recurrence; finding could lead to new monitoring protocols. – Johns Hopkins University Bloomberg School of Public Health

    Oropharyngeal cancer patients who were found to have detectable traces of human papillomavirus type 16 (HPV16) in their saliva following cancer treatment are at an increased risk for recurrence, a study led by researchers at the Johns Hopkins Bloomberg School of Public Health has found.

    The oropharynx is the area of the upper throat that includes the back of the tongue, the soft palate, the tonsils and the walls of the throat. Oropharyngeal cancer accounts for 2.8 percent of new cancers in the United States; it is often treated successfully with surgery.

    In a small study, seven percent (five of 67) of oropharyngeal cancer patients who had HPV16 DNA in their oral rinse at the time of diagnosis were later found to still have traces of HPV16 DNA in their oral rinse following treatment. Of these, all developed a local recurrence of the cancer. The finding, believed to be the first of its kind, could lead to to new follow-up protocols for oropharyngeal cancer patients, the researchers say.

    The study is published July 30 in the journal JAMA Oncology.

    “It’s a very small number so we have to be somewhat cautious,” says Gypsyamber D’Souza, PhD, an associate professor in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health and a member of the Sidney Kimmel Comprehensive Cancer Center. “The fact that all of the patients with persistent HPV16 DNA in their rinses after treatment later had recurrence meant that this may have the potential to become an effective prognostic tool.”

    For their study, researchers tracked 124 patients who had been diagnosed with oropharyngeal cancer, collecting oral rinses from patients at the time of diagnosis and again following treatment, at nine, 12, 18 and 24 months after diagnosis. Patients were asked to rinse and gargle with Scope mouthwash. Of the 124 patients, slightly over half had oral HPV16 DNA in their oral rinse at the time of their cancer diagnosis. Most patients no longer had HPV DNA detectable in their oral rinse after completing treatment, but some did.

    The researchers do not know if the presence of HPV16 DNA in the post-treatment rinse means that the treatment did not completely eradicate the cancer in the first place or if the cancer returned. Either way, the finding suggests that a simple oral rinse could be a powerful diagnostic tool for the reappearance of this type of oral cancer.

    HPV is associated with several types of cancer, most notably cervical and oral cancers. Incidence of HPV-associated cancers is increasing in the United States and the virus is responsible for the majority of oropharyngeal cancer here. HPV-positive oropharyngeal cancer generally has a better prognosis than HPV-negative cancer, but like other cancers, it can recur, potentially in up to 25 percent of cases.

    HPV-related oropharyngeal cancer responds well to surgical treatment, but the success of surgical treatment decreases if the cancer is caught after it has spread to other parts of the body. The researchers hope that the detection of HPV DNA in oral rinses may enable earlier detection of recurrence and, therefore, better overall prognosis should the cancer recur.

    Moreover, most of the recurrences observed in this study were localized oropharyngeal cancer and not cancers that spread to other regions of the body. “Those that had HPV DNA detected in their mouth after treatment had a much higher risk of local recurrence,” says D’Souza.

    Researchers say that in this study disease recurrence was diagnosed roughly seven months after the detection of HPV16 DNA in the oral rinse. Presence of HPV16 DNA in oral rinses may allow for the detection of cancer recurrence before any other clinical signs or symptoms, which enables earlier treatment options.

    “There was a lead time of several months between when we detected HPV16 DNA in the rinse and when they were diagnosed with recurrence,” says D’Souza. “If we had known at the rinse time, it would have given a lead time for treatment.”

    D’Souza stresses that this type of testing is new. She also notes that this is a rare cancer, and that recurrence is even rarer still.

    “It should be reassuring that most people who have been treated for HPV-related oropharyngeal cancers are cured and there is no HPV16 DNA detected in their mouths, but among those that did recur, this was an important potential predictor,” she says.

    ###

    “Prognostic Implication of Persistent Human Papillomavirus 16 DNA Detection in Oral Rinses for Human Papillomavirus-Related Oropharyngeal Carcinoma” was written by Eleni M Rettig, MD; Alicia Wentz, MA; Marshall R Posner, MD; Neil Gross, MD; Robert I Haddad, MD; Maura L Gillison, MD, PhD; Carole Fakhry, MD; Harry Quon, MD; Andrew G Sikora, MD PhD; William J Stott, CCRP; Jochen H Lorch, MD; Christine G Gourin, MD; Yingshi Guo, MS; Weihong Xiao, MD; Brett A Miles, DDS, MD; Jeremy D Richmon, MD; Peter E Anderson, MD; Krzysztof J Misiukiewicz, MD; Christine H Chung, MD; Jennifer E Gerber, MSc; Shirani D Rajan, MSPH; Gypsyamber D’Souza, PhD.

    The research was supported by grants from the Johns Hopkins Richard Gelb Cancer Prevention Award (GD), the Oral Cancer Foundation (GD), the National Institute of Dental and Craniofacial Research (NIDCR) and the National Institutes of Health (NIH) Research Training in Otolaryngology grant 2T32DC000027-26 (EMR).

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

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    HPV Persistence Predicts Poor Prognosis in Head/Neck Cancer

    Thu, Jul 30, 2015

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    Source: www.medscape.com
    Author: Roxanne Nelson, RN, BSN
     

    Among patients with human papillomavirus–positive oropharyngeal cancer (HPV-OPC), persistence of HPV following treatment is associated with a poorer prognosis.

    Results of a new study show that the persistence of HPV16 DNA, detected in oral rinses after treatment has ended, may be predictive of disease recurrence.

    In a cohort of 124 patients with HPV-OPC, HPV16 DNA was detected in oral rinses from 54% (n = 67) of patients at the time of their diagnosis. Following treatment, it was detected in only six patients after treatment, including five patients with persistent oral HPV16 DNA that was also detected at diagnosis.

    All five patients with persistent HPV16 experienced disease recurrence, with three eventually dying of their cancer. Conversely, only nine of 119 patients without persistent oral HPV16 DNA developed recurrent disease.

    “Our findings indicate that persistent HPV16 DNA in oral rinses may be a useful early marker of disease that has either recurred or never fully responded to treatment,” said first author Eleni Rettig, MD, of the Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.

    “In the clinical setting, this could one day be a part of routine surveillance after treatment for HPV-positive oropharyngeal cancers, in addition to clinical examination and imaging,” she told Medscape Medical News.

    The study was published online July 30 in JAMA Oncology.

    Biomarker Potential?

    In an accompanying editorial, Julie E. Bauman, MD, MPH, and Robert L. Ferris, MD, PhD, both of the University of Pittsburgh, in Pennsylvania, point out that HPV-specific biomarkers in oropharyngeal squamous cell carcinoma (OSCC) may be used to improve clinical outcomes, and “this pioneering study demonstrates an association between persistent oral HPV16 DNA detection and recurrence.”

    But an ideal biomarker for recurrence, they say, should have a number of characteristics, including high sensitivity to identify the population with salvageable locoregional recurrence, a high positive predictive value (PPV) so as to avoid the economic, physical, and emotional costs of false-positive evaluations, and accuracy for detecting subclinical locoregional recurrence.

    The prevalence of a positive oral rinse at diagnosis, however, was only 54%, and so the “low sensitivity of the assay, even with gross disease present, raises legitimate questions regarding its utility for diagnosing subclinical disease,” they say.

    Of the six cases in which posttreatment HPV16 DNA was detected, five patients developed recurrent disease, representing a PPV of 83%, the editorialists write. When restricted to the five cases with persistent HPV16 DNA, the PPV then becomes 100%.

    Although this looks impressive, they point out that “persistence can only occur in those who initially test positive — making this recurrence biomarker irrelevant for half of patients with HPV-positive” disease.

    In addition, they add, the PPV can apply to any recurrence, including presentation with distant metastases, and “unfortunately, early diagnosis of disseminated OPSCC [oropharyneal squamous cell carcinoma] has not been associated with improved survival.”

    “Operating characteristics, including low sensitivity, low confidence in the PPV, and high NNT [number needed to treat], preclude immediate clinical adoption,” say Dr Bauman and Dr Ferris. They add that incorporating an HPV-specific biomarker in future surveillance guidelines will require some refinement, including improved sensitivity and perhaps combining it with other serologic markers, such as HPV16 DNA or E6 antibodies.

    “Meanwhile, the high negative predictive value of oral rinse HPV16 DNA detection raises the promise of deintensifying surveillance visits and/or costly imaging, particularly if on a prospective trial,” they conclude.

    Dr Rettig agrees that more studies are needed before this test can be recommended. “For example, we need to understand when and how frequently to administer the test, what exactly we should do with a positive result, and what the cost-effectiveness would be, given the small number of individuals who actually have persistent oral HPV16 ― only five of 124 people in our study,” she said.

    “We also can’t say for sure that all of the HPV16 DNA comes from tumor cells, and in some cases, it might just come from an oral HPV16 infection,” Dr Rettig explained. “For all of these reasons, right now, this test should only be used in the research setting until we have more information from additional studies.”

    Associated With Recurrence

    In this study, Dr D’Souza and colleagues examined HPV DNA detection in oral rinses after treatment for HPV-OPC and how it related to disease recurrence and survival.

    This prospective cohort study included HPV-OPC patients diagnosed from 2009 to 2013 at four centers. Oral rinse samples were collected at diagnosis and after treatment (9, 12, 18, and 24 months after diagnosis) and were evaluated for HPV DNA. One or more posttreatment oral rinses were available for the 124 patients included in the study.

    The median follow-up time was 33 (24-41) months, during which there were 14 recurrences and six deaths — all due to recurrent disease.

    Two years after diagnosis, disease-free survival (DFS) was 92% (95% confidence interval [CI], 94% – 100%), and overall survival was 98% (95% CI, 93% – 99%).

    The presence of HPV16 DNA in oral rinses at the time of diagnosis was not associated with either DFS (P = .15) or overall survival (P = .14), but on univariate analysis, persistent HPV16 DNA detection in oral rinses (eg, both at diagnosis and any time after treatment) was associated with a greater than 20-fold increased risk for recurrence (hazard ratio [HR], 29.7; 95% CI, 9.0 – 98.2) and death (HR, 23.5; 95% CI, 4.7 – 116.9).

    It still remained associated with both DFS (adjusted HR [aHR], 35.8; 95% CI, 8.6 – 149.1) and overall survival (aHR, 16.1; 95% CI, 2.8 – 92.7) after adjusting for pack-years of smoking and tumor stage.

    This research was supported financially by the Johns Hopkins Richard Gelb Cancer Prevention Award (Dr D’Souza), the Oral Cancer Foundation (Dr D’Souza), the National Institute of Dental and Craniofacial Research, and the National Institutes of Health Training in Otolaryngology grant (Dr Rettig). Several of the authors report relationships with industry, as noted in the article. The editorialists report no relevant financial relationships.

    JAMA Oncol. Published online July 30, 2015. Abstract, Editorial

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

     

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    Kissing overtakes smoking as leading risk for head and neck cancers

    Thu, Jul 30, 2015

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    Source: http://www.dailymail.co.uk
    Author: Lauren Grounsell for Daily Mail Australia

    Contracting Human papilloma virus (HPV) infections through kissing is now a larger risk than smoking for developing head or neck cancer. According to Australian head and neck surgeon, Dr Mahiban Thomas, Oral HPV makes head and neck cancer 250 times more likely with 70% of all US cases being caused by the virus.

    While HPV is normally linked with cervical cancer – it can infect both men and women. This oral variant of the virus can be passed through oral sex and open-mouth (french) kissing.

    Dr Thomas told MailOnline: ‘If you look at the figures coming out of the US, 70 per cent of head and neck cancers are due to HPV.
    ‘There has been a change in high-risk behaviour as far as smoking and drinking goes.

    ‘If you have an (HPV) infection, you have 250 times the chance of developing cancer of somebody who does not have HPV.’
    Health authorities advise that the risk of contracting HPV increases with the number of ‘french kissing and oral sex partners you have.

    While most commonly associated with cervical cancers, HPV can affect both men and women. There are more than 100 types of the virus, but only about eight ‘high risk’ strains of HPV that can cause cancers in the oropharynx.

    The Centers for Disease Control and Prevention said studies suggest Oral HPV could be passed on during oral sex or open-mouthed or ‘French’ kissing, and about 7% of people have oral HPV, but only 1% of people have the type of oral HPV that is found in oropharyngeal cancers.

    Dr Thomas said recent studies suggested even engaging in ‘petting’ without sexual interaction could transfer HPV.

    ‘If you look at the figures coming out of the US, 70 per cent of head and neck cancers are due to HPV,’ Dr Thomas said.
    ‘There has been a change in high-risk behaviour as far as smoking and drinking goes.

    ‘If you have an (HPV) infection, you have 250 times the chance of developing cancer of somebody who does not have HPV.’

    Dr Thomas told NT News HPV was responsible for a ‘tsunami’ of head and neck cancer cases. He said your risk of contracting the HPV virus increased with the number of French kissing partners you had, and people underrated the risks associated with oral sex.

    Yesterday marked World Head and Neck Cancer Day. In 2011, 3121 head and neck cancers were diagnosed in Australia, caused by smoking, frequent alcohol use, sun exposure, radiation, asbestos and HPV.

    The Australian Government funds HPV vaccination for 12 to 13-year-old girls and boys which helps protect against cervical cancer, some vaginal, vulva and anal cancers and genital warts.

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    MD Anderson Team wins NIH grant to uncover novel head, neck cancer drug targets

    Thu, Jul 30, 2015

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    Source: www.genomeweb.com
    Author: staff

    The National Institutes of Health this month awarded MD Anderson Cancer Center researchers a four-year grant to bioinformatically and functionally investigate genomic alterations as novel therapeutic targets for head and neck squamous cell carcinoma (HNSCC).

    In recent years, genomic studies have identified numerous genetic alterations in HNSCC, but such alterations “are dominated by tumor suppressor genes and untargetable oncogenes,” MD Anderson’s Jeffrey Myers, who is leading the research, wrote in the grant’s abstract. “Nevertheless, we hypothesize that novel molecular therapeutic targets are present in HNSCC and that these targets exist in parts of the data that have not been effectively analyzed.”

    With the support of the NIH grant, administered by the National Institute of Dental & Craniofacial Research and worth $971,667 in its first year, Myers and his colleagues plan to examine existing genomic data using a combination of computational and functional approaches to identify candidate drug targets.

    The most promising targets will be tested in a high-throughput in vivo screening system in HNSCC lines with known genotypes, with validated targets further tested for genotype co-dependencies. Known drug targets will be studied in preclinical xenograft models.

    For targets that are currently undruggable, the researchers will computationally and experimentally analyze their pathways for additional targets that can be functionally tested.

    Through the work, the MD Anderson investigators aim to generate a broad list of functionally validated novel targets for HNSCC as candidates for drug development.

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    NYU’s Bluestone Center Receives a $369,250 High Priority, Short Term Project Award from NIDCR to Study Oral Cancer Pain

    Wed, Jul 29, 2015

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    Source: www.nyu.edu/news
    Author: Christopher James
     

    Drs. Yamano and Schmidt have developed a novel non-viral gene delivery method, and the proposed studies are designed to test whether this could be used to treat cancer pain effectively and safely.

    Up to 90% of cancer patients suffer from pain, with oral cancer ranked consistently as one of the most painful cancers. The quality of life for oral cancer patients is the lowest of any patients suffering from cancer because the intense uncontrolled pain interferes with necessary oral functions including eating, talking and swallowing.

    “Oral cancer pain is more severe, and the opioid requirement is higher, than pain from any other cancer,” said Dr. Brian L. Schmidt, DDS, MD, PhD, professor in the Department of Oral and Maxillofacial Surgery, and director of NYU’s Bluestone Center for Clinical Research and the NYU Oral Cancer Center. “And in the end, pharmacological agents used to treat cancer pain often lack anatomical specificity and produce off-target effects that create additional suffering.”

    “Gene therapy is emerging as an exciting prospect and alternative to opioids for the treatment of cancer pain,” said Dr. Seiichi Yamano, DDS, PhD, DMD, MMSc, assistant professor of prosthodontics at NYU College of Dentistry. “We seek to eliminate oral cancer pain by reversing epigenetic changes using gene therapy and set the stage for a new class of medicines that selectively disrupt nociceptive signaling with limited off-target effects.”

    To further their research, the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institute of Health (NIH) has awarded Drs. Schmidt and Yamano a one-year, $369,250 High Priority, Short-Term Project Award (R56) to study the efficacy of a novel non-viral gene delivery method. The proposed studies are designed to test whether nonviral gene delivery into the oral cancer could be used to treat cancer pain effectively and safely.

    “Viral vector-based treatment of cancer pain has been evaluated in preclinical studies but problems with immune response, limited DNA carrying capacity, recombination and high cost have been encountered,” said Dr. Schmidt. “Synthetic, non-viral vectors are potential alternatives to viral vectors that preclude these obstacles.”

    To improve non-viral gene transfer efficiency, Dr. Yamano recently created two novel nonviral hybrid vectors: a cell-permeable peptide (CPP) combined with either a cationic lipid (CPP/lipid) or a cationic polymer (CPP/polymer). These nonviral vectors have excellent transfection efficiency with little cytotoxicity across a range of cell lines including different types of cancer cells.

    The researchers also found that the transfection efficiency using the nonviral vector in oral cancer cells has a significantly higher expression (~8-fold) than normal cells and has a higher expression (~65%) than an adenoviral vector (~50%). In vivo transfection with either of these nonviral vectors leads to high and long-term transgene expression (~7 months) after intramuscular injection of the vectors.

    “We recently demonstrated that OPRM1 (the gene for the µ-opioid receptor) is methylated and down regulated in oral cancer compared to matched normal tissues in the same patients; these patients reported pain at the site of cancer,” said Dr. Schmidt. “We further demonstrated that OPRM1 re-expression with viral transduction significantly reduced cancer pain in a mouse model.”

    Based on their preliminary work, the researchers hypothesize that re-expression of the OPRM1 gene within oral cancer using our non-viral vectors will attenuate cancer pain and restore orofacial function without excessive toxicity. Their research has three specific aims:

    1. To determine the efficacy of ex vivo OPRM1 gene transfer with non-viral vectors to attenuate cancer-induced pain, with the goal to move their method of non-viral transfection to the clinic, with the goal of clinicians directly inoculating their non-viral vector into an oral cancer;
    2. To determine the feasibility and efficacy of in vivo OPRM1 gene transfer (i.e. directly into the tongue cancer) with non-viral vectors for attenuation of cancer-induced pain; and
    3. To analyze toxicity and immune response in the cancer mice treated with non-viral OPRM1 gene delivery.

    “The proposed research is significant because we will use a local delivery technique directly into the cancer to reduce the potential side effects of systemic drugs,” continues Dr. Yamano. “Our approach is innovative because we will transduce the cancer cells for the treatment of cancer pain and our non-viral vector more efficiently targets oral cancer cells relative to normal cells. Ultimately, these studies might facilitate the development of an effective therapy to treat cancer pain.”

    The researchers note that, tragically, approximately half of all oral cancer patients will not be cured with surgery, chemotherapy or radiation therapy. Oral cancer is the sixth most common cancer in the US; more patients are afflicted with oral cancer than with melanoma, cervical cancer, or ovarian cancer. The intensity of oral cancer pain escalates with disease progression, and terminal patients generally experience debilitating pain during their final months of life.

    NIH NIDCR R56 grant number: R56DE025393 (Schmidt/Yamano)

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

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    ASCO urges expansion of cancer research to include more older adults

    Wed, Jul 22, 2015

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    Source: www.asco.org
    Author: staff

    ASCO  issued landmark recommendations calling for federal agencies and the cancer research community to broaden clinical trials to include older adults. ASCO also called for redefining eligibility for clinical trials. Both calls to action were published in the Journal of Clinical Oncology.

    More than 60 percent of cancers in the United States occur in people age 65 and older, a population that will grow exponentially over the coming years. Yet, the evidence base for treating older adults is sparse because they are underrepresented in clinical trials and trials designed specifically for them are rare.

    “Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,” said ASCO President Julie M. Vose, MD, MBA, FASCO.  “As we age, for example, the risk of adverse reactions from treatment significantly increases. Older adults must be involved in clinical trials so we can learn the best way to treat older cancer patients resulting in improved outcomes and manageable toxicity.”

    Developed by ASCO’s Cancer Research Committee, the ASCO position statement, “Improving the Evidence Base for Treating Older Adults with Cancer,” makes the five following over-arching recommendations:

    •    Use clinical trials to improve the evidence base for treating older adults.
    •    Leverage research designs and infrastructure to improve the evidence base for treating older adults.
    •    Increase Food and Drug Administration (FDA) authority to incentivize and require research on older adults with cancer.
    •    Increase clinicians’ recruitment of older adults with cancer into clinical trials.
    •    Utilize journal policies to incentivize researchers to consistently report on the age distribution and health risk profiles of research participants.

    ASCO also details 16 specific action steps to implement its recommendations, including asking regulatory agencies, research funders, and researchers to carefully consider whether evidence exists to support eligibility criteria based on age, performance status, or comorbid conditions—three primary reasons older adults are excluded from clinical trials.

    Furthermore, ASCO encourages researchers to adopt innovative trial designs that would fill knowledge gaps in the treatment of older adults with cancer.

    “We need to see clinical trials that mirror the age distribution and health risk profile of patients with cancer,” said Arti Hurria, MD, Director of City of Hope’s Cancer and Aging Research Program and co-author of the ASCO position statement. “ASCO has laid out a multi-pronged approach to expand the participation of older adults in clinical trials, ensuring that all patients will receive high-quality, evidence-based cancer care.”

    Redefining Eligibility Criteria for Clinical Trials

    In a related effort, ASCO’s Cancer Research Committee released a paper, “Modernizing Eligibility Criteria for Molecularly Driven Trials,” which examines the need to redefine eligibility criteria around the specific population being researched especially as molecular medicine advances.

    “Understanding the risks and benefits of a treatment in the intended patient population is the fundamental goal of clinical trials,” said Edward Kim, MD, Chair of Solid Tumor Oncology and Investigational Therapeutics at Carolinas HealthCare System’s Levine Cancer Institute and Immediate Past Chair of the ASCO Cancer Research Committee. “Enrollment into clinical trials has not been optimal and needs urgent reassessment. The era of molecularly-targeted therapy is an exciting one and requires us to reevaluate how we meet this primary objective in order to expedite approval of promising drugs into the clinic.”

    Next Steps

    To advance the issues raised in its position statement and paper, ASCO plans to organize a public meeting with input from regulatory bodies and key stakeholders with the ultimate goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols which may help guide future investigators in the era of molecularly-driven therapy. The meeting will be held in the Fall of 2016.

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    For the war against oral cancer, what’s in your arsenal?

    Wed, Jul 22, 2015

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    Source: www.dentistryiq.com
    Author: Dennis M. Abbott, DDS

    The face of oral cancer has changed: No longer is oral cancer a disease isolated to men over 60 years of age with a long history of smoking and alcohol consumption. Today, the demographic for the disease includes younger people of both sexes with no history of deleterious social habits who are otherwise healthy and active. It spans all socioeconomic, racial, religious, and societal lines. In other words, oral and oropharyngeal cancer is an equal opportunity killer. Today, as you read this article, 24 people in the US will lose their battles with oral cancer. That is one person for each hour of the day, every day of the year. Each of those lost is someone’s sister, a father’s son, a small child’s mommy, or maybe even a person you hold dear to your heart. The truth is, oral and oropharyngeal cancer has several faces . . . and each of those faces is a human being, just like you and me. So how can we, as dental professionals, be instrumental in the war against oral and head and neck cancer?

    Views of the oropharynx, the base of the tongue, and the epiglottis, taken with the Iris HD USB 3.0 intraoral camera using different points of focus. Photos courtesy of the author.

    Views of the oropharynx, the base of the tongue, and the epiglottis, taken with the Iris HD USB 3.0 intraoral camera using different points of focus.
    Photos courtesy of the author.

    The answer, as with most other cancers, lies in early detection. When oral and oropharyngeal cancer is detected early, the five-year survival rate can be as high as 80% to 90%. The harsh reality is that most oral and head and neck cancers are only found at late stages after the cancer has advanced—often to the lymph system. As a result, the chance of the person living for five years after diagnosis falls to approximately 55%.

    As dentists and dental hygienists, we—like it or not—are on the front line of this war. We often have the opportunity to see potential cancer patients more frequently than our medical colleagues do, and we are trained to see abnormalities inside the mouth and in the head and neck region. (This is a huge part of the solution!) Many of my medical colleagues tell me that they do not have the training to see what I can see in the mouth. But I do not have the training to practice oncological medicine like they do. The truth is, it takes all of us doing our jobs to care and manage the individual person—not just the teeth, not just the liver, not just the breast, but the whole patient.

    Years ago, we could almost profile who would or would not be likely to present with oral cancer. It was always the “Marlboro man”—that guy who was older, drank alcohol frequently, and had a smoking pack-year history that was two or three times his age. But those days are long gone. With the recent understanding that the human papillomavirus (HPV), the most common sexually transmitted infection in the United States, is an etiological factor for oral and oropharyngeal cancer, virtually everyone is a potential cancer patient. As such, everyone should be screened. While the individual with classic risk factors still remains at risk for developing oral cancer, many who present with HPV-related oral and head and neck cancers have no other discovered risk factors, other than exposure to HPV and an immune system that, for reasons still unknown, will not adequately clear the virus without repercussions.

    It is believed that 80% to 90% of all Americans have been exposed to HPV at least once in their lifetimes. Most people manage to clear the virus through the immune system’s normal defense function within six to seven months; in some patients, however, damage takes place at the cellular level that may take months, years, or even decades to manifest as cancer. The majority of HPV-related oral and head and neck cancers present in areas that are difficult for us as dental professionals to visualize, such as the tonsils, the base of the tongue, the oropharynx, the posterior pharyngeal wall, and the larynx. That, however, does not give us an excuse not to screen in these areas . . . we just have to think outside of the box and get creative about how we screen.

    Visual inspection combined with palpation remains the essential foundation of screening for oral and oropharyngeal cancers, but where visualization is difficult—such as with the base of the tongue and the lower oropharynx—knowing and asking the right questions can become critically important for identifying potential concerns:
    “Are you noticing any unusual hoarseness?”
    “Are you having any difficulty swallowing?”
    “Do you ever have a sensation as though something is caught in your throat?”
    “How long has that tonsil been inflamed?”
    “Have you noticed any sinus or allergy issues since that tonsil has been enlarged?”
    While these questions may seem unrelated to teeth, they are not unrelated to oral health. Simply asking the right questions can open a dialogue of discovery that may lead to the detection of an oropharyngeal cancer early. And early detection is the key to beating the disease and maintaining a good quality of life during the survivorship years.

    Technology-based adjunctive devices to assist the dental professional in the early detection of oral cancer have existed in the market for the past 10 to 15 years. Much has been written about fluorescence and reflective technologies, which help the examiner to detect subtle changes in tissue through the usage of light in the violet and yellow ranges of visible light, respectively. Examination with these wavelength-specific devices enhances visualization by highlighting changes in the oral mucosa and vasculature. Usage of these adjuncts has also demonstrated value in enabling clinicians to better understand the size of affected tissue surrounding suspected lesions. As such, these may be useful in selecting a field for biopsy that may produce clear, or noncancerous, margins.

    Since the completion of the Human Genome Project (HGP) in 2003, there exists a more clearly defined understanding of how diseases such as cancer affect our cells at the nucleic acid level and how genetic mutations can serve as risk factors or catalysts for cancerous changes in cells. Technology used in the HGP has also provided insight into the genotyping of viruses, leading to a sharper picture of how viral interaction with our genetic code can lead to disease. Today, the dentist and dental hygienist have this technology readily available to move their practice into the era of personalized health.

    Salivary tests, such as the MOP (Molecular Oral Testing) by PCG Molecular, take advantage of innovative, advanced genetic testing to establish the risk or presence of oral or oropharyngeal squamous cell carcinoma. MOP does this by evaluating cellular abnormalities in the oral cavity and oropharynx, DNA damage associated with oral and oropharyngeal cancer, and the presence of HPV. With this information, the clinician can better determine the appropriate course of action for the patient.

    Sometimes striving to provide the best possible patient care means thinking outside of the box to use technology designed for one purpose and discovering a new application to meet an unanswered need. Most of us are at least familiar with intraoral cameras, and many of us have them in our offices. Using the magnified imagery of a quality intraoral camera and a high-resolution monitor, this tool is a favorite device for illustrating the need for proposed treatment and for establishing patient trust. But what if we could use those images to possibly save a life?

    The Iris HD USB 3.0 intraoral camera by Digital Doc LLC has catapulted intraoral photography into the high-definition age. Using the Iris HD precision optical lens array and an advanced HD sensor from Sony, the Iris HD USB 3.0 provides unmatched 720p-resolution clarity that is perfect for the magnification and photographic capture of suspicious areas discovered during a thorough head and neck examination/oral cancer screening. Because of the size of the camera head, the device even makes it possible to examine areas of the oropharynx that were previously difficult for dentists and hygienists to visualize.

    Of course, the camera cannot substitute for laryngeal endoscopy, especially if cancer inferior to the epiglottis is suspected, but the camera’s ability to see beyond the palatopharyngeal arch is an improvement over an angled dental mirror. Most patients can tolerate the necessary posterior placement of the camera to capture an oropharyngeal image either by breathing through the nose or with placement of a topical anesthetic on the posterior soft palate and uvula to suppress the gag reflex.

    Regardless of the power of the technology, the ultimate skill in detecting early-stage oral and oropharyngeal cancer lies in the eyes, hands, and brain of the examiner. Careful inspection, knowledge, discernment, and experience are the real tools of the professional for acquiring and processing all of the available data and for correctly fitting the puzzle pieces into a picture that illustrates either health, concern with reason for reevaluation, or the need to biopsy the area in question. When reevaluation is required, no more than two weeks should elapse between the initial examination and follow-up, as time is of the essence in proceeding to treatment should the suspicious area indeed be cancerous.

    Responsibility to the patient does not end with an abnormal screening result. The dental professional should have a plan in place to either biopsy or refer. The dental professional should biopsy only if he or she is well-experienced in the removal of suspected cancerous lesions. Otherwise, the patient should be referred to an oral/maxillofacial surgeon, periodontist, otolaryngologist, or head and neck surgeon who is comfortable with and experienced in the safe and effective biopsy of a potentially cancerous area. It is most often the case that only one opportunity to obtain a diagnostic tissue sample exists, so the skills of the doctor performing the biopsy should be without question. Every effort should be made to ensure that the patient is seen promptly for biopsy and that the pathology results are returned and shared with the patient expeditiously. Delay can be detrimental to the survival of a patient with oral or oropharyngeal cancer.

    Should a screening result from your office lead to a diagnosis of oral or oropharyngeal cancer, be prepared to counsel and educate your patient about what to expect in his or her cancer journey. Learn about and be prepared to meet the unique dental and oral health needs of patients with oral and head and neck cancers, and become equipped to continue care for your patients throughout their treatment and into survivorship. For all of the destruction and hardship that cancer brings, it can form unbreakable bonds, between doctor and patient and between dentist and physician.

    Don’t be afraid to reach out to your counterparts in the medical community and bridge the gap between medicine and dentistry in your area. Form alliances with head and neck surgeons, radiation oncologists, medical oncologists, and oncology nurses. Let them know about your skills and the services and technology available in your office that place you on the front line of this war on oral cancer. Take time to understand your medical colleagues’ role in treating the disease and become familiar with the technology they are using to save lives and diminish the long-term effects of oral cancer treatment. We are, after all, fighting the same war, and we’re all on the same side. It is all of us against oral and oropharyngeal cancer, with the needs and health of that one patient we’re fighting for leading us in the battle.

    About the author:
    Dennis M. Abbott, DDS, is the founder and CEO of Dental Oncology Professionals, an oral medicine-based practice dedicated to meeting the unique dental and oral health needs of patients battling cancer. In addition to private practice, he is a member of the dental oncology medical staff at Charles A. Sammons Cancer Center at Baylor University Medical Center in Dallas. Dr. Abbott is also the founder of the American Academy of Dental Oncology and serves as a consultant to the national American Cancer Society in the development of oral monitoring guidelines for post-treatment cancer survivors. Dr. Abbott lectures internationally on the topics of dental oncology and oral cancer.

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    B.C. detection test being used to catch oral cancer in early stages

    Wed, Jul 22, 2015

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    Source: www.cbc.ca
    Author: staff

    Doctor says oral cancer is among the deadlier diseases yet rarely talked about.

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    The Canadian Cancer Society estimates 4,400 people will be diagnosed with oral cancer this year. The deadly disease can often go undiagnosed because it is tough to screen for dormant symptoms. But now, researchers at the University of British Columbia (UBC)  are developing a new test that will be able to detect oral cancer at a much earlier stage.

    Dr. Catherine Poh, an oral pathologist who also teaches dentistry at UBC, spoke with the Early Edition’s Rick Cluff about the latest developments.

    What can you tell us about this new brushing test you’re working on?
    We are a proposing a non-invasive approach to analyse genetic material collected from patients mouths using a simple brush. This can be done by a dentist or at a family doctor’s office.

    This test would detect genetic change that happens in human genomes from the cells collected from the mouth. We have shown that it has prediction value for the risk for oral cancer development.

    How does your test compare to how oral cancer is detected right now?
    Right now the majority of oral cancer has been screened by dentists because many of the oral cancer [diagnosis] come with no pain or no symptoms. Through the dental regular checkups it can be detected early, otherwise patients come with a sore in their mouths that is essentially a delay in the diagnosis.

    What symptoms should people look out for?
    Many people know your mouth can be sore and that’s not a sign of oral cancer. I’m suggesting people look for a mouth sore that doesn’t heal within three to four weeks or there’s colour change with white or red bumps that don’t get resolved. [This warrants a] checkup from your family dentist or doctors.

    Who does oral cancer affect?
    Traditionally 75 per cent are smokers and drinkers, however we’re aware there are a number of rising incidents within the younger non-smoker, non-drinker group. Studies show increasing risks of tongue cancer for women aged 18 – 44.

    We don’t know [the exact reason] yet. There are people talking about chronic inflammation and infection so we are looking for more details into that aspect.

    If it is caught early on, what does that mean for someone’s chances of beating cancer?
    Right now, 1 in 2 patients will die in five years so it’s a deadly disease. If caught early…the chance for easier treatment increases. Early detection is the key to really improve a better outcome.

    We promote that patients over 80 should have a regular check up for the disease with their family doctor.

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    Professor Harald zur Hausen: Nobel scientist calls for HPV vaccination for boys

    Mon, Jul 13, 2015

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    Source: www.independent.co.uk
    Author: Charlie Cooper & Gloria Nakajubi
     

    The UK should vaccinate all boys against the cancer-causing human papilloma virus (HPV), the Nobel Prize-winning scientist who discovered the link between HPV and cancer has said.

    Professor Harald zur Hausen, the German virologist whose theory that HPV could be a cause of cervical cancers led to global efforts to vaccinate girls against the virus, said that boys should also be protected.

    There is now a wealth of evidence that HPV also causes cancers in men, including anal, penile and throat cancer. Professor zur Hausen added that there was now a chance to “eradicate” HPV viruses altogether if the world developed global vaccination programmes for all children.

    Since 2008 the UK has offered free vaccinations against HPV to girls aged 12 to 13 – a programme that had an almost 87 per cent uptake from 2013 to 2014 and has led to falls in the number of pre-cancerous abnormalities of the cervix, according to research carried out among vaccinated girls in Scotland.

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    Vaccine authorities in the UK, traditionally an international leader in the field of immunisation, are yet to make a judgement on a publicly funded vaccination programme for boys, which would follow in the wake of those already in place in Australia, Austria, Israel and parts of Canada.

    HPV is the name for a common group of viruses that can affect the moist membranes of the cervix, anus, mouth and throat. It is usually spread through sexual contact.

    Most sexually active people will contract it in their lifetime but usually it causes no ill-effects. However, in some cases it causes changes to cells, which can become cancerous. It is the cause of almost all cases of cervical cancer, a discovery made by Professor zur Hausen in the 1970s, for which he won the Nobel Prize in physiology or medicine in 2008.

    Speaking to HPV Action, in an interview to be published by the campaign group this week, Professor zur Hausen said that vaccinating boys was of “the utmost importance”, not only because boys can also contract HPV-related cancers of the throat, anus and penis, but because protecting boys is key to ending transmission of the virus altogether.

    “The vaccination programme for girls [in the UK] is marvellous – it reaches a very high proportion,” he said. “In my opinion, the vaccination of boys is also of the utmost importance because virus transmission is due to male partners and men are affected by oropharyngeal [cancers of the throat], anal and penile cancers as well as genital warts.”

    Last year the UK’s vaccination authority, the Joint Committee on Vaccination and Immunisation (JCVI), recommended that the UK introduce a vaccination programme for gay men, to be delivered via sexual health clinics. The rationale behind the recommendation is that heterosexual men will be protected from HPV infection because most women will have been immunised, but that men who have sex with men will miss out on “herd immunity”.

    However, campaigners and some experts say this reasoning is flawed, as many gay men will have been sexually active before their first visit to a sexual health clinic, and would most likely have already contracted or transmitted the virus.

    The JCVI is due to consider the cost-effectiveness of vaccination for boys but campaigners do not anticipate any decision until 2017.

    However, the NHS in London is currently planning what would be the first pilot of routine HPV vaccination for boys, with a likely start date of February 2016. The “field test” will work across four sites to establish whether school-age young males would “embrace the uptake of HPV vaccination as part of a community programme”, NHS England’s London office said.

    Rolling out the vaccine to boys would require a public-information campaign because it has previously been presented to parents and children as a girls-only jab to prevent cervical cancer.

    Scientists say changes in sexual behaviour – with more couples having oral and anal sex – may be the cause of increased cases of anal and throat cancers in both men and women in recent decades.

    Margaret Stanley, emeritus professor at the University of Cambridge and a leading expert on HPV, said that cases could continue to rise. “It’s very much under-thirties [having more anal and oral sex] so you can predict there will be a rise in both those cancers. It’s a time bomb,” she said. “Wider exposure to different sexual practices – in other words porn on the internet – is also changing sexual behaviour in teenagers.”

    HPV is also the cause of genital warts, the second-most common sexually transmitted infection in the UK. There are nearly 90,000 cases annually, costing the NHS around £55m. Campaigners hope that figure will be taken into account when the JCVI weighs up the cost-effectiveness of a vaccination programme.

    Despite safety concerns being raised about the vaccine’s alleged side effects in some parts of the world, including Japan, no causal links have been established between the vaccine and reported long-term health problems. It is approved by the World Health Organisation, as well as European and UK vaccine-safety authorities. Professor zur Hausen added that it was “one of the safest vaccines we have”.

    8-Injection-GetRolling out the vaccine to boys would require a public-information campaign because it has previously been presented to parents and children as a girls-only jab to prevent cervical cancer (Getty)

     

    A Department of Health spokesperson said: “The HPV-prevention programme is key in helping us prevent cervical cancer. We have successfully given more than a million doses in the UK since 2008.

    “Our independent vaccination experts are assessing whether it should be extended to prevent cancers in adolescent boys, men who have sex with men, or both.”

    Time for an update?

    Parents are currently advised and asked for consent for their daughters to have the HPV vaccination through a form and information leaflet sent out via schools.

    The vaccine’s preventative effects against cervical cancer and the protection it offers against genital warts are explained. The protection against other cancers is not mentioned.

    Parents and children are told that the vaccine, which is now given in just two doses instead of three, protects against 70 per cent of cervical cancers and that girls will still require cervical screening tests when they are older. Newer versions of the vaccine may protect against more cases in the future.

    Parents are told that the vaccine may cause “soreness, swelling and redness in the arm” that will wear off in a couple of days. The leaflet states that “more serious side effects are extremely rare” and reassures parents that it meets European and UK safety standards. However, parents have the option to deny permission for their daughters to have the jab – and are told it would be “helpful” if they gave reasons for refusal.

    The leaflet is directly targeted at girls and their parents and focuses on cervical cancer. If the Government were to extend the HPV-vaccination programme to boys, they would have to reconsider how the vaccine was presented to parents and children. The current programme has had impressive uptake, possibly in part because the key reason for taking the vaccine – to prevent cervical cancer – is straightforward and well understood. It may be that in a new HPV vaccination programme, the jab could be presented more broadly as protection against “a range of cancers”.

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

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