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    In one study, lower dose treatment for HPV oropharyngeal cancers is successful

    Wed, Jun 25, 2014

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    Author: Anthony Cmelak, M.D.
    Source: medicalnewstoday.com
     

    A new study suggests that lowering the dose of radiation therapy for some head and neck cancer patients may improve outcomes and cause fewer long-term side effects.

    The research was presented by lead author Anthony Cmelak, M.D., professor of Radiation Oncology at Vanderbilt-Ingram Cancer Center (VICC), during the 50th annual meeting of the American Society of Clinical Oncology (ASCO), held recently in Chicago.

    The study focused on patients with newly-diagnosed oropharyngeal cancers related to the human papilloma virus (HPV). More than two-thirds of new head and neck cancer patients have HPV-positive tumors and the number of these patients is on the rise. Cmelak’s prior cooperative group study found that patients with HPV-positive oropharyngeal cancer have significantly longer survival rates than patients whose tumors are HPV negative.

    For the new study, 80 HPV-positive patients with stage III, or IVa,b squamous cell cancer of the oropharynx received inductionchemotherapy, including paclitaxel, cisplatin and cetuximab.

    After chemotherapy, 62 of the patients showed no sign of cancer and were assigned to receive a 25 percent lower dose of intensity-modulated radiation therapy – an advanced technology that targets the radiation beam more accurately to treat the tumor without harming surrounding tissue. The rest of the patients received a standard IMRT dose. The drug cetuximab was also given to both groups of patients along with the IMRT treatment.

    Two years after treatment, the survival for the low-dose IMRT patients was 93 percent. Those who did not have complete resolution of cancer following induction and went on to get full-dose radiation had an 87 percent two-year survival. Eighty percent of the low-dose patients and 65 percent of standard IMRT patients also showed no evidence of tumor recurrence. Ninety-six percent of those who had minimal or no smoking history had no evidence of tumor recurrence after two years following treatment, and long-term side effects were minimal.

    The investigators concluded that patients with HPV-positive cancer who had excellent responses to induction chemotherapy followed by a reduced dose IMRT and cetuximab experienced high rates of tumor control and very low side effects particularly for those with a minimal smoking history.

    Treating tumors in the delicate head and neck region often causes side effects that can be troublesome and long-lasting, including difficulty swallowing, speech impairment, dry mouth, problems with taste and thyroid issues, so any therapy option that reduces these side effects can have an impact on patient quality of life.

    “Treatment for head and neck cancer can be quite grueling, so it’s very encouraging to see we can safely dial back treatment for patients with less aggressive disease and an overall good prognosis, particularly for young patients who have many years to deal with long-term side effects,” said Cmelak.

    He noted that lower-dose IMRT is not recommended for patients with HPV-negative cancer or larger tumors.

    The authors note that further studies of reduced-dose IMRT in HPV-positive patients are warranted.

    Other investigators include Jill Gilbert, M.D., VICC; Shuli Li, Ph.D., Dana Farber Cancer Institute, Boston, Massachusetts; Shanthi Marur, M.D., William Westra, M.D., Christine Chung, M.D., The Johns Hopkins University School of Medicine, Baltimore, Maryland; Weiqiang Zhao, M.D., Ph.D., Maura Gillison, M.D., Ph.D., The Ohio State University, Columbus, Ohio; Julie Bauman, M.D., Robert Ferris, M.D., University of Pittsburgh Cancer Institute; Lynne Wagner, Ph.D., Feinberg School of Medicine, Northwestern University, Chicago, Illinois; David Trevarthen, M.D., Colorado Cancer Research Program, Denver; A. Demetrios Colevas, M.D., Stanford University, California; Balkrishna Jahagirdar, M.D., HealthPartners and Regions Cancer Care Center, St. Paul, Minnesota; Barbara Burtness, M.D., Fox Chase Cancer Center, Philadelphia, Pennsylvania.

    * This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
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    FDA’s tobacco regulation draft proposal weakened by the White House

    Wed, Jun 25, 2014

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    Author: Toni Clarke and Sharon Begley
    Source: huffingtonpost.com
     
     

    WASHINGTON, June 25 (Reuters) – White House changes to proposed rules for tobacco products significantly weakened language detailing health risks from cigars and deleted restrictions that might have prevented online sales of e-cigarettes, published documents show.

    The White House’s Office of Management and Budget (OMB), which analyzes the potential economic consequences of proposed regulations, deleted language in the U.S. Food and Drug Administration’s recently proposed regulations describing how the rules would keep thousands of people from taking up cigar smoking and have enormous public health benefits.

    The OMB also weakened language detailing the FDA’s concerns about the safety of e-cigarettes, according to documents published Tuesday in the Federal Register.

    Emily Cain, a spokeswoman for OMB, said that as with any rule, OMB’s office of information and regulatory affairs conducted an interagency review process “to ensure that the regulations through which agencies implement policies are efficient, well-designed to achieve their objectives, and based upon the best available evidence.”

    “It is routine for agencies to make changes to their draft rules during the course of OMB review,” she added. “The goal is to maximize the effectiveness and benefit of the rules we complete.”

    An FDA spokeswoman, Jennifer Haliski, said the FDA does not comment on changes to a proposal during the review process but said the period for the public to comment on the proposal is still open until Aug. 8.

    “All comments will be carefully considered as the final rule is being developed,” she said in an email. “As the science base continues to develop for these products, the agency has the ability to take additional regulatory actions designed to further minimize the public health burden of tobacco use in this country.”

    The FDA has authority under a 2009 law to regulate cigarettes, smokeless tobacco and roll-your-own tobacco, but must issue new rules before regulating e-cigarettes, cigars, hookahs, water pipes and other tobacco products.

    In April, the FDA issued a proposal which would subject the $2 billion e-cigarette industry to federal regulation for the first time. It would ban the sale of e-cigarettes to people under the age of 18 and vending machine sales.

    The proposal disappointed public health advocates who criticized the agency’s failure to restrict flavored products or television advertising, which they say attracts children, and criticized the agency for not moving to restrict online sales, where it can be harder to verify a person’s age.

    In its draft, the FDA had proposed “prohibition of non-face-to-face sales (e.g. vending machines).” That would have opened the door to a ban on online sales. But OMB edited the sentence so that the prohibition refers only to vending machines.

    In another significant change, OMB turned the FDA’s proposal as it relates to cigars from a two-part rule – one for traditional tobacco products and one for products that have not previously been regulated – into a “two-option” rule, one of which would exempt “premium cigars.”

    The cigar industry, backed by some members of Congress, had lobbied OMB heavily for such an exemption. In a December 2013 letter to FDA Commissioner Margaret Hamburg and Sylvia Mathews Burwell, who was director of OMB at the time and is now Secretary of Health and Human Services, 24 Republican lawmakers asked that premium cigars be exempt.

    “As you know,” they wrote, “premium cigars are a niche product with an adult consumer base, much like fine wines. The majority of people who enjoy a cigar do so occasionally, often in social or celebratory settings.”

    When the proposed rule came out in April, some public health advocates expressed dismay.

    “The part of the proposal we are deeply troubled by is the sweetheart deal for the cigar industry,” Erika Sward, assistant vice president for national advocacy at the American Lung Association.

    OMB also deleted an FDA analysis showing that exempting premium cigars from a proposal to require large warning labels would save manufacturers $1 million to $3 million but incur costs to public health of $32.6 million to $34.2 million.

    The White House office also deleted an extensive section in which the FDA calculated how many lives would be saved by regulating cigars, as well as the value of those lives. And it deleted a similar analysis for the improvements in health that would come from dissuading people from smoking cigars, such as through warning labels.

    The “welfare gain” from reducing the number of cigar smokers, FDA calculated, would be $16 million to $52 million.

    Similarly, OMB modified or deleted FDA concerns about the safety of e-cigarettes, including manufacturing quality.

    It deleted FDA draft language saying it would review electronic cigarette cartridges to respond to evidence of poor quality control, variable nicotine content or toxic ingredients such as diethylene glycol, a chemical that the FDA said has caused mass poisonings in products such as the painkiller acetaminophen and cough syrup.

    Last week a panel of U.S. senators excoriated the chiefs of two of the biggest e-cigarette companies, blu eCigs, which is owned by tobacco giant Lorillard Inc, and privately held NJoy, saying they were irresponsibly targeting children with advertisements depicting cartoon characters, movie stars and other celebrities.

    Both companies defended the advertisements, saying they target adult smokers.

     
    * This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
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    Scientists say that E-Cigarettes and Snuff are not harmless

    Wed, Jun 25, 2014

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    Author: Eliza Gray

    Source: time.com

    New research casts doubt on nicotine’s safety—even if you aren’t smoking

    New research from the American Heart Association journal Circulation shows that patients who stopped using smokeless tobacco after a heart attack had improved life expectancy—similar to that of people who quit smoking. The finding offers new information about the dangers of smokeless tobacco, the risks of which are not as well understood as cigarettes’.

    “That was a big surprise for us,” said Dr. Gabriel Arefalk, lead researcher and a cardiologist at Uppsala University Hospital in Uppsala, Sweden. “For smoking, it has been known for decades now that people benefit from discontinuation, especially after having suffered a heart attack, but for snus we had no idea what to expect.

    ”The researchers reviewed data on 2,474 heart attack survivors under 75 in Sweden who used snus (oral snuff) from 2005 to 2009. About 675 quit. During the two years of follow-up, 69 of those who continued using snus died, compared with only 14 quitters. Based on this data, researchers determined that those who quit snus had almost half the mortality risk of those who didn’t quit, which is similar to the benefit of smoking cessation, according to a release from the American Heart Association.

    Dr. Arefalk, who is also a clinician, said the researchers wanted to study the problem because they didn’t know what to tell patients about the risks of using snus after a heart attack. He cautioned that the study was small and far from enough to determine a causal relationship, but added “It’s the best evidence we’ve got so far, so from our perspective at our clinic, [the advice to patients] is probably that you should discontinue all kinds of tobacco,” if you’ve had a heart attack, Dr. Arefalk told TIME

    The study is one more piece of evidence that ads to our understanding that smokeless tobacco carries its own risk. Though the study was about snus, it has implications for other kinds of nicotine delivery systems, including e-cigarettes.

    The FDA is currently taking comment from experts over the next few weeks as the agency tries to determine the best rules to regulate the nascent e-cig industry, which is approaching nearly $2 billion in U.S. annual sales. And though there isn’t yet enough information or scientific research to back this up, common sense says that e-cigs, which do not burn and contain fewer chemicals than regular tobacco cigarettes, must be better for a smoker’s health. Yet, some cardiologists, as TIME learned, are reluctant to see electronic cigarettes as harm-reduction tools.

    For starters, nicotine is not a benign substance, especially when it comes to cardiovascular health. As Dr. Steven Nissen, Department Chair of Cardiovascular Medicine at the Cleveland Clinic, put it, nicotine has “profound effects on the heart.” The highly addictive drug can lead to surges in heart rate, constriction in the blood vessels, and spikes in blood pressure—the very effects that heart medications are designed to counteract.“To come up with new diabolically clever way to addict Americans to nicotine is a terrible idea,” says Dr. Nissen. “[E-cigarette companies] are pitching very hard that they can make smoking safer. [But] nicotine is an addictive drug, no matter if you smoke it or ‘aerosolize’ it. Why you would want to addict another generation to nicotine is beyond me. Public health suggests we should fight electronic cigarettes the same way we fought tobacco.”

    Another concern, beyond the possible impact of nicotine, are concerns about small, potentially toxic, particles and what they can do to the sensitive cardiovascular system, says Dr. Aruni Bhatnagar, a professor of medicine at the University of Louisville and spokesperson on electronic cigarettes for the American Heart Association

    Dr. Bhatnagar is studying the toxic effects of e-cig vapor on mice. Like all doctors, he is careful to point out that we don’t know enough about these devices. But he says that wishful thinking about harm reduction could be especially problematic when it comes to cardiovascular health. The risk of cardiovascular disease for a person who smokes only 2-3 cigarettes a day is already 80 percent of the risk to a pack-a-day smoke. “Very low levels of smoke are very dangerous for cardiovascular tissues. Cancer is more linear—you have to smoke a large amount for a very long period of time to get lung cancer,” he says. “But reducing harmful levels is not going to mitigate the cardiovascular risk. That is why we are greatly concerned about e-cigarettes when it comes to the high sensitivity of cardiovascular tissues to a low level of these pollutants

    ”Electronic cigarette manufacturers and their customers often point to the low levels of particles in electronic cigarette smoke as compared to the appropriate levels of air pollution determined by agencies like OSHA. But, Dr. Bhatnagar says, these claims can be misleading because the thresholds take into account the necessity of polluting the air to some degree—they aren’t an endorsement of a safe level of pollution. From a cardiovascular perspective, he says: “There is no threshold, there is no level of these particles that you can say is safe.”

    For now: Smokers—and snuffers, and e-cig smokers—beware.

     

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

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    Lower radiation dose may be given to HPV-positive head and neck cancer patients

    Fri, Jun 20, 2014

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    Source: Vanderbilt University
    Published: June 19, 2014
    By: Dagny Stuart

     

    A new study suggests that lowering the dose of radiation therapy for some head and neck cancer patients may improve outcomes and cause fewer long-term side effects.

    The research was presented by lead author Anthony Cmelak, M.D., professor of Radiation Oncology at Vanderbilt-Ingram Cancer Center, during the 50th annual meeting of the American Society of Clinical Oncology (ASCO), held May 30 to June 3 in Chicago.

    The study focused on patients with newly diagnosed oropharyngeal cancers related to the human papilloma virus (HPV). More than two-thirds of new head and neck cancer patients have HPV-positive tumors and the number of these patients is on the rise. Cmelak’s prior study found that patients with HPV-positive oropharyngeal cancer have significantly longer survival rates than patients whose tumors are HPV negative.

    For the new study, 80 HPV-positive patients with stage III, or IVa,b squamous cell cancer of the oropharynx received induction chemotherapy, including paclitaxel, cisplatin and cetuximab.

    After chemotherapy, 62 of the patients showed no sign of cancer and were assigned to receive a 25 percent lower dose of intensity-modulated radiation therapy (IMRT) — an advanced technology that targets the radiation beam more accurately to treat the tumor without harming surrounding tissue. The rest of the patients received a standard IMRT dose. The drug cetuximab was also given to both groups of patients along with the IMRT treatment.

    Two years after treatment, the survival for the low-dose IMRT patients was 93 percent. Those who did not have complete resolution of cancer following induction and went on to get full-dose radiation had an 87 percent two-year survival. Eighty percent of the low-dose patients and 65 percent of standard IMRT patients also showed no evidence of tumor recurrence. Ninety-six percent of those who had minimal or no smoking history had no evidence of tumor recurrence after two years following treatment, and long-term side effects were minimal.

    The investigators concluded that patients with HPV-positive cancer who had excellent responses to induction chemotherapy followed by a reduced dose IMRT and cetuximab experienced high rates of tumor control and very low side effects, particularly for those with a minimal smoking history.

    Treating tumors in the delicate head and neck region often causes side effects that can be troublesome and long-lasting, including difficulty swallowing, speech impairment, dry mouth, problems with taste and thyroid issues, so any therapy option that reduces these side effects can have an impact on patient quality of life.

    “Treatment for head and neck cancer can be quite grueling, so it’s very encouraging to see we can safely dial back treatment for patients with less aggressive disease and an overall good prognosis, particularly for young patients who have many years to deal with long-term side effects,” said Cmelak.

    He noted that lower-dose IMRT is not recommended for patients with HPV-negative cancer or larger tumors.

    The authors note that further studies of reduced-dose IMRT in HPV-positive patients are warranted.

    Funding was provided by The National Cancer Institute, a division of the National Institutes of Health (CDR0000665170).

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

     

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    Tony Gwynn’s untimely death, baseball contemplates issues with tobacco

    Fri, Jun 20, 2014

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    Source: USA TODAY
    Published: June 20, 2014
    By: Jorge L. Ortiz, USA TODAY Sports

     

    OAKLAND – Tony Gwynn’s multitude of accomplishments, career batting average of .338 and his pioneering use of video earned him the rapt attention of players whenever he talked baseball.

    Major League Baseball hopes an even more important message he’s delivering posthumously sinks in as well.

    Gwynn, who died of mouth cancer Monday at 54, speaks out against smokeless tobacco use in a taped segment of an informational video MLB is producing and plans to release this season. The Hall of Fame outfielder believed he developed cancer because of his years-long habit of using spit tobacco, although that was never medically confirmed.

    Whether Gwynn’s untimely death and his stance against smokeless tobacco will curtail its use among players remains an open question.

    1402936251000-6-16-gwynn-nightengale.jpg

    Research by the Pro Baseball Athletic Trainers Society revealed the number of major leaguers who use spit tobacco has declined from about 50% to 33% in the last 20 years.

    However, that’s still about 10 times the amount in the general population, according to the American Cancer Society, whose data from 2012 showed 3.5% of Americans 12 and older – or 9 million – use the highly addictive product.

    “It’s definitely ingrained and something that’s part of our baseball culture, but it’s not exclusive to baseball,” said Oakland Athletics first baseman Brandon Moss, a non-user. “You would hope a figure like (Gwynn), something tragic like that happening, would be a wake-up call for everyone, not just those in baseball. … But most guys are probably going to look at it as the loss of a great man and a great baseball player and leave it at that.”

    Indeed, the stance among players seems to be that they’re aware of the dangers but, like smoking, it’s up to every individual to decide whether to use what remains a legal product.

    1402943407000-AP-ROCKIES-PADRES.jpg

    The National Cancer Institute says in its website that smokeless tobacco contains at least 28 chemicals that have been found to cause cancer – typically of the mouth, esophagus and pancreas – and may also lead to heart disease, gum disease and oral lesions.

    “People understand the risks involved and still choose to do it,” Texas Rangers general manager Jon Daniels said. “We all do stupid things, whatever your vice happens to be. People may criticize these guys for dipping, and then somebody’s texting and driving.”

    And while Gwynn’s passing was lamented throughout the game, it doesn’t figure to be interpreted by many players – who are usually in their 20s or early 30s, with the concomitant sense of invincibility – as a cautionary tale.

    “It’s one of those things that’s scary and obviously you hope you’re not the one,” said A’s catcher Stephen Vogt, who said he dips once in a while. “I don’t think it’s good. I definitely don’t advocate it, but at the same time, it’s an adult decision.”

    Baseball has taken steps to sway that decision, or at least make the practice less visible to minimize the impact on young fans.

    gwynn1.jpg

    The current collective bargaining agreement, in effect from 2012-16, bans players, managers and coaches from using smokeless tobacco during TV interviews and team appearances. And they have to keep tobacco products out of sight while fans are at the ballpark.

    In addition, MLB and the players union have stepped up educational efforts, and teams – which in the past freely distributed cans of dip in the clubhouse – can no longer do so and are now required to administer oral exams as part of the spring training physicals every year.

    Longtime TV announcer Joe Garagiola, who quit his smokeless tobacco habit in his 30s, made it his life’s mission to warn other baseball folks about its dangers, making presentations during spring training alongside former major league outfielder Billy Tuttle, who died of oral cancer at 69 in 1998.

    “I don’t think we talk about it enough anymore,” says Atlanta Braves manager Fredi Gonzalez. “I remember as a young A-ball manager, Joe Garagiola would always come around in spring training with Bill Tuttle. It was scary.

    “And I still see people chewing tobacco. Not only in the big leagues, but you still see kids in junior high and high school.

    For me, it’s not enough yet. It’s a shame.”

    1402968002000-6-16-gwynnx.jpg

    Indeed, the sight of players constantly spitting, some sporting a large wad of tobacco inside their cheek, remains one of the game’s enduring images.

    “Every spring training we have a guy that comes in who’s had mouth cancer through tobacco,” Rangers utilityman Donnie Murphy said. “So you see it. But at the same time, it’s like an addiction thing. You do it for so long, you’re going to want to keep doing it.”

    Players say using smokeless tobacco provides a form of relaxation and becomes part of their routine in a daily sport with lots of down time.

    And with amphetamines now banned from baseball, the jolt of energy from the nicotine in the tobacco – absorbed during a longer stretch through dip or chew than by smoking – can help players navigate the season’s six-month grind.

    Commissioner Bud Selig has expressed a desire to banish smokeless tobacco from the majors the same way MLB barred it from the minors starting in 1993. But the issue is subject to collective bargaining and the players association has declined, opting to protect personal freedoms and emphasize education.

    “The MLBPA discourages the use of smokeless tobacco products by its members or by anyone else. These products carry serious health risks, yet remain legally and widely available,” union spokesman Greg Bouris said via e-mail. “In general terms, included in the smokeless tobacco policy negotiated in 2011 are restrictions/prohibitions on its use, increased emphasis on education and cessation programs, as well as oral examinations. At this point in time, player education continues to be a focus of ours.”

    Contributing: Paul White in Washington

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

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    Gwynn’s death sparks dip debate

    Fri, Jun 20, 2014

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    Source: www.trentonian.com
    Author: Nick Peruffo

    The death of San Diego Padres icon Tony Gwynn due to oral cancer Monday resonated across the baseball world — including the Trenton Thunder clubhouse.

    In addition to being a person tragedy for the Gwynn family, the news also put a renewed focus on the use of chewing tobacco in baseball. Officially, tobacco in any form has been banned in the minor leagues since 1993. If caught with chewing tobacco on the field, players face a $300 fine, while managers are docked $1,000.

    Away from the field, however, it is clear that some players continue to dip.

    “There are so many guys that do it,” said catcher Tyson Blaser, who does not use chewing tobacco. “It’s very common in the major leagues, and even though obviously in the minor leagues you are not supposed to do it, some people don’t adhere to that. To see an icon like (Gwynn) lose his battle with cancer because of a habit a lot of people do, I assume it’d be eye opening to some people.”

    Gwynn, who was just 54, blamed his cancer on dipping tobacco.

    Despite that, manager Tony Franklin conceded that while the coaching staff does its best to dissuade players from using, what they do on their own time is ultimately their own decision.

    “We encourage them not to do it, but they are adults with choices to make,” Franklin said. “The choices they make could be very beneficial and save their lives, so we hope they make the right choices. I will always continue to encourage them not to (chew tobacco).”

    Franklin, who spent 11 seasons as an infield instructor with the Padres, knows of what he speaks. A longtime smoker and chewer, he said he was motivated to quit in part due to peers who had biopsies come back positive.

    “It was probably one of the hardest things that I’ve done,” Franklin said.

    Pitching coach Tommy Phelps — who spent parts of three big league seasons with the Florida Marlins and Milwaukee Brewers — recalled a jarring experience during his first big league camp with the Montreal Expos in 1996 that kept him away from chew.

    Bill Tuttle, a former major league outfielder who had lost half his jaw to cancer, visited the team to show them first hand the potential effects of chewing. Tuttle died two years later.

    “Just seeing that happens makes it real for everybody, that you are not going to be young forever,” Phelps said. “It’s dangerous.”

    According to the Oral Cancer Foundation, an estimated 43,250 Americans will be diagnosed with oral or pharyngeal cancer this year, and 8,000 will die.

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    Long term cerebral and vascular complications after irradiation of the neck in head and neck cancer patients: a prospective cohort study: study rationale and protocol

    Fri, Jun 20, 2014

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    Source: 7thspace.com
    Author: staff

    Successful treatment options for cancer result in more young long-term survivors prone for long-term complications. Carotid artery vasculopathy is a potential long-term complication after radiotherapy of the neck, resulting in cerebrovascular events and probably deficits in cognitive and motor functioning.

    Better insight into the underlying pathofysiology of radiotherapy induced carotid artery vasculopathy is needed for prognostic purposes and to develop preventive strategies.

    Methods: The current study is a prospective cohort study on the long-term cerebral and vascular complications after radiotherapy of the neck, in 103 patients treated for head and neck cancer, included in our study database between 2002 and 2008. Baseline protocol (before radiotherapy) included screening for cerebrovascular risk factors and intima media thickness measurement of carotid arteries by ultrasonography.

    Follow-up assessment more than 5 years after radiotherapy included screening of cerebrovascular risk factors, cerebrovascular events, neurological examination with gait and balance tests, extensive neuropsychological examination, self-report questionnaires, ultrasonography of the carotid arteries with measurement of intima media thickness and elastography, magnetic resonance imaging of the brain and magnetic resonance angiography of the carotid arteries.DiscussionThe current study adds to the understanding of the causes and consequences of long-term cerebral and vascular changes after radiotherapy of the neck. These data will be helpful to develop a protocol for diagnostic and preventive strategies for long-term neurological complications in future head and neck cancer patients with anticipated radiotherapy treatment.

    Authors: Joyce Wilbers, Arnoud C Kappelle, Roy PC Kessels, Stefan CA Steens, Frederick JA Meijer, Johannes H Kaanders, Roy AM Haast, Laura E Versteeg, Anil M Tuladhar, Chris L de Korte, Hendrik HG Hansen, Frank J Hoebers, Willem Boogerd, Erik D van Werkhoven, Marlies E Nowee, Guus Hart

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    Hall of Famer and ‘Mr. Padre’ Tony Gwynn dies at 54 from Oral Cancer

    Tue, Jun 17, 2014

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    Source: abcnews.go.com
    Author: Bernie Wilson
     

    Tony Gwynn could handle a bat like few other major leaguers, whether it was driving the ball through the “5.5 hole” between third base and shortstop or hitting a home run off the facade in Yankee Stadium in the World Series.

    He was a craftsman at the plate, whose sweet left-handed swing made him one of baseball’s greatest hitters.

    Gwynn loved San Diego.

    San Diego loved “Mr. Padre” right back.

    Gwynn, a Hall of Famer and one of the greatest athletes in San Diego’s history, died Monday of oral cancer, a disease he attributed to years of chewing tobacco. He was 54.

    “Our city is a little darker today without him but immeasurably better because of him,” Mayor Kevin Faulconer said in a statement.

    In a rarity in pro sports, Gwynn played his whole career with the Padres, choosing to stay in the city where he was a two-sport star in college, rather than leaving for bigger paychecks elsewhere. His terrific hand-eye coordination made him one of the game’s greatest pure hitters. He had 3,141 hits — 18th on the all-time list — a career .338 average and won eight batting titles to tie Honus Wagner’s NL record.

    He struck out only 434 times in 9,288 career at-bats. He played in San Diego’s only two World Series — batting a combined .371 — and was a 15-time All-Star. He had a memorable home run in Game 1 of the 1998 World Series off fellow San Diegan David Wells, and scored the winning run in the 1994 All-Star Game despite a bum knee.

    Gwynn never hit below .309 in a full season. He spread out his batting titles from 1984, when he batted .351, to 1997, when he hit .372.

    Gwynn was hitting .394 when a players’ strike ended the 1994 season, denying him a shot at becoming the first player to hit .400 since San Diego native Ted Williams hit .406 in 1941.

    Gwynn befriended Williams and the two loved to talk about hitting. Gwynn steadied Williams when he threw out the ceremonial first pitch before the 1999 All-Star Game at Boston’s Fenway Park.

    Fellow Hall of Famer Greg Maddux tweeted, “Tony Gwynn was the best pure hitter I ever faced! Condolences to his family.”

    Gwynn was known for his hearty laugh and warm personality. Every day at 4 p.m., Gwynn sat in the Padres’ dugout and talked baseball or anything else with the media.

    Tim Flannery, who was teammates with Gwynn on the Padres’ 1984 World Series team and later was on San Diego’s coaching staff, said he’ll “remember the cackle to his laugh. He was always laughing, always talking, always happy.”

    “The baseball world is going to miss one of the greats, and the world itself is going to miss one of the great men of mankind,” said Flannery, the San Francisco Giants’ third base coach. “He cared so much for other people. He had a work ethic unlike anybody else, and had a childlike demeanor of playing the game just because he loved it so much.”

    Gwynn had been on a medical leave since late March from his job as baseball coach at San Diego State, his alma mater. He died at a hospital in suburban Poway, agent John Boggs said.

    “He was in a tough battle and the thing I can critique is he’s definitely in a better place,” Boggs said. “He suffered a lot. He battled. That’s probably the best way I can describe his fight against this illness he had, and he was courageous until the end.”

    Gwynn’s wife, Alicia, and other family members were at his side when he died, Boggs said.

    Gwynn’s son, Tony Jr., was with the Philadelphia Phillies, who later placed him on the bereavement list.

    “Today I lost my Dad, my best friend and my mentor,” Gwynn Jr. tweeted. “I’m gonna miss u so much pops. I’m gonna do everything in my power to continue to … Make u proud!”

    Gwynn had two operations for cancer in his right cheek between August 2010 and February 2012. The second surgery was complicated, with surgeons removing a facial nerve because it was intertwined with a tumor inside his right cheek. They grafted a nerve from Gwynn’s neck to help him eventually regain facial movement.

    Gwynn had been in and out of the hospital and had spent time in a rehab facility, Boggs said.

    “For more than 30 years, Tony Gwynn was a source of universal goodwill in the national pastime, and he will be deeply missed by the many people he touched,” Commissioner Bud Selig said.

    Fans paid their respects by visiting the statue of Gwynn on a grassy knoll just beyond the outfield at Petco Park.

    Gwynn was last with his San Diego State team on March 25 before beginning a leave of absence. His Aztecs rallied around a Gwynn bobblehead doll they would set near the bat rack during games, winning the Mountain West Conference tournament and advancing to the NCAA regionals.

    Last week, SDSU announced it was extending Gwynn’s contract one season. The Aztecs play at Tony Gwynn Stadium, which was built in the mid-1990s with a $4 million donation by then-Padres owner John Moores.

    Gwynn was born in Los Angeles on May 9, 1960, and attended high school in Long Beach.

    He was a two-sport star at San Diego State in the late 1970s and early 1980s, playing point guard for the basketball team — he still holds the game, season and career record for assists — and in the outfield on the baseball team.

    Gwynn always wanted to play in the NBA, until realizing during his final year at San Diego State that baseball would be the ticket to the pros.

    He was drafted by both the Padres (third round) and San Diego Clippers (10th round) on the same day in 1981.

    After spending parts of just two seasons in the minor leagues, he made his big league debut on July 19, 1982. Gwynn had two hits that night. After Gwynn hit a double, all-time hits leader Pete Rose, who been trailing the play, said to him: “Hey, kid, what are you trying to do, catch me in one night?”

    In a career full of highlights, Gwynn had his 3,000th hit on Aug. 9, 1999, a first-inning single to right field at Montreal’s Olympic Stadium.

    Gwynn retired after the 2001 season and became a volunteer assistant coach at SDSU in 2002. He took over as head coach after that season.

    He and Cal Ripken Jr. — who spent his entire career with the Baltimore Orioles — were inducted into the Hall of Fame in 2007.

    “I had no idea that all the things in my career were going to happen,” Gwynn said shortly before being inducted. “I sure didn’t see it. I just know the good Lord blessed me with ability, blessed me with good eyesight and a good pair of hands, and then I worked at the rest.”

    Gwynn also is survived by a daughter, Anisha.

    Boggs said services were pending.

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

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    FDA approve Lymphoseek to evaluate head and neck cancer

    Tue, Jun 17, 2014

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    Source: www.medicalnewstoday.com
    Author: Catharine Paddock PhD

    The US Food and Drug Administration have given the OK for doctors to use Lymphoseek – a radioactive diagnostic imaging agent – to evaluate the spread of squamous cell carcinoma in the body’s head and neck region.

    Lymphoseek (technetium 99m tilmanocept) Injection was approved by the Food and Drug Administration (FDA) in 2013 to help doctors identify lymph nodes closest to primary tumors in patients with breast cancer and melanoma.

    The receptor-targeted lymphatic mapping agent is marketed by Navidea, a biopharma company based in Dublin, OH.

    Identification of lymph nodes in cancer is important because they filter fluid that drains from tissue. If this tissue is cancerous then the fluid will contain cancer cells, and testing lymph nodes – via biopsy – for presence of cancer cells helps determine if the cancer has spread.

    The approval of Lymphoseek for use in head and neck cancer patients means doctors will be able to use the agent to guide testing of sentinel nodes – lymph nodes closest to a primary tumor – allowing for the “option of more limited lymph node surgery in patients with sentinel nodes negative for cancer,” say the FDA.

    lymphatic-system

    In a clinical trial, researchers found that “Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system.”

    Dr. Libero Marzella, director of the Division of Medical Imaging Products in the federal agency’s Center for Drug Evaluation and Research, says:
    “For some patients with head and neck cancer, removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation.”

    Lymphoseek contains tiny radioactive molecules that are designed to bind to receptors found in high concentrations on the surface of cells located in lymph nodes.

    To use Lymphoseek, the doctor injects it into the tumor area and uses a handheld gamma counter to find the sentinel lymph nodes that have taken up the radioactive molecules.

    For this new approval, the FDA reviewed a clinical trial that tested Lymphoseek’s safety and effectiveness in 85 patients with squamous cell carcinoma of the lip, oral cavity and skin.

    The trial – which compared Lymphoseek against conventional tumor location and surgical practice – found that “Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system,” notes the FDA announcement.

    The trial found that the most common side effects were pain or irritation at the injection site.

    In March 2014, Medical News Today reported how a commonly used mood-stabilizing drug could reduce risk of head and neck cancer. Writing in the journal Cancer, researchers describe how individuals who took valproic acid – normally used to treat epilepsy and manic-depressive illness, such as bipolar disorder – for at least a year had a 34% lower risk of developing head and neck cancer, compared with those who did not use the medication.

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    Researchers bring oral cancer-fighting patch to patients

    Mon, Jun 9, 2014

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    Source: medicalxpress.com
    Author: staff

    The Ohio State University and the University of Michigan have signed an exclusive worldwide agreement with Ohio-based Venture Therapeutics, Inc, to form a new company to develop and commercialize a pharmaceutical technology targeted for the treatment of precancerous oral lesions. These lesions are currently managed by invasive surgery and approximately a third of these lesions will reoccur after surgery.

    Previously published data shows that about 30 percent of the higher grade precancerous oral lesions progress to oral cancer, specifically oral squamous cell carcinoma. This type of cancer is particularly devastating to patients because treatment entails removal of facial and mouth structures essential for esthetics and function. The National Cancer Institute estimates that 42,440 Americans will be diagnosed with oral cancer and over 8,390 oral cancer related deaths will occur in 2014.

    The pharmaceutical technology developed by researchers at The Ohio State University (OSU) College of Dentistry with secondary appointments at the OSU Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) and the University of Michigan addresses a significant unmet need related to the prevention of oral cancer. Precancerous oral lesions can be seen and touched by patients, so this easy access to the lesion allows the use of local delivery formulations in an oral patch to directly treat the disease without causing adverse side effects.

    “This type of collaboration, involving multiple university partners with strong industry support, is increasingly essential to expedite the discovery, development and delivery of more targeted cancer therapies. There is no routine cancer, and today it takes the collective minds across disciplines, institutions and industry to move the field forward,” says Michael Caligiuri, MD, director of The Ohio State University Comprehensive Cancer Center and chief executive officer of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

    “Ultimately, these collaborations can be the catalyst for new, more effective cancer treatments, leading to better outcomes, faster responses, fewer side effects and more hope for cancer patients everywhere,” said Caligiuri.

    These technologies were developed by a team of university-based researchers who work extensively with the affected patient population and actively explore new drug delivery methods such as the oral patch.

    Susan R. Mallery , DDS, PhD, professor and interim chair of the division of oral pathology and radiology at the Ohio State College of Dentistry and member of the OSUCCC – James Molecular Carcinogenesis/Chemoprevention Research Program, worked alongside Steve P. Schwendeman, PhD, Ara G. Paul Professor and Chair of the Department of Pharmaceutical Sciences, Professor of Biomedical Engineering, at the Biointerfaces Institute, University of Michigan, and his former assistant research scientist, Kashappa Goud Desai, PhD, to invent this breakthrough technology.

    “The oral patch sidesteps any toxicity issues, which have historically been a problem with conventional treatments,” said Mallery. “This technology delivers an excellent chemopreventive compound directly to the precancerous tissues.”

    “Dr. Mallery and I have collaborated for years on translational research projects,” said Schwendeman. “It is very gratifying to see our efforts progress past the preclinical state and into clinical trials where we can directly help patients.”

    The College of Dentistry at Ohio State saw great things for the collaboration between the two universities. “Having two College of Dentistry faculty members from Ohio State engage with researchers from the University of Michigan resulted in a very innovative approach that will dramatically improve patient care and outcomes,” said Dean Patrick Lloyd, College of Dentistry. “Conducting the clinical trials for this innovation at Ohio State’s College of Dentistry is very promising for the technology and prospective patients, and beneficial to both universities on a national level.”

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