head and neck cancer

Immunotherapy extends the life of head and neck cancer patients

Source: Pharmatimes.com
Date: 12/3/18
Author: Anna Smith

A new immunotherapy can greatly extend the lives of a proportion of people with advanced head and neck cancer, with some living for three years or more, reports a major new clinical trial.

The study, by The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, found that the drug – MSD’s Keytruda (pembrolizumab) – has been shown to have significant benefits for patients, with 37% of those who received it surviving for a year or more, compared with only 26.5% of those on standard care.

The drug was evaluated in a trial of nearly 500 patients with very advanced head and neck cancer that had spread around the body and already become resistant to platinum chemotherapy, the first-line treatment for the disease.

Some 247 patients were randomised to receive Keytruda and 248 to standard of care – chemotherapy or the targeted agent Erbitux (cetuximab).

When chemotherapy or targeted therapies stop working, treatment options for people with advanced head and neck cancer are limited, and they are normally expected to survive for less than six months.

Patients in the Keytruda arm survived for a median of 8.4 months, compared to 6.9 months with standard treatment. However, a minority of patients responded extremely well to Keytruda – 36 patients saw their cancer partially or completely disappear, and some are still cancer free three years after first receiving the drug.

“Our findings show that the immunotherapy pembrolizumab extends the life of people with advanced head and neck cancer overall, and in a group of patients has really dramatic benefits. It is also a much kinder treatment than those currently approved,” said Professor Kevin Harrington, professor of Biological Cancer Therapies at The Institute of Cancer Research, London, and consultant at The Royal Marsden NHS Foundation Trust.

“I would like to see pembrolizumab approved for use in the clinic, so that people with advanced head and neck cancer can be offered the chance of a longer life and improved quality of life.

“There is also an urgent need to work out how we can identify in advance which patients are likely to benefit, given that some of these people may do much better than they do on standard treatment.”

The trial was sponsored and funded by MSD, and the results are published in The Lancet.

December, 2018|Oral Cancer News|

Study: Immunotherapy better than chemotherapy for subtype of head and neck cancer

Date: November 30th, 2018
Source: Scienmag

A randomized clinical trial involving 97 medical centers in 20 countries, including Moores Cancer Center at UC San Diego Health, found that treating patients who have chemotherapy-resistant head and neck cancer with the immunotherapy drug pembrolizumab is more effective and less toxic than standard chemotherapy, reports an international team of researchers in the November 30 online issue of The Lancet.

Previous research had shown that pembrolizumab (Keytruda) was safe and effective for treating patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease had progressed while on or after receiving standard chemotherapy. Data from this clinical trial called KEYNOTE-040, a phase III study sponsored by Merck & Co., the manufacturer of the drug, takes the research a step further by comparing the immunotherapy drug head-to-head to three go-to chemotherapy drugs currently used as standard treatment: methotrexate, docetaxel and cetuximab.

“We compared pembrolizumab against standard of care to see if it fulfilled the promise of early data for patients who are unlikely to do well on standard therapy,” said Ezra Cohen, MD, professor of medicine at University of California San Diego School of Medicine and corresponding author on the study.

“In this trial, patients who received pembrolizumab alone had a higher response rate compared to those receiving standard chemotherapy while those responses lasted, on average, one-and-a-half years. Furthermore, the median survival at one year was markedly better. I feel it is safe to say that these types of therapies should be the new standard therapy for people with cancer that recurs and is resistant to therapy.”

Pembrolizumab is an antibody that inhibits the abnormal interaction between the molecule PD-1 on immune cells and the molecule PD-L1 on tumor cells, allowing the immune cells to activate and attack tumors. Similar results were recently published for another anti-PD-1 drug, nivolumab (Opdivo). Both drugs should be considered by treating physicians for patients with this disease, said Cohen.

The study also pointed to potential biomarkers that can guide oncologists to determine which patients are most likely to respond to these anti-PD-1 drugs.

“It’s fairly clear that patients whose tumors express PD-L1 are most likely to benefit from this type of immunotherapy drug,” said Cohen, associate director for translational science at Moores Cancer Center and an internationally recognized physician-scientist who specializes in novel cancer therapies. “In this trial, overall survival was driven by PD-L1 expression. Only patients whose tumors expressed PD-L1 had a response to pembrolizumab and those responses tended to be durable.”

Over a 17-month period, 247 patients were randomized to receive pembrolizumab and 248 patients were randomly selected by their physicians to receive one of the three standard therapies. The median overall survival for patients receiving immunotherapy was 8.4 months and 6.9 months for patients treated with standard care. Patients received treatment until their cancer progressed, they developed unacceptable toxicity, they withdrew or their physician removed them.

The median duration of response was 18.4 months in the pembrolizumab group, compared with five months in the standard therapy group.

Twelve months after initiating the trial, 37 percent of patients receiving pembrolizumab were alive compared to 26.5 percent of patients on standard therapy.

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Co-authors include: Denis Soulières, Centre Hospitalier de l’Université de Montréal; Christophe Le Tourneau, Institut Curie, INSERM U900 Research Unit, Versailles-Saint-Quentinen-Yvelines University; José Dinis, Instituto Português de Oncologia do Porto Francisco Gentil; Lisa Licitra, Fondazione IRCCS Istituto Nazionale dei Tumori; Myung-Ju Ahn, Samsung Medical Centre; Ainara Soria, Hospital Universitario Ramón y Cajal; Jean-Pascal Machiels, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain; Nicolas Mach, Hôpitaux Universitaires de Genève; Ranee Mehra, Fox Chase Cancer Center; Barbara Burtness, Yale University School of Medicine and Yale Cancer Center; Pingye Zhang, Jonathan Cheng, Ramona F Swaby, Merck & Co; and Kevin J Harrington, The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, National Institute of Health Research Biomedical Research Centre.

This research was funded by Merck Sharp & Dohme, a subsidiary of Merck & Co. The funder contributed to study design, data collection, data analysis, data interpretation, and the writing of The Lancet paper. The funder maintained the study database. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Disclosure: Cohen reports grant support to the institution from Merck Sharp & Dohme for clinical research related to the submitted work and serving an advisory role for AstraZeneca, Bristol-Myers Squibb, Eisai, Merck, Human Longevity and Pfizer, all outside the submitted work.

December, 2018|Oral Cancer News|

Penn-led study raises hopes for vaccine to treat head and neck cancer

Date: 09/21/18
Source: The Inquire, philly.com
Author: Marie McCullough

The patient’s head and neck cancer came roaring back, spreading to his lymph nodes and skin, which developed bleeding tumors. Yet despite a grim prognosis, that man is alive and cancer-free more than two years later.

In a study led by the University of Pennsylvania and published Friday, researchers hypothesize that his remarkable remission is due to a promising combination: an experimental cancer vaccine that activated his disease-fighting T cells, plus Opdivo, one of the revolutionary “checkpoint inhibitor” drugs that cut a brake on the immune system.

“Of course, I’m biased,” said Charu Aggarwal, the Penn oncologist who led the study. “In my career, I haven’t seen a vaccine as impactful as this.”

However, the remission may have been due to Opdivo alone; the study lacks data to rule out that possibility.

Robert Ferris, director of the University of Pittsburgh Medical Center’s Hillman Cancer Center and head of the pivotal study leading to approval of Opdivo, called the Penn-led study “an important intermediate step exploring a strategy that we hope will work.”

Conventional vaccines prevent diseases by priming the immune system to recognize the distinctive “antigens” on invading microbes. Therapeutic cancer vaccines, like the one in this study, are intended to work after cancer develops by provoking a heightened immune response.

Despite decades of research, this approach remains experimental. The only approved product, the prostate cancer vaccine Provenge, was barely effective; the maker filed for bankruptcy in 2015.

A major obstacle to treatment vaccines is the fact that cancer arises from the body’s own cells. Although cancer cells produce antigens as they mutate, using these telltale proteins as targets for the immune system has proved to be very difficult.

Even so, at least four pharmaceutical groups are developing therapeutic vaccines that target human papillomavirus, HPV, the sexually transmitted virus that causes cervical cancer, head and neck cancer, and some rare genital cancers.

These diseases can be warded off with the preventive HPV vaccine that is recommended for all adolescents, but it didn’t exist until 12 years ago. Much to the dismay of public health authorities, vaccination rates remain low. And while screening can detect and treat cervical precancers, there are no early detection methods for head and neck cancers; experts call the surging incidence of these malignancies an “epidemic.”

The vaccine in the new study, called MEDI0457, was originally developed by Inovio with technology pioneered at Penn. In 2015, MedImmune, which is part of AstraZeneca, acquired exclusive rights to the drug.

MEDI0457 contains a DNA ring called a plasmid that programs the patient’s cells to produce two HPV antigens. The vaccine is injected into the patient’s muscle and enters cells with the help of a small electrical pulse applied to the skin. When the cells make the antigens, this triggers the immune system to activate disease-fighting white blood cells, so-called “killer” T cells.

For the study, published Friday in Clinical Cancer Research, 22 patients with head and neck cancer received conventional treatment — either surgery or chemotherapy and radiation — that eliminated all signs of cancer. This was supplemented by four doses of the experimental vaccine, which caused no serious side effects.

Eighteen patients, or 80 percent, showed elevated T cell activity that lasted at least three months after the final vaccine dose. While that is an encouraging sign, the study was too preliminary to detect clinical effectiveness such as tumor shrinkage or improved survival.

In the one patient who relapsed, cancer recurred seven months after vaccine treatment and spread to his lymph nodes and skin. He was given Opdivo and, eight weeks later, the cancer was gone.

Aggarwal and her co-authors note that such remarkable remissions do occasionally occur with checkpoint inhibitors. But they speculate that the vaccine revved up the patient’s T cells, then Opdivo removed the immune brake, enabling the T cells to attack the cancer.

“The response suggests the vaccine may in some manner prime the immune system, potentially boosting the effects of subsequent [checkpoint inhibitor] therapy,” Aggarwal said.

Rajarsi Mandal, director of the head and neck cancer immunotherapy research program at Johns Hopkins University, took a more conservative view: “They demonstrated vaccine specific T cell proliferation very nicely. But there is not a lot of data to suggest the vaccine is inducing any clinical response in these patients. Overall, it’s very interesting, but future studies are needed to demonstrate definitive clinical responses to the vaccine.”

Still, the combination approach is sufficiently promising that MedImmune is now funding a Penn-led clinical trial of MEDI0457 and MedImmune’s own experimental checkpoint inhibitor.

Ferris, meanwhile, said he is part of a trial of a competing experimental vaccine for HPV-related cancers, plus the approved checkpoint inhibitor Keytruda.

“The preventive HPV vaccine works really well,” he said. “But if you’re too old to get it, there is hope that you can stimulate the immune system to fight the cancer. This [new study] suggests the next logical step.”

September, 2018|Oral Cancer News|

Recommendation Against Routine Thyroid Cancer Screening Retained

Author: Shreeya Nanda
Date: 05/23/2017
Source: https://www.medwirenews.com

The decision is based on a systematic review of 67 studies, also reported in JAMA, evaluating various aspects of screening, such as the benefits and harms of screening asymptomatic individuals and of treating screen-detected cancers, as well as the diagnostic accuracy of screening modalities.

Although there were no trials directly comparing the benefits of early versus late or delayed treatment, two separate observational studies compared the outcome of treatment versus no surgery or surveillance. However, as neither study accounted for confounding variables, robust conclusions could not be drawn, say Jennifer Lin, from Kaiser Permanente Center for Health Research in Portland, Oregon, USA, and colleagues.

By contrast, they identified 52 studies, including 335,091 patients, that provided information on the harms of treating screen-detected thyroid cancers. A meta-analysis of the data showed that the incidence of permanent hypoparathyroidism varied between 2% and 6%, while the rate of permanent vocal cord paralysis ranged from around 1% to 2%.

Among patients who received radioactive iodine therapy, the excess absolute risk for secondary cancers ranged from 11.9 to 13.3 per 10,000 person–years. And the incidence of dry mouth ranged widely, from approximately 2% to 35%.

The USPSTF commissioned the systematic review due to the rising incidence of thyroid cancers against a background of stable mortality, which is suggestive of overdiagnosis. And in view of the results, the task force concluded with “moderate certainty” that the harms outweigh the benefits of screening, upholding the “D” recommendation.

The USPSTF emphasizes, however, that this recommendation pertains only to the general asymptomatic adult population, and not to individuals who present with throat symptoms, lumps or swelling, or those at high risk for thyroid cancer.

Editorialists Louise Davies (Department of Veterans Affairs Medical Center, White River Junction, Vermont, USA) and Luc Morris (Memorial Sloan Kettering Cancer Center, New York, USA) welcome the decision, noting that “[e]pidemiologic data from around the world demonstrate that finding more cases of cancer, as has occurred over the past approximately 15 years, has not made death from the disease less likely.”

They write in JAMA Otolaryngology–Head & Neck Surgery: “While suggestions to ‘check your neck’ are well intentioned, the USPSTF recommendation indicates that these practices should not be encouraged or endorsed.”

Other commentators are more circumspect. Julie Ann Sosa (Duke University Medical Center, Durham, North Carolina, USA) and co-authors point out in JAMA Surgery that both the incidence and mortality rates of advanced-stage papillary thyroid cancer have risen over the years, as has the overall thyroid cancer incidence-based mortality.

These findings “[challenge] the prevailing hypothesis that overdiagnosis is the sole culprit for the changing epidemiology,” they write.

Sosa and colleagues continue: “If the explanation for the rise in thyroid cancer is, indeed, not just overdiagnosis, and if mortality from thyroid cancer is also increasing, then enthusiasm for this (non)screening recommendation should be more muted.”

Writing in an accompanying piece in JAMA, Anne Cappola (University of Pennsylvania, Philadelphia, USA) notes that “[t]he rationale for the recommendation against screening is compelling,” but she does not want the conversation about screening to stop.

Like Sosa et al, Cappola does not think that over diagnosis explains all and she believes that “additional research into possible environmental etiologies is needed, particularly to inform prevention efforts.”

May, 2017|Oral Cancer News|

Immunotherapies Form New Frontier in Treating Head and Neck Cancers

Source: OncLive.com

Date: January 2nd, 2017

In August 2016, the FDA approved pembrolizumab (Keytruda) for patients with platinum-refractory squamous cell carcinoma of the head and neck (SCCHN).1 Not only was it the first immunotherapy approved for head and neck cancer (HNC), but it marked the first new drug approval for HNC in the United States in 20 years.

“Now we have an agent that really changes the paradigm—a new class of treatment—and we are seeing amazing benefit in some patients,” said Tanguy Seiwert, MD, during an OncLive Peer Exchange® panel held during the 2016 European Society for Medical Oncology (ESMO) Annual Meeting.

Less than a month later, the menu of immunotherapy options expanded as the FDA approved nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy.

During the Peer Exchange, the panelists provided an overview of the immunotherapy terrain in HNC, a discussion that was filled with considerable hope and excitement. “When we try immunotherapies in the second-line setting, we see objective responses—sometimes deep, clinically meaningful, extremely durable responses—and we’re beginning to think that maybe, on some occasions, we may be able to cure patients with relapsed metastatic head and neck cancer,” said Kevin Harrington, MD, PhD. This is especially remarkable since such patients have generally had a survival of ≤1 year.

The panelists concurred that the care of patients with HNC will evolve significantly over the next 5 to 10 years, as the tip of the immunotherapy iceberg is just starting to be scratched. During the Peer Exchange, they provided a rationale for using immunotherapies in HNC, including human papillomavirus (HPV)-positive and HPV-negative disease; outlined key immunotherapy studies; and offered their thoughts on the future of immunotherapies in HNC, including use of biomarkers to guide therapy and the opportunity to improve response by using combination treatments.

“Next-generation sequencing efforts are beginning to shed light on the hidden complexities of these tumors, leading to the identification of multiple molecular subtypes,” said Ezra Cohen, MD, who served as moderator for the session. “As key differences between tumors, with and without HPV infection, are beginning to emerge, the challenge is to find ways to use this information to personalize treatment for individual patients.”

Rationale for Immunotherapy in HNC

In patients with locally advanced HNC, HPV status has generally determined outcomes, with HPV-positive patients having a good prognosis and higher likelihood of cure, and HPV-negative patients having a poorer prognosis and a lower likelihood of cure.

However, outcomes with conventional therapy in recurrent metastatic disease have been poor across the board, especially in the setting of platinum- refractory disease, indicating a tremendous unmet need. Before pembrolizumab was approved in this setting, the recommendation was to use a taxane, such as methotrexate or cetuximab (Erbitux), as a single agent, but the outcomes have been unsatisfactory. In contrast, immunotherapy studies have shown promising results in these patients, with HPV-negative patients also benefiting.

“The rationale for [using immunotherapies] for HPV-positive tumors may be the virus, as well as mutations, and for HPV-negative tumors, it’s likely the mutation load,” said Seiwert. He explained that HPV-negative tumors are often smoking-associated tumors and, therefore, have high mutation loads, a factor that has been associated with good response to immunotherapy, whereas HPV-positive tumors resemble melanoma, with significant inflammation, another factor associated with good response.

Although efficacy was found to be the same for HPV-positive and HPV-negative tumors in KEYNOTE-012, which was the study that led to pembrolizumab’s approval for HNC, some CheckMate-141 subanalyses suggest there might be slightly more activity in HPV-positive patients, noted Seiwert.

Despite such findings, he said, “HPV status should not actually dissuade us one way or the other from using immunotherapy—it’s clearly active in both HPV-negative and HPV-positive tumors.” And, as Harrington pointed out earlier in the discussion, since nothing else works well in the second-line setting, “why not try it?”

Key Pembrolizumab Studies

The panelists proceeded to provide an overview of several instrumental pembrolizumab studies, including the KEYNOTE-012 expansion study and KEYNOTE-055 studies, and of the phase III CheckMate-141 study, which paved the way for nivolumab’s approval.2-4 They also discussed a subanalysis of CheckMate-141 presented at ESMO that demonstrated good patient-reported outcomes following nivolumab therapy, lending further support to its use in SCCHN.5

KEYNOTE-012 Expansion Study

The phase Ib KEYNOTE-012 expansion study administered 200 mg of pembrolizumab intravenously once every 3 weeks to 132 patients with recurrent or metastatic SCCHN, irrespective of their programmed death-ligand 1 (PD-L1) or HPV status.2 Primary endpoints included overall response rate (ORR), and safety and secondary endpoints included progression-free survival (PFS), overall survival (OS), and PD-L1 expression’s impact on response.

Pembrolizumab was well tolerated, and yielded a clinically meaningful ORR with evidence of durable responses; median duration of response was not reached. The ORR was 18% by central imaging vendor review and 20% by investigator analysis. A statistically significant increase in ORR was observed for PD-L1–positive versus PD- L1–negative patients (22% vs 4%, respectively; P = .021).

At 6 months, PFS and OS rates were 23% and 59%, respectively. “And we have patients living far beyond what we usually expect for metastatic disease…we now have patients who have completed 2 years of treatment in a setting with a median life expectancy of about 6 months,” revealed Seiwert, who is involved with the study.

Pembrolizumab was also well tolerated. Grade ≥3 events occurred in 9% of patients. “[This is] within the range of toxicities that we have seen in other studies,” said Viktor Grünwald, MD. “Because we’re approaching a very sick and morbid patient population, we might expect different toxicity outcomes, so I think it’s very reassuring that we’re seeing the same amount of toxicity as in other studies,” he explained.

While checkpoint inhibitors are generally well tolerated and have favorable toxicity profiles, the panelists warned that severe side effects can occur and careful patient monitoring is required. A key concern they discussed is pneumonitis.

“Although it only occurs in about 1% to 2% of patients, you must screen for it because it’s life threatening,” said Seiwert. “If somebody says, ‘I am short of breath’ or ‘I have a little bit of a cough,’ I scan them right away to look for it,” he said, explaining that immediate treatment with high-dose steroids is warranted.

KEYNOTE-055 Preliminary Results

KEYNOTE-055 enrolled 172 patients with recurrent or metastatic SCCHN to receive pembrolizumab 200 mg every 3 weeks after progression on platinum plus cetuximab. The preliminary analysis, which reported on 92 evaluable patients, was initially presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.3 Primary endpoints include ORR and safety.

As with KEYNOTE-012, pembrolizumab was found to be well tolerated and to have significant antitumor activity, with 17% to 18% response rates. Evaluation of the full study cohort will include analyses of HPV status and response by anatomic site. “I think that’s the story we’re seeing for pembrolizumab in head and neck cancer—patients are already being treated in single-arm clinical studies, which is somewhat unusual, but reflects the speed of knowledge that we’re gaining that is leading to approvals,” said Grünwald.

Nivolumab also had a lower incidence of treatment-related adverse events (TRAEs) than IC. Any grade TRAEs occurred in 59.3% and 77.5% of patients on nivolumab or IC, respectively. Grade 3/4 TRAEs occurred in 13.6% and 35.1% of patients, respectively, indicating the treatment is well tolerated, which also translated to improvements in quality of life in the patient-reported outcomes study.5

“A very detailed analysis of patient-reported outcomes using 3 well-validated questionnaires showed nivolumab was able to maintain good patient-re- ported outcomes in terms of their quality of life, their functioning, and their symptom scores, whereas IC showed serious detriment in those scores,” said Harrington.

In the study,5 patients treated with nivolumab had delayed worsening of functioning and symptoms compared with IC at approximately 4 months of follow-up, with patients receiving nivolumab reporting longer maintenance of function and less pain, fatigue, and dyspnea on treatment, as compared with those receiving IC.

“So not only do we have clear evidence that these drugs can work in terms of improving survival and delivering meaningful responses, but they do so with fewer episodes of treatment-related toxicity and disease-associated morbidity,” said Harrington.

Future of Immunotherapy in HNC

The panelists noted that use of biomarkers and combination therapies are key areas of future development for HNC. Both areas are already being examined in clinical trials and have relevance across the vast HNC spectrum, from those with minimal disease to those with previously treated advanced disease, potentially offering a curative pathway to more patients.

“It’s fantastic to have drugs that work in second-line relapsed metastatic or first-line metastatic setting, but what I want and what patients want is to be cured at the time they first present with their disease so they never have treatment in relapsed metastatic setting,” said Harrington.

Biomarkers

Although biomarkers such as PD-L1 expression are already being used and can help identify patients who are more likely to respond, high PD-L1 expression does not guarantee response, nor does no or low PD-L1 expression ensure lack of response or lack of durable response.

Subsequently, use of pembrolizumab and nivolumab is without use of this biomarker for patient selection. “While [a PD-L1 assay] can help inform patients of their likelihood to respond, it is not an assay that can select patients,” said Seiwert, who is working to identify novel biomarkers.

“I’ve been involved in looking at a novel biomarker called interferon gamma signature, which can be assayed quite easily with a rapid turn-around, and seems to perform somewhat better than PD-L1 expression,” said Seiwert. “It seems to have a high negative predictive value, and it may eventually allow us to exclude some patients who have no chance of having benefit, but it needs further validation.” He said that other biomarkers are also under investigation, including mutational load, immunogenic mutations, and dynamic biomarkers, but all are still experimental.

“What we really need is a biomarker that would predict progressive disease,” said Grünwald. “To me, that would be much more usable than an assay that just allows us to say to patients ‘your chance of response is 30%.’ I see biomarkers as having the potential to guide development of treatment algorithms,” he said.

Combinations

Currently, PD-L1–targeted agents have seen the greatest development, and studies are starting to suggest that response with these agents can be enhanced when they are combined with other treatments, including chemotherapy, CTLA-4 blockade, and radiotherapy. “About 70% of HNCs have some level of PD-L1 expression—some level of inflammation—but we only see responses in 15% to 18% of patients, so the pool of patients who might benefit from combinations is huge,” said Seiwert.

He noted that the melanoma and lung cancer settings have already shown combining PD-1 inhibitors with chemotherapy or a second checkpoint inhibitor to be particularly promising in the front line, and he suspects one or both combinations will eventually receive approval in these settings and warrant serious investigation for patients with SCCHN.

“Some of our patients do not benefit from a checkpoint inhibitor, and we can’t identify these patients in advance, but giving them chemotherapy might buy us time,” he said. “It’s almost like a pharmacodynamic effect, where we have more time for the immunotherapy to work, and maybe, also make the immune system stronger and expose antigens.”

In the locally advanced setting, animal studies have shown promise combining chemoradiotherapy with immunotherapy, but results of a small study presented at ESMO revealed some dosing challenges in humans.6

In the study, 18 patients with various forms of intermediate- or high-risk SCCHN received ipilimumab, an anti–CTLA-4 antibody, in addition to standard intensity-modulated radiotherapy with cetuximab. Dermatologic immune-related adverse events limited dosing. “There are some safety hints that it may not be a piece of cake getting through radiotherapy, and maybe cetuximab might not be the optimal part now, but I think there is still a lot of promise combining radiochemotherapy with immunotherapy,” said Grünwald. “It could be a future way in how we successfully treat early forms of localized SCCHN.”

Combining checkpoint inhibition with radiation is another intriguing combination, and one that has the potential to act like an in situ vaccination that can lead to abscopal responses (ie, responses at distant sites), noted Harrington, something he has, thus far, only observed rarely with radiation.

“The idea behind combining checkpoint inhibition and radiation is that we could use the confluence of the two different mechanisms to make abscopal responses more predictable and more effective at a distant site, while engendering an immunologically relevant response that allows us to treat macroscopic metastatic disease while also getting rid of micrometastatic disease that could lead to metastatic failure,” he said.

Although immunotherapy combinations are showing promise in SCCHN and other cancers, the panelists warned that they should only be attempted as part of clinical trials. “There are still a lot of question marks about combinations, so they must be done as part of a clinical trial,” said Seiwert. Not only are toxicities and immunosuppressive effects best managed in clinical trials, but trials are essential in advancing these therapies and identifying the next breakthroughs in the field, he said.

 

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

January, 2017|Oral Cancer News|

Expert Asserts Pembrolizumab to Play Important Role in Head and Neck Cancer Treatment

Source: www.targetedonc.com
Author: Laura Panjwani

Joshua-Bauml

The FDA approval of pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in August 2016 was extremely significant for this patient population, which previously had limited options following progression on a platinum-based chemotherapy.

The approval was based on the phase Ib KEYNOTE-012 study, which demonstrated that pembrolizumab had an overall response rate (ORR) of 18% and a stable disease rate of 17% in patients with recurrent/metastatic HNSCC.

Several other studies are further evaluating the immunotherapy agent in HNSCC.Preliminary results of the phase II KEYNOTE-055 study—which included 92 evaluable patients who received pembrolizumab after failing platinum and cetuximab therapies—were presented at the 2016 ASCO Annual Meeting.

In an interview with Targeted Oncology, lead study author Joshua M. Bauml, MD, an assistant professor of Medicine, Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center, discusses the impact of pembrolizumab’s success in HNSCC, the results of the KEYNOTE-055 study, and what he sees on the horizon for the PD-1 inhibitor in this field.

TARGETED ONCOLOGY: What role do you envision pembrolizumab having in this patient population?

Baumi: It is going to play a critical role in head and neck cancer. The other agents that are available have limited efficacy, and are associated with significant toxicities. This is a clear improvement for our patient population with limited options.

TARGETED ONCOLOGY: What were the key takeaways from KEYNOTE-055? Baumi: Patients with recurrent/metastatic head and neck cancer that is refractory to both platinum-based therapy and cetuximab (Erbitux) really have very few options. The historical reference population we usually use is patients treated with methotrexate, which has a response rate of 5% and an overall survival (OS) of only about 6 months. There is a really great need for this. For pembrolizumab, which is an anti–PD-L1 agent, there is biologic rationale to think that it would be active in this patient population. PD-L1 and PD-L2 are unregulated in head and neck cancer.

What KEYNOTE-055 did is really try and create a homogenous patient population. Rather than a large phase I study, here are patients all who have failed both platinum-based therapy and cetuximab. We have really identified the sickest patient population.

What we are able to show in this study was that the drug was well tolerated and it has a response rate of 17% to 18%, which compares favorably for the 5% seen with the prior data with methotrexate. The OS rate was 8 months, which again compares very favorably to the 6 months seen with methotrexate. This was true, even though 85% of patients had received at least 2 prior treatments for head and neck cancer.

TARGETED ONCOLOGY: What did this study tell us about the safety of pembrolizumab in head and neck cancer?

Baumi: The rate of grade 3 through 5 treatment-related adverse events was 12% in our study. Nearly all of the side effects are what you would expect with pembrolizumab; those have been reported in multiple other studies. There was 1 treatment-related death due to pneumonitis, which is a rare side effect of this class of drugs.

Outside of that, it was a really well-tolerated agent. The fact that if you compared grade 3 through 5 toxicities of 12% with cytotoxic chemotherapy, this is a very well-tolerated agent.

TARGETED ONCOLOGY: How common is it for patients to fail both platinum-based therapy and cetuximab?

Baumi: Any patient who has recurrent or metastatic head and neck cancer is going to go through these agents if they survive long enough to get them. Basically, we know that these are the limited tools in our toolbox. We have platinum, we have cetuximab, and then we are really out of options. Many patients have received cetuximab in the locally advanced setting and so we have already lost one of our active treatments. This affects a lot of people.

TARGETED ONCOLOGY: What is next for pembrolizumab in head and neck cancer?

Baumi: There are currently phase III studies evaluating pembrolizumab in head and neck cancer both in combination with and versus traditional cytotoxic chemotherapy to see if we can move up the treatment earlier for patients. The key difference between pembrolizumab and cytotoxics is beyond the improved safety profile. However, we have durable responses; 75% of those patients who responded are still responding to this day. That is really not something that we see.

TARGETED ONCOLOGY: What are the biggest questions that remain regarding the treatment of patients with metastatic head and neck cancer?

Baumi: One of the key questions that relates to immunotherapy—and this covers all tumors—is trying to identify who the 20% of patients are that will respond. Eighty percent of our patients are not responding to our therapies.

Identifying a biomarker to enrich this patient population is very critical. Right now, I would not select patients for pembrolizumab by virtue of PD-L1 status because there were responses in the PD-L1–negative cohorts.

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

September, 2016|Oral Cancer News|

Expert says Nivolumab Poised to Change Standard of Care in SCCHN

Source: www.onclive.com
Author: Laura Panjwani

Robert-Ferris

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

August, 2016|Oral Cancer News|

FDA Spends $36 Million on Anti-Chewing Tobacco Ad Campaign

Source: www.freebeacon.com
Author: Elizabeth Harrington
Cans of smokeless tobacco sit in the Tampa Bay Rays dugout before a baseball game between the Rays and the Baltimore Orioles, Wednesday, April 14, 2010, in Baltimore. After hounding Major League Baseball and its players union over steroids, Congress now wants the sport to ban smokeless tobacco. (AP Photo/Rob Carr)

Cans of smokeless tobacco sit in the Tampa Bay Rays dugout before a baseball game between the Rays and the Baltimore Orioles, Wednesday, April 14, 2010, in Baltimore. After hounding Major League Baseball and its players union over steroids, Congress now wants the sport to ban smokeless tobacco. (AP Photo/Rob Carr)

The Food and Drug Administration is spending $36 million on an anti-chewing tobacco advertising campaign targeted at white male teenagers in the midwest.

The federal agency announced Tuesday it is expanding its “Real Cost” anti-tobacco campaign to “educate rural, white male teenagers” and convince them to stop dipping.

“Smokeless tobacco use is culturally ingrained in many rural communities,” the FDA said. “For many, it has become a rite of passage, with these teenagers seeing smokeless tobacco used by role models, such as fathers, grandfathers, older brothers, and community leaders.”

The campaign will run television, radio, and print advertisements, as well as put up public signs and billboards and post on social media.

An FDA spokesperson told the Washington Free Beacon that the total cost for the campaign is $36 million, which will be financed through taxes on tobacco manufacturers. Paid ads will cost $20 million, and the remaining budget will cover “research, strategic planning, creative development, and contract management.”

The agency is also partnering with two dozen minor league baseball teams in the midwest that will host anti-chewing tobacco events and feature advertisements from the campaign.

“Amplification of messaging from the campaign will take place at 25 Minor League Baseball stadiums throughout this summer using a variety of efforts, including sponsoring in-stadium events, the placement of print ads, running of television ad spots, and opportunities for fans to engage with players who support the FDA’s efforts on smokeless tobacco,” said Tara Goodin, an FDA spokesperson.

The list of minor league clubs participating in the campaign includes the Albuquerque Isotopes, the Fargo-Moorhead Redhawks, the Traverse City Beach Bums in Michigan, the Sioux Falls Canaries, and the Burlington Bees, an Iowa farm team for the Los Angeles Angels.

Chewing tobacco has been banned at ballparks in Los Angeles, San Francisco, and Boston, including Fenway Park, and major leaguers can face $250 fines and “are subject to discipline” from Major League Baseball’s Commissioner Rob Manfred if they dip during games.

ESPN reported that signs are now posted in Fenway with a phone number so individuals can call to report on other fans they see chewing tobacco to “alert security.”

The FDA provided an example of one of its new campaign ads, which features a man at a bowling alley with a can of chewing tobacco in his back pocket.

FDA-TRC-Smokeless-Prevention-Campaign-Ad

“This can can cause mouth cancer, tooth loss, brown teeth, jaw pain, white patches, gum disease,” text on the ad reads.

The campaign is targeted at white males aged 12 to 17 who are using smokeless tobacco, which the FDA estimates to be 629,000 nationwide, or 0.19 percent of the U.S. population of 318.9 million.

“Not only is the target audience using smokeless tobacco at a high rate, but many do not fully understand the negative health consequences of their actions,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “In communities where smokeless tobacco use is part of the culture, reaching at-risk teens with compelling messaging is critical to help change their understanding of the risks and harms associated with smokeless tobacco use.”

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

April, 2016|Oral Cancer News|

Minimizing Imaging for Recurrence of HPV-Associated Head & Neck Cancer

Source: www.journals.lww.com/oncologytimes
Author: Robert H. Carlson

 

SCOTTSDALE, ARIZ.—Most recurrences of HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) can be found through imaging and physical exams within six months after treatment, according to a study from the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Fla.

“For most patients with HPV-associated oropharyngeal cancer who have had a negative three-month PET scan, physical exams with history and direct visualization are sufficient to find recurrences,” said Jessica M. Frakes, MD, Assistant Member of the Department of Radiation Oncology at the institute and lead author on the study, in a presentation at the 2016 Multidisciplinary Head & Neck Cancer Symposium.

“Minimizing the number of exams that do not compromise outcomes not only helps decrease anxiety and stress for our patients, but also eases the financial burden of cancer care,” she said.

 
 

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The study also supports the effectiveness of specialist teams in treating HPV-positive OPSCC with definitive radiation therapy. Frakes said local control at three years was 97.8; regional control 95.3 percent; locoregional control 94 percent; and freedom from distant metastases 91.4 percent.

Three-year overall survival was 91 percent.

“The number of OPSCC patients and survivors is growing, so there is a great need to determine the general time to recurrence and the most effective modes of recurrence detection in order to guide optimal follow-up care,” Frakes said.

But National Comprehensive Cancer Network (NCCN) guidelines for treatment of OPSCC are “one size fits all,” she said, with the same follow-up recommendations whether the disease is HPV-associated or not.

To identify patterns in recurrence detection, the researchers examined 246 cases of HPV- or p16-positive non-metastatic OPSCC patients treated with definitive radiation therapy at Moffitt between 2006 and 2014. Of those, 84.6 percent received radiation therapy and a concurrent systemic therapy, and 15.4 percent received definitive radiation therapy alone.

Patients then underwent a PET/CT scan three months after completing treatment. They also had physical exams every three months in the first year following treatment, every four months in the second year, and every six months in years three through five.

Median follow-up care length for all patients was 36 months. Recurrence and survival rates were calculated from the end of radiation therapy.

“Our local control was excellent,” Frakes said, reporting 98 percent of local failures were detected by physical exam, with either direct visualization (two cases) or flexible laryngoscopy (four cases); 89 percent of regional failures were found due to symptoms—primarily a neck mass—or by three-month post-treatment imaging; and 71 percent of distant metastases were found due to symptoms or three-month post-treatment imaging.

Frakes described some disease characteristics that increased the likelihood of recurrence: patients with five or more nodes or with level IV low-neck nodes present were more likely to suffer regional failure; and there was increased risk of distant metastases with involved lymph nodes greater than 6 cm (N3 disease), bilateral lymph node involvement, five or more involved lymph nodes, or level IV lymph nodes.

Toxicity rates were low, she said, with only 9 percent of patients experiencing severe late side effects.

“And the majority of those patients had resolution of the side effects at the time of last follow-up, meaning the feeding tube was taken out or they were treated with hyperbaric oxygen for necrosis,” she said.

Sixty-four percent of toxicities and/or recurrences occurred within the first six months following treatment, and only four events occurred more than two years following treatment.

“We were pleasantly surprised by the high cure rates and the low permanent side effect rates for these patients,” Frakes said.

These findings show individuals with HPV-associated oropharyngeal cancer treated with definitive radiation therapy and cared for by multidisciplinary specialists have excellent outcomes, Frakes concluded.

Surveillance: Too Much or Too Little?

There is much debate as to whether whether the surveillance done for the HPV-positive subset of OPSCC is too much or too little, said Bhishamjit S. Chera, MD, Associate Professor and Director of Patient Safety and Quality in the Department of Radiation Oncology, University of North Carolina Hospitals, Chapel Hill, who was asked to comment on this study for OT.

“This study’s primary objective was to evaluate whether the standard cancer survivorship program that we have used for oropharyngeal cancer is appropriate, and this abstract shows that the standard cancer survivorship program adequately detected the majority of cancer recurrences.”

Chera said repeated imaging, such as with PET/CT every 3-6 months, is not likely to detect recurrences faster in these patients, and it would clearly be more costly.

“I conclude from this study that more frequent surveillance with imaging or visits is not necessary for HPV-positive OPSCC,” Chera said. “Their cancer control is so good that we may be following them too closely or too often.”

He said future studies should evaluate following these favorable prognosis HPV-positive OPSCC less often.

Imaging After Three Months Not Routine

Christine G. Gourin, MD, Associate Professor of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, and moderator of an online/audio preview of this meeting for the press, said she appreciated the Moffitt study’s findings.

“I think we probably do too much post-treatment surveillance imaging,” she said, “and the NCCN guidelines are fairly vague about when to perform imaging.”

Gourin said her institution has stopped routinely imaging patients after three months if a PET scan is negative.

“And it’s true we pick up recurrences more clinically than radiologically, and, of course, a false-positive causes much more morbidity.”

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

April, 2016|Oral Cancer News|

Head & Neck Cancer Patients Face Social Isolation, Financial Burdens

Source: www.journals.lww.com/oncologytimes
Author: Robert H. Carlson
 

SCOTTSDALE, Ariz.—Locally advanced head and neck cancer (LAHNC) has high morbidity and is expensive to treat. The cost of the disease, not only in financial burden but also degradation of the patient’s quality of life, was highlighted in a recent study from University of Chicago Pritzker School of Medicine.

The study, using data from 73 treatment-naïve LAHNC patients, showed that 69 percent relied on one or more lifestyle-altering cost-coping strategies while managing their cancer, including spending savings (62 percent), borrowing money (42 percent), selling possessions (25 percent), and having family members work more hours (23 percent).

A more subtle disruption of patients’ lives was also identified, that of perceived social isolation— defined as a lack of social support coupled with increased loneliness—as a risk factor for less than optimal medication adherence and use of health care resources during treatment. That meant more days of missed medication, more missed appointments, and longer inpatient hospital stays.

The study was presented at the 2016 Multidisciplinary Head & Neck Cancer Symposium, sponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology.

“Physical side effects are not the only ones our head and neck cancer patients endure,” said Sunny Kung, a second-year medical student and lead author on the study. “It is important for physicians to screen for social isolation just as we screen for depression and identify patients with high social isolation so we can intervene earlier on before they experience these negative financial side effects of their care.”

Senior study author is Jonas de Souza, MD, Assistant Professor of Medicine at The University of Chicago Medicine and frequent author on healthcare economics as well as head and neck malignancies.

Research Findings

The researchers examined factors associated with social side effects by following patients diagnosed with head and neck cancer over six months to assess how they coped with the cost of their cancer treatment, as well as whether perceived social isolation or the lack of social support was a barrier to their care.

“It was surprising that patients who had a high degree of perceived social isolation had a greater likelihood of using more lifestyle coping strategies,” Kung said, during an online press conference held in advance of the symposium.

The prospective longitudinal study collected six monthly lifestyle surveys from patients diagnosed between May 2013 and November 2014.

Most patients in the study were male (78 percent), Caucasian (74 percent), and covered by private health insurance (54.8 percent). Multivariable regression modeling was used to assess the influence of patient characteristics on the use of cost-coping strategies and perceived social isolation.

The survey assessed the use of lifestyle-altering financial burdens including extra out-of-pocket costs, loss of productivity, low compliance with their medication regimen, and added health care utilization, specifically, longer inpatient length of hospital stays and more missed appointments.

The researchers also measured patients’ demographics, health insurance status, wealth, household income, and type of tumor. Perceived social isolation was evaluated prior to treatment for each patient.

During the online preview of the symposium, Kung elaborated on the concept of social isolation as measured in two components: loneliness and lack of social support.

The first was measured using the validated UCLA Loneliness Scale, and the second by the 19-item Medical Outcomes Social Support Survey. The two scores were combined in a formula to determine low, intermediate, or high social isolation.

Kung said that, compared to LAHNC patients with adequate social support, those with a high level of perceived social isolation reported:

* more days missing the prescribed dose of medication, 21.4 days for those with high perceived social isolation versus 5.45 days for those with low/moderate perceived social isolation;

* more missed appointments, seven for those with high perceived social isolation versus three for those with low/moderate perceived social isolation; and

* longer inpatient hospital stays, 32.7 versus 27.6 days.

“Many of the patients we treat for advanced head and neck cancers need support beyond their medical care,” Kung concluded. “Social interventions can be introduced for patients who feel isolated in order to minimize financial burden while maximizing effective health care utilization.”

For example, she said, providers can work with patient navigators to improve adherence to medical care among vulnerable populations.

Need for Support

The moderator of the press preview, Randall Kimple, MD, Assistant Professor in the Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, said this study’s findings would have to be replicated in other institutions.

“Even so, these are important lessons for us to learn about what our patients go through, and potential areas of research into how to lessen social isolation and all the other hardships while still doing everything we can cure as many patients as possible,” Kimple said.

This study’s findings on social isolation may apply to other cancers, he said, but he noted that head and neck cancer is unique in the intensity of therapy and the side effects that come with therapy and that affect quality of life.

“Losing the ability speak, to eat, to work, and the social isolation that can result, these can be devastating, but we as physicians can help to address many of these issues with teaching and support, and have a real impact on the lives of our patients,” Kimple said.

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

April, 2016|Oral Cancer News|