ASCO Urges Aggressive Efforts to Increase HPV Vaccination

Mon, Apr 18, 2016

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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.

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Cowboy raises awareness for oral cancer

Fri, Apr 15, 2016

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Source: www.kristv.com
Author: Annie Sabo
 
KRISTV cody interview

In an environment where smokeless and spit tobacco is prevalent, cowboy, Cody Kiser, says he feels like the luckiest guy in the world to represent the Oral Cancer Foundation.

He told us, “I just happened to be in a class with a classmate. Their sister works for the oral cancer foundation…one thing led to another and they said  we’ve been looking for a cowboy that doesn’t smoke or chew and we’d love to be able to work out some kind of deal where we help you out you help us out…now I’m here.”
Although Cody has not been personally affected by the cancer, he wears a special patch on his shirt to raise awareness for the deadly disease.

He said, “I’m very lucky that I haven’t had any family members or friends be affected by oral cancer. I’ve made friends with people that have been now and it’s a real eye opener.”

Since partnering with the oral cancer foundation, he works hard to promote this message: “Be smart don’t start…we want to get out to the kids and fans who haven’t smoking or chewing yet.”

Cody says the best part about working for the oral cancer foundation is serving as a role model for children. He told us, “You can be an elite athlete and an amazing cowboy without having to smoke or chew. That’s our goal is to get to those kids before they do that. I just want to be a good role model for these kids.”

Rodeo after Rodeo, Kiser hopes to make a difference.

10334178_GKiser wears this patch every time he competes.

 

View Cody Kiser’s full inter view here: http://www.kristv.com/clip/12364598/rodeo-cowboy-has-a-special-message-at-buc-days

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

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Merck Says FDA Accepts Its SBLA For Keytruda For Treatment Of Head & Neck Cancer

Wed, Apr 13, 2016

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Source: www.finchannel.com
Author: Fin Channel News Editorial Staff
 
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The FINANCIAL — Merck, known as MSD outside the United States and Canada, on April 13 announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

The application is seeking approval for KEYTRUDA as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted Priority Review with a PDUFA, or target action, date of Aug. 9; the sBLA will be reviewed under the FDA’s Accelerated Approval program, according to Merck.

“Starting in the early days of our development program, we have explored the role of KEYTRUDA for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are encouraged by the data emerging from our program in this type of cancer, and welcome today’s news as this is an important step toward making KEYTRUDA available to these patients.”

Merck currently has the largest immuno-oncology clinical development program in head and neck cancer and is advancing multiple registration-enabling studies with KEYTRUDA as a single agent and in combination with chemotherapy.

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

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The burden of cancer isn’t just cancer

Mon, Apr 11, 2016

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Source: www.news.doximity.com
Author: Carolyn Y. Johnson
 

Money is low on the list of things most people want to think about after a doctor says the scary word “cancer.” And it’s not just patients — physicians also want to weigh the best treatment options to rout the cancer, unburdened by financial nitty gritty. But a growing body of evidence suggests that, far from crass, ignoring cost could be harmful to patients’ health.

In the age of $10,000-a-month cancer drugs and health plans that shift more of the cost of health care onto patients, research suggests we’ve been underestimating one of cancer’s real harms: “financial toxicity.”

The financial difficulties that stem from dealing with cancer can lead people to avoid or delay care or drugs, studies suggest, and also may cause stress that can lead to mental and physical health problems.

“When people are diagnosed, it behooves the provider to assess their financial risk at baseline — to find out if they’re at risk, and if they are, to be very aggressive with getting them to financial planning, to patient assistance programs to reduce their likelihood of having financial devastation,” said Scott Ramsey, a health economist and physician at the Fred Hutchinson Cancer Research Center in Seattle who showed in 2013 that people with cancer are 2.65 times more likely to file for bankruptcy than people without cancer. “We think unless you do, it’ll be hard to keep people from ending up in this situation.”

For years, the evidence has accrued that cancer patients experience greater financial challenges than other groups of sick people. A study in the Journal of Clinical Oncology found that 13 percent of non-elderly patients with cancer spend at least a fifth of their income on treatment. Among people on Medicare, cancer patients spent an average of $4,727 of their own money on health care, according to a 2013 Cancer study — about $1,000 more than people without cancer.

What has been far less clear is whether the distress is simply a financial problem or also a health issue. No one would say financial stress is desirable, but does it affect how long or well cancer patients lived? Were people skipping doctor’s visits, drugs or other treatments?

There’s some evidence that higher co-pays deter patients from filling their prescriptions — one study found that a copay of about $50 a month or more was enough to keep nearly a fifth of patients from continuing to fill prescriptions for a remarkably effective rare leukemia treatment.

But cancer’s burden isn’t just high drug costs. Last month, Ramsey and colleagues reported that not only are cancer patients more likely to declare bankruptcy than those without; those who declared bankruptcy were 1.8 times as likely to die of any cause than cancer patients with the same diagnoses and initial treatments who did not.

Another study published in the journal Cancer last month examined Medicare data and found that among nearly 20 million cancer survivors, 29 percent reported financial burden of some kind, ranging from bankruptcy to borrowing money to not being able to pay for medical visits. Among those reporting financial burdens, 86 percent had health insurance during their cancer treatment.

“Another thing that concerns me with the way most insurance policies are set up is it seems they do a good job of protecting you at sort of middle-range expenses, but if you get to really high expenses, people incur a lot of out-of-pocket costs. The thing you want insurance to insure you against is financial catastrophe, but the way these policies are set up, for a lot of people, they don’t,” said Norman Carroll, a professor of pharmacoeconomics and health outcomes at the Virginia Commonwealth University School of Pharmacy who led the Cancer study.

How financial toxicity hurts

The big question underlying this research is how financial distress hurts and what should be done about it. Are patients skipping appointments and not taking drugs that could extend their lives because they’re going broke? Or are they losing their jobs or earning less after cancer and is worry about going broke having a snowball effect, bringing on other ill health effects?

There aren’t definitive answers, but worrisome hints.

A 2013 study published in The Oncologist found that nearly half of cancer patients with insurance surveyed cut back on their spending on food and clothing or dipped into savings to pay for their treatment. The majority cut back on leisure activities. Three-quarters of them received financial assistance with their drug copayments.

A study of Medicare beneficiaries in the Journal of Managed Care Pharmacy found that for expensive cancer drugs that are given as pills, patients were more likely to stop or delay drug therapy as the portion they paid increased. For every $10 increase in out of patient costs per month, the likelihood of stopping or delaying use of the drug increased — 12.7 percent for a leukemia drug called imatinib.

Add to that Carroll’s recent study, which found cancer patients who reported three or more financial problems had clinically meaningful differences in physical health. The study also tracked depression, and people with any kind of financial burden had meaningful differences in mental health — and as the number of financial problems increased, so did the mental health burden.

“Physicians probably should focus more on shared decision-making with patients to the extent that’s possible, and spend more time than I think has been spent in the past to see if you can find equally effective, lower cost treatment,” Carroll said.

But researchers still don’t know enough about the problem — or what the best therapy is. Ramsey said he is now working on a pilot where financial information will be collected at oncology clinics when people are seen, to see how treatments affect patients’ financial health in real time.

“It’s easy for me to say that, but it’s hard to really do, because doctors don’t really want to deal with it, patients don’t want to,” Ramsey said

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

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Study supports immunotherapy/radiation combo in head and neck cancer

Mon, Apr 11, 2016

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Source: www.onclive.com
Author: Laura Panjwani

There may be potential synergy between radiation therapy, given with or without chemotherapy, and immune checkpoint inhibitors in patients with squamous cell carcinoma of the head and neck (SCCHN), according to results of a prospective study.

The study, which was presented at the the 2016 Multidisciplinary Head and Neck Cancer Symposium in February 2016, examined blood samples from 16 consecutive patients with SCCHN undergoing curative-intent radiation therapies.

Samples were obtained at week 1 and week 6 to 7. Patients received a median of 70 Gy for disease in the oropharynx (n = 12, 75%), nasopharynx (n = 2, 12%), larynx (n = 1, 6%), or oral cavity (n = 1, 6%). The majority of patients had stage IV disease that was metastatic to regional lymph nodes and received concurrent platinum-based chemotherapy.

The analysis found that, during radiation treatment, circulating CD8-positive T-effector cells increased (P = .01), as did CD4-positive PD-1–positive cells (P = .02), CD8-positive LAG3-positive cells (P = .02), and regulatory T cells (P = .04). sPD-L1 levels also increased, mirroring increases in CD8-positive T cells over the course of therapy (P = .047).

While the extent to which these systemic changes reflect changes in the tumor microenvironment is unknown, the study authors noted that these findings support the “complex immunologic effects of fractionated chemoradiation therapy and mechanisms for potential synergy between chemotherapy, radiation treatment, and immunotherapy in SCCHN.”

To learn more about the impact of the research, OncLive spoke to one of the study’s authors, Jonathan D. Schoenfeld, MD, physician, assistant professor of Radiation Oncology, Harvard Medical School, Dana-Farber Cancer Institute, who presented the findings at the meeting.

OncLive: What were the goals of this study?

Schoenfeld: Immunotherapy, particularly immune checkpoint blockade, is demonstrating some exciting results in head and neck cancer. Largely, that work has been done in metastatic head and neck cancer. Our goal was to look at the immunologic effects of a treatment that is commonly given to patients with early-stage head and neck cancer: chemotherapy and radiation.

We found that the combination of chemotherapy and radiation—and in some cases, just radiation alone—led to immune effects that we could see not just in the site where we were radiating, but also if we looked at markers in the peripheral blood.

One of the interesting things that we found was that radiation, with or without chemotherapy, has the potential to increase the number of tumor antigens that were targeted by the host immune response. One of the ways that we hope to use radiation in the future is to stimulate an initial immune response.

Based on the data that is emerging with PD-1 inhibitors, we know that the majority of patients will not respond to these agents. We need to determine if we can use radiation and chemotherapy to increase the number of responders initially that can then be stimulated even further with immune checkpoint blockade.

What immune effects were investigated?
We looked at a variety of effects. We looked at chemokines, which are cytokines that could mediate effects outside of the radiation treatment field. We looked at circulating T cells, including CD8-positive T cells, CD4-positve T cells, and markers of activated T cells.

We also looked at potentially inhibitory T cells as well, including T-regulatory cells, T cells that were expressing checkpoint receptors, and myeloid-derived suppressor cells. We also looked, in more detail, at the types of T-cell receptors that were expressed on the surface of these T cells, and it looked like the combination of radiation and chemotherapy could change the clonality of the receptor on these T cells, suggesting that radiation or targeted tumor death could stimulate a more targeted immune response.

What can a community oncologist take away from these findings?

Chemotherapy and radiation have long been appreciated for their immunosuppressive effects. We all know that when you treat someone with radiation or chemotherapy, you can see a decrease in cytopenia and lymphocytes.

We are now learning that certain types of chemotherapy and radiation, given in the proper circumstance, can cause immunogenic cell death. That can possibly synergize with the newer types of immune checkpoint blockade that are being developed.

One of our study’s findings was that we saw an increase in T cells expressed in the PD-1 receptor. Those could potentially be targeted with new checkpoint inhibitors that target the PD-1 receptor. As we develop these therapies even further, there are exciting new combinations between immunotherapies and some of the traditional therapies that have long been used for head and neck cancer with potential.

In melanoma, there are case reports of patients who have progressed on immune checkpoint blockade and are then treated with high-dose palliative radiation that then began to experience a response outside of the radiation treatment field. That is a very exciting avenue of research for head and neck cancer, as well. Can we take patients who don’t respond to the current checkpoint inhibitors that we have and use radiation in a targeted way to stimulate a broader immune response?

Radiation and chemotherapy are a backbone of some of the definitive treatments currently used for head and neck cancer. There is a lot of interest with the success of PD-1/PD-L1 inhibitors to integrate these into the definitive management, and combine them the proper way with chemotherapy and radiation to better maximize our results.

Chemotherapy and radiation are still very important for patients with curative head and neck cancer, but perhaps we should be giving these treatments in a different way—different types of radiation and chemotherapy and different targets for radiation. All of these things need to be explored, as new therapies, such as immune checkpoint inhibitors, are developed in this disease.

What impact will immunotherapy will have in head and neck cancer?
It will have a huge impact. Exciting data are emerging in metastatic head and neck cancer that show that PD-1 inhibitors offer real benefit to patients. Many of these patients had very few other treatment options and could obtain a survival benefit after treatment with PD-1 inhibitors. That opens up a whole new realm of opportunities to study immunotherapy in different settings, in different groups of patients, and in combination with other agents.

Source:
Sridharan V, Margalit D, Curreri S, et al. Systemic immunologic effects of definitive radiation in head and neck cancer. Presented at: 2016 Multidisciplinary Head and Neck Cancer Symposium; February 18-20, 2016; Scottsdale, AZ. Abstract 2.

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Forgotten patients: New guidelines help those with head-and-neck cancers

Mon, Apr 11, 2016

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Source: www.fredhutch.org
Author: Diane Mapes and Sabrina Richards

Stigma, isolation and medical complexity may keep patients from getting all the care they need; recommendations aim to change that.

Like many cancer patients, Jennifer Giesel has side effects from treatment.

There’s the neuropathy in her hands, a holdover from chemo. There’s jaw stiffness from her multiple surgeries: an emergency intubation when she couldn’t breathe due to the golf ball-sized tumor on her larynx and two follow-up surgeries to remove the cancer. And then there’s hypothyroidism and xerostomia, or dry mouth, a result of the 35 radiation treatments that beat back the cancer but destroyed her salivary glands and thyroid.

“I went to my primary care doctor a couple of times and mentioned the side effects,” said the 41-year-old laryngeal cancer patient from Cleveland, who was diagnosed two years ago. “She was great but she didn’t seem too knowledgeable about what I was telling her. She was like, ‘Oh really?’ It was more like she was learning from me.”

Patients like Giesel should have an easier time communicating their unique treatment side effects to health care providers with the recent release of new head-and-neck cancer survivorship guidelines. Created by a team of experts in oncology, primary care, dentistry, psychology, speech pathology, physical therapy and rehabilitation (with input from patients and nurses), the guidelines are designed to help primary care physicians and other health practitioners without expertise in head-and-neck cancer better understand the common side effects resulting from its treatment. The goal is that they’ll then be able to better make referrals or offer a holistic plan for patients to get the support they need.

“Head-and-neck cancer survivors can have enormous aftereffects from the disease and treatment by virtue of the location of the primary tumor,” said Dr. Gary Lyman, a public health researcher with Fred Hutchinson Cancer Research Center who helped create the guidelines. “There are functional interruptions, like losing the ability to talk, eat or taste. And some of the surgeries can be disfiguring.

“I’m really glad the American Cancer Society decided to take this on,” he said. “These guidelines are sorely needed, long overdue and will serve cancer patients who are incredibly affected — both physically and emotionally.”

Currently, there are more than 430,000 head-and-neck cancer, or HNC, survivors in the U.S., accounting for around 3 percent of the cancer patient population.

As with many other cancers, HNC is an umbrella term for a number of different malignancies, including cancers that develop in or around the mouth, tongue, throat, nose, sinuses or larynx. Brain, thyroid and esophageal cancer are not considered head-and-neck cancers.

HNC has traditionally been linked to tobacco and alcohol use, and about 75 percent of HNC are related to these risk factors. Increasingly, though, human papillomavirus, or HPV, is causing a significant number of head-and-neck cancers (another reason why the HPV vaccine is such an important prevention tool).

An isolating group of diseases
For some patients with HNC, there can be a certain amount of stigma and isolation, due to its association with drinking and smoking. Treatment can also isolate patients since it sometimes mars a person’s appearance or alters their speech.

Some patients, literally, have no voice.

HNC’s complicated nature — it’s not one disease but several, all of which behave and respond to treatment differently — also results in very small patient populations, which can hinder research.

“Head-and-neck cancer patients have historically been somewhat ignored,” said Lyman, an oncologist with Seattle Cancer Care Alliance, Fred Hutch’s treatment arm. “Many view this as a lifestyle-associated cancer, like lung cancer, heavily influenced by tobacco exposure and [drinking] alcohol to excess. And people may have difficulty dealing with the appearance of some of the more severely affected patients.”

t’s a sentiment echoed by Dr. Eduardo Méndez, a Fred Hutch clinical researcher and head-and-neck cancer surgeon at SCCA.

“It’s in a location that affects your appearance, it affects your ability to speak and to swallow, and those are all things that you need to interact with others,” he said. “It can have an effect of shutting you down from the rest of society. Even the treatment for head-and-neck cancer can have consequences that affect those very same things that the tumor was affecting — swallowing, speech, appearance.”

Not surprisingly, many HNC survivors suffer from depression and/or body image and self-esteem issues after diagnosis and treatment.

“I struggle with body image issues every day,” said Beci Steelman, a 42-year-old court clerk from Bushnell, Illinois, who went through radiation and eight surgeries, including a total right maxillectomy (a surgery of the upper jaw), after being diagnosed with a rare head and neck tumor in 2010.

“You can see that my eye looks like someone’s pulling it halfway down my cheek,” she said. ”My mom and I just call it my googly eye and joke that I have ‘really good face days’ and others that are just ‘face days.’ Clearly something’s not right. When I smile, you can see a bit of metal from the obturator, this weird rubbery dental piece that plugs the hole in the roof of my mouth. Some days I just feel like I’m so ugly.”

Holistic approach benefits patients
There is good news with these cancers: most patients are diagnosed with HNC in its early, most curable stages.

“The majority will be completely functional and normal [after treatment],” said Dr. Christina Rodriguez, the medical oncologist who oversees the majority of HNC patient care at SCCA.

According to the National Comprehensive Cancer Network, around 80 to 90 percent of early stage patients (stage 1 and 2) go into remission after receiving surgery or radiation. Advanced stage patients (stage 3 and 4) receive more aggressive treatment and have lower cure rates, with the exception of patients with HPV-related head-and-neck cancers. Their 5-year cure rates are close to 90 percent.

But even those who go into remission may have to contend with a constellation of difficult side effects.

The head and neck area is “like a fine-tuned machine,” said Dr. Keith Eaton, a medical oncologist at SCCA and Fred Hutch who specializes in lung cancer and HNC. “There are so many dedicated structures that we can’t do without. If you get rid of half your liver, not a problem. If your epiglottis doesn’t work, you aspirate.”

In addition to trouble with swallowing and speech, stiffness in the jaw and problems with shoulder and neck mobility, HNC patients can be left with hypothyroidism, hearing loss, taste issues, periodontitis and lymphedema, the swelling that comes after lymph nodes are surgically removed, a common step in cancer treatment. Because of this complexity, patients need a holistic approach, said Méndez.

Steelman’s cancer extended to the orbital floor of her right eye which meant she had to undergo extensive surgery to her face including the removal of four back teeth, an incision to the roof of her mouth and the shortening of a jaw muscle.

“They got the tumor out and then put me back together,” she said. “I feel like Humpty Dumpty.”

She now wears a prosthetic (which requires daily maintenance) and has had injectable fillers to help with the atrophy around her right eye (an implant in the area became infected and had to be removed). She’s lost hearing in her right ear, her speech is sometimes “a little marble-y,” she has dry mouth from damage to her salivary glands and her jaw will not open as wide as it once did.

Steelman tapped a number of specialists to help her deal with these issues, including an otolaryngologist (ear, nose and throat doctor), speech pathologist, a prosthodontist (an expert in the restoration and replacement of teeth) and a plastic surgeon.

“You have to be your own advocate,” she said. “You learn that very quickly.”

Get help early
Physical therapists, speech pathologists, dietitians and providers with expertise in palliative and pain care (also called supportive care) can improve survivors’ quality of life enormously, especially when therapy is started early.

“Careful — and early — attention to side effects and treatment-related complications can help optimize survivors’ quality of life,” said Eaton, the SCCA oncologist.

Dr. Elisabeth Tomere, a physical therapist at SCCA, said she and her colleagues prescribe exercises that help patients regain strength, range of motion and tissue flexibility that surgery and/or radiation may have diminished. Some patients, for instance, need help building up their trapezius muscle to improve shoulder function they have lost after neck surgery. Others need to learn movements that strengthen the front of their necks and the muscles needed to maintain posture.

Patients with lymphedema in the face and neck — a common side effect from HNC treatments — can also benefit from early intervention by a physical therapist, said Tomere.

“These issues are all helpful to address as quickly as possible so they’re not ongoing,” she said, adding that it may take up to two years for patients to mentally and physically recover from treatment.

“We try to give people a realistic timeline,” she said.

The new ACS guidelines should help providers without expertise in head-and-neck cancers find the right specialists for their patients, she said.

Cancer physical therapy, while new, is becoming more standard. Both the American Physical Therapy Association and the Lymphology Association of North America allow providers or patients to search for specialized physical therapists near them — a boon to primary care providers who are not “connected to that world,” said Tomere.

Dietitians can play a key role, too, since many HNC patients struggle to eat. Treatments can cause dry mouth, taste changes or make chewing difficult. Food can become unappetizing or difficult to ingest.

“There’s an emotional component. Food becomes medicine,” said Linda Kasser, an SCCA dietitian and specialist in oncology nutrition. Patients must eat to keep their weight up, “but it can become exhausting … Sometimes they need to force themselves to eat. They feel pressured, which can contribute to family tensions and even food aversions.”

Dietitians can offer approaches to help patients maintain their weight and strength, from using new cooking strategies to make food more palatable to recommending temporary feeding tubes inserted into the stomach that help patients avoid the pain of chewing and swallowing altogether. They also help alleviate patients’ worries about food and separate “nutrition fallacy from fact,” said Kasser.

Not surprisingly, communication is strongly emphasized in the guidelines.

“We wanted to make sure that there is open communication between the providers and caregivers,” said Lyman. “That there’s a care plan that the patient understands and the caregiver understands. All the different specialists involved in the care should be on the same page.”

The new guidelines also emphasize lifestyle choices that will help to reduce the risk of HNC recurrence and secondary cancers: smoking cessation, limiting use of alcohol, regular exercise and good oral hygiene.

Exciting new research
Chemotherapy, radiation and surgery remain the standard of care for HNC — and drive many of the side effects covered by the new ACS care guidelines — but recent advances are making researchers like Méndez very optimistic for future care.

Thanks to advances in genomics, researchers now know that the mutations found in head and neck tumors vary widely.

“One size will not fit all,” said Méndez. “Treatment will have to be individualized.”

Méndez is leading efforts at Fred Hutch to develop tailored therapies based on the cancer’s genomic mutations, zeroing in on cancer cells’ “Achilles heels” — molecular pathways that tumor cells rely on to survive but that normal cells can do without. The approach is already paying dividends: Méndez is currently leading a clinical trial of a drug he and his team identified that exploits a vulnerability unique to head and neck tumors missing a key gene called p53.

“Once we understand the genotype driving tumor growth, strategies [for treatment] can become more targeted, more effective and less toxic,” he said.

New robotic-assisted surgery has also transformed the procedure for certain patients with tumors in the larynx and at the base of the tongue, allowing surgeons to perform fewer incisions and better preserve functions like swallowing and speech, he said.

Immunotherapy also looks like a very promising path to better HNC treatments.

“New immunotherapy drugs are getting FDA approval for head and neck cancer,” said Méndez. “I think in the next few years we will see it moving to a first-line therapy. It’s a very exciting time for head and neck cancer.”

For patients like Steelman and Giesel, that’s great news.

“I had a social worker who helped me get through the thick of [treatment], but nobody talked about what it would be like when treatment was over,” said Giesel, who had to teach herself how to swallow food a new way (she no longer has an epiglottis). “I thought I’d be returned to myself and I’d be fine, but it was not like that in any way.”

These new guidelines, she said, will help patients like her get the help they truly need.

“Primary care doctors need to know about the physical and emotional effects,” she said. ”I have a lot of good support and know how to ask for help, but I can’t imagine how [patients] who don’t know how to ask for help explain how they’re feeling.”

Do you or someone you love have a head-and-neck cancer? Join the conversation about treatment challenges and how the new guidelines might help on our Facebook page.

About the authors:
Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor and patient advocate, she writes the breast cancer blog doublewhammied.com and tweets @double_whammied. Reach her at dmapes@fredhutch.org.

Sabrina Richards is a staff writer at Fred Hutchinson Cancer Research Center. She has written about scientific research and the environment for The Scientist and OnEarth Magazine. She has a Ph.D. in immunology from the University of Washington, an M.A. in journalism and an advanced certificate from the Science, Health and Environmental Reporting Program at New York University. Reach her at srichar2@fredhutch.org.

Note:
1. Original article available at: http://www.fredhutch.org/en/news/center-news/2016/04/new-survivorship-guidelines-spotlight-head-and-neck-cancers.html

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Increased frequency of unknown primary SCC linked to HPV–positive disease

Mon, Apr 11, 2016

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Source: www.healio.com
Author: staff

The occurrence of HPV–positive unknown primary squamous cell carcinoma of the head and neck has significantly increased in recent years, according to the results of a retrospective study. HPV–positive unknown primary squamous cell carcinoma (UPSCC) appeared most prevalent among younger men.

UPSCC of the head and neck is comparatively rare, accounting for approximately 4% of squamous cell carcinomas. Trends, frequency and detection rates of UPSCCs have not been studied in the context of HPV tumor status.

Carole Fakhry, MD, MPH, associate professor of oncology and otolaryngology–head and neck surgery at Johns Hopkins School of Medicine, and colleagues conducted a retrospective study to observe the frequency of UPSCC over time, and to evaluate the proportion of UPSCCs that are HPV positive.

Researchers accessed a case series of 84 patients (mean age, 57.3 years; range, 29-80; 88.1% men) with UPSCC treated at Johns Hopkins Hospital between January 2005 and June 2014. They determined HPV tumor status through p16 immunohistochemical analysis or through high-risk HPV DNA in situ hybridization, when clinically available.

The researchers observed an increase in the frequency of UPSCC over time (P for trend = .01). The trend appeared significantly higher during the most recent calendar periods (14 cases during 2005-2008 vs. 39 cases during 2012-2014; P = .03).

A total of 90.7% of patients (n = 69) had HPV–positive tumors. These patients appeared more likely to be men (91% vs. 42.9%; P = .005) and younger (56.1 years vs. 67.7 years; P = .002) than patients with HPV–negative tumors.

The researchers detected the primary tumor site in over half the patients (59.3%), 95.7% of whom were HPV positive. All of the primary tumors were found in the oropharynx.

When researchers evaluated the trends in detection of the primary tumor over time, they observed an insignificant increase in the detection rate from 50% in 2005 to 2008 to 64.9% in 2012 to 2014.

The researchers then calculated the proportion of primary tumors identified before and after transoral robotic surgery (TORS) lingual tonsillectomy became available in 2011. Fewer primary tumor sites were identified prior to the availability of TORS (53.8% vs. 64.3%); however, this difference did not reach statistical significance.

“The findings of this study indicate an increasing frequency of UPSCCs and that most of these cases are HPV positive,” Fakhry and colleagues wrote. “It is likely that the increase in HPV–related tumors is driving the increase in UPSCC. HPV–positive UPSCCs differ from HPV–negative UPSCCs by clinicodemographic characteristics.” – by Cameron Kelsall

Reference:
Motz K, et al. JAMA Otolaryngol Head Neck Surg. 2016;doi:10.1001/jamaoto.2015.3228.

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Suicide: A Major Threat to Head and Neck Cancer Survivorship

Thu, Mar 24, 2016

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Source: www.jco.ascopubs.com
Authors: Nosayaba Osazuwa-Peters, Eric Adjei Boakye, and Ronald J. Walker
, Mark A. Varvares
 

TO THE EDITOR: The article by Ringash that was recently published in Journal of Clinical Oncology provided a compelling narrative of both the improvements made in head and neck cancer survivorship, as well as the challenges created by longer-term treatment and associated toxicities. There are currently at least 280,000 head and neck cancer survivors in the United States. As the article by Ringash stated, the upturn in head and neck cancer survivorship in the last three decades has coincided with the emergence of human papilloma virus-positive oropharyngeal cancer, as well as a decrease in tobacco use in the general population. These make it a challenge to isolate survival gains as a function of improved therapy from the natural prognostic value of a diagnosis of human papilloma virus-positive oropharyngeal cancer. Whatever the case, the fact that more than one-quarter million Americans are currently alive after a diagnosis of head and neck cancer means there needs to be a more deliberate effort in longer-term management of treatment-related toxicities, some of which are lifelong.

We agree with Ringash’s conclusion that new models of care need to be developed in response to the significant quality-of-life issues faced by patients with head and neck cancer. The Institute of Medicine publication From Cancer Patient to Cancer Survivor: Lost in Transition, also cited by Ringash, called for a clear individualized survivorship plan for cancer patients. There is a serious need for this model to be implemented universally in head and neck cancer management. Although we agree with Ringash that patients with head and neck cancer face competing mortality risks from second primary cancers and other noncancers, what we found lacking was recognition of an important competing cause of mortality in head and neck cancer survivors: suicide.

Suicide associated with head and neck cancer is not just a competing cause of death; it is also a quality-of-life issue. Many authors agree that head and neck cancer is among the top cancer sites associated with suicide. One national study of 1.3 million cancer patients even found that head and neck cancer carried the highest risk of suicide among cancer survivors. As a quality-of-life issue as well as a competing cause of death, the elevated risk of head and neck cancer-related suicide, although it peaks during the first few years after diagnosis, remains virtually throughout the course of the cancer survivor’s life. Additionally, some other well-known quality-of-life issues associated with head and neck cancer (eg, pain, disability, esthetic compromise and body image issues, psychosocial function, anxiety, emotional distress, and depression) are all associated with suicide. Therefore, it is difficult to have a discussion of quality-of-life interventions in head and neck cancer without addressing the issue of suicide.

Thus, we believe that suicide in patients with head and neck cancer should be addressed as a major threat to cancer survivorship. Cardiovascular disease, for example, is a known competing cause of death among patients with head and neck cancer, and is listed in Figure 4 of Ringash’s article. Cardiovascular disease may be managed for a long time; however, when a cancer patient decides that he/she is “better off dead,” a finality, or terminality, is invoked. This is quite unique to suicide compared with other competing causes of death.

Thus, in the urgent call for “new strategies and models of care to better address quality-of-life issues and meet the needs of survivors of head and neck cancer,” we believe it is pertinent that suicide is recognized as an important threat to head and neck cancer survivorship.

DOI: 10.1200/JCO.2015.65.4673; published online ahead of print at www.jco.org on January 19, 2016

To read or download the full article, please visit: http://jco.ascopubs.org/content/34/10/1151.full.pdf+html

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
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Nonsurgical surveillance safe, cost-effective for head, neck cancer

Thu, Mar 24, 2016

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Source: www.healio.com
Author: Mehanna H, et al.

Patients with head and neck cancer who underwent PET/CT–guided surveillance achieved similar survival outcomes as those who underwent planned neck dissections, according to the results of a prospective, randomized controlled trial. However, surveillance led to fewer surgical operations and complications and appeared more cost-effective than neck dissection, results showed.

Patients with head and neck cancer frequently undergo invasive surgery following treatment to remove remaining cancer cells, according to study background.

“After treatment, remaining cancer cells play something akin to hide and seek,” Hisham Mehanna, MBChB, PhD, FRCS, chair of head and neck surgery at University of Birmingham and director of the Institute of Head and Neck Studies and Education, said in a press release. “Our study shows that we can hunt them down, find them and remove them effectively.”

Mehanna and colleagues sought to define the role of image-guided surveillance compared with planned neck dissection for the management of patients with advanced, nodal head and neck squamous cell carcinoma previously treated with primary chemoradiotherapy. The analysis included data from 564 patients (mean age, 58 years; 82% men) who researchers randomly assigned to PET/CT–guided surveillance (n = 282) performed 12 weeks after the end of treatment or planned neck dissection (n = 282).

Oropharyngeal cancer served as the most common cancer subtype (84%). Seventy-five percent of patients had HPV-16–positive disease. Patients assigned surveillance only underwent neck dissection if their PET/CT scans showed incomplete or equivocal response to chemoradiotherapy.

The trial was designed to assess noninferiority of PET/CT–guided surveillance. OS served as a coprimary endpoint. Median follow-up was 36 months, with 92% of patients (n = 520) followed for at least 2 years. Ninety-six percent of patients assigned surveillance underwent PET/CT per protocol at 12 weeks. Fifty-four patients in the surveillance arm underwent neck dissections compared with 221 patients in the planned surgery arm. The surgical complication rate was similar in both cohorts (42% vs. 38%). Overall, 122 patients had died at the time of reporting (surveillance, n = 60; neck dissection, n = 62).

The rate of 2-year OS was 84.9% (95% CI, 80.7-89.1) in the surveillance arm compared with 81.5% (95% CI, 76.9-86.3) in the planned neck dissection arm. These data met the study’s noninferiority threshold (HR = 0.92; 95% CI, 0.65-1.32).

HPV–16 status did not have a significant effect on OS. Survival appeared comparable between the planned surgery and surveillance groups among patients with p16–positive (HR = 0.74; 95% CI, 0.4-1.37) and p16–negative tumors (HR = 0.98; 95% CI, 0.58-1.66). Both arms had similar rates of 2-year locoregional control (91.9% vs. 91.4%).

More patients assigned neck dissection experienced an adverse event (169 vs. 113). Patients in the surveillance arm had better quality of life scores at 6 months (P = .03); however, this difference became nonsignificant by 12 months. Surveillance appeared more cost-effective than neck dissection, with a per-person cost savings of $2,190.

“Patient outcomes, and avoiding unnecessary surgery, are the main goals of this study,” Mehanna said. “But there is a cost saving to be made, too. … Carry that [savings] across the tens of thousands of cases each year across the world and you see a significant saving that can be redistributed into other therapies.” – by Cameron Kelsall

Source:
N Engl J Med. 2016;doi:10.1056/NEJMoa1514493.

Disclosure:
The National Institute for Health Research Health Technology Assessment Program funded this study. Please see the full study for a list of the researchers’ relevant financial disclosures.

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ACS now has a guideline for care of head and neck cancer survivors

Thu, Mar 24, 2016

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Source: www.ajmc.com
Author: Surabhi Dangi-Garimella, PhD

With an increasing population of head and neck cancer survivors in the United States, the American Cancer Society identified the need to develop survivorship guidelines that can lend support to primary care clinicians and other health practitioners as they care for survivors.

With an increasing population of head and neck cancer (HNC) survivors in the United States, the American Cancer Society (ACS) identified the need to develop survivorship guidelines that can lend support to primary care clinicians and other health practitioners as they care for survivors. The guideline emphasizes monitoring for recurrence, screening for second primary cancers, assessment and management of long-term and late effects, health promotion, and care coordination.

According to ACS estimates, nearly 3% (436,060) of cancer survivors in the United States have survived a bout of HNC. With these numbers in mind, ACS convened an expert panel that included members with expertise in primary care, dentistry, surgical oncology, medical oncology, radiation oncology, clinical psychology, speech language pathology, physical medicine and rehabilitation, nursing, and a HNC survivor who provided a patient perspective. The panel reviewed existing guidelines and research evidence through April 2015, and created recommendations, which the committee has stressed “should be viewed as consensus-management strategies” to assist survivors. While 2081 articles were identified from a preliminary search, only 184 were finally included as evidence base.

Published online in CA: A Cancer Journal for Clinicians, the following are some of the key recommendations provided by the guideline for primary care physicians:

  1. Surveillance for HNC recurrence
    a. History and physical. Primary care clinicians should
    i. individualize clinical follow-up care provided to HNC survivors based on age, specific diagnosis, and treatment protocol as recommended by the treating oncology team
    ii. conduct a detailed cancer-related history and physical examination every 1-3 months for the first year after primary treatment, every 2-6 months in the second year, every 4-8 months in years 3-5, and annually after 5 years
    iii. confirm continued follow-up with otolaryngologist or HNC specialist for HN-focused examination
    b. Education. Primary care clinicians should educate survivors on signs of local recurrence and refer them to an HNC specialist is symptoms of recurrence are observed.
  2. Screening and detection of second primary cancers. HNC survivors should be screened similar to the general population for early detection of primary cancers, including lung cancer and another head and neck and esophageal cancer (as if at increased risk).
  3.  Physical and psychosocial support. Long term and late effects of HNC should be regularly assessed at each follow-up visit.
  4. Guideline recommends assessing for spinal accessory nerve palsy, cervical dystonia/muscle spasms/neuropathies, shoulder dysfunction, trismus, dysphagia, gastroesophageal reflux disease, and lymphedema
  5. Additional recommendations are for monitoring fatigue, altered of loss of taste, hearing loss, vertigo, vestibular neuropathy, sleep apnea, speech disturbance, hypothyroidism, oral and dental caries, periodontitis, xerostomia, osteonecrosis, and oral infections.
  6. Body and self-image. If HNC survivors have body or self-image concerns, they should be referred to psychosocial care.
  7. Distress or anxiety. Following regular assessment, primary care clinicians should either provide in-office counseling, provide pharmacotherapy, and/or refer HNC survivors to appropriate psycho-oncology and mental health resources or social workers per their need.
  8. Health promotion. These recommendations include educating HNC survivors on their treatment and its side effects, maintaining a healthy weight, encouraging physical activity, adequate nutrition, tobacco cessation, and the importance of personal and oral hygiene.
  9. Care coordination and practice implications. Clinicians should obtain the survivor’s treatment summary and survivorship care plan from the oncology team, maintain a continued dialogue with the oncology team, and should include caregivers, spouses, or partners in the process or care and support.

Reference
Cohen EE, LaMonte SJ, Erb NL, et al. American Cancer Society head and neck cancer survivorship care guideline. CA Cancer J Clin. 2016;66(1):43-73. doi:10.3322/caac.21343.

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