cervical cancer

Cancer-Preventing Vaccines Given To Less Than Half Of US Kids

Source: www.houstonpublicmedia.org
Author: Carrie Feibel

U.S. regulators approved a vaccine to protect against the human papilloma virus (HPV) in 2006, but cancer experts say misconceptions and stigma continue to hamper acceptance by both doctors and parents.

Eighty percent of Americans are exposed to the human papilloma virus in their lifetimes. Some strains of HPV can cause genital warts, but most people experience no symptoms and clear the virus from their systems within a year or two. But for an unlucky minority, the virus causes damage that, years later, leads to cervical cancer, throat cancer, and other types.

Researchers at MD Anderson are frustrated that ten years after the first vaccine arrived on the market, only 42 percent of U.S. girls, and 28 percent of boys, are getting the three-shot series.

The series can be given to girls and boys between the ages of 9 and 26, but the immune response is strongest at younger ages, before sexual activity begins.

n 2007, then-Texas governor Rick Perry proposed making the HPV vaccine mandatory for all preteen girls.  At the time, the vaccine was only approved and marketed for girls.

Dr. Lois Ramondetta, a cervical cancer specialist at MD Anderson, remembers the outcry.

“A lot of people felt that was the right idea, but the wrong way to go about it. Nobody really likes being told what to do, especially in Texas,” Ramondetta said. “I think there was a lot of backlash.”

Eventually, the legislature rejected Perry’s plan, even though it included an opt-out provision. Ramondetta said too many politicians focused on the fact that HPV is sexually transmitted. That had the unfortunate effect of skewing the conversation away from health care and into debates about morality and sexuality. She said the best and most accurate way to discuss the vaccine is to describe it as something that can prevent illness and death.

“I try to remove the whole concept of sexuality,” Ramondetta said. “When you’re talking about an infection that infects 80 percent of people, you’re really talking about something that is part of the human condition. Kind of like, it’s important to wash your hands because staph and strep are on all of us.”

Today, only Virginia, Rhode Island and Washington, D.C. mandate HPV vaccines.

“Our vaccination rates are really terrible right now,” Ramondetta said.

In Texas, only 41 percent of girls get all three of the required shots, and only 24 percent of boys.

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Kara Million of League City finds those numbers upsetting.  Million survived two rounds of treatment for cervical cancer.

“Even if you had a chance that your kid could have any kind of cancer, and you could have given them two shots or three shots for it? To me, it’s a no-brainer,” Million said.

Million always got regular Pap tests. But she missed one appointment during a busy time following the birth of her second child. When she went back, it had been only 15 months since her last Pap test. But the doctor found cervical cancer, and it had already progressed to stage 3.

“That was a huge surprise,” Million recalled.

Million had chemotherapy and radiation at MD Anderson. But a year later the cancer returned.

The next step was surgery, a radical procedure called a total pelvic exenteration.

Million and her husband looked it up online.

“When I was reading it, I was just, like, ‘this is so barbaric, there is no way they are still doing this in this day and age,’” Million said. “‘For certain, in 2010 we have better surgeries to do than this.’”

But there weren’t better surgeries. This was her only option.

“I had a total hysterectomy; they pulled all the reproductive system out,” she explained. “They take your bladder out, they take part of your rectum, they take part of your colon, they take your vagina, all of that in your pelvic area comes out.”

The surgery took 13 hours, and left her with a permanent colostomy bag and urostomy bag.

“At that point, with two kids at that age – I think they were one-and-a-half and three – there’s no option. I’m a mom, so I’m going to do whatever it takes so they can have their mom.”

Most women survive cervical cancer if it’s caught early enough. But Million’s cancer was diagnosed at a later stage, where only a third of women make it past five years. She has already made it past that five-year anniversary, and she’s not wasting any time.

She now volunteers as a peer counselor at MD Anderson to other cervical cancer patients, and she urges parents to vaccinate their kids.

“If most of cervical cancer is caused by HPV, and now we have something that can help prevent what I went through, and what my friends went through, and the friends that I lost?” Million says, “I don’t understand why people don’t line up at the door to get their kids vaccinated for it.”

But Dr. Ramondetta said parents can’t consent to the vaccination if pediatricians or family doctors don’t offer it. And they’re not offering it nearly enough, she said.

Some doctors don’t know how to broach the topic, fearing it will lead to a difficult conversation about sexual behavior. Some mistakenly think boys don’t need it, although they do – not only to protect their partners from HPV, but to protect themselves against oropharyngeal and anal cancers, which are also caused by HPV.  Ramondetta added that some doctors incorrectly assume that giving the vaccine will promote promiscuity.

Ramondetta says extensive research actually shows it doesn’t.

“There should be this understanding of an ethical responsibility. That this is part of cancer screening and prevention, just like recommending mammograms and colonoscopies.”

In Texas, only 41 percent of girls get all three of the required shots, and only 24 percent of boys.

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

September, 2016|Oral Cancer News|

HPV is changing the face of head and neck cancers

Source: www.healio.com
Author: Christine Cona
 

A drastic increase in the number of HPV-associated oropharynx cancers, particularly those of the tonsil and base of tongue, has captured the attention of head and neck oncologists worldwide.

In February, at the Multidisciplinary Head and Neck Cancer Symposium in Chandler, Ariz., Maura Gillison, MD, PhD, professor and Jeg Coughlin Chair of Cancer Research at The Ohio State University in Columbus, presented data that showed that the proportion of all head and neck squamous cell cancers that were of the oropharynx — which are most commonly HPV-positive cancers — increased from 18% in 1973 to 32% in 2005.

9ea467bbf8646a69da2a432f8fcc5452Maura Gillison, MD, PhD, Jeg Coughlin Chair of Cancer Research at The Ohio State University, said screening for HPV in the head and neck is years behind cervical screening for HPV.

 

In addition, studies from the United States, Europe, Denmark and Australia indicate that HPV-positive patients have a more than twofold increased cancer survival than HPV-negative patients, according to Gillison.

With the rising incidence of HPV-related oropharynx cancers, it will soon be the predominant type of cancer in the oral or head and neck region, according to Andy Trotti, MD, director of radiation oncology clinical research, H. Lee Moffitt Cancer Center & Research Institute, in Tampa, Fla.

“We should be focusing on HPV-related oropharyngeal cancer because it will dominate the field of head and neck cancers for many years,” he said during an interview with HemOnc Today. “It is certainly an important population for which to continue to conduct research.”

Because HPV-associated oropharyngeal cancer is emerging as a distinct biological entity, the recent rise in incidence will significantly affect treatment, and prevention and screening techniques, essentially reshaping current clinical practice.

Social change driving incidence

In the analysis performed by Gillison and colleagues, trends demonstrated that change in the rates of head and neck cancers was largely due to birth cohort effects, meaning that one of the greatest determinants of risk was the year in which patients were born.

The increased incidence of HPV-related oropharyngeal squamous cell carcinoma started to occur in birth cohorts born after 1935, indicating that people who were aged in their teens and twenties in the 1960s were demonstrating increased incidence, Gillison said.

“Two important and probably related events happened in the 1960s. In 1964, the surgeon general published a report citing smoking as a risk factor for lung cancer, and public health policy began promoting smoking cessation along with encouragement not to start smoking,” she told HemOnc Today.

If you were 40 years old between 2000 and 2005, your risk for having HPV-related cancer is more than someone who was between the age of 40 and 45 years in 1970, according to Gillison. Social changes that occurred among people born after 1935, for example, a reduction in the number of smokers, is consistent with the increasing proportion of oropharyngeal cancers that were HPV-related.

“The rates for HPV-related cancers began to increase and the rates for HPV-unrelated cancers started to decline, consistent with the known decline in tobacco use in the U.S. population,” she said.

Now, most cases of head and neck squamous cell carcinoma in non-smokers are HPV-related; however, oral HPV infection is common and is a cause of oropharyngeal cancer in both smokers and non-smokers, research shows.

In addition to a decrease in tobacco use reducing HPV-unrelated oral cavity cancers, the number of sexual partners may have increased during this time and have helped to increase HPV-related oropharyngeal cancers, according to Gillison.

Determining the cause of the elevated incidence is only a small piece of the puzzle. Screening, establishing who is at risk, and weighing vaccination and treatment options are all relevant issues that must be addressed.

Screening is problematic

A critical area for examination and research is the issue of screening for oral cancers. In contrast to cervical cancer, there is no accepted screening that has been shown to reduce incidence or death from oropharyngeal cancer, according to Gillison.

Not many studies have examined the issue of screening for HPV-unrelated oral cancers, and the few that have, tend to include design flaws.

Gillison said there is a hope that dentists would examine the oral cavity and palpate the lymph nodes in the neck as a front-line screen for oral cancer; however, in her experience, and from her perspective as a scientist, this has never been shown to provide benefit for oral cancer as a whole.

Another caveat with regard to HPV detection is that head and neck HPV screening is about 20 years behind the cervical field.

“Clinicians screening for HPV in the field of gynecology were incredibly fortunate because Pap smear screening was already an accepted cervical cancer screening method before HPV was even identified,” she said. “There was already a treatment algorithm: If there were cytologic abnormalities, patients were referred to the gynecologist, who in turn did a colposcopy and biopsy.”

A similar infrastructure does not exist for oropharyngeal cancer. People with HPV16 oral infection are at a 15-fold higher risk for oropharynx cancer and a 50-fold increased risk for HPV-positive head and neck cancer, yet there is no algorithm for treatment and management of these at-risk individuals, Gillison said.

In 2007, WHO said there was sufficient evidence to conclude that HPV16 was the cause of oropharynx cancer, but with no clinical algorithm already established, progress in this area is much further behind.

Another problematic aspect of HPV-related oropharyngeal cancer screening is that the site where the cancer arises is not accessible to a brush sampling, according to Gillison.

“To try to find this incredibly small lesion in the submucosal area that you cannot see and cannot get access to with a brush, highlights that we need to develop new techniques, new technologies and new approaches,” she said.

The near future consists of establishing the actual rates of infection in the oral cavity and oropharynx, and then screening for early diagnosis, according to Erich Madison Sturgis, MD, MPH, associate professor in the department of head and neck surgery and the department of epidemiology at The University of Texas M.D. Anderson Cancer Center.

“I am not extremely hopeful because the oropharyngeal anatomy makes screening complicated, and these cancers likely begin in small areas within the tonsils and the base of the tongue,” Sturgis told HemOnc Today. “I am hopeful, however, that preventive vaccines will eventually, at a population level, start to prevent these cancers by helping people avoid initial infection by immunity through vaccination earlier in life.”

Much of the currently known information surrounding the issue of HPV-related oral cancers is new, so researchers continue to conduct research in various relevant areas. One key question to answer is who may be at higher risk for HPV-related oropharynx cancers.

Who is at risk?

As mentioned earlier, the number of oral sex partners seems to play a role in the risk for contracting the HPV virus.

In one study published in The New England Journal of Medicine in 2007, findings demonstrated that a high lifetime number of oral sex partners (at least six partners) was associated with an increased risk for oropharyngeal cancer (OR=3.4; 95% CI, 1.3-8.8).

In addition to a higher number of oral sex partners, other still unknown factors may be contributing to risk. This is an area that needs further research, according to Barbara Burtness, MD, chief of head and neck oncology, and professor of medical oncology at Fox Chase Cancer Center in Philadelphia.

The effect of smoking status is another area that needs further research. According to Burtness, smokers with HPV-associated oropharynx cancer have less favorable outcomes.

When discussing the prognosis of HPV-associated cancers, Sturgis said low risk is defined as low or no tobacco exposure and positive HPV status, and intermediate risk is defined as significant tobacco exposure but an HPV-positive tumor, and the highest risk group appears to be the HPV-negative group.

Although HPV-negative cancers are overwhelmingly tobacco-related cancers and tend to have multiple mutations, it appears that HPV-positive cancers, particularly those in patients with low tobacco and alcohol exposure, tend to lack mutations and to have a better prognosis, and this may ultimately help to guide treatment practices, according to Sturgis. Yet, there is still much to learn about HPV-related oropharyngeal cancers on various fronts.

Vaccination a hopeful ally

In HPV-related head and neck cancer, particularly oropharynx cancers, more than 90% of patients who have an HPV-type DNA identified, have type 16, according to Sturgis.

The two current HPV vaccines, Gardasil (Merck) and Cervarix (GlaxoSmithKline), which are approved for cervical cancers, include HPV types 16 and 18; therefore, in theory, they should be protective against the development of infections in the oropharynx and protective at preventing these HPV-associated cancers from occurring.

The presumption is that if there was a population-wide vaccination against HPV, there would be less person-to-person transmission, and this would lead to fewer oropharynx cancers, according to Burtness, who said this theory still needs further research.

There is excitement at the possibility that therapeutic vaccines could be developed, and various groups are investigating this, Burtness added.

“There is reason to think that the vaccines may be helpful; however, when HPV infects the tonsillar tissues, it exerts control in the host cells by making two proteins: E6 and E7; so another potentially exciting therapeutic avenue would be to target those specific viral proteins,” she told HemOnc Today.

Anxiety about protection from the HPV virus is palpable, according to Sturgis. He described the worry that many patients experience about contracting and transmitting HPV infection.

“Many patients are concerned they will put their spouses and/or children at risk in ways such as kissing them; and we need to tone down those worries until we have better data,” he said.

Screening and vaccination are fundamental aspects of current ongoing research, but of equal importance is determining what clinicians should do to treat a population of patients with HPV-related oropharyngeal cancers.

HPV status may influence treatment

With rates of HPV-related cancers escalating, determining the appropriate treatment for these patients is crucial.

During the past 10 years, findings from retrospective studies have shown that patients with HPV-related cancers have a much better prognosis than patients who test negative for HPV. Findings from several retrospective analyses from clinical trials conducted during the past 2 years have come to the same conclusion, according to Gillison: HPV-positive patients have half the risk for death compared with patients negative for HPV.

Therefore, there may be several alternative treatment options, including the possibility of reducing the dose of radiation given to patients after chemotherapy, thereby reducing toxicity.

Comparing HPV-negative and HPV-positive patients may not be enough to determine proper treatment, researchers said. Data between different cohorts of HPV-positive patients also needs to be examined. Smoking, for example, may play a role in patient outcome.

In a prospective Radiation Therapy Oncology Group clinical trial (RTOG 0129), presented by Gillison at the 2009 ASCO Annual Meeting and recently published in The New England Journal of Medicine (see page 53), researchers conducted a subanalysis of the effect of smoking on outcome in uniformly staged and treated HPV-positive and HPV-negative patients while accounting for a number of potential confounders. HPV-positive patients who were never smokers had a 3-year OS of 93% compared with heavy smoking HPV-negative patients who had an OS of 46%.

The study found that smoking was independently associated with OS and PFS. Patients had a 1% increased risk for death and cancer relapse for each additional pack-year of smoking. This risk was evident in both HPV-positive and HPV-negative patients. Gillison said smoking data must be paid attention to, and she encouraged cooperative group research on the topic.

Most of the findings demonstrate improved outcomes for patients with HPV-positive oropharyngeal cancers vs. patients with HPV-negative oropharyngeal cancers, according to the experts interviewed by HemOnc Today.

Dose de-intensification for less toxicity

To date, there is no evidence that HPV-related cancers should be managed differently than HPV-unrelated cancers, but it is a hot topic among clinicians in the field, according to Burtness.

The superior outcomes for HPV-associated oropharynx cancer have suggested the possibility of treatment de-intensification. The use of effective induction chemotherapy may permit definitive treatment with a lower total radiation dose. In theory, this would reduce the severity of late toxic effects of radiation, such as swallowing dysfunction. Such a trial is being conducted by the Eastern Cooperative Oncology Group. Burtness said this is currently pure research question.

“There is still much research that needs to be done before clinicians can safely reduce the dose of radiation administered to HPV-positive patients,” Burtness said.

Currently, she and colleagues in the ECOG are conducting a study of patients with HPV-associated stage III or IV oropharynx cancers to examine the possibility of tailoring therapy to these patients. Patients are assigned to one of two groups: low-dose intensity-modulated radiotherapy 5 days per week for 5 weeks (27 fractions) plus IV cetuximab (Erbitux, ImClone) once weekly for 6 weeks, or standard-dose intensity-modulated radiotherapy 5 days per week for 6 weeks (33 fractions) plus IV cetuximab once weekly for 7 weeks.

If patients have a very good clinical response to chemotherapy, which is likely to happen with HPV-associated cancers, they are eligible to receive a reduced dose of radiation, and hopefully, they would experience less adverse effects, Burtness said.

“Patients who are treated with the full course of radiation for head and neck cancer are now getting 70 Gy, and they are often left with dry mouth, and speech and swallowing difficulty,” she said. “We are hopeful that if these particular cancers are treatment responsive to chemotherapy, we may be able to spare the patient the last 14 Gy of radiation.”

Immunotherapy a viable treatment

Another possible treatment technique that may benefit patients with HPV-related cancers is immunotherapy. One form of immunotherapy uses lymphocytes collected from the patient, and training the cells in the laboratory to recognize in this case a virus that is associated with a tumor and consequently attack it. This approach potentially may be used to treat HPV-related oropharynx cancers, according to Carlos A. Ramos, MD, assistant professor at the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston.

“With some infections that lead to cancer, even though the virus is present in the tumor cells, the proteins shown to the immune system are limited; therefore, they do not drive a very strong immune response,” Ramos told HemOnc Today. “Training the immune system cells, T lymphocytes, may make them respond better to antigens.”

Data from ongoing trials that are taking T lymphocytes from patients and educating them to recognize antigens in patients with the Epstein-Barr virus associated tumors have shown some activity against them, according to Ramos. This adoptive transfer appears to be safe and may have the same effect on the HPV virus associated tumors. Immunotherapy does not cause the usual toxicities associated with chemotherapy, he said.

“There are currently no trials showing whether we can prevent more recurrences with this approach, but the results of trials examining viruses such as Epstein-Barr are good so far, in both patients who have no evidence of disease and in those who still have disease,” he said.

Even patients with active disease who have not responded to other therapies have responded to this therapy, Ramos said. He and colleagues are working toward compiling preclinical data to study the possibility of using immunotherapy to treat patients with HPV-related cancers.

Journey is just beginning

Much of what is known about risk, screening, prevention and treatment of HPV-related oropharynx cancers is in the early stages of discovery and much is still theoretical, according to Sturgis.

“As far as we can tell, these infections are transmitted sexually; the hope is that as we have better vaccines for prevention of cervical dysplasia, the downstream effect will help prevent other HPV-related cancers, such as anal cancers and penile cancers and oropharyngeal cancers,” he said.

Several recent studies examining new therapies that may reduce the intensity of traditional treatments while maintaining survival rates would have a major effect on the field, according to Sturgis.

Gillison said the rise in the number of cases of HPV-related cancers is changing the patient population considered to be at risk, and more research is vital.

“The most important thing for clinicians to do is be aware that trials are being developed and strongly encourage their patients to participate,” she said.  Christen Cona

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

June, 2016|Oral Cancer News|

ASCO Urges Aggressive Efforts to Increase HPV Vaccination

Source: www.medscape.com
Author: Zosia Chustecka
 

Human papillomavirus (HPV) vaccines have now been available for 10 years, but despite many medical professional bodies strongly recommending the vaccine, uptake in the United States remains low.

Data from a national survey show that about 36% of girls and 14% of boys have received the full schedule of HPV vaccines needed to provide protection (Vaccine. 2013;31:1673-1679).

Now the American Society of Clinical Oncology (ASCO) has become involved, and in a position statement issued today the organization calls for aggressive efforts to increase uptake of the HPV vaccines to “protect young people from life-threatening cancers.”

“With safe and effective vaccines readily available, no young person today should have to face the devastating diagnosis of a preventable cancer like cervical cancer. But unless we rapidly increase vaccination rates for boys and girls, many of them will,” ASCO President Julie M. Vose, MD, said in a statement.

“As oncologists, we see the terrible effects of these cancers first hand, and we have to contribute to improving today’s alarmingly low vaccination rates,” she added.

The new policy statement is published online April 11 in the Journal of Clinical Oncology.

The statement notes that HPV vaccination has been previously recommended by many US medical societies, including the American Cancer Society, the American College of Obstetrics and Gynecology Committee, the American Dental Association, the American Head and Neck Society, the American Nurses Association, the American Pharmacists Association, the Association of Immunization Managers, the Society for Adolescent Medicine, and the Society of Gynecologic Oncology.

In addition, a joint letter was sent out to all physicians urging them to give a strong recommendation from the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, the Centers for Disease Control and Prevention, and the Immunization Action Coalition.

Now oncologists are specifically being asked by their professional body, ASCO, to join in with the push toward greater uptake of the HPV vaccines.

“ASCO believes oncologists can play a vital role in increasing the uptake of HPV vaccines,” the new policy statement says. “Although most oncologists will not be direct providers of these preventive measures, this does not abrogate us from contributing to this process. Our unassailable role in the mission to lessen the burden of cancer…places us in a position of influence. We should use interactions with our patients, primary care colleagues, and health care systems to raise awareness of HPV-related cancers and the role of vaccination in preventing them.”

Oncology providers have a responsibility to serve as community educators.

“Oncology providers have a responsibility to serve as community educators, disseminating evidence-based information to combat misconceptions concerning the safety and effectiveness of the HPV vaccine,” it continues.

“ASCO encourages oncologists to advocate for and actively promote policy change to increase vaccination uptake,” the statement concludes.

Issues With the Statement

However, there are a few issues with the statement, says a prominent researcher in the field of HPV and cervical cancer, Diane Harper MD, professor and chair of the department of Family and Geriatric Medicine, University of Louisville, Kentucky. Dr Harper, who was approached for comment, was involved in early clinical trials with both HPV vaccines (Gardasil, Merck & Co, and Cervarix, GlaxoSmithKline), and has emphasized the need for ongoing screening with Pap tests to prevent cervical cancer.

This is also one of the issues she raises about the ASCO statement, which does not mention screening. “All messages about HPV vaccination must be couched in terms of continued lifetime screening for cervical cancer,” Dr Harper told Medscape Medical News.

The ASCO statement highlights the potential that HPV vaccination has for preventing cancer. (Both vaccines protect against HPV types 16 and 18, and Gardasil offers additional protection against several other types). The statement notes that HPV is the cause of nearly all cervical cancer cases and that HPV genotypes 16 and 18 are responsible for 70% of cervical cancers. In the United States, HPV is responsible for 60% of oropharyngeal cancers, 90% of which are caused by HPV 16. HPV is also the cause of 91% of anal cancers, 75% of vaginal cancers, 69% of vulvar cancers, and 63% of penile cancers, again with HPV 16 as the predominant oncogenic genotype.

However, the statement also notes that “because of the long latency and the prolonged preinvasive phase after infection with HPV, many years of follow-up are needed for the ongoing trials to demonstrate a significant reduction in HPV-related cancers.”

Therefore, intermediate outcomes are being used as surrogate endpoints, it continues. HPV vaccines have been shown to prevent new cancer-causing HPV genotype-specific infections and resultant diseases, such as grades 2 and 3 cervical intraepithelial neoplasias (CIN), vaginal, vulvar, and anal intraepithelial neoplasias (as precursor lesions to cancer).

There is “almost certainty that cancers caused by oncogenic HPV genotypes will be dramatically reduced,” according to the statement.

Dr Harper told Medscape Medical News that the studies conducted to date have shown that “Cervarix has a 93% efficacy against CIN 3 regardless of HPV type; Gardasil has a 47% efficacy against CIN 3 regardless of HPV type, and Gardasil 9 is equivalent to Gardasil in the prevention of CIN 3 disease regardless of HPV type. None of these vaccines can prevent all CIN 3 or potentially all cancers.”

“Hence, the most important take home point is that screening is absolutely necessary as a prevention tool for preventing cancer by early detection of disease that when found, is curable,” Dr Harper emphasized.

Also, Dr Harper noted that the studies ended at prevention of CIN 2/3 disease as a clinical outcome. CIN 3 on average progresses to cancer in 20% of women within 5 years, and to 40% of women in 30 years. But, she points out, “there are no long-term follow-up studies that show that cancers will be averted.”

“The modeling exercises indicate that we have to wait at least 40 years before we will have a detectable decrease in cervical cancers from vaccination, assuming that at least 70% of the population being surveyed is vaccinated,” she added.

In its statement, ASCO cites the success of widespread vaccination against hepatitis B virus in reducing the incidence of liver cirrhosis and liver cancer as “an exemplary health model that supports more widespread HPV vaccination.”

But Dr Harper argues that “the prevention of liver cancer was an unexpected highlight of HBV vaccination. The primary purpose was to relieve the symptoms of chronic HBV sufferers. The continual re-infection with HBV seems to allow a natural infection to act as a booster in this population, which may not be the same for HPV.”

There also remains a question of how long the protection offered by HPV vaccination will last.

The ASCO statement says, “Both vaccines have a known duration of protection of at least 5 years, with ongoing study of the full duration of their effect,” and it notes that “additional research is needed to evaluate duration of protection to determine if booster doses are required.”

Dr Harper said, “Estimates of long-term effectiveness are based on antibody titers, yet there is no surrogate of protection defined by antibody titers.”

She added: “I agree that observational studies will inform the public health authorities about when a booster will be needed and whether it is needed sooner if only 2 doses are received vs later if 3 doses​ are received.”

Last, but not least, there is the issue of safety.

The ASCO statement notes that both Gardasil and Cervarix “reported excellent short- and long-term safety results in clinical trials. The most common adverse effects were mild and included injection site pain (approximately nine in 10 people) and swelling (approximately one in three), fever (approximately one in eight), headache, and fatigue (approximately one in two). These symptoms were transient and resolved spontaneously. The incidence of serious adverse effects was low and was similar to those who received placebo (aluminum-containing placebo or hepatitis A vaccine).”

However, worldwide there continue to be reports of adolescents who report chronic side effects and pain syndromes after being vaccinated against HPV. Some of these have been documented in the medical literature, with physicians reporting instances of previously healthy athletic girls becoming incapacitated with pain, fatigue, and autonomic dysfunction, and some remaining permanently disabled.

The US Food and Drug Administration and the Centers for Disease Control and Prevention have repeatedly said that HPV vaccines have an excellent safety record and that no causal associations have been found with atypical or unusual pain syndromes or autonomic dysfunction. The European authorities have investigated two chronic syndromes reported with HPV vaccination, and have said that there is no evidence to show causation.

However, Danish researchers who were among the first to report these syndromes criticized the investigation and are conducting their own study. There have also been lawsuits filed in several countries, and a class action lawsuit is now planned in Japan against the government and the vaccine manufacturers.

In an interview with Medscape Medical News, lead author on the ASCO statement, Howard H. Bailey, MD, from the University of Wisconsin Carbone Cancer Center, Madison, said that the concerns over safety should not be dismissed and should be studied further.

These issues need to be studied further, even if the authorities say that the vaccines are safe, he emphasized. These reports of girls becoming very ill, having pain syndrome and weakness, should not be diminished, he said, adding: “We can’t just ignore these reports…if there is risk involved, then that needs to be sorted out better.”

However, there is always a possibility that the syndromes and side effects that have been reported “have nothing to do with the vaccine,” Dr Bailey commented, citing the case of now-discredited theory linking autism to the pediatric vaccine for measles, mumps, and rubella.

There may be other explanations for the symptoms that are reported, or it could be that the symptoms/syndrome would have developed in the individual, anyway, but the vaccination precipitated it sooner, he suggested.

Dr Bailey noted that across the United States physicians are very sensitive to the fact that rates of pediatric vaccination have gone down because of the link that had been made to autism, subsequently shown to be false. Even though science eventually showed no link between the vaccine and autism, public confidence in the vaccine was damaged.

“When a person’s life has been devastated by an illness, that is very important, but if it turns out that the illness is not related to the vaccine, and in the meantime, the concerns over safety have stopped thousands of young people from being vaccinated….”well, eventually this will mean that there are more people who die from cancer, he said.

“I would be very reluctant right now to shut down the goals of vaccination over what has been reported, because the bottom line is that we have a tremendous problem with the rising incidence of HPV related cancers including in men as well as women when it comes to oropharyngeal cancers here in the States,” he added.

“The data, at least in my opinion, are so strong that HPV vaccination if it’s done in a [systematic] way will reduce the incidence of these cancers…I don’t want to stop whatever progress we are making when there is at best disagreement over whether these things are associated,” he said, although he also added that “maybe if it was my daughter, I would feel differently.”

Dr Bailey also addressed some of the other issues that had been raised about the ASCO statement, and said he agreed about the importance of screening.

“Even if vaccination does all the things we expect it to do, there is no doubt that cervical cancer screening needs to continue, and that’s a pretty standard recommendation across all of the groups,” he said. “We do not mean to diminish the importance of continued screening,” he said, but he added that screening lies in the domain of other physicians, such as primary care and gynecology, whereas this statement was targeted specifically at oncologists. “To take a step back, we are taking the view of cancer physicians, who take care of women, who are unfortunately too often dying of cervical cancer, and…we wanted to remind people that HPV vaccination can prevent this…as well as other associated cancers,” he said.

“The audience in North America has not been paying attention to this vaccination issue very much,” he continued, and “we wanted to remind oncologists and the public that at the heart of the issue is cancer prevention.

“We have this relatively easy way of preventing cancers over and above the ways that we already use,” he added.

“We wanted to remind people, especially in the oncology community, that there is this intervention out there that we think is highly, highly likely — if applied and used in a population format — will significantly reduce the number of women dying of cervical cancer, the number of men and women dying from oropharyngeal cancer, which is increasing in the US…and that was the main focus of the article,” Dr Bailey commented.

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

April, 2016|Oral Cancer News|

Cancer-causing HPV plummeted in teens since vaccine, study finds

Source: www.cnn.com
Author: Sarina Storres
 

(CNN)The human papillomavirus vaccine was first recommended for adolescent girls in the United States in 2006. Since that time, the prevalence of the cancer-causing virus has been dropping among young women, according to a new study.

Researchers at the Centers for Disease Control and Prevention compared the rates of HPV infection in women 14 to 34 years of age during the years before the vaccine was recommended, between 2003 and 2006, with the most recent years for which data are available, 2009 to 2012.

Among girls 14 to 19 years old, rates of infection with the four types of HPV included in the 4vHPV vaccine decreased from 11.5% to 4.3%. There was also a drop, although smaller, in women 20 to 24 years old, from 18.5% to 12.1%. Among the older groups, women ages 25 to 29 and 30 to 34, the prevalence of these HPV types did not change and was about 12% and 9%, respectively.

“These results are very encouraging and show the effectiveness of the vaccine,” said Dr. Lauri E. Markowitz, a medical epidemiologist at the CDC and lead author of the study, which was published Monday in the journal Pediatrics. “Eventually we expect to see decreases in HPV in older groups as women who were young (enough to get the vaccine) age,” Markowitz added.

Among the 14- to 24-year-old women in the study who were sexually active, rates of infection with the HPV types in the vaccine was only 2.1% among those who were vaccinated, compared with 16.9% among their unvaccinated counterparts.

The CDC Advisory Committee on Immunization Practices recommends the three-dose HPV vaccine for girls, and as of 2011 also boys, 11 to 12 years of age. The vaccine is recommended for women and men up to ages 26 and 21, respectively.

The researchers found that 51% of girls 14 to 19 years old reported having received at least one dose of the HPV vaccine. Rates were 33% and 15% among the women 20 to 24 and 25 to 29, respectively. Among the 30- to 34-year-olds, only 3% said they had gotten the vaccine because they were generally too old to receive it by the time it was first recommended.

There are signs that rates of HPV vaccination are on the rise. National surveys reported that the number of girls 13 to 17 years of age who received at least one dose of the HPV vaccine climbed from 44% in 2009 to 54% in 2012.

More vaccine coverage coming

In keeping with the trend toward greater vaccine coverage, an earlier study by Markowitz and her colleagues found that the prevalence of HPV types was 5.1% among 13- to 17-year-olds between 2007 and 2010, the first years after the vaccine was available, slightly higher than the 4.3% in the current study among 14- to 19-year-olds between 2009 and 2012. The waning prevalence of HPV among adolescent girls in more recent years is probably the result of more adolescent girls getting the HPV vaccine, Markowitz said.

However, among women in their 20s and 30s, there was no decrease in the prevalence of HPV between 2007 and 2010, compared with 2003 to 2006, because these women were already too old to receive the vaccine when it became available.

It may be possible for HPV to go the way of other largely eliminated infectious diseases in the United States such as measles, but only if vaccination rates improve, Markowitz said. The CDC is working with many groups, including large medical organizations such as the American Cancer Society, to increase knowledge among health care professionals and give them guidance for talking with families about the vaccine.

“Like all vaccines, having a strong recommendation by the clinician is one of greatest predictors of getting vaccinated,” Markowitz said.

It’s important for patients and parents to think of the HPV vaccine as another one of the vaccines that you get, like those for measles, mumps and rubella, said Dr. Sarah Feldman, co-director of ambulatory gynecologic oncology at Brigham and Women’s Hospital.

There have been some safety concerns, though unfounded, about the HPV vaccine, but the bigger issue is probably that parents shy away from vaccines for young children that protect against sexually transmitted diseases, Feldman said. But as people become more familiar with the vaccine, Feldman hopes there will be less focus on how HPV is transmitted. “We don’t talk about sexual activity as a way of transmitting hepatitis B, we just give the vaccine,” so when children get older and become sexually active, they are protected, she said.

“More and more, it’s becoming clear that this is a cancer prevention vaccine, and if we could get 100% of our boys and 100% of our girls vaccinated, we could probably eradicate the worst HPV types,” Feldman said.

New HPV vaccine

The current study did not detect a difference in rates of infection with HPV types other than the types present in the 4vHPV vaccine, or another vaccine called 2vHPV. Both vaccines include the two HPV types responsible for 66% of cervical cancers in the United States. Markowitz suspects that it is still possible that some cross-protection is happening, if, for example, other HPV types look similar enough to the types in the vaccine that the immune system recognizes them.

However, this question is largely a moot point now that many people in the United States are receiving a new HPV vaccine called 9vHPV, approved in 2014, which protects against a total of nine HPV types, said Dr. Rebecca B. Perkins, associate professor of obstetrics and gynecology at Boston University School of Medicine and Boston Medical Center.

The Advisory Committee on Immunization Practices included 9vHPV as an option in this year’s immunization schedule, along with 4vHPV and 2vHPV. The 9vHPV vaccine protects against five additional cancer-causing HPV types, giving it the potential to prevent about 90% of HPV-associated cancers.

But even with the earlier forms of HPV vaccines, “the vaccine is doing exactly what it’s supposed to,” Perkins said. The current study is a “really strong call to get people vaccinated,” she added.

HPV vaccination could benefit more groups than in the current study, and in more ways. The CDC researchers are planning to look at the rates of HPV infection in males after the vaccine was recommended for boys in 2011. “You should expect to see similar effects in men because trials showed the vaccine worked as well in men as women,” Perkins said.

The CDC researchers are also going to look at rates of oral HPV infection since the HPV vaccine became available. A clinical trial suggested that the vaccine could effectively prevent throat cancers associated with HPV. These cancers are becoming increasingly common, and the trial predicted that in the next few decades, there will be more cases of oral cancers caused by HPV in the United States than cervical cancer.

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

February, 2016|Oral Cancer News|

Study: HPV vaccine reduces HPV incidence in teenage girls

Source: www.upi.com
Author: Stephen Feller
 
Study-HPV-vaccine-reduces-HPV-incidence-in-teenage-girlsJust over half of girls have received the HPV vaccination, but a new CDC study shows it has significantly reduced prevalence of the cancer-causing STI among females who have received the vaccine when compared with those who have not. Photo by Adam Gregor/Shutterstock

 

WASHINGTON, Feb. 22 (UPI) — The prevalence of human papillomavirus infection among teenage and young adult women is down nearly two-thirds since the U.S. Centers for Disease Control and Prevention started recommending vaccine in 2006, according to a new study.

The study is the first to show a drop in prevalence among women in their 20s, and continues to show decreases seen in smaller studies during the last few years, but researchers say the effect could be much stronger.

The vaccine is recommended by the CDC and other organizations for girls and boys starting at age 11, experts say, in order to protect children from HPV before they become sexually active and can become infected.

Concerns that the vaccine would influence teens’ sexual practices have also been unfounded, as research has shown the vaccine does not make children more likely to engage in risky sexual behavior, based on a the lack of an increase in other STI incidence among vaccinated girls.

“It’s just like putting on your seatbelt before turning on the car,” Dr. Alix Casler, medical director of pediatrics for Orlando Health, told UPI. She suggests separating the adolescents’ eventual discovery of sex from the effort to prevent life-threatening diseases.

Recommendations for the HPV vaccine — Cervarix, Gardasil and Gardasil 9 — have been expanded to boys, because of the wide range of cancers for which HPV increases risk, including cervical, anal, head and neck cancer, though a 2015 study showed vaccination rates remain relatively low, with just 57 percent of eligible girls and 35 percent of boys vaccinated.

“We are continuing to see decreases in the HPV types that are targeted by the vaccine,” Dr. Lauri Markowitz, a medical epidemiologist at the CDC, told CBS News. “We have seen declines in genital warts [caused by HPV] already. The next thing we expect to see is a decline in pre-cancers, then later on declines in cancer.”

For the study, published in the journal Pediatrics, used survey information collected as part of the National Health and Nutrition Examination Survey between 2003 and 2006 and between 2009 and 2012 on females between the ages of 14 and 34.

The researchers compared prevalence of HPV between the pre-vaccine group before 2006 and post-vaccine group after the vaccine was introduced, finding HPV prevalence declined by 64 percent, from 11.5 percent to 4.3 percent, in girls between age 14 and 19, and by 34 percent, from 18.5 percent to 12.1 percent, among women age 20 to 24.

Among women aged 14 to 24, the prevalence of HPV among vaccinated women, at 2.1 percent, was also significantly lower than the 16.9 percent of unvaccinated women with the STI.

The research is based on the 4vHPV vaccine, which protects against the four most common forms, though the 9vHPV vaccine was approved by the FDA for use to prevent more forms of HPV.

Casler said data in the next several years is likely to show continuing decreases in HPV prevalence as more adolescents receive the vaccine, however some pediatricians are hesitant because of personal bias. Many parents also are nervous the vaccine will act as a message to teens that sex is OK, making some parents want to delay vaccination until their adolescents are sexually active — by which time it may be too late.

“The infection is sexually transmitted, but that doesn’t need to be part of the conversation,” Dr. Joseph A. Bocchini, a pediatric infectious disease specialist at Louisiana State University, told the New York Times. “If a parent is concerned, physicians should be prepared to talk about it. But we don’t really discuss how people become infected with every vaccine-preventable disease.”

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

February, 2016|Oral Cancer News|

NCI-designated Cancer Centers Urge HPV Vaccination for the Prevention of Cancer

Source: www.medicine.wustl.edu
Author: Washington University School of Medicine in St. Louis Staff
 

Approximately 79 million people in the United States are currently infected with a human papillomavirus (HPV) according to the Centers for Disease Control and Prevention (CDC), and 14 million new infections occur each year. Several types of high-risk HPV are responsible for the vast majority of
cervical, anal, oropharyngeal (middle throat) and other genital cancers. The CDC also reports that each year in the U.S., 27,000 men and women are diagnosed with an HPV-related cancer, which amounts to a new case every 20 minutes. Even though many of these HPV-related cancers are preventable with a safe and effective vaccine, HPV vaccination rates across the U.S. remain low.

Together we, a group of the National Cancer Institute (NCI)- designated Cancer Centers, recognize these low rates of HPV vaccination as a serious public health threat. HPV vaccination represents a rare opportunity to prevent many cases of cancer that is tragically underused. As national leaders in cancer research and clinical care, we are compelled to jointly issue this call to action.

According to a 2015 CDC report, only 40 percent of girls and 21 percent of boys in the U.S. are receiving the recommended three doses of the HPV vaccine. This falls far short of the goal of 80 percent by the end of this decade, set forth by the U.S. Department of Health and Human Service’s Healthy People 2020 mission. Furthermore, U.S. rates are significantly lower than those of countries such as Australia (75 percent), the United Kingdom (84-92 percent) and Rwanda (93 percent), which have shown that high vaccination rates are currently achievable. The HPV vaccines, like all vaccines used in the U.S., passed extensive safety testing before and after being approved by the U.S. Food and Drug Administration (FDA). The vaccines
have a safety profile similar to that of other vaccines approved for adolescents in the U.S. Internationally, the safety of HPV vaccines has been tested and approved by the World Health Organization’s Global Advisory Committee on Vaccine Safety. CDC recommends that boys and girls receive three doses of HPV vaccine at ages 11 or 12 years. The HPV vaccine series can be started in preteens as early as age 9 and should be completed before the 13th birthday. The HPV vaccine is more effective the earlier it is given; however, it is also recommended for young women until age 26 and young men until age 21.The low vaccination rates are alarming given our current ability to safely and effectively save lives by preventing HPV infection
and its associated cancers. Therefore, we urge parents and health care providers to protect the health of our children through a number of actions:

  • We encourage all parents and guardians to have their sons and daughters complete the 3-dose HPV vaccine series before the 13th birthday, and complete the series as soon as possible in children aged 13 to 17. Parents and guardians should talk to their health care provider to learn more about HPV vaccines and their benefits.
  • We encourage young men (up to age 21) and young women (up to age 26), who were not vaccinated as preteens or teens, to complete the 3-dose HPV vaccine series to protect themselves against HPV.
  • We encourage all health care providers to be advocates for cancer prevention by making strong recommendations for childhood HPV vaccination. We ask providers to join forces to educate parents/guardians and colleagues about the importance and benefits of HPV vaccination. HPV vaccination is our best defense in stopping HPV infection  in our youth and preventing HPV-related cancers in our communities. The HPV vaccine is CANCER PREVENTION. More information is available from the CDC.

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

 

February, 2016|Oral Cancer News|

HPV debate reframed to focus on cancer

January 27, 2016

By Dr. Rachel Tompa / Fred Hutch News Science

 

U.S. cancer centers unanimously call for increase in vaccine use for cancer prevention.

Gardasil Vaccine

Amid recent talk of “moonshot” cancer cures and new treatments in development, it can be easy to forget that we already have an effective, simple way to prevent at least six types of cancer.

It’s called the HPV vaccine and it protects people from infection with the strains of human papillomavirus responsible for causing nearly all cervical and anal cancers, as well as many other genital cancers and certain head and neck cancers. And it’s not getting used.

The Centers for Disease Control and Prevention recommends that all adolescent boys and girls receive the three-dose vaccine series at age 11 or 12. But in 2014, only about 40 percent of eligible teenage girls and just over 21 percent of boys had received the full course, according to the CDC’s latest data.

Now, all 69 National Cancer Institute-designated cancer centers are joining together to voice their frustration at the low uptake of the HPV vaccine — with the hope of refocusing the lens of the vaccination discussion on cancer prevention.

Public debate about the vaccine — and, possibly, the low levels of vaccine use among adolescents — likely stems from the virus’ sexual transmission, said Fred Hutchinson Cancer Research Center virologist Dr. Denise Galloway. Galloway made critical discoveries linking HPV to cervical and other cancers and her laboratory helped lay the groundwork that made the vaccine’s development possible.

“[The low uptake] has to do with it being considered a vaccine to protect against a sexually transmitted infection, that’s likely the case,” said Galloway in a previous interview. “Even though hepatitis B should fall in that same category, it’s been portrayed more as protecting against a liver disease.”

Galloway and her colleagues at Fred Hutch, which is among the NCI-designated cancer centers issuing the statement in support of HPV vaccination, want parents and adolescents to think about the HPV vaccine in the light of cancer, not sex.

“I think people in the United States are leery of vaccines or they don’t trust pharma or they don’t want to talk about sex,” Galloway said. “So something that could prevent cancer is not having the impact that it should.”

Proactive steps to combat a public health threat

Even though so few U.S. families are following recommendations for this particular vaccine, it is still having a positive effect: HPV infection rates among adolescent girls dropped from nearly 12 percent in the years before the vaccine was routinely available to about 5 percent after the vaccine was introduced in 2006.

The CDC also estimates that every year, 27,000 men and women are diagnosed with HPV-driven cancers. The majority of these diseases can be prevented with currently available HPV vaccines.

“The HPV vaccine is an amazing public health advance, but it doesn’t guarantee eradication of HPV. It’s important to remember that the vaccine works best in those who haven’t been infected with the virus, which means, essentially, people who are not yet sexually active,” said Dr. Gary Gilliland, president and director of Fred Hutch.

The cancer centers’ consensus statement arose from a summit held at MD Anderson Cancer Center in Houston last November to discuss concerns about low HPV vaccination rates in the U.S. and ways to improve uptake. Experts from more than half of NCI-designated cancer centers, the NCI, CDC and American Cancer Society met at the event, starting conversations to develop the shared endorsement for HPV vaccination.

The statement also echoes the spirit of President Barack Obama’s recent call for a “moonshot” to cure cancer. In 2013, the President’s Cancer Panel, comprised of expert advisers to the president on cancer-related topics, chose to focus its yearly report and recommendations on improving HPV vaccine uptake.

“The President’s Cancer Panel applauds the NCI-designated cancer centers for issuing this consensus statement urging HPV vaccination for the prevention of cancer in support of the Panel’s recommendations,” Dr. Barbara Rimer, chair of the panel, said in an email.  “We are confident that if HPV vaccination for girls and boys is made a public health priority, hundreds of thousands will be protected from these HPV-associated diseases and cancers over their lifetimes.”

Cancer center representatives hope that by joining together, they will send a stronger message to the U.S. public that the vaccine is a safe and important means to prevent potentially deadly cancers.

“Every day we delay, that means more people are going to get infections that in the future could end up causing cancers that could have been prevented,” said Dr. Melinda Wharton, director of the CDC’s National Center for Immunization and Respiratory Diseases, at the summit. “There really is great urgency to stop this from happening.”

Addressing concerns

Many parents have real concerns that may put up barriers to agreeing to the vaccine, Galloway said. These barriers range from worries about the vaccine’s possible side effects to fear that vaccinating against an STD could increase teen sex to a lack of awareness of the benefits of the vaccine.

Many care providers aren’t following the CDC’s guidelines to improve HPV vaccine uptake among their patients. A 2015 survey led by researchers at Harvard Medical School found that more than a quarter of physicians don’t strongly endorse the vaccine or bring it up to families at the recommended time. And nearly 60 percent said they recommend the vaccine more strongly to adolescents they felt are at high risk of HPV infection, even though public health officials say everyone should receive the vaccine to increase herd immunity.

“There’s some reluctance and ambivalence among a lot of primary care providers in terms of just building HPV vaccination into the normal course of care,” said the NCI’s Dr. Robert Croyle at the MD Anderson summit.

Here’s a quick roundup of expert responses to some of the most common barriers to HPV vaccination:

Does it work? The HPV vaccine works incredibly well to protect against several strains of HPV. Although it’s too soon to say whether the vaccine is going to reduce rates of HPV-related cancers on a population level, there have been studies done on reduction of precancerous lesions and genital warts, which are earlier indications that the vaccine is working to reduce HPV in the population. “If you look at places like Australia or parts of the U.K. where the uptake of the vaccine is 80 percent, and you look at the earliest manifestation of HPV-associated disease, which is genital warts, there’s virtually none in Australia. And not only was there none in the girls, who they started vaccinating in 2006, but there’s none in boys, who weren’t vaccinated until 2012. Herd immunity really works if you can get high uptake of the vaccine,” Galloway said.

Will it increase teen sex? No — a large 2015 study found that girls aged 12 to 18 who’d received the HPV vaccine did not have increased sexual activity as compared to teens who hadn’t been vaccinated.

Is it affordable? Yes — The Affordable Care Act mandates coverage of the vaccine by private insurance plans. In Washington state, the HPV vaccine — like all childhood vaccines — is free to children aged 18 and under. Nationwide, the CDC provides free vaccines for children who can’t afford to pay for them through the Vaccines For Children program.

Is it safe?Yes — like every other CDC-recommended vaccine, the three HPV vaccines on the market have been through rigorous safety testing before their release to the public. Since the vaccines’ release, there have been numerous studies in the U.S. and Europe of hundreds of thousands of adolescents who received the vaccine — and again, no adverse safety effects have been found to be linked to the vaccine.

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

 

January, 2016|Oral Cancer News|

HPV vaccines: Research on safety, racial disparities in vaccination rates and male participation

Source: journalistsresource.us1.list-manage.com
Author: staff

Since it became available in the United States in 2006, the Human Papillomavirus (HPV) vaccine has been a source of debate, with proponents lauding it as a substantial gain in the fight against cancer, and opponents concerned with its implications for sexual activity among youth. With the U.S. Food and Drug Administration’s recent approval of Gardasil-9 — a vaccine that protects against nine of the most common strains of HPV that account for approximately 90 percent of cervical, vulvar, vaginal and anal cancers — there is both a renewed interest and concern that calls for a nuanced and comprehensive review of the science.

HPV is the most common sexually transmitted infection in the United States, with nearly all sexually active men and women believed to contract at least one form of it during their lifetime. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 79 million Americans have HPV, and about 14 million become newly infected annually. While most infections clear the body within two years, some can persist and result in genital warts, cervical cancer or other types of cancers in men and women. Of the many HPV strains that exist, HPV types 16 and 18 have been identified as high risk, accounting for about 70 percent of all cervical cancer, as well as a large proportion of other HPV-related cancers.

While cervical cancer was previously a leading cause of death among women in the U.S., death rates declined substantially after the introduction of the Pap test in the 1950s. Nevertheless, according to the CDC, more than 12,000 women in the U.S. are diagnosed with cervical cancer each year, and more than 4,000 die from it. Public discourse around HPV tends to focus on the health of women because they disproportionately bear the burden of its health consequences. However, men also face substantial risk, particularly as it relates to oral and anal cancers.

Although screening procedures are in place for early detection of cervical cancer, there are no comparable strategies to identify HPV-related cancer in its early stages for men. Consequently, the administration of a vaccine to prevent infection and transmission presents an important line of protection. Currently, the HPV vaccine is administered over a course of three injections, which must be completed within six months to confer full protection. A 2012 review of clinical trials of HPV vaccines shows that vaccines designed to protect against two or four of the most common strains have very high efficacy rates, ranging between 90 percent and 100 percent. For that reason, large public health efforts have focused on improving vaccination rates before boys and girls become sexually active.

Today, both the CDC and American Academy of Pediatrics recommend routine vaccination against HPV for all 11-year-olds and 12-year-olds in the U.S. Although the early age of vaccination has been a source of public debate, medical recommendations are based partly on evidence that shows that antibody responses are highest during this age period. Also, it is a good idea to vaccinate adolescents before they come into contact with the virus as the vaccine is not effective against HPV types that already have been acquired. Despite such recommendations from medical professionals, vaccination completion rates remain low — 40 percent for girls and 20 percent for boys in 2014. That is substantially lower than the vaccination rate for tetanus, diphtheria, and pertussis and the vaccination rate for meningitis among members of the same age group.

Below are a series of studies that will help journalists understand and explain this important health topic from a variety of angles, including vaccine safety and racial and gender disparities in vaccination rates. Beat reporters can find related reports and statistics from organizations such as the CDC, National Cancer Institute and World Health Organization.

__________________________

Barriers to vaccination

“Reasons for Not Vaccinating Adolescents: National Immunization Survey of Teens, 2008-2010”
Darden, P.M.; et al. Pediatrics, April 2013, Vol. 131. doi: 10.1542/peds.2012-2384.

Summary: Using data from the National Immunization Survey of Teens, researchers found that parental intentions to not vaccinate for HPV increased from 39.8 percent in 2008 to 43.9 percent in 2010. The most commonly cited reasons for not vaccinating were “not recommended/needed,” “not sexually active,” and “safety concerns/side effects.” Vaccine safety concerns increased from 4.5 percent in 2008 to 16.4 percent in 2010.

“Barriers to Human Papillomavirus Vaccination Among US Adolescents: A Systematic Review of the Literature”
Holman, D.M.; et al. JAMA Pediatrics, January 2014, Vol. 168. doi: 10.1001/jamapediatrics.2013.2752.

Summary: “Health care professionals cited financial concerns and parental attitudes and concerns as barriers to providing the HPV vaccine to patients. Parents often reported needing more information before vaccinating their children. Concerns about the vaccine’s effect on sexual behavior, low perceived risk of HPV infection, social influences, irregular preventive care, and vaccine cost were also identified as potential barriers among parents.”

Vaccine safety

“Adverse Events Following Immunization in Ontario’s Female School-Based HPV Program”
Harris, T.; Williams, D.M.; Feiurek, J.; Scott, T.; Deeks, S.L. Vaccine, January 2014, Vol. 32. doi: 10.1016/j.vaccine.2014.01.004.

Summary: After a school-based HPV vaccination program was implemented among eighth grade girls in Ontario, Canada, researchers analyzed reports of adverse events following immunization over the following four years. From 2007 to 2011, nearly 700,000 HPV vaccine doses were administered and 133 confirmed cases of adverse events were reported. The most commonly reported side effects included allergic reactions (25 percent), rashes (22 percent), reactions at the injection site (20 percent), and non-specific “other events” (26 percent). Ten serious cases were identified, which included two cases of anaphylaxis, two seizures, one thrombocytopenia, and one death, which was concluded by the coroner to be due to a previously undiagnosed cardiac condition. Ultimately, the researchers conclude that the findings are in line with existing evidence on the safety profile of the HPV vaccine, and no new safety concerns were identified.

“Safety of Human Papillomavirus Vaccines: A Review”
Macartney, K.K.; Chiu, C.; Georgousakis, M.; Brotherton, J.M.L. Drug Safety, June 2013, Vol. 36. doi: 10.1007/s40264-013-0039-5.

Abstract: “Both vaccines are associated with relatively high rates of injection site reactions, particularly pain, but this is usually of short duration and resolves spontaneously. Systemic reactions have generally been mild and self-limited. Post vaccination syncope has occurred, but can be avoided with appropriate care. Serious vaccine-attributable adverse events, such as anaphylaxis, are rare, and although not recommended for use in pregnancy, abnormal pregnancy outcomes following inadvertent administration do not appear to be associated with vaccination. HPV vaccines are used in a three-dose schedule predominantly in adolescent females: as such, case reports linking vaccination with a range of new onset chronic conditions, including autoimmune diseases, have been made. However, well-conducted population-based studies show no association between HPV vaccine and a range of such conditions.”

Disparities in vaccination rates

“Racial/Ethnic and Poverty Disparities in Human Papillomavirus Vaccination Completion”
Niccolai, L.M.; Mehta, N.R.; Hadler, J.L. American Journal of Preventive Medicine, October 2011, Vol. 41. doi: 10.1016/j.amepre.2011.06.032.

Abstract: “Data from the 2008-2009 National Immunization Survey-Teen for girls aged 13-17 years who received at least one dose of HPV vaccine (n=7606) were analyzed in 2010-2011. During this 2-year period, 55 percent of adolescent girls who initiated vaccination completed the three-dose series. Completion was significantly higher in 2009 (60 percent) compared to 2008 (48 percent; p<0.001). After controlling for covariates, adolescents who were black or Hispanic were significantly less likely to complete vaccination than whites. Adolescents living below the federal poverty level were significantly less likely to complete vaccination than adolescents with household incomes >$75,000.”

“Social Inequalities in Adolescent Human Papillomavirus (HPV) Vaccination: A Test of Fundamental Cause Theory”
Polonijo, A.N.; Carpiano, R.M. Social Science & Medicine, April 2013, Vol. 82. doi: 10.1016/j.socscimed.2012.12.020.

Abstract: “Analyses of 2008, 2009, and 2010 United States National Immunization Survey-Teen data (n = 41,358) reveal disparities particularly for vaccine knowledge and receipt of a health professional recommendation. While parental knowledge is a prerequisite to adolescent vaccine uptake, low socioeconomic status (SES) and racial/ethnic minority parents have significantly lower odds of knowing about the vaccine. Receipt of a health professional’s recommendation to vaccinate is strongly associated with vaccine uptake, however the odds of receiving a recommendation are negatively associated with low SES and black racial/ethnic status.”

“Sociodemographic Differences in Human Papillomavirus Vaccine Initiation by Adolescent Males”
Agawu, A.; et al. Journal of Adolescent Health, November 2015, Vol. 57. doi: 10.1016/j.jadohealth.2015.07.002.

Summary: Researchers studied patterns of HPV vaccination among a sample of 58,757 adolescent males between the ages of 11 and 18 in a large primary care network. Results showed that African American males with private health insurance were twice as likely to initiate vaccination than White males with private insurance, while African American males on Medicaid were nearly three times more likely. Similar trends were observed among Hispanic males. The authors conclude that, “although the true mechanism underlying these differences remains unknown, potential candidates include provider recommendation patterns and differential vaccine acceptance within these groups.”

HPV vaccine and young males

“HPV Vaccination Coverage of Male Adolescents in the United States”
Lu, P.J.; et al. Pediatrics, October 2015, Vol. 136. doi: 10.1542/peds.2015-1631.

Summary: Researchers used data from the 2013 National Immunization Survey-Teen to investigate trends in HPV vaccination of adolescent boys. Findings revealed low rates of both vaccine uptake (34.6 percent) and completion (13.9 percent), however African American and Hispanic males were more likely to receive the vaccine than their White peers. In order to improve vaccination coverage, the authors conclude that a comprehensive approach is needed which includes physicians regularly assessing their patient’s vaccination status, educating doctors about current HPV vaccine recommendations as well as information on vaccine efficacy and safety, reducing costs, and improving health communication strategies to dispel misinformation about the vaccine.

“Longitudinal Predictors of Human Papillomavirus Vaccination Among a National Sample of Adolescent Males”
Reiter, P.L.; et al. American Journal of Public Health, August 2013, Vol. 103. doi: 10.2105/AJPH.2012.301189.

Abstract: “In fall 2010 and 2011, a national sample of parents with sons aged 11 to 17 years (n = 327) and their sons (n = 228) completed online surveys to identify predictors of HPV vaccination. Only 2 percent of sons had received any doses of HPV vaccine at baseline, with an increase to 8 percent by follow-up. About 55 percent of parents who had ever received a doctor’s recommendation to get their sons HPV vaccine did vaccinate between baseline and follow-up, compared with only 1 percent of parents without a recommendation. Willingness to get sons the HPV vaccine decreased from baseline to follow-up among both parents and sons.”

“Acceptability of Human Papillomavirus Vaccine for Males: A Review of the Literature”
Liddon, N.; Hood, J.; Wynn, B.A.; Markowitz, L.E. Journal of Adolescent Health, February 2010, Vol. 46. doi:10.1016/j.jadohealth.2009.11.199.

Abstract: “Among mothers of sons, support of HPV vaccination varied widely from 12 percent to 100 percent, depending on the mother’s ethnicity and type of vaccine, but was generally high for a vaccine that would protect against both genital warts and cervical cancer. Health providers’ intention to recommend HPV vaccine to male patients varied by patient age but was high (82 percent-92 percent) for older adolescent patients. A preference to vaccinate females over males was reported in a majority of studies among parents and health care providers. Messages about cervical cancer prevention for female partners did not resonate among adult males or parents. Future acceptability studies might incorporate more recent data on HPV-related disease, HPV vaccines, and cost-effectiveness data to provide more current information on vaccine acceptability.”

“Parents’ Decisions About HPV Vaccine for Sons: The Importance of Protecting Sons’ Future Female Partners”
Schuler, C.L.; DeSousa, N.S.; Coyne-Beasley, T. Journal of Community Health, October 2014, Vol. 39. doi: 10.1007/s10900-014-9859-1.

Abstract: “76 percent of parents reported vaccine decisions for sons were likely to be influenced by preventing HPV transmission from sons to their female partners. Parents likely to be influenced by female partner protection in vaccine decisions had greater intention to vaccinate sons than their counterparts (adjusted odds ratio 2.54). Because parents likely to consider female partners had increased intention to vaccinate sons, future efforts to improve vaccine uptake in boys should explore the benefits of highlighting potential female partner protection, as this concept may resonate with many parents.”

January, 2016|Oral Cancer News|

Expanded age indication cleared for Gardasil 9 in males

Source: www.FormularyJournal.ModernMedicine.com
Author: Erin Bastick
 

FDA approved an expanded age indication for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9, Merck) in males.

Seven HPV types in Gardasil 9 (HPV 16, 18, 31, 33, 45, 52, and 58) cause approximately 90% to 95% of HPV-related anal cancers, 90% of cervical cancers, and 80% of high-grade cervical lesions worldwide.These 7 types also cause the majority of HPV-related vulvar and vaginal cancers. Gardasil 9 includes the greatest number of HPV (Human Papillomavirus) types of any available HPV vaccine.

Gardasil 9 was previously approved for use in girls and young women aged 9 to 26 years for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 22, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. As for use in male patients, the vaccine was previously approved for use in boys aged 9 to 15 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

With the newest approval, Gardasil 9 is now also indicated for use in males aged 16 to 26 years for the prevention of these diseases. According to the CDC, HPV vaccination rates are unacceptably low compared to rates for other adolescent vaccines, and vaccination coverage in males is especially low in males. The approval of the expanded age indication in male patients was based on results from a clinical trial program for Gardasil 9 that was designed to build upon the safety and efficacy established in clinical trials with Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant].

“Any health plans that have not yet made a decision regarding coverage for Gardasil 9 for males 16-26 can do so now that that the vaccine is indicated in this population,” according to a company statement from Merck. “Most managed care plans have already made decisions to cover the cost of Gardasil 9, including for males 16 through 26 years of age, making the number of plans covering Gardasil 9 similar to the number covering the cost of Gardasil. The approval of Gardasil 9 for males 16 through 26 years of age is a milestone in the planned transition from Gardasil to Gardasil 9, as both products are now approved for the same populations.”

The most common adverse reactions associated with the use of Gardasil 9 in males aged 16 to 26 years included injection-site pain, swelling, and erythema. Not all vulvar, vaginal and anal cancers are caused by HPV; Gardasil 9 only protects against those cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58. Gardasil 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or Gardasil.

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

December, 2015|Oral Cancer News|

A cancer on the rise, and the vaccine too late for Gen X

Source: www.cnn.com
Author: Martha Shade
 
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(CNN)The vaccine given to prevent cervical cancer in women could end up saving men’s lives, too.

Evidence is mounting that the HPV vaccine is also effective in preventing other HPV-related cancers, including those of the head and neck. Although most people who get HPV do not develop cancer, rates of HPV-related head and neck cancers are dramatically rising for men aged 40 to 50, according to Dr. Maura L. Gillison, the Jeg Coughlin Chair of Cancer Research at the Ohio State University Comprehensive Cancer Center.

When Gillison recently gave a presentation showing the increasing rate of HPV-related head and neck cancer among men, her audience was shocked. “I’ve never shown a slide where the audience gasps,” she said.

Related: Yes, oral sex can lead to cancer

“The risk of getting this cancer is strongly related to when you were born. If you are currently a 40- to 45-year-old man, your risk of getting this cancer is dramatically higher than a 40- to 45-year-old man three or four decades ago,” Gillison said.

Today’s 40- to 50-year-old men have had more sexual partners and have engaged in more oral sex than previous generations, according to experts, significantly raising their risk of an HPV-related head and neck cancer.

Actor Michael Douglas made headlines in 2013 when he announced he was battling an HPV-related cancer and that he got it from performing oral sex. Douglas was 68 when he was diagnosed, but many of the men being diagnosed with these HPV-related cancers are much younger.

What’s a Gen X’er to do?

HPV is usually acquired when young. It can lay dormant, and most oropharyngeal cancer (a type of head and neck cancer) is diagnosed decades later, beginning around age 40 to 50. And the more partners you have, the greater your risk.

HPV vaccines weren’t recommended and approved in the United States until 2006. And the vaccine was not even recommended for boys until 2011.

So what’s an aging Gen X’er to do?

“You’re starting to get colonoscopies; you’re starting to get checked for prostate cancer. This is one more thing to add to that list that you really have to watch for,” said Brian Hill, founder of the Oral Cancer Foundation.

Warning signs of HPV-related head and neck cancer

• Persistent lump on neck

• Persistent earache on one side

• Swelling or lump in the mouth

• Chronic sore throat

• Difficult or painful swallowing

• Change in voice

Source: Oral Cancer Foundation, Dr. Carole Fakhry

Symptoms of HPV-related head and neck cancer include a change in voice, a sore throat that doesn’t go away, an earache on one side and difficult or painful swallowing.

Hill’s story is typical: His doctors initially assumed he had an enlarged lymph node due to an infection. Two doctors gave him antibiotics before he was diagnosed with late-stage oropharyngeal cancer. His experience led him to form the Oral Cancer Foundation.

Finding the disease at an early stage is lifesaving. When it’s diagnosed early, these HPV-related cancers are survivable, according to Dr. Carole Fakhry of the Johns Hopkins Head & Neck Cancer Center. “If you have a lump in your neck, make sure to get checked.

“A very common story is: ‘I was shaving and I noticed this lump in my neck,” she said. “And he goes through two or three rounds of antibiotics and then someone finally thinks about cancer.”

‘Dental hygienists are becoming the best screeners’

Traditionally, cancers of the head and neck were often linked to alcohol or smoking, and these non-HPV cancers tend to be located at the front of the mouth and the voice box. Incidence of these cancers are dropping.

“The truth of the matter is that smoking-related cancers are declining,” Fakhry said. “On the other hand, cancers related to HPV are increasing.”

HPV-related cancers usually originate in the back of the mouth. “Most of these cancers are tonsils and back-of-tongue cancers,” she said. “Tonsils are basically these crypts, and tumors grow deep within these crypts, so these tumors can be hard to find.”

Since tumors are often hidden, dentists and dental hygienists are becoming the first line of attack. Men may also be more likely to visit a dentist regularly than a doctor, according to Hill.

“Dental hygienists are becoming the best screeners for this. They’re becoming the point at the end of the spear when it comes to screening and finding abnormalities,” he said.

Dentists and hygienists are encouraged to look for telltale signs of HPV-related cancer: asymmetrical or swollen tonsils, or a lesion in the back of the throat. But these cancers are notoriously tough to spot and tend to be diagnosed after patients develop a lump in the neck.

So what can you do?

“Make sure you get your kids vaccinated (for HPV),” Fakhry said.

Dr. Dan Beachler, lead author of a new study that found further evidence the HPV vaccine protects against multiple types of HPV-related cancers, agrees: “We still don’t know that much about oral HPV. Primary prevention through vaccination might have the most potential.”

Besides the cervix and the head and neck, some strains of HPV can also lead to cancer of the anus, penis and vulva.

A preventive HPV vaccine is most effective when given to children before they become exposed to HPV. The three dose series is recommended at age 11 or 12.

Initially recommended just for girls, the Centers for Disease Control and Prevention now recommends that boys be vaccinated, too. In addition, vaccination is recommended through the age of 26 in women and through age 21 in men who were not vaccinated previously.

“Young people do not avoid oral sex. That being a given, the best thing we can do is increase the vaccination rate. The second thing we can do is be highly aware of signs and symptoms,” Hill said.

And don’t panic. Although HPV-related cancers are on the rise, they’re still uncommon.

“Even though the rates are dramatically increasing, it’s still a relatively rare cancer. We don’t want to create a panic. We just want to raise awareness,” Gillison said.