Study explores the effect of graphic warning labels on cigarette packaging among US smokers

Source: www.news-medical.net
Author: Reviewed by Emily Henderson, B.Sc

Purchase a pack of cigarettes in Australia and be prepared to be accosted with graphic warning labels depicting the dangers of tobacco use – including images of gangrene of the foot, a newborn with a breathing tube and throat cancer.

“Graphic warning labels are used in more than 120 countries to counter marketing that promotes cigarette smoking. We wanted to know what effect such cigarette packaging would have on United States smokers,” said David Strong, professor at the Herbert Wertheim School of Public Health and Human Longevity Science at University of California San Diego.

Graphic warning labels were mandated by the United States Congress in 2009 but implementation has been stopped pending the outcome of legal challenges to the law by the tobacco industry.

In a paper published online in JAMA Network Open on Aug. 4, 2021, Strong and colleagues at UC San Diego Moores Cancer Center, California State University San Marcos, San Diego County Public Health Services, and San Diego State University, demonstrated that graphic warning labels are effective reminders of the negative health consequences of smoking.

“Graphic warning labels caused daily smokers in the United States to perceive cigarettes to be less positive and it increased their concerns about the health effects of smoking on both themselves and their loved ones,” said corresponding-author John P. Pierce, Distinguished Professor at the Herbert Wertheim School of Public Health.

The study manufactured special cigarette packs that incorporated the graphic warning labels used on cigarette packs in Australia (under license from the Australian government). Study participants were 357 smokers living in San Diego who agreed to purchase their preferred brand of cigarettes from a study website. Participants were randomized to receive their cigarettes in one of three pack designs: in package with a graphic warning label, with a blank pack, or in a standard commercially available U.S. pack.

During the study, participants were queried by interactive text messaging about concerns over health risks and about their perceptions of the most recent cigarettes that they smoked. Changes in consumption and smoking status were assessed at the end of the three-month intervention.

Participants who received cigarettes in the standard pack or a blank pack had no change in their positive perceptions of their cigarettes, while smokers randomized to the graphic warning label arm perceived their cigarettes less favorably. Health concerns increased in all three groups, likely due to the intervention that made them think about health consequences more often, said the study authors.


“While these labels make smokers more likely to think about quitting, it did not make them more likely to make a serious quit attempt, nor was it sufficient to help them quit their nicotine addiction. Thus, graphic warning labels are an integral component of tobacco control strategies but they are only one tool for governments to reduce the societal costs from the death and disease caused by tobacco smoking.”
Karen Messer, senior-author, professor of biostatistics, Herbert Wertheim School of Public Health

Journal reference:
Strong, D.R., et al. (2021) Effect of Graphic Warning Labels on Cigarette Packs on US Smokers’ Cognitions and Smoking Behavior After 3 Months. JAMA. doi.org/10.1001/jamanetworkopen.2021.21387.

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Shades of Big Tobacco: How (and why) Juul bought an entire issue of a scientific journal

Source: Salon
Date: July 20th, 2021
Author: Jon Skolnik

 

Facing the imminent threat of corporate death, the embattled e-cigarette maker Juul is pulling out all the stops in its fight to convince the Food and Drug Administration that its vaping products are more beneficial than harmful.

If that sounds like a stretch, it probably is. Last month, Juul settled a $40 million lawsuit that accused the company of luring in teens to use its flavored vape products, allowing Juul to avoid the potential PR nightmare of a widely covered jury trial. Juul has also spent tens of millions in federal lobbying efforts over the past several years, presumably in an effort to block comprehensive regulations on the sale of e-cigarettes.

But the most bizarre Juul news came two weeks ago, when the New York Times reported that the company had funded an entire issue of a scientific journal, in which every article presented evidence that vaping is a beneficial harm-reduction practice that can wean smokers off tobacco cigarettes.

Last month, the American Journal of Health and Behavior (AJHB), a 44-year-old academic journal that has published many nationally recognized scholars, released a special edition specifically devoted to the question of whether e-cigarettes are harmful or helpful. The 219-page issue is unusual not just by virtue of its niche subject matter — e-cigarettes are a relatively new phenomenon in the field of health behavior — but also because its publication was bankrolled entirely by one source: Juul Labs.

This fraught episode comes at an exceptionally tumultuous time for the vape maker. In early 2019, Juul, a company founded just four years earlier, was riding a wave of explosive success, boasting $1 billion in revenue. Sales had grown by 641% from 2016 to 2017 alone. A national survey in 2019 found that nearly 30% of U.S. high school students reported using e-cigarettes in the last month, with 60% of them naming Juul as their preferred brand.

In 2018, the tobacco giant Altria — previously known as Philip Morris — took a 35% stake in Juul, believing the acquisition might help recover some of the company’s losses from an overall decline in U.S. cigarette sales over the past several decades. Only a few months later, however, disaster struck. A mysterious respiratory ailment, clearly linked to vaping, sickened more than 1,000 people in the U.S., and by the fall of 2019, 34 vape users had died from lung injuries. Facing an array of potentially devastating lawsuits and pressure from the Food and Drug Administration (FDA), Juul voluntarily pulled its products from many store shelves and canceled its youth advertising campaigns, rapidly losing more than 30% of its market share.

Now Juul remains in something like corporate limbo, awaiting FDA approval to continue selling its vape products in the U.S. The agency will likely decide this year whether the alleged health benefits of Juul products outweigh their potentially addictive qualities. It’s not entirely surprising, then, that Juul wanted to subsidize an entire edition of a medical journal: Its survival as a corporation is on the line.

But is the Juul-sponsored journal ethical? That’s a murkier question than it might appear. The special issue of AJHB makes no attempt to conceal the fact that essentially all the studies it contains were funded and facilitated by Juul. As The American Prospect notes, a cursory glance at the journal’s “Conflict of Interest” statements reveals that 18 co-authors of articles in the special issue are Juul employees.

Five other co-authors work at PinneyAssociates, a firm that “provides consulting on harm reduction exclusively to JUUL Labs,” as its senior scientific adviser, Dr. Saul Shiffman, told Salon by e-mail. “We participate in JUUL’s work to publish their scientific research to inform the public dialogue about tobacco harm reduction,” he added. An additional three co-authors are involved in the Centre for Substance Use Research, another consulting firm that has a contract with Juul. Nearly every study in the issue features the brand name in its title, and all of them effectively conclude that Juul’s products are a safe form of harm reduction.

As one paper in the journal, a study based on population modeling, puts it, “after considering both potentially beneficial and potentially harmful transitions and based on the available evidence to date — the (continued) availability of ENDS [i.e., vape products such as Juul’s] in the US is likely to have a positive impact on population mortality.”

The edition’s closing perspective, written by Dr. Karl O. Fagerström, a Swedish psychologist who specializes in smoking cessation and “tobacco harm reduction,” waxes a bit more philosophical. “Because it is unlikely that humankind will give up drugs, nicotine included,” he writes, “the findings from the studies presented in this issue suggest that ENDS, and JUUL in particular, can be an acceptable substitute for more harmful cigarette alternatives.” (It is duly noted that Fagerström has served as a paid consultant to Philip Morris International and British American Tobacco.)

Outside the world of corporate-sponsored research, the existing scientific literature is mixed, at best, on the question of whether products like Juul offer effective means of smoking cessation. One study from the University of California, San Francisco, found last year that Juul’s products deliver “more nicotine to the blood per puff than cigarettes or previous-generation e-cigarettes (e-cigs) and [impair] blood vessel function comparable to cigarette smoke.”

Another study published this year in Pediatrics, the official journal of the American Academy of Pediatrics, found that e-cigarette smokers are three times more likely to switch to tobacco cigarettes later on. Other studies have found that e-cigarettes elevate the risk of heart disease, high cholesterol and depression.

To get a better sense of how this strange edition of a previously respected journal came into being, Salon contacted dozens of people listed as associate editors or senior associate editors at AJHB — none of whom are paid for their work there. Virtually none of them knew about the Juul-sponsored edition prior to its release.

“There was certainly no email sent out to any of the editors that this was going to happen,” Dr. Richard Olmstead, a research psychologist at UCLA’s Semel Institute for Neuroscience and Human Behavior, and an associate editor of AJHB, told Salon. “I think there would have been quite a bit of pushback had there been some forewarning about it.”

Dr. Carl Fertman, a professor emeritus at the University of Pittsburgh’s School of Education and an associate editor at the journal, described the special issue as a “complete surprise.”

“There was no transparency,” he said in an interview with Salon. “I don’t want to be associated with this journal. It’s upsetting.”

“I think it’s fairly unusual that a single company would sponsor a special issue,” another associate editor told Salon, asking not to be identified by name. “I was surprised to see they called out a specific company in every article.” This person added that was “different” from anything they’d seen before in “any scientific behavioral journal.”

A number of editors, however, acknowledged that there’s nothing new about seeing corporations sponsor scientific research they believe will be favorable to their bottom line.

For decades, the tobacco industry worked diligently to steer the scientific consensus away from the conclusion — now universally accepted — that cigarette smoking causes lung cancer, emphysema and other serious or life-threatening health problems. Central to that strategy was ginning up fake controversy by pushing junk science that appeared to contradict the overwhelming weight of scientific and medical evidence. Tobacco companies poured money into shadowy front groups that supported dubious science, paid consultants to prepare “expert” testimony to Congress and regulatory bodies and suppressed internal research findings that made clear that the companies themselves understood their products were killing people.

In 1998, a torrent of secret internal documents from a number of tobacco giants was released to the public as part of the Tobacco Master Settlement Agreement. By the early 2000s, the veil was just about lifted. Ruling on a landmark Justice Department suit back in 2006, U.S. District Judge Gladys E. Kessler found that several big-name tobacco companies, including Philip Morris, had systematically defrauded the American public with a decades-long effort to launder pro-tobacco “science” through academic and government channels.

To be clear, Juul is not a tobacco company. It makes and sells e-cigarettes, aka “vapes,” which contain no tobacco and are meant to simulate the experience of smoking cigarettes. They deliver high doses of nicotine to the brain through water vapor, often flavored in various ways. Whether vaping is “safe” remains an unsettled question, but it’s not the same thing as smoking.

Still, the fact Altria holds a significant interest in Juul creates an uncomfortable parallel, even if the two companies’ products would seem to be in competition. Juul’s decision to bankroll an entire edition of a medical journal struck many people as reminiscent of the Big Tobacco playbook.

Following AJHB’s publication of the special edition, a number of editors resigned from the journal, according to New York Times reporting later confirmed by Salon. Most editors declined to comment on the scientific merit of the papers published in the special edition. But there are reasons to be dubious about how the journal’s peer-review process worked in this case.

Before studies are published in any scientific journal, they are typically subject to peer review, in which experts in the relevant field read the papers and offer comments. As AHJB states in its ethical guidelines: “To decrease bias during the editorial process, we employ the classic double-blind peer review process. … The Editor-in-Chief transmits reviewer evaluations and comments to the corresponding author, usually within 4 weeks.”

AJHB editor-in-chief Dr. Elbert Glover, however, apparently told reviewers that the issue was about e-cigarettes in general — and then offered them cash rewards to complete their reviews within a week, according the the Philadelphia Inquirer. Many editors told Salon that in itself was unusual. Only after reviewers reportedly began to ask questions about “fishy” aspects of the studies did Glover reveal that the entire issue was funded by Juul. One reviewer told the Inquirer that the design of one particular study seemed so biased that she recommended it be rejected outright. “I thought, ‘No way it wasn’t funded by Juul,'” she said.

In an email exchange with Salon, Glover acknowledged that he had been privately approached by Juul, who personally paid him $57,500 to publish the edition. (Glover is the sole owner of the publication.) He maintained, however, that the peer review process was conducted in good faith.

“Reviewers were not initially notified regarding the funder of the special issue as it has been journal policy to not identify the funder of special issues during the review process,” Glover wrote to Salon. “However, during the review process, one reviewer requested the identity of the funder. As a result of the reviewer’s response, I decided to share the identity of the funder with all the reviewers of the special issue.”

Asked whether he believed it was appropriate to publish a corporate-sponsored special issue without consulting the other listed editors, Glover responded that it had not occurred to him, saying he “was more concerned about the science and did not consider who funded this issue.”

“I should have been more perceptive to their issue,” he said. “In retrospect, it was probably an error but I still do not understand the ability to ignore science and allow negative bias to enter into the decision.

“My philosophy is to allow the scientific merit to determine publication, not personal bias. Just because the tobacco industry lied, manipulated data and currently promote a product that causes death, does not mean that I have to compromise my values.”

But it’s precisely because of the tobacco industry’s dark history of lies and manipulative spin that Glover should have come clean about Juul’s sponsorship from the beginning, say experts on the other side of the issue.

“The problem is that the tobacco industry has a decades long history of spinning science to meet its regulatory, legal and PR needs,” wrote Dr. Stanton Glantz, former director of the Center for Tobacco Control Research and Education, in a blog post responding to AJHB’s special issue.

As one meta-analysis of research data found in 1998, “the only factor associated with concluding that passive smoking is not harmful was whether an author was affiliated with the tobacco industry.”

A number of AJHB editors told Salon that any study funded by an interested party, especially a large corporation, should be met with heightened scrutiny. One said it was “a red flag when the authors are part of the organization that sponsored the research,” adding: “It doesn’t mean that one can dismiss all of the findings, but it needs to be carefully scrutinized.”

It remains unclear which way the wind is blowing for Juul. In September 2019, the FDA issued a formal warning to the company, making clear that “before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful.”

“JUUL has ignored the law,” the department added, “and very concerningly, has made some of these statements in school to our nation’s youth.”

Months later, it was reported that Juul had begun beefing up its scientific staff, hiring a number of former FDA officials and recruiting researchers in hopes of clearing potential regulatory hurdles. Last July, Juul submitted a Premarket Tobacco Product Application (PMTA) to the FDA, providing “detailed scientific data from over 110 studies totaling over 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.”

The Juul-sponsored special issue of AJHB is one aspect one part of the company’s PMTA, a Juul spokesperson told Salon in a statement.

“The research in the special issue derives from an extensive research program designed to provide the US Food and Drug Administration’s Center for Tobacco Products with information, scientific data, and analysis to determine whether JUUL products are appropriate for the protection of public health,” the statement read. “This determination, through the submission of Premarket Tobacco Product Applications (PMTAs), is based on a rigorous, science-based process. Indeed, FDA has received not only the findings and reports reflected in the published papers, but also the subject-level data and other supporting information required through the PMTA process.”

In April of this year, six major health organizations — including the American Academy of Pediatrics, the American Cancer Society, the American Heart Association and the American Lung Association — wrote a letter to the FDA urging the agency to reject Juul’s Premarket Tobacco Product Application.

“The devastating combination of appealing flavors that appeal to youth, targeted marketing strategies, and technological innovations that deliver a powerful hit of nicotine, has caused enormous damage to public health, primarily through youth uptake,” they wrote. “Because of this, no JUUL products currently on the market can meet the public health standard, and therefore, none should be authorized by CTP or be allowed to stay on the market.”

The FDA is expected to rule on Juul’s application by Sept. 9.

Head-and-neck surgeons buoyant about new, just-right robot

Source: newsroom.uw.edu
Author: Brian Donohue

You know how great it feels when someone makes a pie or cake just for you? University of Washington Medicine head and neck surgeons have been feeling that kind of love lately, and on Feb. 5 they shared the first slice, so to speak, with patient Steven Higley.

Surgical assistants work near patient Steven Higley on Feb. 5. Lead surgeon Jeff Houlton is obscured by the robotics.

The cake in this story is actually a da Vinci robotic-assist system built especially for head and neck procedures. It is easier to maneuver than the robotic device they’ve used for the past decade, which was designed for operations to the chest and abdomen.

Higley underwent surgery to have a cancerous tonsil and part of his throat removed. Sitting at a console a few feet from the patient, Dr. Jeff Houlton manipulated the miniature surgical tools emanating from the robot’s single port, positioned just outside Higley’s open mouth. It was UW Medicine’s first trans-oral surgery with the new tool.

“If you think about laparoscopic surgery in the belly area, robotics provides the advantage of multiple mechanical arms approaching from different angles,” Houlton said. “But it’s a challenge to have three robotic arms that all need to go through a patient’s mouth. With this machine, the three arms are designed to come through one garden hose-like entry port and then articulate out from there.

“Pretty interesting, though, that in the past 10 years we built a nationally recognized practice for robotic head and neck surgery with a device designed for a different part of the body,” he added, laughing.

The new robot’s single port, left, through which all surgical instruments travel. At right, Dr. Jeff Houlton manipulates the instruments from a distant console. Photos by Randy Carnell, UW Medicine

Higley’s radical tonsillectomy entailed the removal of a margin of tissue beyond the visible tonsil and tumor. Houlton’s incisions exposed cranial nerves and branches of the carotid artery. Working in tight quarters with such vital anatomy, Houlton and his head-and-neck colleagues in surgery, Brittany Barber and Neal Futran, welcome the improvement in maneuverability.

Head and neck cancers represent only 3% of all oncology cases in United States. But case numbers are rising, Houlton said, with increased incidence of throat cancer involving human papillomavirus (HPV), as was the case with Higley, 68.

“Most of these cancers are HPV-mediated rather than smoking- and drinking-related,” Houlton said. “We call it an epidemic because it’s a viral cancer that’s gone up significantly since about the year 2000. In terms of HPV, cancer of the oropharynx (mouth, throat and tongue) is actually more common than cervical cancer now.”

Higley’s cancer came to light last fall after a yearly physical with his Olympia-based physician.

“I had no trouble swallowing, no pain,” Higley recalled. “I didn’t notice anything until my doctor said, ‘Hey, this looks like something we should check out.’ ” His referral to UW Medicine led to a biopsy in mid-December, and on Dec. 23, he learned that he had cancer.

“I’m glad they found it early and so is my wife,” Higley said. “If I could’ve had surgery the next day, it would’ve been OK with her.”

After the robotic part of the surgery, Houlton incised Higley’s neck and removed more than a dozen lymph nodes to be biopsied for cancer cells. Higley hopes they’ll concur with the pre-surgery PET scan that indicated his cancer was constrained to the tonsil.

Patient outcomes data suggests Higley’s prognosis is encouraging: 90-95% of patients who undergo surgery for this cancer survive five years or more.

Higley is already swallowing liquids and soft foods, but he’ll manage sore throat for about a month, Houlton said.

2021-02-12T18:43:12-07:00February, 2021|Oral Cancer News|

Is poor survivorship care driving high second-cancer risk?

Source: www.medscape.com
Author: Kristin Jenkins

In the United States, men and women who survive adult-onset cancers for at least 5 years are at significantly increased risk of developing and dying from new primary cancers, particularly those driven by smoking and obesity, a new study shows.

“This was disturbing but at the same time provides tremendous opportunities for cancer prevention and control, not only to mitigate the subsequent cancer risk but also to minimize comorbidities,” lead author Hyuna Sung, PhD, of the American Cancer Society in Atlanta, Georgia, told Medscape Medical News.

“The importance of smoking cessation, weight control, physical activity, and other factors consonant with adoption of a healthy lifestyle should be consistently emphasized to cancer survivors,” Sung said.

Results from a retrospective analysis of the most recent Surveillance, Epidemiology, and End Results (SEER) data from a cohort of 1.5 million survivors of first primary cancers (FPCs) show that male survivors — excluding those with prostate cancer — had a 45% higher risk of dying from any subsequent primary cancer (SPC) compared with men in the general population without a history of cancer.

Female survivors had a 33% higher risk of any SPC-related mortality, the study authors report in the Journal of the American Medical Association.

A significant proportion of the total incidence and mortality from SPCs was made up of smoking- or obesity-associated SPCs, the analysis shows.

“The risks of smoking-related SPCs were commonly elevated following many types of smoking-related FPCs, suggesting the role of smoking as a shared risk factor,” the researchers say.

Overall, four common smoking-related SPCs — lung, urinary bladder, oral cavity/pharynx, and esophagus — accounted for 26% to 45% of the total SPC incidence and mortality. Lung cancer alone accounted for 33% of the SPC-associated mortality in men and 31% of the mortality in women.

As previously reported by Medscape Medical News, second lung cancers occurring up to a decade after the first are on the rise, supporting long-term surveillance in survivors.

The current study also shows that in both men and women, four common obesity-related cancers — colorectal, pancreatic, uterine and liver — comprised 22% to 26% of the total SPC mortality.

“Survivorship care guidelines recommending health promotion need wider dissemination and implementation in oncology and primary care,” the study authors write about recommendations from the cancer society.

The investigators point out that in spite of evidence that a body mass index beyond the range of normal in survivors of breast and colorectal cancer increased risk of second obesity-associated cancers, many patients say they have never discussed with a doctor how to modify their lifestyle for a healthy body weight.

In 2018, the National Cancer Institute (NCI) reported that 67% of US cancer survivors were overweight or obese, Sung and colleagues note.

In an accompanying editorial, Patricia Ganz, MD, and Jacqueline Casillas, MD, of the David Geffen School of Medicine at UCLA, Los Angeles, California, agreed that the current study findings indicate “research and implementation of evidence-based interventions to promote smoking cessation and energy balance are a priority.”

The editorialists also point to issues of poor communication in clinical practice. “Among patients who survive a primary cancer, concern about recurrence, especially metastatic disease, is extremely common; however, information about future risk for subsequent primary cancers is seldom communicated to these patients, leading to missed opportunities to prevent or detect SPCs at an early stage.”

Close collaboration with primary care physicians during the early follow-up period is “a must,” Ganz told Medscape Medical News.

Oncologists should start the discussion right after initial treatment, when survivors are looking for ways they can prevent cancer recurrence or the development of new cancer, Ganz suggests.

“The ones I worry about the most are the young adults who could really benefit from the prevention outlook that primary care clinicians espouse,” she says, citing a 2016 study.

“If they continue to smoke or gain weight, that increases their risk of SPCs but also of comorbid chronic conditions…so it’s very important for them to get into the hands of a primary care physician. This issue is in the primary care provider court.”

Reorganization of Care and Payment Needed
For the study, Sung and colleagues analyzed data from 12 SEERS registries of FPC survivors diagnosed between 1992 and 2011. All patients had survived 5 years or more after initial diagnosis and had been followed to the end of 2017. Mean follow-up was 7.3 years.

The incidence and mortality of SPCs per 10,000 person-years were expressed as a standardized incidence ratio (SIR) and standardized mortality ratio (SMR) compared with expected risk in the general population.

A total of 30 FPC types were identified, including 12 smoking-related cancers and 12 obesity-related cancers.

In men, the highest risk of developing and dying from any SPC was estimated among survivors of laryngeal cancer (SIR 1.75) and gallbladder cancer (SMR 3.82), and among female survivors of laryngeal cancer (SIR 2.48; SMR 4.56).

Compared with men in the general population without a history of cancer, male survivors had an overall risk of developing any SPC that was significantly higher for 18 of the 30 FPC types. Male survivors also had an overall mortality risk for any SPC that was significantly higher for 27 of 30 FPC types.

This increased risk pattern looked much the same in female survivors when compared with women in the general population without cancer. The overall risk of developing and dying from any SPCs was significantly higher in female survivors for 21 and 28 of 31 FPC types, respectively.

The most common SPCs — after lung cancer — included colorectal cancer (8.8% of male survivors); pancreatic cancer (8.5% of male and 9.4% of female survivors); non-Hodgkin lymphoma (6% of male survivors); and breast cancer (5.8% of female survivors).

The study also shows that the risk for alcohol- and infection-related cancers was significantly higher following a diagnosis of most alcohol- and infection-related cancers.

These findings also have implications for reducing the economic burden of care, Sung and colleagues say.

“With the growing number of long-term survivors, the costs of treating patients with multiple primary cancers will increase, amplifying financial burden for cancer survivors and their families, particularly among elderly persons who may be living on fixed incomes. This consideration also has implications for the Medicare program, the primary payer for the population aged 65 years and older, as well as other health care payers,” the authors write, citing related financial research.

When it comes to improving outcomes for cancer survivors, “SPCs are just the tip of the iceberg,” Ganz warns. We will need some reorganization of healthcare delivery and payment schemes to make it happen, I think.”

She notes that recommendations for long-term survivorship care after cancer treatment were summarized following the 2017 National Cancer Policy Forum Workshop. Since then, “there has not been much movement,” Ganz says.

Current NCI-funded studies of innovative survivorship care planning and implementation are important, but results will not be forthcoming for at least 5 more years, she points out. “We really need more immediate efforts to transform care delivery.”

This study was funded by the American Cancer Society. Sung, study coauthors, and editorialists Ganz and Casillas have disclosed no relevant financial relationships.

JAMA. Published online December 22, 2020. Full text

2020-12-30T11:53:06-07:00December, 2020|Oral Cancer News|

Fighting throat cancer with T cells

Source: www.miragenews.com
Author: press release, Centenary Institute

Research led by the Centenary Institute has discovered that immune cells accumulating within the tumor environment, called tumor-resident T cells, are a critical determinant in survival rates of patients suffering from throat cancer.

Reported in the prestigious ‘Journal for ImmunoTherapy of Cancer’, the research suggests that strategies aiming to boost these T-cells at tumor sites could be beneficial to patients.

“Oropharyngeal squamous cell carcinoma (OPSCC) is a form of throat cancer. It can be caused by environmental factors such as smoking or by human papillomavirus infection (HPV), the same virus that causes cervical cancer in women,” said Ms Rehana Hewavisenti, lead author of the study and researcher at the Centenary Institute and the University of Sydney.

“We knew that patients with HPV-related OPSCC had far better clinical outcomes compared to other OPSCC patients but we didn’t know why,” she said.

In examining over sixty patient samples, Ms Hewavisenti and her colleagues discovered that increased levels of tumor-resident T cells, whether in HPV or non-HPV OPSCC cases, was clearly associated with improved patient survival outcomes.

“It was the accumulation of these immune T-cells, in and around the tumour site that appeared to be key,” said Ms Hewavisenti.

The researchers also found in their study that HPV OPSCC patients generally had far higher levels of tumour-resident T cells compared to their non-HPV OPSCC patient counterparts.

“We think these HPV positive patients tended to have better clinical outcomes as HPV infection is likely to favor the accumulation of these beneficial T-cells within the tumor area,” she said.

Dr Mainthan Palendira, Head of the Centenary Institute’s Human Viral and Cancer Immunology Laboratory and senior author on the research paper believes the research findings have major implications.

“Now that we understand how important this immune response is in relation to OPSCC, we can begin developing new treatment strategies focused on recruiting these favourable tumor-resident T cells directly to tumors,” he said.

Dr Palendira believes that looking at the amount of these T-cells in cancer could help clinicians to personalize the best treatment approach for individual patients.

“We also think that our research demonstrating viral (HPV) links with this tumor-resident T cell accumulation could help in future cancer vaccine development efforts too,” he said.

Gambling today: time to ban smoking in casinos

Source: www.si.com
Author: Frankie Taddeo

Casinos are working feverishly towards making guests feel they are not at risk when they travel back to properties with newly implemented safety measures. Among all these new features, there is one important change blatantly missing: prohibiting smoking.

Smoking could easily spread the COVID-19 virus, not only because of the need to remove your mask but because of an individual’s pattern of fingers to mouth while in constant contact with each game they decide to participate in.

Many doctors and experts have gone on record expressing that smoking or exposure to secondhand smoke can lead to coughing which in turn can aid in the spread of the infection. Unfortunately, casino operators don’t appear to have all the health interests of both their guests and employees at the heart of their newly implemented changes. Should that change, now is the time to play the hand being dealt and push all the collective chips into the middle.

Patrons either turning on the news or coming across signs in local establishments are told to avoid touching surfaces others have touched, and then touching your face, mouth, or eyes. In casinos, gamblers continuously touch cards, chips, dice, slot machine buttons, and above all, money. Even those of us who are not medical experts can rationalize that the act of smoking could likely lead to a higher risk of transmission during uncertain times

Also, what about the risks to non-smokers resulting from secondhand smoke? Part of the outline in the current Nevada Gaming Control Board’s reopening plan only requires properties to provide face masks or cloth face coverings upon request. Rather than make it a requirement, they only encourage guests to wear them.

The rationale behind the decision is not about safety, but money. Management running the properties are worried people would stop coming to play, leading to money lost from international tourism where many gamblers do not face such restrictions.

Dating to the days of Frank Sinatra to Sammy Davis Jr, many iconic images depict “Sin City” as a gambling destination where smoking has been synonymous with the lifestyle and imagery of the city’s bustling nightlife. But times have changed, and the goal should be to not only attempt to limit the spread of COVID-19, but to help others avoid the fate of Davis, an avid smoker who eventually passed away from throat cancer.

University of Nevada, Las Vegas gambling expert and author David Schwartz recently told USA Today that the current state of the world presents an ideal time for Nevada gaming operators to consider implementing the change:

“Coming back from COVID-19, both casino patrons and employees may have increased concerns about the presence of cigarette smoke. Given that the customer experience will be very different when casinos reopen, this may be an ideal time for Nevada gaming operators to consider changing where they allow smoking on their properties.”

Additionally, Ashley Herbert, Director of Government Relations with the American Heart Association, recently told the Shreveport Times:

“No one should have to choose between their health and a paycheck…there should not be one class of worker that is unprotected from the harmful effects of secondhand smoke,” Herbert told The Times.

If the focus of state officials is truly on the health and safety of the public, then directives should be made demanding casinos in every state become smoke-free. If considered, the greatest gambling destination in the world can implement a change that validates the health and safety of guests and workers at the forefront of the new reality.

Novel intervention looks to improve timeliness, equity of head and neck cancer care delivery

Source: www.miragenews.com
Author: staff report, Medical University of South Carolina

Many factors go into surviving cancer.

Hollings Cancer Center researcher Evan Graboyes, M.D., specializes in head and neck cancer, a disease with poor survival prospects despite intense therapy with combinations of surgery, radiation and chemotherapy. While head and neck cancer only accounts for 4% of all cancer cases each year in the US, it has a high mortality rate. The American Cancer Society estimates that more than 14,000 patients died from this disease in the U.S. in 2019.

Overall, only 50% of head and neck cancer patients are alive at five years. Unfortunately, the mortality rate is even worse for African American head and neck cancer patients. That’s why researchers are looking for new strategies to improve patient survival and decrease racial disparities in outcomes for these patients.

Graboyes and MUSC Hollings Cancer Center researchers Chanita Hughes-Halbert, Ph.D., Katherine Sterba, Ph.D., Hong Li, Ph.D., and Graham Warren, M.D., Ph.D., have teamed up to develop and test a novel intervention to improve the timeliness, equity and quality of head and neck cancer care delivery, which they think might one day be the key to improving survival for these patients.

Funded by a $1.3 million 5-year grant from the National Cancer Institute, their study – Improving the Timeliness and Equity of Adjuvant Therapy Following Surgery for Head and Neck Cancer-started in September 2019 and built upon important research funded by grants from Hollings Cancer Center.

Graboyes explained that for patients with advanced head and neck cancer who are treated with surgery, national guidelines recommend that postoperative radiation therapy should start within six weeks of surgery.

“However, we know from our research that despite national guidelines, over half of the patients nationally don’t get radiation started in a timely fashion. Patients who have delays with radiation are more likely to die and have their cancer recur,” he said. “We are trying to find new ways to deliver timely head and neck cancer care. It’s an appealing way to help improve survival for this group.”

Innovative approach
The study is designed in three parts. The first part aims to identify the underlying reasons for why delays starting postoperative radiation are so common for this patient population. The researchers then developed a new multilevel health care delivery intervention called NDURE (Navigation for Disparities and Untimely Radiation thErapy), that specifically targets the barriers that lead to delays.

In the second part of the grant, the researchers will pilot the NDURE intervention in a small group of patients to make sure that it’s feasible and acceptable and refine the intervention based on participant feedback. In the third and final part of the study, they will compare NDURE to standard care in a randomized controlled trial to see whether NDURE is effective at decreasing treatment delays.

“This study interests me because it is clinically important. To help patients with head and neck cancer live longer, you don’t need to invent a new drug. All you need to do is get them the treatment they’re supposed to be getting. If we can find a way to deliver timely guideline-recommended care, it could have such a large impact on their survival,” he said

“It’s also a scientifically important study. Head and neck cancer treated with surgery followed by radiation is a great model system for us to understand how we deliver cancer care. Right now, we spend a lot of time and effort helping get people in to initiate cancer care. However, we understand a lot less about how cancer patients move through complicated treatment plans.”

Graboyes said South Carolina is primarily a rural state with some geographic barriers that present obstacles for patients to navigate. “Many of the patients will have surgery at a regional center like MUSC, then because radiation is five days a week for six weeks, they’ll get radiation at a different facility closer to where they live. We have to coordinate cancer care across health care systems, which presents some barriers that can lead to treatment delays.”

Graboyes emphasized that head and neck cancer is a major concern for the state of South Carolina and Hollings Cancer Center, a National Cancer Institute-Designated Cancer Center. The two major causes of head and neck cancer are smoking and human papillomavirus (HPV). The state’s population is affected by both, due to high rates of tobacco use and very low rates of HPV vaccination.

“As a result, Hollings has recognized this issue and has really invested a lot in the clinical enterprise of head and neck cancer because it’s such a problem in South Carolina.”

Hollings also has a strong cancer control program dedicated to reducing issues of health disparities and equity in the state, he explained.

“We think that NDURE, our intervention targeting the multilevel barriers to timely head and neck postoperative radiation, will be an effective way to help improve timely cancer care delivery for these patients, which will lead to higher rates of survival and low recurrence and decrease racial disparities and outcomes. That’s very exciting to our team.”

Did you know?
About 70% of cancers in the oropharynx (which includes the tonsils, soft palate and base of the tongue) are linked to HPV.

Dedicated to the mission of raising HPV vaccination rates for teens and young adults, Hollings Cancer Center has initiated a $700,000 three-year project. The Centers for Disease Control and Prevention recommends speaking with a doctor about the HPV vaccination. The HPV vaccine can prevent new infections with the types of HPV that most often cause oropharyngeal and other cancers.

Test that looks at your spit to tell if you have mouth or throat cancer caused by HPV ‘could save thousands of lives if rolled out for doctors to use’

Source: www.dailymail.co.uk
Author: Connor Boyd, Health Reporter

A saliva test that diagnoses mouth and throat cancer caused by HPV could save thousands of lives each year, a study suggests. Scientists at Duke University in North Carolina discovered the test was 80 per cent accurate at spotting the killer diseases.

Doctors say it is able to detect the cancers early on, giving patients much higher hopes of surviving their battle. Before it can be used in hospitals around the world, further trials will be needed to confirm the technology works. But the researchers are hopeful, claiming the cheaper test – which gives results in as little as 10 minutes – has significant ‘potential’.

Rates of oral cancers are soaring in the Western world, with the number of patients diagnosed in the UK having doubled in a generation. US doctors have also seen a similar spike in the diseases, which can be caused by human papilloma virus (HPV).

The infection – spread through oral sex, as well as anal and vaginal intercourse – is thought to cause around 70 per cent of all cases. Other risk factors include drinking excessive amounts of alcohol over long periods of time and smoking cigarettes.

Professor Tony Jun Huang, study co-author, said there are around 115,000 cases of oropharyngeal cancers each year across the world. He said it is ‘one of the fastest-rising cancers in Western countries due to increasing HPV-related incidence, especially in younger patients’.

Orophayngeal cancer starts in the oropharynx, the back of the throat which includes the base of the tongue and tonsils. It sits under the branch of head and neck cancers, which also includes mouth cancer – another type that can be caused by HPV. Detecting the disease early can boost survival odds from 50 per cent to 90 per cent, according to the NHS. But patients are often not diagnosed until they become advanced, partly because their location makes them difficult to see during routine clinical exams.

The new test uses a chip developed to isolate tiny micro-particles, known as exosomes, in saliva.These particles are secreted into body fluids and several types of cancers are known to multiply their numbers. Exosomes are responsible for transferring molecules between cancer and various cells.

The new test isolates them by filtering out larger particles in the saliva and probing the exosomes for DNA shed by tumours. It also scans fluid in the mouth for HPV-16, one strain of the STI that can put people at risk of oropharyngeal cancer. The test takes five minutes to conduct and a further five to process the results. Experts also said it is cheap – but did not elaborate on the cost. In comparison, current biopsies take around eight hours because they need to be sent away to be assessed by a surgeon.

Professor Huang said: ‘It is paramount that surveillance methods are developed to improve early detection and outcomes.’ He added the successful detection of HPV from saliva ‘offers advantages including early detection, risk assessment, and screening’.

The test was a collaboration between Duke University, the University of California and University of Birmingham in Britain.

Orophayngeal cancer killed 2,722 Britons last year and took the lives of 9,750 people in the US, figures show. New cases of the disease in the UK have risen to 8,302 a year, a jump of 135 per cent compared with 20 years’ ago.

According to the researchers, this technology can also be used to analyse blood, urine, and plasma. The findings were published in the Journal of Molecular Diagnostics.

The Oral Health Foundation last month urged people to wise up to the causes of the ‘devastating’ disease, mainly HPV and alcohol. Dr Nigel Carter OBE, chief executive of the OHF, said: ‘While most cancers are on the decrease, cases of mouth cancer continue to rise at an alarming rate.

‘Traditional causes like smoking and drinking alcohol to excess are quickly being caught by emerging risk factors like the human papillomavirus (HPV).

‘We have seen first-hand the devastating affect mouth cancer can have on a person’s life.’

2019-12-14T11:12:24-07:00December, 2019|Oral Cancer News|

Researchers: Favorable survival, fewer side effects after reduced therapy for HPV-linked head and neck cancer

Source: medicalxpress.com
Author: University of North Carolina at Chapel Hill School of Medicine

University of North Carolina Lineberger Comprehensive Cancer Center researchers reported that reducing the intensity of radiation treatment for patients with human papillomavirus-associated head and neck cancer produced a promising two-year progression-free survival rate and resulted in fewer side effects.

The findings, published in the Journal of Clinical Oncology, were drawn from a phase II clinical trial that included 114 patients with HPV-linked head and neck cancer and a limited smoking history. The researchers reported that they saw a similar progression free survival rate, and that patients experienced fewer long-term side effects in the study compared with patients who received standard intensity treatment in previous studies.

“A simple de-intensification strategy of reducing radiation and chemotherapy appears to be as effective at cancer control as the standard seven-week regimen,” said UNC Lineberger’s Bhishamjit S. Chera, MD, associate professor in the UNC School of Medicine Department of Radiation Oncology. “Furthermore, there were fewer toxicities.”

For the trial, patients received six weeks of treatment, including a reduced intensity of radiation therapy of 60 Gray with weekly low-dose chemotherapy of cisplatin. The standard of care regimen is seven weeks of treatment 70 Gray and high-dose chemotherapy.

The main outcome that the researchers were studying was two-year progression-free survival. On the reduced regimen, researchers found that the two-year progression free survival was 86 percent, compared to a two-year progression free survival reported from other studies using standard treatment doses of 87 percent.

Chera said the major long-term side effects of radiation treatment are related to swallowing and dry mouth. Previous studies have shown the majority of patients treated with standard intensity chemoradiotherapy require a temporary feeding tube and some have significant long-term swallowing dysfunction.

Notably, in this study, patients reported that their swallowing returned to baseline after de-intensified treatment, and only 34 percent required a temporary feeding tube.

The results need to be validated in larger, randomized clinical trials, Chera said, and studies are ongoing to investigate this.

He added that while this study included patients with a limited smoking history, other current studies include patients with more extensive smoking histories.

Chera said that researchers want to continue to improve two-year progression free response rates while achieving better side effect results. They want to do that by identifying additional biomarkers to drive precision medicine strategies.

Although traditional clinical risk help clinicians predict outcomes and select patients for clinical trials of de-intensified treatments, Chera said that these risk factors are imprecise. He and his colleagues are currently evaluating additional novel biomarkers that they believe could be used to better predict a patient’s prognosis and outline a course of treatment.

Specifically, they have shown in a previous study how levels of circulating HPV DNA in the blood, and how quickly patients clear this from the blood, were linked to outcomes.

2019-09-14T09:18:38-07:00September, 2019|Oral Cancer News|

‘Whitish patch’: increase in oral dysplasia in young adults

Source: www.medscape.com
Author: Kristin Jenkins

Most 8-year-olds with a wiggly tooth expect the Tooth Fairy to tuck some money under their pillow. In the case of one little Canadian boy, his wiggly tooth got him an incisional biopsy, a diagnosis of oral squamous cell carcinoma (OSCC), a partial maxillectomy, and a defect that was closed with local advancement flaps.

“This was the most unusual case we’ve seen,” said Marco A. Magalhaes, DDS, PhD, assistant professor of oral pathology and oral medicine in the Faculty of Dentistry at the University of Toronto in Ontario, Canada.

“OSCC predominantly affects patients 40 years of age and older,” write Magalhaes and colleagues in a case study report published in November 2016 in Oral Surgery Oral Medicine Oral Pathology Oral Radiology. “It is extremely rare in patients younger than 20 years of age.”

The clinical, radiographic, and histologic findings in this young patient were distinctive. Although the diagnosis and treatment were challenging, the clinical course was favorable at follow-up, the authors said. This case illustrates the fact that even pediatric patients can be at risk for OSCC. Magalhaes said that he and other dentists are concerned about the rising number of OSCC cases in patients who are in their 20s and 30s. These patients have no known risk factors and are often without symptoms. Many are diagnosed with high-grade oral epithelial dysplasia (OED) that rapidly progresses to cancer, Magalhaes told Medscape Medical News.

“When you look at the distribution of cases of oral dysplasia or carcinoma, you see that they tend to occur in older males in their 50s with a history of smoking and a low risk of [malignant] transformation,” he explained.

“What we are seeing in practice, however, is a lot of dysplasia in younger individuals without risk factors. These cases are the most concerning,” he commented.

At the time of presentation, patients may say, “I’m not sure why I’m here, but I saw a whitish patch in my mouth,’ ” said Magalhaes.

Others may be asymptomatic and have “absolutely no concerns,” he pointed out. “Unfortunately, this story is becoming more common.”

Nonhealing Sore in Mouth
Oral cancer usually presents as a nonhealing sore that is often painful. OED can be more difficult to diagnose because it manifests as a faint whitish or red patch anywhere in the oral cavity.

The gums, tongue, soft palate, and the inside of the cheeks can be affected. Most commonly, the floor of the mouth is affected.

Currently, Magalhaes and colleagues are conducting a review of more than 3000 cases of dysplasia in Ontario to determine group distribution, pattern, and, potentially, risk factors.

Although oral cancer has multiple causal factors, Magalhaes noted that smoking is “by far” the most significant and well-recognized risk factor. Heavy alcohol consumption is also a well-known risk factor. Human papillomavirus accounts for 5% to 6% of oral cancers, he noted.

A regular dental checkup is important, and early detection is critical for survival, Magalhaes emphasized.

For high-grade OED, the risk for progression to frank carcinoma is 18% to 30%, he noted. For moderate-grade OED, the risk is 10% to 15%, and for low-grade oral dysplasia, it is 1% to 4%.

“Physicians should reinforce to their patients the importance of dental checkups at least twice a year,” Magalhaes said. “This alone would increase the chances of early lesion detection.”

Review of Biopsy Specimens
A recent review of 63,483 biopsy specimens submitted by dentists to the Toronto Oral Pathology Service (TOPS) primarily from 2005 through 2015 bears this out. The review, led by Magalhaes, was published online April 25 in the Journal of the American Dental Association.

TOPS is operated by the Faculty of Dentistry at the University of Toronto and is one of the largest oral pathology services in Canada, noted Magalhaes, who works there.

The results show that generally, the incidence of OED (2679 cases) and OSCC (828 cases) in Ontario remained stable from 2005 to 2015. It also showed that when it comes to early detection of oral lesions, dentists have seriously stepped up their game. During the 10-year period, detection of OED by dentists increased 3.8-fold. The number of OSCC cases they detected doubled. OSCC accounted for about 10% of all oral cancers in the province in 2015.

“These biopsy specimens were submitted mostly by specialists in oral and maxillofacial surgery, periodontics, endodontics, and oral and maxillofacial pathology and oral medicine,” the authors write.

“However,” they continue, “informal discussion with clinicians who submitted the biopsy specimens has indicated that the initial detection of the mucosal abnormality was often accomplished by the general practice dentist, dental hygienist, or both, who referred the patient to specialists for evaluation, biopsy, and case management.”

The study also shows that potentially malignant lesions made up 4.68% of all cases and that OED accounted for 90%. An increased awareness of early lesions with malignant potential can result in early diagnosis and decreased morbidity and mortality from OSCC, the researchers say.

Both dentists and patients appear to be maintaining a high index of suspicion, according to Magalhaes.

“Dentists are increasingly aware of the presence of these early lesions and are either biopsying them themselves or sending them for biopsy,” he explained. “We’ve also noticed that patients are more aware of mouth changes and are asking dentists about lesions that they have identified.”

During a routine dental checkup, an examination for early signs of oral cancer is performed. This includes inspection of the lymph glands in the neck and a check of all mucosal surfaces in the oral cavity for signs of ulcers or red or white patches.

The severity of OED determines treatment, noted Magalhaes. In cases of low-grade OED, the lesion is monitored every 6 months, and a repeat biopsy is performed if warranted. A high-grade OED that is accessible and relatively well contained is treated with complete surgical excision. This is followed by monitoring two or three times a year. When the lesion is diffuse, affects 60% of the oral cavity, or extends into areas that are difficult to access without significant morbidity, the patient is closely monitored with examinations four times a year, he said.

Source:
J Am Dent Assoc. Published online April 25, 2019. Abstract

Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Nov;122:e179-e185. Full text

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