human papillomavirus

Nivolumab Demonstrated Survival Benefit, Good Tolerance in Refractory HNSCC

Source: www.asco.org
Author: Tim Donald, ELS
 

In the phase III comparative CheckMate 141 trial, nivolumab demonstrated a “significant improval in survival” in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), compared with therapy of the investigator’s choice, according to Robert L. Ferris, MD, PhD, FACS, of the University of Pittsburgh Cancer Institute (Abstract 6009). There were fewer treatment-related adverse events with the PD-1 inhibitor than with investigator’s choice therapy, Dr. Ferris said, and nivolumab stabilized patient-reported quality-of-life outcome measures, whereas the investigator’s choice therapy led to meaningful declines in function and worsening of symptoms.

AM16.6009-Ferris2Dr. Robert L. Ferris

“Nivolumab is a new standard-of-care option for patients with refractory or metastatic HNSCC after platinum-based therapy,” Dr. Ferris said.

Dr. Ferris presented the trial results at the “Harnessing the Immune System in Head and Neck Cancer: Evolving Standards in Metastatic Disease” Clinical Science Symposium on June 6. He noted that in this trial of patients whose disease had progressed after platinum-based therapy, nivolumab doubled the 1-year overall survival (OS) rate, with 36.0% OS for the immunotherapeutic drug compared with 16.6% for the investigator’s choice therapy. These top-line results were presented at the 2016 American Association of Cancer Research meeting1; Dr. Ferris presented data the additional endpoints of quality of life, correlative biomarkers, and safety.

There is an extremely poor prognosis for patients with platinum-refractory recurrent or metastatic HNSCC, with median OS of 6 months or fewer. Previous research, by Dr. Ferris and others, has shown that HNSCC can express T-cell suppressive ligands, such as PD-L1, thereby evading host immune response. PD-L1 is frequently expressed on HNSCC cells, both HPV-positive and -negative.

The phase III CheckMate 141 study enrolled patients with HNSCC aged 18 and older with ECOG status 0 or 1, and with disease progression within 6 months after the most recent dose of platinum-based therapy. Patients were enrolled regardless of PD-L1 status and irrespective of number of previous lines of therapy. Immunohistochemistry testing for p16 was performed to determine HPV status. Patients were randomly assigned 2:1 to nivolumab (3 mg/kg intravenous [IV] every 2 weeks) or investigator’s choice of single-agent therapy with methotrexate (40 mg/m² IV weekly), docetaxel (30 mg/m² IV weekly), or cetuximab (400 mg/m² IV once, then 250 mg/m² weekly).

OS was compared between arms and by PD-L1 expression and HPV (p16) status. Nivolumab demonstrated a survival benefit in the overall study population, regardless of PD-L1 expression or p16 status, Dr. Ferris said. The magnitude of the OS benefit of nivolumab was greater in patients expressing PD-L1 at 1% or more (HR 0.55, 95% CI [0.36, 0.83]) compared with those expressing PD-L1 at less than 1% (HR 0.89, 95% CI [0.54, 1.45]). However, increasing levels of PD-L1 expression ( ≥ 5%, ≥ 10%) did not result in further OS benefit.

The OS benefit was greater with nivolumab than investigator’s choice therapy in both patients who were p16 positive (HR 0.56, 95% CI [0.32, 0.99]) and p16 negative (HR 0.73, 95% CI [0.42, 1.25]). When OS was analyzed for both PD-L1 expression and p16 status, the hazard ratios favored nivolumab for all subgroups.

Treatment-related adverse events of any grade were lower in the nivolumab arm (58.9%) than the investigator’s choice therapy arm (77.5%). Serious (grade 3 or 4) treatment-related adverse events were also lower in the nivolumab arm (13.1%) than in the investigator’s choice therapy arm (35.1%). Patient-reported outcome measures for quality of life were assessed based on two EORTC scales. Treatment with nivolumab stabilized the outcome measures of physical function, social function, absence of sensory problems, and absence of trouble with social contact, whereas the investigator’s choice therapy led to meaningful declines in function and worsening of symptoms.

AM16.6009-Uppaluri_0Dr. Ravindra Uppaluri

Discussant Ravindra Uppaluri, MD, PhD, of Washington University School of Medicine, said that the CheckMate 141 trial “continues to highlight the use of PD-L1 status as a stratifier.” The trial results “offer hope for patients with refractory or metastatic HNSCC,” he said. “Obviously better biomarkers are needed, and, ultimately, a composite immune profile may be required.”

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

June, 2016|Oral Cancer News|

Heading back to the office following head and neck cancer

Source: blogs.biomedcentral.com
Author: Daniel Caley

In Cancers of the Head & Neck launching today publishes the first study looking at disability and employment outcomes in patients with head and neck cancer related to the human papillomavirus (HPV). Dr Shrujal Baxi, Section Editor for survivorship and patient related outcomes and author of this study, explains more about their work in this Q&A:

The rates of patients diagnosed with HPV-related head and neck cancer is rising annually. By 2020, there will be more cases of HPV-related head and neck cancer than HPV-related cervical cancer in the United States. Numerous studies have shown that most patients with this diagnosis are likely to be cured of their disease, placing an increased emphasis on quality of life and non-cancer outcomes in this population of survivors. The majority of patients diagnosed with HPV-related head and neck cancer are working-age adults and employment is a serious issue both financially and psychologically.

How can treatment for head and neck cancer impact employment?
Treatment for head and neck cancer often involves a combination of chemotherapy and radiation given over a six to seven week period, often known as concurrent chemoradiation or combined modality chemoradiation. This process is considered toxic and can impact a patient’s ability to function normally including speaking, chewing, breathing and swallowing. Many patients require numerous supportive medications to get through treatment including narcotics for pain and anti-nausea medications. Patients can lose on average 10-15% of their weight within a few months and can suffer from severe fatigue and post-treatment depression.

Who was in your study?
We included 102 participants with HPV-related head and neck cancer treated with chemoradiation at our institution who were employed full-time for pay at the time of diagnosis.

How did the treatment impact employment?
97% of patients had to change their employment responsibilities in some way from reducing work, taking a break and then returning at a later date, or stopping altogether and not returning. There were 73 patients that stopped but eventually returned to work after treatment, and they required a median of 14.5 weeks to return. This is longer than the 12 weeks currently allowed according to the Family Medical Leave Act (FMLA).

Eight patients stopped working altogether and never went back. Eight patients stopped working during treatment and never returned to work. Aside from younger age predicting extra time off before returning to work, we did not find a patient, treatment or disease factor that accounted for needing extra time off.

What happened to these patients?
The majority of patients who returned to work continued. At nearly two years from completion of treatment, 85% of the original 102 patients were working for pay. Overall, survivors were doing very well in terms of quality of life with the majority not having any major limitations secondary to their treatment.

There were a group of survivors who were dissatisfied with their ability to work. Some were working but not satisfied with their abilities, while others were looking for work. Compared to those who were satisfied with their abilities, those that were unsatisfied were more likely to have more functional problems and more head and neck specific late toxicities from their treatment.

What does this mean for patients and providers?
I think that this study provides some guidance for patients and providers as they prepare for chemoradiation to treat HPV-related head and neck cancer. It is hopeful that most patients will return to work, but realistic expectations of ability to work will help in treatment planning. Employment is another reason why managing late toxicities remains an important aspect of optimal care for head and neck cancer survivors.

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

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

April, 2016|Oral Cancer News|

Imaging, physical examination find most recurrences of HPV-positive oropharyngeal cancer

Source: www.oncologynurseadvisor.com
Author: Kathy Boltz, PhD

Posttreatment imaging at 3 months and physical examinations during the 6 months following treatment can detect most recurrences in patients treated with definitive radiation therapy for oropharyngeal cancer caused by human papillomavirus (HPV).1 This research was presented at the 2016 Multidisciplinary Head and Neck Cancer Symposium.

A dramatic increase in oropharyngeal squamous cell carcinoma (OPSCC) cases associated with HPV has been reported by the American Cancer Society. Survival rates after definitive radiation therapy have also increased. This has led to the need to determine general time to recurrence and the most effective modes of recurrence detection, to guide standards for optimal follow-up care by oncology teams.

This study examined 246 cases of HPV-positive or p16-positive non-metastatic OPSCC treated with definitive radiation therapy at a single, large-volume cancer center between 2006 and 2014.

Follow-up care included a PET/CT scan 3 months after completing treatment and physical examinations every 3 months in the first year following treatment, every 4 months in the second year and every 6 months in years 3 through 5. Median follow-up care length for all patients was 36 months. Patient outcomes, including recurrence and survival rates, were calculated using the Kaplan-Meier method from the end of radiation therapy.

Most recurrences were detected either by persistent disease appearing on 3-month post-treatment imaging or by patients presenting with symptoms at follow-up examinations.

Disease characteristics that increase the likelihood of recurrence include presenting with 5 or more nodes or having level 4 lymph nodes (P < .05). Distant metastases were a greater risk in patients with a lymph node larger than 6 cm or with bilateral lymphadenopathy (P < .05). “For most patients with HPV-associated oropharynx cancer, after a negative 3-month PET scan, physical exams with history and direct visualization are sufficient to find recurrences,” said Jessica M. Frakes, MD, an assistant member of the department of radiation oncology at the H. Lee Moffitt Cancer Center in Tampa, Florida, and lead author in the study. “Minimizing the number of unnecessary tests may alleviate the financial and emotional burden on these patients, including overall health care costs, time spent away from work and family, and the anxiety of waiting for scan results.” This study also supports the effectiveness of specialist teams in treating HPV-positive OPSCC with definitive radiotherapy (RT). Within 3 years, local control was achieved in 97.8% of all patients in the study; regional control in 95.3%; locoregional control in 94%; and freedom from distant metastases in 91.4%. The 3-year overall survival rate was 91%. “We were pleasantly surprised by the high cure rates and the low permanent side effect rates for these patients,” said Frakes. “These findings demonstrate that individuals with HPV-associated oropharyngeal cancer who are treated with definitive RT and cared for by multidisciplinary specialists have excellent outcomes.” Reference: 1. Frakes JM, Naghavi AO, Strom T, et al. Detection of recurrence in HPV associated oropharynx squamous cell carcinoma. Presented at 2016 Multidisciplinary Head and Neck Cancer Symposium; Scottsdale, AZ; February 18, 2016. Abstract 6.

March, 2016|Oral Cancer News|

NCCN Is ‘Vague,’ So Study Clarifies H&N Cancer Follow-up

Source: www.medscape.com
Author: Nick Mulcahy
 

Clinical guidelines can sometimes be slow to respond to epidemiology.

Take the case of oropharyngeal cancers that are associated with human papillomavirus (HPV) infection. They are increasingly common in the United States and, as several studies have demonstrated, have better survival than cancers of this type that are not HPV-positive.

Nonetheless, one of the beacons in oncology care, the National Comprehensive Cancer Network (NCCN), recommends the same follow-up care guidance for oropharynx squamous cell carcinoma whether it is associated with HPV or not, according to two experts.

For post-treatment follow-up, including recurrence detection, “the NCCN guidelines are one-size-fits-all,” said Jessica Frakes, MD, a radiation oncologist at the Moffitt Cancer Center and Research Institute in Tampa, Florida.

She spoke during a press briefing at the Multidisciplinary Head and Neck Cancer Symposium 2016 in Scottsdale, Arizona.

“You are exactly right: the NCCN is fairly vague about when to perform imaging,” said Christine Gourin, MD, an otolaryngologist at Johns Hopkins University in Baltimore, who moderated the press briefing.

Dr Frakes and her colleagues have stepped into this informational breach with a new study that might help clinicians gain clarity on the use of surveillance imaging in HPV-positive oropharyngeal cancer and reduce its frequency.

“The purpose of our study is to determine when these patients fail and when they have side effects so we know how to guide optimal follow-up,” Dr Frakes explained.

The study authors examined 246 cases of nonmetastatic HPV-positive oropharynx squamous cell carcinoma treated with radiation therapy at Moffitt from 2006 to 2014. Most patients (84.6%) received radiation therapy and a concurrent systemic therapy; a minority (15.4%) received radiation alone. Most patients had locally advanced disease.

The team’s major finding was that the great majority of recurrences and toxicities can be detected with imaging 3 months after treatment with definitive radiation therapy and physical exams during the 6 months after treatment.

Specifically, all six local failures were detected by sight or with flexible laryngoscopy conducted during physical exams in that 6-month period.

Eight of the nine regional recurrences (89%), 12 of the 13 locoregional failures (92%), and 15 of the 21 distant recurrences (71%) were detected from symptoms or with a PET/CT scan 3 months after treatment

“For most patients with HPV-associated oropharynx cancer, after a negative 3-month PET scan, physical exams with history and direct visualization are sufficient to find recurrences,” said Dr Frakes in a press statement.

The findings — and the suggestion that PET scans can be suspended after 3 months — are akin to what happens in clinical practice at Johns Hopkins, Dr Gourin reported.

“We have stopped routinely imaging patients after 3 months if a PET is negative, and it’s true that we do pick up more recurrences clinically than radiologically,” she said.

Cutting down on PET scans in this patient population is a good thing, suggested Dr Gourin. “I think we probably do too much post-treatment surveillance imaging,” she said.

There are multiple benefits to suspending imaging, including potentially lowering patient stress because they know their recurrence risk is low and don’t have anxiety related to test results.

Plus, there is a cost reduction.

“A PET scan costs $1500 [for the patient],” said Dr Frakes. Dr Gourin noted that the test is even more expensive in her geographic region.

Factors That Increase Recurrence Risk

The study authors also identified disease characteristics that increase the likelihood of recurrence.

Both regional and distant failures were more common in patients who presented with five or more positive lymph nodes or who had level IV lymph nodes (P < .05).

And the risk of developing distant metastases was greater in patients with a lymph node larger than 6 cm or with bilateral lymphadenopathy (P < .05).

But overall, the results are “excellent,” said Dr Frakes. Within 3 years, the rate of local control was 97.8%, of regional control was 95.3%, of locoregional control was 94.0%, and of freedom from distant metastases was 91.4%. The rate of 3-year overall survival was 91.0%.

Toxicities were also low, which is an endorsement of the multidisciplinary care, said Dr Frakes.

Only 9% of patients experienced severe late toxicities, including 19 grade 3 toxicities and two grade 4 toxicities. These were resolved in 16 of 21 toxicities (76%) at the time of last follow-up.

Most of the toxicities and/or recurrences (64%) occurred in the first 6 months after treatment; only four events occurred more than 2 years after treatment.

Dr Gourin questioned the low rate of serious late toxicities seen with this nonsurgical management of patients. Such a low rate “has not been our experience” at Johns Hopkins, she said.

Dr Frakes and Dr Gourin have disclosed no relevant financial relationships.

Multidisciplinary Head and Neck Cancer Symposium (MHNCS) 2016: Abstract 6. Presented February 19, 2016.

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

February, 2016|Oral Cancer News|

Oral cancer less likely in women who have more sex; but not the same for men

Source: www.parentherald.com
Author: Diane Ting

Having more sex partners reduces the chance of oral cancer for women. Unfortunately, men are more likely to become infected as the number of oral sex partners increases.

A study suggests that women who have more vaginal sex partners appear to have a lower risk of oral human papillomavirus (HPV) infections. The information was released during the annual conference of the American Association for the Advancement of Science. Throat and mouth cancer are linked to HPV, which is one of the most prevalent sexually transmitted diseases. HPV is rather common, as most people are treated of the virus within two years.

According to the study published by the Journal of the American Medical Association (JAMA), oral sex may increase the risk of head and neck cancer by 22 percent. In the last 20 years, the number of oral cancer patients has risen to 225 percent.

Oral cancer is typically linked to lifestyle causes such as heavy drinking and smoking, according to Mirror. Two in three sufferers of oral cancer were men, which made experts question the imbalance.

HPV is the same cancer that causes cervical cancer in women. Research states that because women are first exposed to HPV vaginally, they may develop an immune response that prevents them from getting the infection.

Unfortunately, research suggests that this may not be the same for men as they are found twice more likely to develop oral cancer. As the number of oral sex partners increase, the risk of oral HPV infections also increases. It is believed that oral sex may be the main cause at which the HPV ends up in the mouth. “Our research shows that once you become infected, men are less likely to clear this infection than women, further contributing for the cancer risk,” according to Gypsyamber D’Souza, a professor at Johns Hopkins University in Baltimore.

Oral sex can dramatically increase a person’s risk of the common human papillomavirus (HPV) by 22 times, which can eventually lead to cancer, according to a study. While HPV is very common and easily treatable, HPV may not go away in some cases particularly with men. In some rare instances, the virus can lead to cellular changes in the mouth and throat, which can lead to cancer.

Middle-aged white men are particularly at high risk compared to other races, according to Daily Mail. The US Centers for Diseases Control and Prevention (CDC) has highly recommended all pre-teenagers to take the HPV vaccination before they become sexually active.

February, 2016|Oral Cancer News|

HPV vaccination rates are low, especially in Kansas and Missouri, and cancer experts are alarmed

Source: www.kansascity.com
Author: Lisa Gutierrez
HPV (2)The HPV vaccine is recommended for girls and boys starting at ages 11 to 12. But in state-by-state comparisons, children in Kansas and Missouri rank at or near the bottom of the list. John Amis The Associated Press

 

The University of Kansas Cancer Center recently joined nearly 70 other cancer centers across the country to sound an alarm about the HPV vaccine.

Many children still are not getting the recommended vaccine for human papillomavirus, which causes head and neck cancer in men and women, cervical cancer in women and a host of other cancers in both.

In Kansas and Missouri, less than 49 percent of girls have received the vaccine, according to the Centers for Disease Control and Prevention. Kansas ranks dead last in the nation, and Missouri is near the bottom. Both states rank low for the number of boys who are vaccinated too.

The public call from KU’s cancer center was blunt: The vaccine prevents cancer. What’s the problem?

“It absolutely breaks my heart,” said Terry Tsue, physician-in-chief at the University of Kansas Cancer Center. “We have two vaccines against cancers that are caused by virus, the hepatitis A vaccine and the HPV vaccine. Otherwise, we don’t have a vaccine that prevents cancer.

“There are thousands and thousands of people dying annually from this disease that could have been prevented had we had this vaccine 30 years ago. We didn’t have it and were so slow in adopting it that for the next 30 years we’re going to lose the same number of people, and more, because it’s spreading.”

The nation’s cancer centers banding together to issue a collective statement was a rare move for those involved in cancer research and prevention.

The low HPV vaccination numbers represent a public health threat, said cancer center officials, who asked health care providers and parents to take advantage of the vaccine.

Considering President Barack Obama’s new “moonshot” efforts to cure cancer, “this is one example of actions that can be taken today to make a very big difference in the future cancer burden,” said a statement from Ernest Hawk, vice president and division head of cancer prevention and population sciences at the University of Texas MD Anderson Cancer Center.

Tsue is stunned by what people don’t know about HPV. For instance, about 70 percent of parents apparently don’t know that the vaccine is recommended for boys as well as girls.

The vaccine not only prevents “female” cancers — cervical, vaginal, vulvar — but it also prevents cancer in the throat, known as oropharyngeal cancers. And three times as many men as women get throat cancer from HPV, says Tsue.

Twenty percent of patients with HPV-related throat cancers die within five years.

“Our practitioners aren’t aware of the magnitude and this kind of tsunami of cases,” said Tsue, a head and neck surgeon. “Throat cancer related to HPV is growing up to 5 percent a year. No other cancer is growing like that. And it will surpass cervical cancer caused by HPV by 2020.”

According to the CDC, HPV infections are responsible for about 27,000 new cancer diagnoses each year in the U.S.

So the CDC recommends that all boys and girls get a three-dose round of HPV vaccine shots at the ages of 11 or 12. The vaccine can be up to 93 percent effective when it’s given at that optimal time, CDC officials say.

But vaccination rates are low. The U.S. Department of Health and Human Services set a goal to have 80 percent of American girls ages 13 to 15 fully vaccinated by the year 2020. But four out of 10 girls remain unvaccinated, according to CDC statistics, and fewer than six out of 10 boys have been vaccinated.

Tsue says that health professionals are battling a lot of misinformation and misconception among the public. Surveys of parents, for instance, show that many mistakenly think HPV has something to do with HIV.

Tsue thinks another issue is that parents equate the vaccine with sex because the virus is most commonly sexually transmitted, though it can sometimes be transmitted without sexual contact.

Parents tells survey takers that their children don’t need the vaccine because their kids aren’t having sex.

However, most men and women in the United States will be infected with at least one type of HPV at some time in their lives.

“Eighty percent of adults get HPV in their lives — 80,” said Tsue. “So this isn’t for the hooker on the corner of the red light district. This is 80 percent of the U.S. population will have HPV sometime in their life.”

Tsue thinks that some parents also believe that having their children vaccinated will somehow give them free rein to have sex or will promote promiscuity, though studies have shown that getting the vaccine doesn’t make kids more likely to have sex at a younger age.

“So your 10-year-old who has no idea what the shot they’re getting is will subsequently go out and have sex the next week because they got a shot that prevents the HPV virus?” said Tsue. “That’s (what) we’re dealing with.”

Though the vaccine is not known to cause serious or long-term side effects, questions about its safety linger for some parents, particularly those who have sworn off childhood vaccines. Five years ago, then-congresswoman Michele Bachmann of Minnesota charged during a presidential debate that the vaccine was “very dangerous” and caused “mental retardation.”

A study published in Pediatrics in 2013 showed that among the most frequent reasons parents gave for not having their children vaccinated was fear of the vaccine’s safety.

The website VacTruth.com — run by a father who says his son was harmed by childhood vaccinations — published a story last month charging that reports of serious side effects and deaths linked to HPV vaccines are being kept secret from the public.

Thousands of young girls, the story claims, “have fallen seriously ill, have had their health completely ruined after these vaccines and many have died.”

It cited records from the website Judicial Watch, which describes itself as “a conservative, nonpartisan educational foundation,” claiming that one of the HPV vaccines, Gardasil, is linked to “thousands of serious adverse reactions and debilitating side effects, including seizures, blindness, paralysis and dozens of deaths.”

Judicial Watch, which has been investigating the vaccine for the last few years, has dubbed the HPV vaccine “a large-scale public health experiment.”

The medical community considers the vaccine one of the safest around.

“All this bad press about vaccines, how it kills people, how it causes autism, all false,” said Tsue.

Tsue talks to small groups of health care professionals about HPV-related cancers on his quest to promote the vaccine. He believes that more pediatricians and family practitioners should start talking to parents about it too.

“We need to help providers to make a strong cancer prevention recommendation for vaccinating 11- and 12-year-old boys and girls with the HPV vaccine,” Anna Giuliano, director of the Center for Infection Research in Cancer at Moffitt Cancer Center in Tampa, Fla., told NPR earlier this month.

“If all the pediatricians and family practice doctors were making that strong recommendation, I think we would see a strong increase in the rate of uptake in that vaccine.”

Tsue and other cancer experts would like to see the HPV vaccine added to the lineup of regularly scheduled vaccines schoolchildren already receive: tetanus, diphtheria, whooping cough and meningitis, among them.

Tsue supports mandatory vaccination too — neither Kansas nor Missouri mandates the vaccine — but that’s been a hard sell already.

In 2011, Gov. Rick Perry of Texas had to reverse his decision to make the vaccine mandatory when conservative parents in his state revolted.

The Rhode Island General Assembly faced the same objections last year after it required the vaccine for all seventh-graders. The Rhode Island Center for Freedom & Prosperity held a rally protesting the mandate on the vaccine with parents who said their children got sick from it.

Parents also argue that they should be allowed to make the vaccination decision themselves, a point that the American Civil Liberties Union supports Rhode Island parents on.

Meanwhile, public health officials in Massachusetts itching to do something to raise the rate of HPV vaccinations there are watching Rhode Island’s success with the mandate, according to The Boston Globe.

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

February, 2016|Oral Cancer News|

New research opens door to understanding human tonsil cancer



Source: medicalxpress.com
Author: staff

Researchers at Simon Fraser University and the BC Cancer Agency have developed a groundbreaking method to identify and separate stem cells that reside in the tonsils. Their research, which sheds new light on the fight against oral cancer, is published today in the journal Stem Cell Reports.

While stem cells in many other body tissues have been well studied, little is known about these stem cells, says researcher Catherine Kang, a PhD student in the Department of Biomedical Physiology and Kinesiology and lead author of the paper. Ninety per cent of human tonsil cancers show evidence of HPV (human papillomavirus) infection. But little is known about its role in causing these cancers. Researchers suspect it is a key player, as HPV is the major risk factor for cervical cancer.

Kang, who is working with BPK professor Miriam Rosin, director of the BC Oral Cancer Prevention Program, and UBC professor Connie Eaves of the Terry Fox Laboratory, was interested in finding out why the tonsil is particularly susceptible to HPV and wondered if it might have something to do with the stem cells of the tissue that coats the tonsils.

When she purified these cells and made them incorporate a cancer-causing gene normally transmitted by HPV, the cells grew abnormally in a special tissue culture system, and created what one might imagine what the beginning stages of human tonsil cancer would look like.

“This is a very exciting finding, as it is the first stage of human cancer development that researchers need to learn how to detect and eliminate,” says Kang. The study shows how it can now be done and then studied at will in a petri dish using cells isolated directly from human tonsils.

Cancer of oropharynx, or the tonsils in particular, is an important health concern with rising incidence worldwide, especially in men. The researchers, including Dr. Raj Kannan of the BC Cancer Agency’s Terry Fox Laboratory, say this new method will now allow these next steps to go forward not just here, but around the world, to stop this global trend in its tracks.

November, 2015|Oral Cancer News|

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

Source: www.medpagetoday.com
Author: Charles Bankhead
 

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

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

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

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

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

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

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

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

Background

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

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

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

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

Key Findings

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

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

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

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

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

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

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

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

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

October, 2015|Oral Cancer News|

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

Source: www.theage.com.au
Author: Julia Medew

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

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

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

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

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

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

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

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

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

October, 2015|Oral Cancer News|