Expert says Nivolumab Poised to Change Standard of Care in SCCHN

Author: Laura Panjwani


Nivolumab (Opdivo) is a game-changing agent for the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN), according to Robert L. Ferris, MD, PhD.

“Recent findings have shown us that this agent is really the new standard-of-care option for all platinum-refractory patients with head and neck cancer,” says Ferris, vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute. “This is regardless of whether patients are PD-L1–positive or negative or whether they are HPV-positive or negative.”

The PD-L1 inhibitor received a priority review designation by the FDA in July 2016 based on the CheckMate-141 study, which demonstrated a median overall survival (OS) with nivolumab of 7.5 months compared with 5.1 months with investigator’s choice of therapy (HR, 0.70; 95% CI, 0.51-0.96; P = .0101) in patients with recurrent or metastatic SCCHN.

The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator’s choice. The FDA is scheduled to make a decision on the application for the PD-1 inhibitor by November 11, 2016, as part of the Prescription Drug User Fee Act.

Ferris was the lead author on an analysis that further evaluated preliminary data from CheckMate-141, which was presented at the 2016 ASCO Annual Meeting. In an interview with OncLive, he discusses the findings of this study, potential biomarkers for nivolumab, and questions that remain regarding the use of the immunotherapy in SCCHN.

OncLive: What were the updated findings from CheckMate-141 presented at ASCO?

Ferris: The data that were presented at the 2016 ASCO Annual Meeting were further evaluations and follow-up on some preliminary data—originally presented at the 2016 AACR Annual Meeting—that listed the OS results.

At ASCO, we recapped the primary endpoint of OS as an important endpoint for immunotherapies because response rate and progression-free survival may not be as accurate. Ultimately, the FDA and people at large want OS. In this study, OS was 36% at 1 year in the nivolumab-treated arm and 16.6% in the comparator arm, which was investigator’s choice of single-agent chemotherapy, consisting of methotrexate, docetaxel, or cetuximab. In this phase III randomized trial, nivolumab was given in a 2:1 randomization: 240 patients received nivolumab and 120 received investigator’s choice.

Also at ASCO, we presented further evaluations consisting of what the regimens are in the comparator arm. There was about 20% each of docetaxel and methotrexate and 12% of cetuximab. Approximately 60% of the patients had prior cetuximab exposure and we stratified by cetuximab as a prior therapy. We also demonstrated the ORR, which was 13.3% in the nivolumab-treated arm versus 5.8% in the investigator’s choice arm.

Therefore, there was an improvement in overall response, but the difference seemed more modest than the OS benefit—which was a doubling—with 20% more patients alive at 1 year. This reinforces the concept that perhaps response rate may not be the best endpoint. Progression-free survival (PFS) was double at 6 months, with about 20% in the nivolumab arm versus about 9.9% in the investigator’s choice arm. The median PFS was not different, but the 6-month PFS was twice as high. The time to response was about 2 months in each arm at the first assessment.

Your analysis also looked at biomarkers. Can you discuss these findings and their significance?

The p16 or HPV-positive group had a better hazard ratio for OS than the overall study population. The hazard ratio was .73 for the overall population, using a preplanned interim analysis. With the HPV-positive group, we had a hazard ratio of .55 and the HPV-negative group had a hazard ratio of .99. It is still favoring the nivolumab-treated patients but, with the curves separated earlier in the HPV-positive group, one could see the improvement with nivolumab at about 1 to 2 months. It took 7 or 8 months with the HPV-negative group to show a separation of the curves in favor of nivolumab.

We looked at PD-L1 levels, and PD-L1—using a 1% or above level—had an improvement in the PD-L1–positive patients in favor of nivolumab in terms of OS and ORR. When we looked at 5% and 10% thresholds of PD-L1, the OS did not seem to improve. Therefore, in all levels above 1%, the OS was similarly beneficial over the PD-L1 less-than-1% group. However, essentially all levels of PD-L1–positivity and PD-L1–negativity still favored nivolumab, but the benefit was more when its levels were greater than 1%.

We could combine HPV status with PD-L1 status and look at subsets; however, essentially every subset benefited, whether it was PD-L1–negative or positive. This indicates that, in this group of patients, who progress within 6 months of platinum-based therapy, that no current systemic therapeutic options benefit patients as well as nivolumab.

With regard to these findings, what are you most excited about?

Head and neck cancer is a difficult disease. Until recently, we didn’t know the impact of this enrichment for HPV-positive virus-induced subsets and we didn’t know if this was an immune responsive cancer. Clearly, it is. We have all of the hallmarks that we have seen for a bright future—based on the melanoma data—and a series of other cancers indicating response rates in the 15% to 20% range, suggesting that we now have a platform of the PD-1 pathway to combine with other checkpoints and to integrate earlier in disease with radiation and chemotherapy.

We have a demonstration of head and neck cancer as an immune-responsive cancer. We are beginning to get an idea of the biomarkers and starting to be able to segment patients who will benefit. Now, we have a large comparative trial with an OS endpoint and tissue to look at biomarkers to try and understand what the best future combinations will be.

What are some questions that you still hope to answer regarding nivolumab in head and neck cancer?

We have to get down deeper into the nonresponders. We should acknowledge that the majority of patients neither had a response nor benefited. Understanding who is more likely to benefit is useful, but we also need to understand the levels of alternative checkpoint receptors or other biomarkers of resistance.

We have sequential lymphocyte specimens from the peripheral blood, tissues, and serum so those are intensively under evaluation. There are interferon gamma signatures that have risen from the melanoma checkpoint field that will certainty be applied, as well.

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

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August, 2016|Oral Cancer News|

NYU Expert Says Cancer Pain Varies by Tumor Type

Author: Jane de Lartigue, PhD

Brian L. Schmidt, DDS, MD, PhD, is a specialist in head and neck cancers whose research focus includes an exploration of the biological and molecular mechanisms of pain related to cancer and associated treatments.

He is the director of the New York University (NYU) Oral Cancer Center and of the Bluestone Center for Clinical Research, and a professor of oral and maxillofacial surgery at the NYU School of Dentistry. In June 2016, the National Institutes of Health awarded Schmidt and colleagues a $1.2 million grant to study gene therapy for the treatment of patients with oral cancer pain.

Schmidt talked to OncLive about the difficulties of studying cancer pain and developing new drugs.

OncLive: How has our understanding of the mechanisms of cancer pain changed in the past decade?
Schmidt: The field was developed probably in about 1999. That’s the first publication that I’m aware of that looked at mechanisms in terms of using preclinical models, and by that I mean animal models. Before that time we really had no understanding of basic mechanisms, so there’s been significant advancement over the last 10 years.

Could you briefly describe our current understanding of how cancer pain develops?

Let me tell you what it’s not, because I think that’s important. For many years, people were writing about it but we weren’t testing the possible mechanisms, and what people were writing turned out probably not to be true.

It was initially thought that the pain was due to the cancers growing and pressing on the nerves and we clearly don’t think that’s the underlying mechanism now. Possibly in some cancers that plays a role, but this whole idea of “pressing” really doesn’t work because it’s pretty hard to compress a nerve and there are actually a number of tumors that are not cancer that can compress nerves and those don’t hurt.

There might be a circumstance, for example, if you had a cancer in a perfect location, either let’s say in your leg where the femoral nerve is, or in the paravertebral skeleton where you have what are called spinal roots. In these cases, the cancer could press on the nerve and it would hurt, but that’s probably not a common mechanism.

Probably the best explanation for cancer pain we have is that the cancers produce a number of different molecules—and that depends on the type of cancer—that sensitize the nerves, which makes them respond to stimuli that’s normally not painful. And so the nerves that are surrounding the cancer become fragile, for lack of a better term, and those nerves fire in response to minimal stimuli.

What is the most effective therapy currently available?
I can tell you what’s most commonly used and its effectiveness is highly variable. We’re basically using the same drugs that have been used for thousands of years for pain, which are the opioids. So the narcotics—morphine, fentanyl, methadone, oxycodone, hydrocodone—that entire class of drugs. That’s what’s most commonly used.

Have researchers made any headway in developing drugs that target the underlying causes of cancer pain?
No, they haven’t. Probably the biggest development, and it’s not really targeted therapy, but the biggest development has been for cancers that go to the bone. Those include breast cancer, prostate cancer, multiple myeloma, lung cancer—those cancers go to the bone and cause a lot of bone pain.

We started using a class of drugs called bisphos phonates, which inhibit the cells that break down bone. They specifically inhibit a cell type called osteoclasts. Those drugs work for some patients who have bone metastasis. But we have not discovered true targeted therapies, and one of the challenges has been that the same obstacle that is present for oncologists treating the cancer has also proved an issue for pain physicians, which is that these cancers all behave differently, even within a specific type of cancer, so one colon cancer doesn’t behave like another one, for example.

So, where some cancer patients respond better to a particular drug than others, we think that the challenge of treating cancer pain is going to be the same—the drug will work for one patient but not for another. There is a class of drugs with an unusual mechanism of action—they are monoclonal antibodies that bind nerve growth factor. The history of those drugs has been interesting. Pfizer was the first company that produced one of these drugs and tested it in a clinical trial for low back pain, but the trial was stopped because patients on the drug were requiring hip replacement and it’s not entirely clear why. So there was a hold on the drug, but recently the FDA opened up the drug and so it’s going to be tested again.

It is thought that tanezumab would be very good for cancer pain, and Pfizer and Eli Lilly have joined together to test the drug. They’re both interested in seeing how it works for cancer pain.

What are the key unanswered questions relating to the effective treatment of cancer pain?
The key challenge, as I mentioned earlier, is going to be that all of the cancers behave differently, so they are independent of each other. It’s not like osteoarthritic pain, where the mechanism for causing osteoarthritic pain is, if not the same, then very similar between patients. Cancers are not that way. Even if you were to take a glimpse at the cancer at a fixed point in time, let’s say across 2 patients, now if you add the dimension of time, because cancers change over time, then in a patient 1 drug might be effective for a short time but then the cancer will change and it won’t be effective any longer. Again, this is similar to what oncologists face in treating cancer, where a drug is effective for a couple of months, but then patients stop responding and the tumor grows back.

Another challenge is that cancer pain clinical trials are also very difficult to recruit for because the patients are sick or dying, so they typically don’t want to enroll in studies. They are often on a lot of drugs. So of all the clinical trials, they are probably the most difficult for which to recruit.

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August, 2016|Oral Cancer News|

Henry Schein Donates Medical Supplies In Support of Free Oral Cancer Screening Events throughout the United States

Author: Api Potter

Company’s Donation to Support 77 Screening Events in 2016 and 2017 by the Oral Cancer Foundation

Press Release – MELVILLE, N.Y., July 25, 2016 – Henry Schein, Inc. (Nasdaq: HSIC) announced today that it is donating more than $10,000 in medical supplies to the Oral Cancer Foundation (OCF) in support of 77 free oral cancer screening events being held throughout the United States in 2016 and 2017. Each OCF-hosted event aims to boost awareness of the disease and increase early detection.

The Company’s donation of gauze, tongue depressors, and disposable dental mirrors, facemasks, and gloves is an initiative of Henry Schein Cares, the Company’s global corporate social responsibility program, and continues the Company’s support of OCF’s screening events. OCF hosts the events in a range of locations, including pharmacy parking lots, health fairs, farmer’s markets, colleges, and OCF Walk/Run for Awareness events.

“The health of our mouths greatly impacts our ability to eat and drink, communicate thoughts and ideas, and express feelings for loved ones,” said Brian Hill, Founder of the Oral Cancer Foundation. “When cancer affects our mouths, it does more than take away these everyday functions, it too often takes our lives. Our screening events are designed to identify signs of oral cancer before it ever gets that far, and we thank Henry Schein for this generous donation and its continued support of oral cancer awareness and early detection efforts.”

The donation comes at a time when nearly 500,000 people worldwide are diagnosed annually with oral and oropharyngeal cancer, according to data from the International Agency for Research on Cancer’s Globocan 2000 database and the World Health Organization’s Mortality Database. Of that number, between one-third and one-half lose their lives annually while many more suffer from the complications of treatment. Despite the easy accessibility to these body sites by health care providers and the overall impact early detection can have on a person’s overall health, more than two-thirds of these patients are diagnosed in advanced stages where the cancer has already spread to regional lymph nodes or beyond.

“Regular oral cancer screening events raise awareness and enhance early detection and prevention efforts, which are critical to reducing the disease’s incidence and impact,” said Steven W. Kess, Vice President of Global Professional Relations at Henry Schein. “Oral cancer is a stark reminder of the vital importance of good oral health in relation to a person’s overall health, and that’s why Henry Schein is pleased to support the Oral Cancer Foundation.”

Henry Schein’s donation continues the Company’s long-standing commitment to exploring ways of reducing the disease’s global impact. Earlier this year, the Henry Schein Cares Foundation, Inc.—an independent 501(c)(3) organization founded by the Company to foster, support, and promote dental, medical, and animal health by helping to increase access to care in communities around the world—funded the Global Oral Cancer Forum. The Forum gathered many of the world’s foremost experts on oral cancer, as well as clinicians, scientists, epidemiologists, activists, public health experts, nonprofit organizations, government agencies, and other stakeholders who are working to understand how to reduce the global oral cancer burden.

About Henry Schein Cares

Henry Schein Cares stands on four pillars: engaging Team Schein Members to reach their potential, ensuring accountability by extending ethical business practices to all levels within Henry Schein, promoting environmental sustainability, and expanding access to health care for underserved and at-risk communities around the world. Health care activities supported by Henry Schein Cares focus on three main areas: advancing wellness, building capacity in the delivery of health care services, and assisting in emergency preparedness and relief.

Firmly rooted in a deep commitment to social responsibility and the concept of enlightened self-interest championed by Benjamin Franklin, the philosophy behind Henry Schein Cares is a vision of “doing well by doing good.” Through the work of Henry Schein Cares to enhance access to care for those in need, the Company believes that it is furthering its long-term success. “Helping Health Happen Blog” is a platform for health care professionals to share their volunteer experiences delivering assistance to those in need globally. To read more about how Henry Schein Cares is making a difference, please visit our blog:

About Henry Schein, Inc.

Henry Schein, Inc. (Nasdaq: HSIC) is the world’s largest provider of health care products and services to office-based dental, animal health and medical practitioners. The Company also serves dental laboratories, government and institutional health care clinics, and other alternate care sites. A Fortune 500® Company and a member of the S&P 500® and the Nasdaq 100® indexes, Henry Schein employs nearly 19,000 Team Schein Members and serves more than one million customers.

The Company offers a comprehensive selection of products and services, including value-added solutions for operating efficient practices and delivering high-quality care. Henry Schein operates through a centralized and automated distribution network, with a selection of more than 110,000 branded products and Henry Schein private-brand products in stock, as well as more than 150,000 additional products available as special-order items. The Company also offers its customers exclusive, innovative technology solutions, including practice management software and e-commerce solutions, as well as a broad range of financial services.

Headquartered in Melville, N.Y., Henry Schein has operations or affiliates in 33 countries. The Company’s sales reached a record $10.6 billion in 2015, and have grown at a compound annual rate of approximately 15 percent since Henry Schein became a public company in 1995. For more information, visit Henry Schein at, and @HenrySchein on Twitter.

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

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Knowledgeability, Attitude and Behavior of Primary Care Providers Towards Oral Cancer: a Pilot Study

Authors: Neel Shimpi, Aditi Bharatkumar, Monica Jethwani, Po-Huang Cyou, Ingrid Glurich, Jake Blamer, Amit Acharya


The objective of this study was to assess current knowledgeability, attitudes, and practice behaviors of primary care providers (PCPs) towards oral cancer screening. Applying a cross-sectional design, a 14-question survey was emailed to 307 PCPs practicing at a large, multi-specialty, rurally based healthcare system. Survey data were collected and managed using REDCap and analyzed applying descriptive statistics. A 20 % response rate (n = 61/307) was achieved for survey completion. Approximately 70 % of respondents were physicians, 16 % were nurse practitioners, and 13 % were physician assistants. Nearly 60 % of respondents were family medicine practitioners. Limited training surrounding oral cancer screening during medical training was reported by 64 %. Although 78 % of respondents reported never performing oral cancer screening on patients in their practice, >90 % answered knowledge-based questions correctly. Frequency rate for specialist referral for suspicious lesions by PCPs was 56 % “frequently”. Optimal periodicity for oral cancer screening on all patients selected by respondents was 61 % “annually”, 3 % “every 6 months”, 3 % “every visit”, 2 % “not at all”, and 31 % “unsure”. This study established a baseline surrounding current knowledgeability, practice patterns, and opinions of PCPs towards oral cancer screening at a single, large, regional healthcare system. In the absence of evidence-based support for population-based cancer screening, this study result suggests a need for better integration of oral cancer surveillance into the medical setting, supplemented by education and training with emphasis on assessment of high-risk patients to achieve early detection. Prospectively, larger studies are needed to validate these findings.

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

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July, 2016|Oral Cancer News|

Bucking the trend: Cody Kiser, bronc rider

Author: Champ Robinson

Cody Kiser always had a fascination with the rodeo. The 25-year-old out of Carson City, Nevada competed in the high school rodeo as a bull rider, but Kiser used that term loosely.


“I was more of a bull getter-oner than a bull rider,” Kiser joked. “I had a bad tendency of holding onto the rope until the very last second.”

This time, that bad habit would cause significant injuries during a high school rodeo competition when Kiser was 14.

“I hit the ground and I don’t know if I was on my chest or my back, but one foot (of the bull) landed on my face and the other on my chest or back,” Kiser said.

The impact of the bull crushed Kiser’s left side of his face that broke his hinge bone and jaw bone and shattered his cheek bone. Kiser had to undergo plastic surgery to fix the injuries which required two plates and eight screws to be inserted to do so. Kiser spent a year recovering from the accident before returning to riding – this time horses.

“Riding bucking horses was something I always wanted to do,” Kiser said. “My dad (P.D. Kiser), that’s actually what he did. I thought I’d give that a go and turns out I was a little better at it and now I’m here today.”

When Kiser returned to riding, the nerves were there, but in a good way.

“I think I was more excited than anything,” Kiser said. “Sure, you get nervous, but you can’t think about that. You can’t think about getting hurt. You got to think about winning and doing your best. Think about staying positive.”

Having competed in the PRCA for the past five years, this will mark only the second time Kiser has participated in the California Rodeo Salinas.

“The first time I was here was probably three years ago or so. I think I was on my permit still, so I was still new to the PRCA rodeo and I was just awestruck by the rodeo and the guys I was riding with.

“It was just a mind-blowing experience. Now I’m here this year, I’m excited. I got a good horse that I’m excited to get on and I’m just ready to go.”

Kiser said the stuff he’s learned in his five years in the PRCA has helped him improve as a bareback bronc rider tremendously.

“I’m able to break down my rides and think through what I did wrong and what I can do right next time. What I did really good and focus on that and move on for the next one and just have fun most of all and see all of these amazing places.”

When preparing for a run at an event, Kiser said there’s little time for thinking once the gate opens.

“It’s more of a reaction,” Kiser said. “I trained for this and mentally try to get myself prepared before I get on the horse where I can just relax and react to what the horse does.”

Kiser said he’s seen some success during his time in the PRCA, but the greatest accomplishment to him is outside of the arena as a spokesperson for the Oral Cancer Foundation.

“It’s just been a crazy experience to be a part of the Oral Cancer Foundation and help out with the message that they try to get out there,” Kiser said. “That’s one of the things I’m really proud of.

“There’s been some rodeo wins here and there over the years, but being a part of that is something I’ll never forget.”

Kiser said he became involved with the Oral Cancer Foundation through a classmate at the University of Nevada, Reno.

“Her sister works for the Oral Cancer Foundation and they were looking for a cowboy that didn’t smoke or chew,” Kiser said. “I ended up talking to the founder Brian Hill and one thing led to another and it’s just been a great partnership ever since then.

“It just kind of fell into my lap. I’m just the luckiest guy in the world really.”

Kiser said he’s never personally experienced a family member having to go through a battle with cancer, but credits the way he was raised as to why he decided to take part in this cause.

“I grew up in a family that instilled into me that you don’t want to smoke or chew and if you want to make it far in this game, you got to be an athlete so I just never did that.”

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Alcohol consumption increases risk for seven types of cancer: Study

Author: Diana Bretting

An analysis of past health studies that have looked at the association between drinking and cancer has unveiled that having alcoholic beverages can increase the risk for seven types of cancer, including head, neck, esophageal, liver, colorectal and breast cancer.

The analysis carried out by Jennie Connor of the University of Otago, in New Zealand included comprehensive reviews conducted by the prestigious organizations, which include the World Cancer Research Fund and the American Institute for Cancer Research among others.

The researchers came to know that the risk did not go down even if there were different alcohol types like rum, whiskey, wine or beer. The risk increases with higher consumption, which as per the researchers is known as a dose-response relationship.

Connor was of the view that there is little evidence suggesting that the risk lessens for head and neck and liver cancers when consumption declines. Dr. Susan Gapstur, Vice-President of the Epidemiology Research Program at the American Cancer Society, said that the analysis has strengthened what is already known about the link between alcohol and cancer.

Dr. Gapstur said, “This is a review of an existing body of literature. Essentially the author has interpreted the literature to help people to understand. But it’s not a study of any new data. These seven cancer sites have long been established”.

Health officials were of the view that the study might help regular drinkers to cut their drinking habit. Dr. Jana Witt, of Cancer Research UK said that the best way would be to not have alcohol for few days in a week. It acts as a great way to cut down on drinking. One can swap alcoholic drink with soft drink, having smaller servings of alcohol and not to keep a stock at home.

According to a report in CBS News by Mary Brophy Marcus, “Drinking alcoholic beverages can raise the risk for seven types of cancer, according to a new study. Even moderate drinking is linked with a higher risk. The cancers include head, neck, esophageal, liver, colorectal and female breast cancer, according to the analysis of existing studies looking at the association between drinking and cancer. The findings are published in the journal Addiction.”

“Having some alcohol-free days each week is a good way to cut down on the amount you’re drinking,” “Also, try swapping every other alcoholic drink for a soft drink, choosing smaller servings or less alcoholic versions of drinks, and not keeping a stock of booze at home.” The study also found that the risk of certain mouth and throat cancers was even higher among people who both smoked and drank alcohol.

A report published in the Live Science said, “Previous studies have found an association between drinking alcohol and a higher risk of developing certain cancers, according to the study. However, it was not clear from the studies if drinking alcohol directly caused cancer.”

The link between alcohol and cancers of the mouth and throat were stronger than the link between alcohol and other cancers, Connor wrote. For example, drinking more than 50 grams of alcohol a day is was associated with a four to seven times greater risk of developing mouth, throat or esophagus cancer compared with not drinking at all.(The number of grams of alcohol in 1 ounce of a drink can vary. For example, there are 2.4 to 2.8 grams of alcohol in an ounce of wine, but there are 1 to 1.2 grams of alcohol per ounce of beer.)

“Health experts endorsed the findings and said they showed that ministers should initiate more education campaigns in order to tackle widespread public ignorance about how closely alcohol and cancer are connected. The study sparked renewed calls for regular drinkers to be encouraged to take alcohol-free days, and for alcohol packaging to carry warning labels,” according to a news report published by The Guardian.

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Despite medical backing, HPV vaccine rates remain low amid sexual and moral controversy

Author: Rick Ruggles, World-Herald staff writer


The HPV vaccine can reduce the rates of certain cancers, including many cervical and oral cancers, physicians and medical organizations say. But opposition by some individuals is strong, and HPV vaccination rates remain low when compared with other kinds of vaccinations recommended for adolescents.

Because the human papillomavirus is sexually transmitted and seventh grade is considered the ideal time to receive the three-dose vaccine regimen, the issue is rife with sexual and moral implications. Perhaps more potent today, though, are Internet horror stories and concerns about side effects.

A World-Herald Facebook request for views on the HPV vaccine generated far more negatives than positives. “NO NO & NO!! There is NO reason for this vaccine,” one wrote. Another called it a “deadly shot.”

Two Omaha mothers who were interviewed expressed their belief that it’s wise to have children vaccinated, and said their kids suffered no side effects. But an Iowa man described health problems suffered by his daughter, and he and an Ohio physician believe the girl was injured by the HPV vaccinations.

So mediocre are HPV vaccination rates that GSK, the maker of Cervarix, plans to cease distribution of its HPV vaccine in the United States in September. It will continue to supply it in many other nations, such as Great Britain, Germany, France and Mexico. The departure of Cervarix leaves the market to Gardasil, a vaccine produced by Merck.

“GSK has made the decision to stop supplying Cervarix … in the U.S. due to very low market demand,” the company told The World-Herald last week by email.

Many doctors in the Omaha area express disappointment with the low HPV vaccination rates but are optimistic that the situation will improve.

“As pediatricians, we’re trying to change that,” said Dr. Katrena Lacey, a Methodist Physicians Clinic pediatrician in Gretna. “I think we’re on the right track.”

A survey of adolescents reported last year by the federal Centers for Disease Control and Prevention found that 39.7 percent of girls ages 13 to 17 had received the three-dose regimen of the HPV vaccine in 2014, and 21.6 percent of boys.

This compares with 87.6 percent of boys and girls who had received the tetanus-diphtheria-pertussis vaccination and 79.3 percent who had received the meningococcal vaccine.

Dr. Megann Sauer, a pediatrician with Boys Town Pediatrics, said parents accept use of the vaccine if it’s explained well and described as a cancer-prevention strategy. “It’s a huge responsibility for us as providers to offer this to our patients,” Sauer said. “My job is to keep my patients healthy.”

Gardasil was approved in the United States 10 years ago. It was met with concern that having a child vaccinated for HPV, which is the most common sexually transmitted infection, would promote promiscuity.

Today, the global Christian ministry Focus on the Family says it “supports universal availability of HPV vaccines,” but it opposes government-mandated HPV vaccinations for public-school enrollment. The mandates are in place in Virginia, Rhode Island and Washington, D.C.

Tom Venzor of the Nebraska Catholic Conference said the vaccine itself isn’t morally problematic. But “the promotion of chastity and parental consent should never be undermined in the promotion of the HPV vaccine,” Venzor said in an email.

The Kaiser Family Foundation estimates that there are more than 14 million new human papillomavirus infections annually in the U.S. Most resolve on their own, but some chronic HPV infections can embed in tissues and lead to cervical cancers and tongue, tonsil, anal, vulvar, vaginal and penile cancers.

The American Cancer Society estimated there will be close to 13,000 new cases of cervical cancer this year and 4,120 deaths. HPV was detected in more than 90 percent of cervical cancers, a 2015 study reported in the Journal of the National Cancer Institute said.

“If you’ve ever seen anyone die of cervical cancer, it will tear you apart, because it’s a nasty, nasty disease,” said Dr. Steve Remmenga, a specialist in gynecologic oncology at the University of Nebraska Medical Center. Remmenga advocates getting the vaccination.

The CDC recommends routine HPV vaccinations beginning at 11 or 12 years of age for girls and boys, but the series can start as early as 9 years of age. The second dose should be given a month or two later and the third at least six months after the first. The vaccinations may be completed by 26 years of age. The recommendations have been adopted by the American Cancer Society and other medical organizations.

The recommendations suggest children receive the vaccinations “so they are protected before ever being exposed to the virus,” the CDC said. The agency said clinical trials indicate the vaccination provides “limited or no protection” against HPV-related diseases for women older than 26.

The CDC says the vaccine has repeatedly been shown to be safe.

Kari Nelson, a biology instructor at the University of Nebraska at Omaha, said two of her daughters, Claire and Emma, have had the full regimen and her third daughter, Gretchen, is about to get her second shot.

“I definitely believe in protecting my kids as much as possible,” Nelson said. “I do always try to weigh the pros and cons of anything. I just feel that the pros far outweigh the cons in this case.”

The Nelsons’ pediatrician, Dr. Tina Scott-Mordhorst, supports children and adolescents receiving the HPV vaccine. Why, she asked, would anyone not get a shot that might prevent cancer? “It works,” said Scott-Mordhorst, a clinical professor in UNMC’s department of pediatrics.

A study reported this year in the journal Pediatrics found that among sexually active females ages 14 to 24, the prevalence of four key HPV types was 16.9 percent among the unvaccinated and 2.1 percent among the vaccinated.

Scientists say it can take many years for chronic HPV to turn cancerous.

Dr. Bill Lydiatt, a head and neck cancer surgeon at Methodist Hospital, said oral sex and the sexual revolution of the late 1960s have contributed to an increase in cancers of the pharynx, or tonsil and back of tongue. The cancer society reported there will be 16,420 cases of cancer of the pharynx this year, most of them in men, compared with 8,950 in 2006. More than 3,000 will die this year from that kind of cancer, the society says.

Lydiatt said scientists only about 10 years ago made the clear link between HPV and cancers of the pharynx and tonsils.

There are more than 150 strains of HPV and more than 40 that can cause cancer, the Kaiser Family Foundation reported. The first form of Gardasil protected against four strains, including the two believed to be most prevalent in cancers. Two years ago the FDA approved a Gardasil vaccine that protected against nine strains. The study in the Journal of the National Cancer Institute says that “current vaccines will reduce most HPV-associated cancers.”

The vaccines are expensive. The Gardasil nine-strain vaccine is close to $250 per dose at Kohll’s Pharmacy if a family pays out of pocket. But many insurers, such as Blue Cross Blue Shield of Nebraska, Aetna/Coventry and UnitedHealthcare, participate in the payment.

A Merck spokeswoman said GSK’s decision to cease supplying Cervarix to the U.S. market hasn’t affected Gardasil prices as of now. An Omaha pharmacist said it wouldn’t be unusual to see prices go up with the departure of a competitor. “The reality is that they can,” Mohamed Jalloh said. “I’m not saying they’re going to.”

Merck has applied to the Food and Drug Administration to market a two-dose regimen of Gardasil, which would reduce the overall price of the series.

Facebook posts and the Internet contain scathing reviews of Gardasil, including stories of children being hurt and families being scared of the vaccination.

Laura Hansen, a cancer researcher at Creighton University, said she wishes she could find the words to persuade people to get their kids vaccinated.

“About all of us have family members impacted by cancer,” said Hansen, a professor of biomedical sciences. By having their kids vaccinated, she said, “Every parent could make an impact on cancer deaths.”

She said it’s hard to fight Internet scare stories and “anecdotal science” as opposed to real science and legitimate studies. The discussion should be “more about facts and less about hysteria,” said Hansen, who saw to it that her two teen-age sons, Charlie and Jack, were vaccinated.

Jeff Weggen of Muscatine, Iowa, has an entirely different view. Weggen said his daughter, Sydney, had the vaccines about four years ago. Soon after, she began to lose weight, suffered back pain and became pale. Over a period of months she was hospitalized and saw specialists in state and out-of-state. She was eventually found to have a fungal infection and a large tissue mass in her chest.

Weggen eventually linked Sydney’s ongoing medical problems to Gardasil, he said. Online groups, other parents and the timeline of her vaccines and her illness helped lead him to this opinion, he said. An anti-Gardasil Facebook post introduced him to a doctor in Ohio who early this year generally confirmed Weggen’s suspicions.

Dr. Phillip DeMio of the Cleveland area said he has several patients he believes were sickened by Gardasil. DeMio, a general practitioner who said his practice focuses on chronically ill people, said some of his patients have been injured by other vaccines, too.

“These are challenging situations, no two ways about it,” he said. Most people have received a variety of vaccinations, he said, and he believes the aluminum in Gardasil and other vaccines can be a problem for some people.

He saw Sydney early this year. Based on the extensive testing that ruled out other diseases, the severity of her illness, the timing of vaccination and other factors, he said he believes “there’s a component of vaccine damage for her and for many of my patients.”

He said there are good reasons to have an adolescent receive Gardasil and mentioned the likelihood that some individuals will be sexually active. But it makes no sense to have a 9-year-old get it, he said. He said parents should be well-informed of the risks and benefits of Gardasil and other vaccines.

“I think people should have a choice,” he said. “I’m not saying I’m against the vaccine.”

The CDC sent a written statement saying that millions of doses of Gardasil have been administered.

Scientific studies have detected no link to “unusual or unexpected adverse reactions,” the CDC said.

Side effects can include pain from the shot and occasionally a patient might faint after any injectable vaccine, the CDC said. But “the benefits of vaccination far outweigh any risks.”

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Rate of HPV-associated cancers on the rise in U.S., according to new CDC report

Author: Andrew J. Roth

Though the first preventive human papilloma virus (HPV) vaccine was approved by the U.S. Food and Drug Administration 10 years ago, the incidence of HPV-associated cancers is on the rise.

From 2008 to 2012, the number of HPV-associated cancers diagnosed per year increased by approximately 16 percent compared with the previous five-year period, according to a new report by the Centers for Disease Control and Prevention (CDC).

Nearly all sexually active individuals in the U.S. will get at least one type of HPV in their lifetime, making it the most common sexually-transmitted infection in the country. And though about 90 percent of HPV infections will clear a person’s system within two years, some infections persist and can cause cervical cancers and some types of vulvar, oropharyngeal, penile, rectal and cancers.

There are over 40 HPV types, and vaccines are available for HPV types 16 and 18 (which account for 63 percent of HPV-associated cancers), as well as for types 31, 33, 45, 52 and 58 (which account for an additional 10 percent). Type 16 is the most likely to persist and develop into cancer.

In this new report, the CDC analyzed data from its own National Program of Cancer Registries as well as the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database. In total, 38,793 HPV-associated cancers (11.7 per 100,000 persons), on average, were diagnosed annually from 2008 to 2012 compared with 33,369 diagnoses (10.8 per 100,000 persons) from 2004 to 2008. Researchers then multiplied the number of cancers that could have been associated with HPV by the rate actually believed to be attributable to HPV, and found that an estimated 30,700 (79 percent) of the cancers could have been attributed to the virus.

The report highlights numerous challenges to controlling HPV-related cancers. First, not enough adolescents are receiving all three HPV vaccines. The CDC recommends that all males and females should start the HPV vaccine series at the age of 11 or 12 years. The CDC also notes that males can receive the series through age 21 and females can receive it through age 26.

According to this CDC report, though, in 2014, just 60 percent of females aged 13 to 17 received at least one dose, 50.3 percent received at least two doses and 39.7 percent received three doses. Among males, the rates were worse: 41.7 percent received at least one dose, 31.4 percent received at least two doses and 21.6 percent received three doses.

Additionally, differences exist between races. In the 2008 to 2012 study, rates of cervical cancer were higher among blacks compared with whites and higher among Hispanics compared with non-Hispanics. Rates of both vulvar and oropharyngeal cancers were lower, however, among blacks and Hispanics versus whites and non-Hispanics, respectively. Rates of anal cancer were lower among black women and Hispanics, but higher among black men, compared with their counterparts.

HPV-associated cancer rates also differed based on geographic location: Utah had the lowest rate (7.5 per 100,000 persons) while Kentucky had the highest rate (14.7 per 100,000). The study’s authors noted that most states with rates higher than the overall U.S. rate (11.7 per 100,000) were located in the South.

Study authors pointed out that most cervical cancers can be prevented by regularly screening women aged 21 to 65 for precancerous lesions, though there are no effective population-based screening tools for other HPV-associated cancers.

The authors also reviewed two challenges with the report itself. Though the CDC and SEER databases are reliable, the authors wrote, “no registry routinely collects or reports information on HPV DNA status in cancer tissue, so the HPV-attributable cancers are only estimates.” The authors also noted that race and ethnicity data came from medical records and may be inaccurate in a small number of cases.

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HPV-related cancer Is ‘epidemic’—but few get vaccinated

Author: Michael Harthorne, Newser Staff

“Every parent should ask the question: If there was a vaccine I could give my child that would prevent him/her from developing six different cancers, would I give it to them?” Electra Paskett, co-director of the Cancer Control Research Program at Ohio State University, tells CBS News. The answer appears to be no. According to NBC News, a CDC report released Thursday shows a 17% increase in HPV-related cancers between 2004 and 2012 to nearly 39,000 per year. Dr. Lois Ramondetta, an expert in gynecologic oncology, says it’s become an “epidemic” especially for men, in whom HPV can cause cancers of the mouth, tongue, and throat. HPV increases the risk of those cancers by at least seven times, and unlike with HPV-caused cervical cancer in women, there’s no screening for them.
The CDC report found 93% of all HPV-related cancers could be prevented with the currently available vaccine. That’s approximately 28,500 fewer cases of cancer every year, AFP reports. And yet in 2014, only 40% of teen girls and 22% of teen boys received the necessary three doses of the vaccine, which works best if administered before teens become sexually active. Paskett calls those numbers “extremely sad.” “We must change the perception of the HPV vaccine from something that prevents a sexually transmitted disease to a vaccine that prevents cancer,” she tells CBS. (Some British teens invented condoms that change color near HPV and other STDs.)

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Rodeo Competitors Fight Smokeless Tobacco Use at Laramie Jubilee Days

Author: Nick Learned

Cody Kiser and Carly Twisselman

Two professional rodeo contestants will ride exclusively for the Oral Cancer Foundation this weekend as part of Laramie Jubilee Days with a goal of preventing young fans from using smokeless tobacco.

Cody Kiser and Carly Twisselman each aim to show rodeo fans, particularly the younger ones, chewing or using other forms of smokeless tobacco isn’t what makes them who they are. They promote the Foundation’s campaign which uses the slogan “Be Smart. Don’t Start.”

Their approach is anything but confrontational or aggressive. Rather than encouraging people to quit, they hope to encourage young fans to never pick up the habit in the first place. And where some rely on statistics to make the point, Kiser and Twisselman take a different approach. Simply giving attention to young rodeo fans is a big part of getting their message across.

“Its not the facts that they’re going to take home,” Kiser says. “Everybody knows that tobacco’s bad; you can get cancer and you can die. But the biggest impact that I see is just acknowledging those kids or acknowledging those people in the audience that want to know more, and you can show them what you can do without tobacco.”

“I’m not out there to tell anybody how to live their life or preach to them about needing to quit,” Kiser says.

“It’s not our place to do that,” Twisselman says. “People most of the time aren’t going to listen when you tell them something like that anyway.”

The pair will be wearing Oral Cancer Foundation gear and handing out buttons, wristbands and bandanas bearing campaign messaging.

As they travel the rodeo circuit, Kiser and Twisselman each say they often see other riders use various types of smokeless tobacco such as chew and snuff.

“It’s very common,” says Kiser. “You see it everywhere.”

“One of my traveling partners, he started when he was in high school. He was just around it all the time,” says Kiser. “It was just the ‘cowboy’ thing to do, I guess.”

“A lot of people are very respectful about it,” Twisselman says. “They’ll see me in my shirt and be like ‘oh yeah, you represent the Oral Cancer Foundation’ and they’ll spit their chew out. I think that in itself is a positive side effect of it.”

“I think a large part of a lot of these cowboys is, it’s the cowboy thing to do, so they start doing it,” Kiser says. “And that’s where I want to step in and show the younger generation that you don’t have to chew to be a cowboy. You can be a cowboy athlete and not chew and treat your body as best you can, because what we do is very difficult and it’s hard on the body.”

“A lot of folks started when they young,” Kiser says. “And I’ve talked to guys who started chewing later in life and they can’t quit, or it’s hard for them. It’s a vicious thing.”

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

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