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Researchers Find Hookah Smoking Can Lead to Serious Oral Conditions – Equivalent To Smoking 100 Cigarettes

Thu, Oct 29, 2015


Author: PR Newswire

CHICAGO, Oct. 28, 2015 /PRNewswire/ — According to the Centers for Disease Control and Prevention, 2.3 million Americans smoke tobacco from pipes, and many of those who smoke waterpipes, or hookahs, believe it’s less harmful than cigarettes. However, research published in The Journal of the American Dental Association (JADA) suggests hookah smoking is associated with serious oral conditions including gum diseases and cancer.

“We found that waterpipe smoking is associated with serious health problems affecting the head and neck region,” said study author Teja Munshi, B.D.S., M.P.H of Rutgers University. “The public needs to know they are putting themselves at risk. They should be made aware of the dangers of smoking hookahs.”

The authors conducted a literature review that focused on waterpipe smoking and head and neck conditions. They found waterpipe smoking to be associated with gum diseases, dry socket, oral cancer and esophageal cancer among other conditions. According to the World Health Organization, smoking a hookah is the equivalent of smoking 100 cigarettes, based on the duration and number of puffs in a smoking session.

“This study sheds light on the common misconception that smoking from a waterpipe is somehow safer than smoking a cigarette,” said JADA Editor Michael Glick, D.M.D. “Whether you are smoking a cigarette, an e-cigarette, a cigar, or tobacco from a waterpipe, smoking is dangerous not only to your oral health but to your overall health.”

The American Cancer Society is hosting The Great American Smokeout on November 19, 2015, an annual event that encourages smokers of all kinds to give up the habit. The event asks smokers to quit even for just one day to take a step toward a healthier life.

Millions of Americans still use traditional methods of smoking, but emerging trends in the smoking industry, such as hookah smoking and e-cigarettes pose dangers as well. E-cigarettes are devices that turn liquid into a vapor containing nicotine. In an editorial in the September 2015 issue of JADA, authors warned readers of the potential dangers of e-cigarettes, indicating that oral health effects of their use has been inadequately investigated.

“Additional research is needed on the impact smoking has on overall health, but it’s clear that smoking of all kinds has the potential to be dangerous,” said Dr. Glick.

Dentists have an important role in advising patients of the dangers of smoking. The American Dental Association has long been a proponent of educating the public about its hazards and has urged for continued research into the adverse health effects of tobacco use. For more information on smoking and its oral health effects, visit


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

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Manitoba expands HPV vaccination program to include boys

Fri, Oct 23, 2015


Author: Cody Griffin

While most HPV infections go away over time with no treatment, a few can go on to cause cancer.

Health Minister Sharon Blady said the province’s vaccine program will be expanded next year to include Grade 6 and Grade 9 boys as part of Manitoba’s cancer strategy.

The province will also be doing a catch-up period in grade 9. About 59 percent of the physicians recommended HPV vaccination more often for adolescents who they perceived to be at higher risk for getting an HPV infection, as opposed to recommending it routinely for all adolescents.

“Human papillomavirus can cause abnormal cell changes that can lead to cervical cancer, as well as cancer of the vagina, vulva, penis, anus, mouth and throat”, said Dr. Sri Navaratnam, president and CEO, CancerCare Manitoba.

A study in Texas found that a more rigorous, information driven outreach program increased the number of children receiving the vaccine, and other recent studies have reinforced the efficacy of the vaccine to prevent cancer and not promote promiscuity among teenagers.

Any girl or boy who misses the vaccine in Grade 6 will be eligible to get it in later years free of charge under the province’s “once eligible, always eligible”, program. But now we know it causes cancer in men as well.

Gilkey and colleagues found that 27 percent of physicians across the country reported that they do not strongly endorse HPV vaccination, and 26 percent and 39 percent reported that they do not provide timely recommendations for vaccinating girls and boys, respectively.

“The vaccine’s definitely most effective when you’re younger because you have A better immune response to vaccines and when you haven’t been exposed to the virus yet”, he said.

Routledge also said parents will need to give consent for their kids to receive the shot.

Saskatchewan Health Minister Dustin Duncan says offering the HPV vaccine for free to boys is something the province is looking at. “Vaccinating boys with the HPV vaccine will help prevent transmission of the virus and help reduce the incidence and mortality of all HPV-related cancers”. Nova Scotia has announced it plans to do the same.

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

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Less Is More for HPV Oropharyngeal Cancer Reduced-intensity regimen clears disease in 86% of cases

Wed, Oct 21, 2015


Author: Charles Bankhead

SAN ANTONIO — Less intense treatment of low-risk human papillomavirus (HPV)-related oropharyngeal cancer achieved a high rate of pathologic complete response (pCR) and favorable patient-reported outcomes, a preliminary trial showed.

Overall, 37 of 43 (86%) patients achieved pCR with deintensified chemoradiation, including all but one evaluable primary tumor. The pCR rate was virtually identical to historical rates achieved with standard regimens, according to Bhishamjit Chera, MD, of the University of North Carolina (UNC) at Chapel Hill, and colleagues.

Selected patient-reported adverse events peaked during the first 6 to 8 weeks and then declined thereafter. About 40% of patients required feeding tubes for a median duration of 15 weeks, but no patients required permanent feeding tubes, they reported here at the American Society for Radiation Oncology meeting.

The regimen consists of lower doses of radiotherapy and concurrent cisplatin, administered over 6 weeks. With high-dose therapy, the radiation protocol requires an additional week.

“Though we have limited follow-up, the pathological complete response rate with this reduced-intensity chemoradiotherapy regimen is very high in patients with favorable-risk oropharyngeal squamous-cell carcinoma,” Chera said. “The early quality-of-life measurements are encouraging, particularly the data on swallowing. We are optimistic that these results with reduced-intensity treatment will translate into good long-term disease control with less toxicity.”

The study reflects the current trend and momentum in the management of HPV-positive oropharyngeal cancer, said Zain Husain, MD, of Yale Cancer Center in New Haven, Conn.

“This is the second study to show that de-escalation of therapy might work, and so far, the results really look good,” Husain told MedPage Today. “This is a really important issue, and all of our trials are moving in that direction.”

NRG Oncology (formerly RTOG) has already launched a trial using the UNC regimen, “which gives us a lot of confidence that this is a good regimen,” Husain added. Nonetheless, reduced-intensity treatment remains investigational and should not be used in clinical practice. Randomized clinical trials with adequate follow-up will be required to determine the ultimate role of less intense therapy for HPV-positive oropharyngeal cancer, he said.


HPV-positive oropharyngeal cancer accounts for 60% to 70% of new cases of oropharyngeal cancer in the U.S., and the incidence has continued to rise. In general, HPV-positive disease has a more favorable prognosis as compared with HPV-negative oropharyngeal cancer.

At many institutions, standard therapy for newly diagnosed HPV-positive oropharyngeal cancer consists of total-dose radiotherapy of 70 Gy administered over 7 weeks, and concurrent cisplatin 100 mg/m2 for 3 weeks. The regimen achieves a high rate of pCR but causes substantial toxicity. Given the overall favorable prognosis of HPV-positive oropharyngeal cancer, many specialists have begun to ask whether reduced-intensity treatment might be just as effective with less toxicity.

Chera reported findings from a prospective phase II trial of reduced-intensity chemoradiation for low-risk HPV-positive oropharyngeal cancer. Eligible patients had diagnoses of T0-3, N0-2c, M0 disease associated with minimal or negative smoking history. Treatment consisted of a total radiation dose of 60 Gy administered in 2-Gy fractions daily for 6 weeks, plus concurrent weekly cisplatin 30 mg/m2. The regimen represented a 10-Gy reduction in the usual radiation dose and a 40% reduction in the usual chemotherapy dose, Chera said.

The primary outcome was pCR and was based on experience with usual high-dose therapy, which has been associated with a pCR rate of 87%. Patients undergo biopsy of the primary site 6 to 14 weeks after completing chemoradiation, as well as resection of any initially-positive lymph nodes. Secondary endpoints included toxicity, quality of life (QOL), and clinical outcomes of treatment.

Key Findings

The 86% pCR rate compared favorably with the 87% rate demonstrated by historical data. The overall results included pCR in 40 of 41 evaluable primary tumors (two of which were stage T0 at baseline) and pCR in the neck in 33 of 39 patients (four of whom had N0 status at baseline).

After a median follow-up of 21 months, all 43 patients remain alive and without evidence of disease, including 38 patients who have at least 1 year of follow-up.

Investigators evaluated QOL by means of an instrument developed by the European Organization for Research and Treatment of Cancer (EORTC QLQ H&N-35). Focusing on common adverse effects of chemoradiation for head and neck cancer, Chera noted that the severity score for dry mouth, sticky saliva, and swallowing all increased during the first 6 to 8 weeks, particularly dry mouth and sticky saliva.

The score for dry mouth peaked at about 70 on the 100-point scale and the score for sticky saliva rose to a maximum of about 60. Score for dry mouth remained at about 60 at 12 months, whereas the saliva score declined to about 40. The effect on swallowing was less severe, reaching a maximum of about 20 and then declining to less than 10 at 12 months.

Patient-reported symptoms exhibited a similar pattern as the dry mouth score averaged less than 0.5 (0 to 4 scale) at baseline, increasing to almost 2.5 at 6 to 8 weeks, and then declining to less than 2.0 by 1 year. Patient-rated swallowing difficulty was less than 0.5 at baseline, about 1.0 at 6 to 8 weeks, and slightly less than 1.0 at 1 year.

Physician-rated grade 3/4 toxicity and patient-rated severe/very severe toxicity included mucositis (34%/45%), pain (5%/48%), nausea (18%/52%), vomiting (5%/34%), dysphagia (39%/55%), and xerostomia (2%/75%).

Chera and colleagues have already closed enrollment for another phase II trial that will evaluate a reduced-intensity regimen that makes surgery optional, omits chemotherapy for patients with T1-2 N0-1 disease, and includes patients with as much as a 30 pack-year smoking history but who have a 5-year period of abstinence.

A planned “third-generation” phase II trial will evaluate the feasibility of cancer genetics risk-based stratification of patients and examine more specifically the question of whether reduced-intensity treatment is possible for patients with a >10 pack-year smoking history.

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

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Athletes drive increase in high schoolers’ use of smokless tobacco, CDC study shows

Mon, Oct 19, 2015


Author: web staff


High-school athletes are using more smokeless tobacco, even though overall tobacco use among high-school students has declined, according to a study published by the federal Centers for Disease Control and Prevention.

We can do more to protect America’s youth from a lifetime of addiction,” Tom Frieden, CDC director, said in a press release. “The fact is, smokeless tobacco products, such as chewing tobacco, snuff or dip, can cause cancer of the mouth, esophagus and pancreas. And the nicotine in these products is harmful to the developing brain. Because we know tobacco-free policies in schools and other public recreational areas work, we must take action now so that our children are safe from these toxins.”

Student responses to the national Youth Risk Behavior Survey from 2001 through 2013 show that the share reporting any tobacco use dropped to 22.4 percent from 33.9 percent, and the rate of those smoking combustible tobacco products dropped to 19.5 percent from 31.5 percent. However, those who reported using smokeless tobacco products increased to 8.8 percent from 8.2 percent.

The increased use of smokeless tobacco was driven by athletes. The rate among non-athletes remained unchanged at 5.9 percent but has “increased significantly” to 11.1 percent from 10 percent in youth athletes.

Researchers suggest that athletes are aware of the adverse consequences of smoking on athletic performance, but may view smokeless tobacco as “less harmful, socially acceptable, or even a way to enhance athletic performance.”

The 2013 YRBS found that 26.3 percent of Kentucky’s high school youth reported any use of tobacco; 17.9 percent were smoking cigarettes, and 13.2 percent reported using smokeless tobacco.

“Tobacco use among youth athletes is of particular concern because most adult tobacco users first try tobacco before age 18,” Brian King, deputy director for research translation in the CDC Office on Smoking and Health, said in a press release. “The younger people are when they start using tobacco, the more likely they are to become addicted and the more heavily addicted they can become.”

The reports calls for increased education about the dangers of smokeless tobacco; recognition that the tobacco industry pushes smokeless tobacco as an alternative to smoking where it is prohibited; that the role of professional athletes, many who use smokeless tobacco, must be part of the discussion because they are often considered role models by youth; and that “implementing and enforcing tobacco-free policies that prohibit all tobacco use on school campuses and at all public recreational facilities, including stadiums, parks, and school gymnasiums, by players, coaches, referees, and fans might help reduce tobacco use among student athletes.”

As of September, Kentucky had 47 school districts with comprehensive tobacco free policies. These policies cover 45 percent of Kentucky’s students and represents 27 percent of the school districts in the state, according to the Kentucky 100% Tobacco Free Schools website.

“Creating 100 percent tobacco-free environments is one of the best ways we can set our kids up for a healthy future,” U.S. Surgeon General Vivek H. Murthy said in the release. “It helps them see that being tobacco-free is the way to better health and a longer life.”


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

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Multisite HPV16/18 Vaccine Efficacy Against Cervical, Anal, and Oral HPV Infection

Fri, Oct 16, 2015


Authors: Daniel Bleacher, Aimee Kreimer, Mark Schiffman, Rolando Herrero, Ana Cecilia Rodriguez, Douglas Lowy, Carolina Porras, John Schiller, Wim Quint, Silvia Jiminez, Mahboobeh Safaeian, Linda Struijk, John Scchussler, Allan Hildesheim, Paula Gonzalez


Background: Previous Costa Rica Vaccine Trial (CVT) reports separately demonstrated vaccine efficacy against HPV16 and HPV18 (HPV16/18) infections at the cervical, anal, and oral regions; however, the combined overall multisite efficacy (protection at all three sites) and vaccine efficacy among women infected with HPV16 or HPV18 prior to vaccination are less known.

Methods: Women age 18 to 25 years from the CVT were randomly assigned to the HPV16/18 vaccine (Cervarix) or a hepatitis A vaccine. Cervical, oral, and anal specimens were collected at the four-year follow-up visit from 4186 women. Multisite and single-site vaccine efficacies (VEs) and 95% confidence intervals (CIs) were computed for one-time detection of point prevalent HPV16/18 in the cervical, anal, and oral regions four years after vaccination. All statistical tests were two-sided.

Results: The multisite woman-level vaccine efficacy was highest among “naïve” women (HPV16/18 seronegative and cervical HPV high-risk DNA negative at vaccination) (vaccine efficacy = 83.5%, 95% CI = 72.1% to 90.8%). Multisite woman-level vaccine efficacy was also demonstrated among women with evidence of a pre-enrollment HPV16 or HPV18 infection (seropositive for HPV16 and/or HPV18 but cervical HPV16/18 DNA negative at vaccination) (vaccine efficacy = 57.8%, 95% CI = 34.4% to 73.4%), but not in those with cervical HPV16 and/or HPV18 DNA at vaccination (anal/oral HPV16/18 VE = 25.3%, 95% CI = -40.4% to 61.1%). Concordant HPV16/18 infections at two or three sites were also less common in HPV16/18-infected women in the HPV vaccine vs control arm (7.4% vs 30.4%, P < .001).

Conclusions: This study found high multisite vaccine efficacy among “naïve” women and also suggests the vaccine may provide protection against HPV16/18 infections at one or more anatomic sites among some women infected with these types prior to HPV16/18 vaccination.

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

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Alternative Tobacco Products as a Second Front in the War on Tobacco

Wed, Oct 14, 2015


Authors: Samir Soneji, PhD; James D. Sargent, MD; Susanne E. Tanski, MD, MPH; Brian A. Primack, MD, PhD

Associations Between Initial Water Pipe Tobacco Smoking and Snus Use and Subsequent Cigarette Smoking: Results From a Longitudinal Study of US Adolescents and Young Adults

Importance Many adolescents and young adults use alternative tobacco products, such as water pipes and snus, instead of cigarettes.

Objective To assess whether prior water pipe tobacco smoking and snus use among never smokers are risk factors for subsequent cigarette smoking.

Design, Setting, and Participants We conducted a 2-wave national longitudinal study in the United States among 2541 individuals aged 15 to 23 years old. At baseline (October 25, 2010, through June 11, 2011), we ascertained whether respondents had smoked cigarettes, smoked water pipe tobacco, or used snus. At the 2-year follow-up (October 27, 2012, through March 31, 2013), we determined whether baseline non–cigarette smokers had subsequently tried cigarette smoking, were current (past 30 days) cigarette smokers, or were high-intensity cigarette smokers. We fit multivariable logistic regression models among baseline non–cigarette smokers to assess whether baseline water pipe tobacco smoking and baseline snus use were associated with subsequent cigarette smoking initiation and current cigarette smoking, accounting for established sociodemographic and behavioral risk factors. We fit similarly specified multivariable ordinal logistic regression models to assess whether baseline water pipe tobacco smoking and baseline snus use were associated with high-intensity cigarette smoking at follow-up.

Exposures Water pipe tobacco smoking and the use of snus at baseline.

Main Outcomes and Measures Among baseline non–cigarette smokers, cigarette smoking initiation, current (past 30 days) cigarette smoking at follow-up, and the intensity of cigarette smoking at follow-up.

Results Among 1596 respondents, 1048 had never smoked cigarettes at baseline, of whom 71 had smoked water pipe tobacco and 20 had used snus at baseline. At follow-up, accounting for behavioral and sociodemographic risk factors, baseline water pipe tobacco smoking and snus use were independently associated with cigarette smoking initiation (adjusted odds ratios: 2.56; 95% CI, 1.46-4.47 and 3.73; 95% CI, 1.43-9.76, respectively), current cigarette smoking (adjusted odds ratios: 2.48; 95% CI, 1.01-6.06 and 6.19; 95% CI, 1.86-20.56, respectively), and higher intensity of cigarette smoking (adjusted proportional odds ratios: 2.55; 95% CI, 1.48-4.38 and 4.45; 95% CI, 1.75-11.27, respectively).

Conclusions and Relevance Water pipe tobacco smoking and the use of snus independently predicted the onset of cigarette smoking and current cigarette smoking at follow-up. Comprehensive Food and Drug Administration regulation of these tobacco products may limit their appeal to youth and curb the onset of cigarette smoking.

JAMA Pediatr. 2015;169(2):129-136. doi:10.1001/jamapediatrics.2014.2697

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


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Throat and tongue cancers linked to sexually transmitted virus on the rise

Tue, Oct 13, 2015


Author: Julia Medew

The sexual revolution is producing a new wave of throat and tongue cancers among middle-aged people, who are falling victim to a rare side effect of the “common cold of sexually transmitted infections”.

A growing number of Australians with oropharyngeal cancer are testing positive to the human papillomavirus (HPV), suggesting it has caused their disease rather than smoking or heavy drinking – factors responsible for many head and neck cancers in the past. Oropharyngeal cancer is usually found in the back third of the tongue or the tonsils. In 2014, about 125 Victorians were diagnosed with it. Most were men.

An Australian study of 515 patients diagnosed with the condition between 1987 and 2010 found that the proportion of people with an HPV-related diagnosis increased from 20 per cent between 1987 and 1995 to 64 per cent between 2006 and 2010. Over the same period, the proportion of people diagnosed with throat cancer who had never smoked increased from 19 per cent to 34 per cent, suggesting HPV may overtake smoking and drinking as a cause of the cancer in future.

American doctors say more oral sex following the sexual revolution of the 1960s probably spread HPV to more people’s mouths and throats. Actor Michael Douglas said he believed oral sex was to blame for his HPV-related throat cancer in 2013. But Dr Matthew Magarey​, an ear nose and throat surgeon at Epworth and Peter MacCallum hospitals in Melbourne, said while HPV-related throat cancers were occurring in more people aged 40 to 60, it should not necessarily be associated with oral sex because scientists believe HPV may be transmitted through kissing or simple hand to mouth contact as well.

Up to 80 per cent of the adult population is thought to have had some sort of HPV infection during their life (there are more than 100 strains) and most of them will not have experience any symptoms. Many people clear the virus within months of getting it.

Dr Magarey said a tiny proportion of people will get an HPV-related cancer, such as cervical, anal, or throat cancer. He said HPV in the throat probably took 30 to 40 years to turn into a cancer in the minority of people it affects in that way. He said treatments were getting better for the cancer, which has a high survival rate if found early. Depending on the circumstances of the cancer, radiation, chemotherapy and sometimes surgery are used to treat it. While the surgery has been long and complicated in the past, Dr Magarey said a new robotic procedure available at Peter Mac and Epworth was helping surgeons remove cancers more precisely and in less time. This was reducing long-term recovery problems such as difficulty eating and drinking and swallowing.

Dr Magarey said the most common first sign of throat cancer was a lump in the neck that persists for more than two or three weeks. Symptoms can also include a sore throat that persists for more than three weeks and difficulty swallowing.

“If you have these symptoms, see your GP and get a referral to a qualified ENT surgeon who can properly examine the throat. Just looking in the mouth is not enough,” he said.

Dr Marcus Chen, a sexual health specialist with Alfred Health, said the Australian government’s HPV Gardasil vaccination program for young people will reduce such cancers in future. In the meantime, he said testing for HPV – the “common cold of sexually transmitted infections” – was not recommended because there is no way of treating the virus or preventing it from being passed on to others.

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California to big-league ballplayers: Stop chewing tobacco

Tue, Oct 13, 2015


Author: John Rogers

California lawmakers have taken the first step toward accomplishing something Major League Baseball could never do: Stop players from stuffing those big wads of chewing tobacco into their mouths during games. With Gov. Jerry Brown signing a bill earlier this week banning the use of smokeless tobacco in all California ballparks, a practice dating to the days of Babe Ruth and Ty Cobb now seems headed toward the sport’s endangered species list.

Although California is only one state, it is home to five of Major League Baseball’s 30 teams, and team owners themselves have been pressing for a ban for years. Last May they got one in San Francisco, home of the reigning World Series champion Giants. In August they got another in Boston, site of fabled Fenway Park, and when Brown signed Assembly Bill 768 on Sunday one was already in the works for Los Angeles.

“Major League Baseball has long supported a ban of smokeless tobacco at the Major League level and the Los Angeles Dodgers fully support the Los Angeles City Tobacco ordinance and Campaign for Tobacco-Free Kids,” the Dodgers said in a statement last month.

Major League Baseball still needs buy-in from the players, however, because the statewide ban that takes effect before next season has no provision for enforcement.

“The question we’ve been asked is are we going to have police officers walking around checking lips, and no, that’s not the case,” said Opio Dupree, chief of staff to Assemblyman Tony Thurmond, D-Richmond, who introduced the bill. “It’s going to be left to the team and the league.”

Interviews with players in recent years indicate that many are ready to quit — if they could.

“I grew up with it,” pitcher Jake Peavy told the Boston Globe last year when the newspaper polled 58 players the Boston Red Sox had invited to spring training and found 21 were users.

“It was big with my family,” said Peavy who is now with the San Francisco Giants. “Next thing you know, you’re buying cans and you’re addicted to nicotine.”

He added he would like to quit to set a better example for his sons.

Last year’s World Series MVP, San Francisco Giant’s pitching ace Madison Bumgarner, also chews tobacco but told The Associated Press earlier this year he planned to quit after San Francisco became the first city in the nation to adopt a ban. That one, like the statewide provision, also takes effect next year.

“I’ll be all right. I can quit,” Bumgarner said in August. “I quit every once in a while for a little while to make sure I can do it.”

All the players should, said Christian Zwicky, a former Southern California Babe Ruth League most valuable player who grew up watching the Los Angeles Dodgers play and says he never cared for seeing all that tobacco chewing and the spitting of tobacco juice that follows.

It didn’t influence him to take up the practice, the 22-year-old college student says, but he can see how it might have affected others.

“I understand the sentiment there,” said Zwicky who adds he’s not a big fan of government regulation but supports this law. “You don’t want these people that kids look up to using these products that could influence children in a negative way.”

Moves to adopt a comprehensive ban have been gaining support in recent years, fueled by such things as last year’s death of popular Hall of Famer Tony Gwynn of the San Diego Padres, who blamed his fatal mouth cancer on years of chewing tobacco. Former pitcher Curt Schilling, a cancer survivor, has also taken up the cause.

Use of smokeless tobacco has been banned in the minor leagues for more than 20 years, but Major League Baseball and its players union haven’t been able to reach agreement on a similar restriction. Players and coaches are prohibited from chewing tobacco during television interviews and can’t been seen carrying tobacco products when fans are in the ballparks. But the chewing during the game continues.

“It’s a tough deal for some of these players who have grown up playing with it and there are so many triggers in the game,” San Francisco Giants manager Bruce Bochy told the AP earlier this year.

“I certainly don’t endorse it,” said Bochy, an on-and-off-again user for decades. “With my two sons, the one thing I asked them is don’t ever start dipping.”

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SA Developed Melanoma Drug Now Seen Effective in Fighting Lung Cancer

Tue, Oct 6, 2015


Author: News Radio 1200 WOAI Staff


1229_1264794779Keytruda, a cancer drug developed largely at San Antonio’s START Center, has already proven to be effective in treating advanced melanoma to the point that it is the major part of former President Jimmy Carter’s treatment.  Now, News Radio 1200 WOAI reports Keytruda has been given ‘fast track’ approval by the FDA for use in treating lung cancer, the leading cause of cancer deaths in the United States.

Dr. Amita Patnaik, a researcher and oncologist at START who helped develop the drug, says the impact of Keytruda on lung cancer patients has been amazing.

“Close to 40% of those patients will receive a response,” she said.  “And of those patients who receive a response, about 80% of those patients will have a long term response.”

The life saving potential of Keytruda in fighting non small cell lung tumors is obvious.  An estimated 221,000 Americans are diagnosed with lung cancer each year, and 158,000 die of the disease annually.

Dr. Patnaik says Keytruda is becoming the most successful of what are known as ‘targeted therapies,’ drugs which trigger the body to take action to fight the cancer.  She says both melanoma and lung cancer work essentially the same way to undermine the body’s defenses.

“The commonality between melanoma and lung cancer is there is a supressive effect of the cancer on the immune system.”

She says Keytruda essentially overrides that supressive effect, prompting the body to restart its natural immune defenses and fight the cancer.

That means the treatment takes place without chemotherapy.

“Thus avoiding some of the toxicities associated with chemotherapy including hair loss, fatigue, a drop in counts, nausea and vomiting, and the spectrum of negative side effects you get with chemo.”

Dr. Patnaik says several other types of cancers work the same way, ‘turning off’ the body’s natural immune systems, and she says there are indications that Keytruda will work for those cancers as well.

“Keytruda is showing activity in about ten or more other cancers, including liver cancer, head and neck cancer, and in a rare form of breast cancer.”

The FDA granted Keytruda ‘breakthrough therapy designation’ because of demonstrated preliminary clinical evidence that the drug may ‘offer a substantial improvement over available therapies.’

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

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Research Leader Discusses FDA-Funded Immunotherapy for Head and Neck Cancer

Tue, Sep 29, 2015


Author: Gina Columbus
Brett Miles, MD, DDS


The investigational immunotherapy axalimogene filolisbac (ADXS11-001) has emerged as a potentially practice-changing agent in the treatment of HPV-related oropharyngeal cancer.

Shown to generate T cells directed against a cancer antigen and neutralize suppressor regulatory T cells and myeloid-derived suppressor cells that protect the tumor microenvironment from an immunologic attack and contribute to tumor growth, ADXS11-001 is the first of its kind—a therapeutic vaccine for the disease.

The agent is being examined in an ongoing phase II trial, which was reported as one of 18 recipients of research grants recently awarded by the FDA’s Office of Orphan Product Development. The grants, given to sites for product development in rare diseases, total more than $19 million. The ADXS11-001 grant provides collaborating researchers from Baylor College of Medicine and the Icahn School of Medicine at Mount Sinai with more than $1.1 million over 3 years.

Eligible patients for the phase II study are newly diagnosed with stage II to IV HPV16-positive oropharynx squamous cell carcinoma who are scheduled to receive ablative transoral robotic surgery.

In an interview with OncLive, the study’s surgical principal investigator, Brett Miles, MD, DDS, associate professor of Otolaryngology Head and Neck Surgery, co-chief, Division of Head and Neck Oncology, Icahn School of Medicine at Mount Sinai, discusses the potential of ADXS11-001 in HPV-associated head and neck cancer and other emerging therapies and treatment strategies.

OncLive: Congratulations on your study being awarded a research grant from the FDA. How does it feel to be selected and how will it help further the phase II research?

  1. Miles: Number one, the beauty of having this award is that it allows us to know that we are in line with what the FDA is interested in and, especially, what the National Institutes of Health (NIH) is interested in, in terms of immunotherapy for head and neck cancer. It gives a little bit of confirmation that our work is headed in the right direction from the standpoint of the major funding agencies.

    Certainly, having that NIH funding is actually going to allow us to propel this study along. We are getting some preliminary results that appear to be encouraging and we really need to confirm those results; this is going to allow us to do that. That is the most exciting part.

Can you provide an overview of ADXS11-001 and how it operates in the immune system?

This is a therapeutic vaccine for HPV-related head and neck cancer and other cancers that are HPV-related. It is contrasting to the preventative vaccines that are widely known, such as Gardasil, for example. Gardasil is a vaccine that if you have not been exposed to the virus, it allows your immune system to fight HPV infection before it happens. The concept behind ADXS11-001 is to allow your immune system to recognize and attack cells that have already been infected with HPV. Therefore, it is a therapeutic vaccine, not a preventative vaccine. It is the only one available for head and neck cancer at this time in a clinical trial.

This is an attenuated virus that is given to the patient in the form of two vaccines, and then it tricks the immune system into thinking that these cells are infected with the bacteria. However, what they are recognizing is the viral proteins. Therefore, they attack the cells that are infected with HPV. That is the theory.

We have administered it to several patients on the trial, and we just got some preliminary data back on the response, and we are seeing some definite changes in the immune system and in the cell surface markers in patients who have had the vaccine. We do not have quite enough data yet to interpret what those changes mean. In other words, we know the vaccine is causing some type of immune response; we are not sure if that vaccine is effectively killing tumor cells yet, and we have not confirmed what those T cells are doing. We are still gathering data for that. Hopefully, with the next batch of patients that we enroll, we will be able to tell if this is actually an effective therapy for this disease. That is kind of where we are right now.

How has the safety profile of ADXS11-001 been thus far?

Patients have been tolerating it quite well. In terms of toxicity, it is like an immunotherapy. Therefore, you may get rashes and low-grade fevers, kind of feeling like you have the flu, and some other things that are relatively standard with immunotherapies. Remember, anything that activates your immune system to a sufficient level to fight off a tumor infection is also going to cause some level of low-grade side effects. However, we have not seen any severe side effects or any major issues with it. We have seen some changes in blood pressure during the infusions, so we give the vaccine in the cancer center. It is two doses and you are supervised for several hours after administration of the vaccine. We have not seen any major toxicities with the vaccine, but the low-grade ones are relatively common. People know when their immune system has been activated, that’s for sure.

What other immunotherapy agents on the horizon do you see having promise in the treatment of head and neck cancer?

One other study, that we have not yet opened but we are going to do, is combining the ADXS11-001 vaccine with MEDI4736, a PD-L1 inhibitor. That study will be for patients who have metastatic or recurrent disease. This ought to be kind of interesting because then you are attacking the immune system from two different angles. It is going to compare ADXS11-001 monotherapy with the PD-L1 monotherapy with a third arm that has both agents combined. I am not sure when that trial is going to be open, but that is the one coming up on the horizon.

Aside from immunotherapy, what other treatment-related research in head and neck cancer are you interested in seeing the results of?

The other main trial is our robotic surgery trial, which is called a de-escalation trial. As you may be aware, patients with HPV-related head and neck cancer have a good prognosis. One of the problems is, when they get standard concurrent chemoradiotherapy, they have a lot of functional morbidity. We have an ongoing robotics trial that basically treats patients with robotic surgery upfront and then they get standard chemotherapy with a reduced dose of radiation, a reduced dose of radiation, or no radiation based on their pathology.

We are hoping to offer the same cure rate for these earlier-stage HPV-related cancers, but with a more functional long-term outcome by tailoring what the patient gets, based on the pathology report, after the minimally invasive robotic surgery. That is something we are currently accruing for, and we are really excited to see if our survival data is comparable, which we think it will be. Our functional outcomes, based on the data we have, should certainly be improved over standard therapy.

There was research presented at the 2015 ASCO Annual Meeting that showed that reducing radiation and chemotherapy dosage in low-risk HPV-associated oropharyngeal squamous cell carcinoma may prevent disease recurrence while still improving quality of life. Can you comment on this study?

Both of these studies are consistent with the prevailing thoughts on de-escalation of therapy in appropriately selected patients. When properly stratified, many patients can enjoy high rates of oncologic cure, with reduced long-term morbidity. It highlights the difficult balance between administering just enough therapy to cure the cancer, without permanently destroying the quality of life in terms of speech and swallowing.

The investigational immunotherapy axalimogene filolisbac (ADXS11-001) has emerged as a potentially practice-changing agent in the treatment of HPV-related oropharyngeal cancer.

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

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