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Tackling side effects in head and neck cancer treatment – the end of the road for hyperbaric oxygen?

Source: Cancer Research UK
Date: May 2, 2019
Author: Katie Roberts

Some side effects appear years after cancer treatment. That’s the case for one side effect of radiotherapy for head and neck cancer, called osteoradionecrosis.

This painful condition results from damage to the jaw bone, which often doesn’t heal properly and can cause bone fractures or even bone death.

It can develop without an obvious trigger, but it’s often linked to dental work like tooth extractions or implants. And it can happen even if the dental work is carried out 20 years after radiotherapy.

Professor Richard Shaw, a Cancer Research UK-funded head and neck surgeon at the University of Liverpool, treats the difficult condition quite frequently through reconstructive surgery.

Shaw says that these procedures are often bigger and harder than patients’ original cancer surgery, because they’ve already had so much treatment in that area.

For that reason, researchers have looked for ways to prevent osteoradionecrosis from developing. And that’s where hyperbaric oxygen comes in. It started with a small trial in the 80s, which has influenced the way doctors prepare patients for dental surgery ever since.

But new Stand Up To Cancer trial data, led by Shaw and published in the International Journal of Radiation Oncology, shows the hyperbaric oxygen hype may have been a bit premature.

The trial of hyperbaric oxygen

Back in the 1980s, a small trial in the US showed that giving hyperbaric oxygen before dental surgery could reduce the risk of osteoradionecrosis developing.

What is hyperbaric oxygen therapy?

Hyperbaric oxygen treatment involves sitting in a chamber where the oxygen is at a higher pressure than the air we normally breathe. It’s thought the increase in oxygen can help to promote healing. Sessions typically last 60-90 minutes.

“Prevention is obviously a very good idea, but I think there was concern around whether hyperbaric oxygen was the answer,” says Shaw.

A big question that lingered around the treatment was how applicable the 34-year-old trial results were to patient’s today. Radiotherapy has become a lot more targeted than it was a few decades ago, which may affect the risk of someone developing osteoradionecrosis.

“There really was no recent, good evidence for hyperbaric oxygen,” says Shaw.

No one wants to take the risk with our patients who, after all, had been cured of head and neck cancer and saw themselves as long-term survivors.

– Professor Richard Shaw

The verdict’s in

Shaw and his team ran a trial testing hyperbaric oxygen treatment in 144 patients who’d had head and neck cancer and now needed dental surgery. Half the patients had a course of hyperbaric oxygen before surgery, the other half didn’t.
Patients were then monitored after dental treatment to see who developed osteoradionecrosis, as well as monitoring pain levels and quality of life.

The first thing the team learnt was that osteoradionecrosis is a lot less common now than it was in the 80s.

“We can now say that with modern radiotherapy, someone’s risk of having this jaw problem is about 1 in 20. Which is a lot lower than the previous trial, which had shown it was around 1 in 3,” says Shaw.

The other big finding was that hyperbaric oxygen had no impact on the number of people developing osteoradionecrosis – the numbers were pretty much the same in each side of the trial.

And although people who had hyperbaric oxygen reported fewer short-term side effects and less pain immediately after surgery, there was no difference in long-term pain or quality of life between the two groups.

“It’s very clear that in our health system, hyperbaric oxygen is no longer justified,” says Shaw. “In some ways it could be reported as a negative finding, because hyperbaric oxygen didn’t work. But I think it has given us a definitive change of practice.”

What’s next?

As well as changing practice, the trial leaves another legacy: patient samples. Shaw is planning to use these to understand more about who develops osteoradionecrosis.

“What you’ll deduce with 6% of patients developing osteoradionecrosis in this trial is that 94% of people didn’t, even though they were considered high risk,” he says.

Right now, risk is assessed based on where the radiotherapy was aimed, as well as the type of follow-up dental work that’s being done. But Shaw believes risk could be predicted more precisely. The team will now study the patient samples to look if there are any differences in the DNA of patients who went on to develop osteoradionecrosis.

“We’re looking for a genetic signal or a ‘fingerprint’ that identifies people at high risk of osteoradionecrosis that we could validate in future trials,” says Shaw.

For now, Shaw says doctors can help to reduce the risk of osteoradionecrosis by making sure patients’ teeth are in the best possible condition before and after radiotherapy.

This, Shaw says, could help make sure “these conditions that require surgery don’t arise in the first place.”

May, 2019|Oral Cancer News|

Oral HPV DNA Persistence After Head and Neck Cancer Treatment Linked to Disease Progression

Source: genomeweb
Date: May 2, 2019
Author: Staff Reporter

NEW YORK (GenomeWeb) – Persistent traces of human papilloma virus DNA after treatment for HPV-positive head and neck cancer is linked to an increased recurrence risk, a new study has found.

Head and neck cancers affect some 53,000 people in the US each year, according to the National Cancer Institute, and HPV has been implicated in many of those cases. In general, patients with HPV-positive tumors have higher survival rates than those with HPV-negative tumors.

A team of MD Anderson Cancer Center-led researchers collected oral rinse samples from nearly 400 patients with head and neck squamous cell carcinomas at diagnosis and as their treatments progressed. As they reported today in JAMA Oncology, the researchers found that viral load in patients’ oral samples broadly decreased as they underwent therapy. But some patients’ viral loads persisted despite treatment, which was linked to an increased risk of cancer recurrence and death, the researchers reported.

“Our data suggest that a subset of patients with HPV-positive HNSCC at high risk for locoregional recurrence can be identified by detection of persistent, oral HPV after treatment,” MD Anderson’s Maura Gillison and her colleagues write in their paper.

The researchers enrolled 396 patients with oral cavity, oropharyngeal, or unknown primary HNSCC in their study. They tested the patients’ tumors for the presence of 13 high-risk HPV types using an mRNA expression test and found 202 patients had HPV-positive tumors.

At the same time, the researchers collected oral rinse samples from patients at diagnosis, after surgery, and at six months. Additionally, patients who underwent radiotherapy provided weekly oral rinse samples. The researchers tested these samples — a total of 2,922 oral rinse samples — for the presence of HPV using a multiplex PCR-based approach.

At diagnosis, patients with HPV-positive tumors were significantly more likely to have oral rinse samples positive for HPV than were patients with HPV-negative tumors. In particular, the researchers reported that the detection of any oral HPV DNA had a sensitivity of 84 percent, a specificity of 88 percent, a positive predictive value of 88 percent, and a negative predictive value of 84 percent for the diagnosis of an HPV-positive tumor.

The prevalence of oral HPV DNA, though, went down after treatment, the researchers reported. Prior to treatment, the prevalence of HPV DNA in oral rinses that matched that of HPV in the tumor sample was 69 percent. But after primary surgical resection, it was about 14 percent. Its prevalence fell similarly for patients who underwent radiotherapy, going from 85 percent before treatment to 9 percent after radiotherapy.

As expected, overall and recurrence-free survival was higher for patients with HPV-positive tumors than with HPV-negative tumors. Patients with HPV-positive tumors had a two-year overall survival of 91 percent, as compared to 75 percent for patients with HPV-negative tumors.

But for a subset of patients with HPV-positive tumors — about 14 percent — the prevalence of oral HPV DNA didn’t decline with treatment. These patients were more likely to recurrent disease, with about 45 percent experiencing disease recurrence within two years. Additionally, this subset had a lower two-year overall survival of 68 percent.

These patients, the researchers noted, might benefit from increased surveillance or adjuvant therapy.

The researchers added that their findings suggest that oral rinses to detect HPV DNA in head and neck cancer patients might be helpful. They cautioned, though, that its clinical utility might be limited by the need to identify tumor-type infections.

“Ongoing studies will evaluate whether multiplexed detection of plasma HPV DNA can improve these limitations,” the researchers added.

NOTE: This research was paid for in part by the Oral Cancer Foundation,www.oralcancer.org

May, 2019|Oral Cancer News|

E-cig users develop some of the same cancer-related molecular changes as cigarette smokers

Source: EurekAlert!
Date: February 14, 2019

If you think vaping is benign, think again.

A small USC study shows that e-cig users develop some of the same cancer-related molecular changes in oral tissue as cigarette smokers, adding to the growing concern that e-cigs aren’t a harmless alternative to smoking.

The research, published this week in the International Journal of Molecular Sciences, comes amid a mushrooming e-cig market and mounting public health worries. On a positive note, recent research found vaping is almost twice as effective as other nicotine replacement therapies in helping smokers quit.

But among adolescents, vaping now surpasses smoking, and there’s evidence that e-cig use leads to nicotine addiction and future smoking in teens.

“The existing data show that e-cig vapor is not merely ‘water vapor’ as some people believe,” said Ahmad Besaratinia, an associate professor at Keck School of Medicine of USC and the study’s senior author. “Although the concentrations of most carcinogenic compounds in e-cig products are much lower than those in cigarette smoke, there is no safe level of exposure to carcinogens.”

Besaratinia emphasized that the molecular changes seen in the study aren’t cancer, or even pre-cancer, but rather an early warning of a process that could potentially lead to cancer if unchecked.

The researchers looked at gene expression in oral cells collected from 42 e-cig users, 24 cigarette smokers and 27 people who didn’t smoke or vape. Gene expression is the process by which instructions in our DNA are converted into a functional product, such as a protein. Certain alterations in gene expression can lead to cancer.

They focused on oral epithelial cells, which line the mouth, because over 90 percent of smoking-related cancers originate in epithelial tissue, and oral cancer is associated with tobacco use.

Both smokers and vapers showed abnormal expression, or deregulation, in a large number of genes linked to cancer development. Twenty-six percent of the deregulated genes in e-cig users were identical to those found in smokers. Some deregulated genes found in e-cig users, but not in smokers, are nevertheless implicated in lung cancer, esophageal cancer, bladder cancer, ovarian cancer and leukemia.

Besaratinia and his team plan to replicate his findings in a larger group of subjects and explore the mechanisms that cause gene deregulation. He’s also launching another experiment in which smokers switch to e-cigs; he wants to see whether any changes in gene regulation occur after the switch.

“For the most part, the participants are as curious as we are to know whether these products are safe,” he said.

In addition to Besaratinia, the study’s other authors are first author Stella Tommasi, Andrew Caliri, Amanda Caceres, Debra Moreno, Meng Li, Yibu Chen and Kimberly Siegmund, all of USC.

The research was supported by grants from the National Institute of Dental and Craniofacial Research of the National Institutes of Health (1R01DE026043) and the University of California Tobacco-Related Disease Research Program (TRDRP-25IP-0001 and TRDRP-26IR-0015).

February, 2019|Oral Cancer News|

Merck’s Keytruda looks to zoom past Opdivo with fast head and neck cancer review

Source: Fierce Pharma
Date: February 11, 2019
Author: Carly Helfand

Merck & Co.’s Keytruda is duking it out with Bristol-Myers Squibb’s Opdivo in the head and neck cancer marketplace, but Keytruda just took one step toward a green light that would give it a big edge.

The FDA has tagged Merck’s approval application for the immuno-oncology superstar—alone or in tandem with chemo—with its priority review designation in previously untreated patients with head and neck cancer. The move, which Merck announced Monday, sets Keytruda up for a quick trip down the regulatory pathway; the agency expects to have a decision by June 10, Merck said.

FDA staffers based their decision on data Merck trotted out at last year’s European Society for Medical Oncology (ESMO) meeting in October. Results showed that solo Keytruda, when pitted against a standard-of-care regimen dubbed by doctors as “Extreme,” could cut the risk of death by 22% in patients testing positive for the biomarker PD-L1. In patients with high levels of PD-L1 in their tumors, that figure shot up to 39%.

And when paired with chemo, Keytruda pared down the risk of death by 23% regardless of patients’ PD-L1 status.

Based on “the limited interaction we’ve had with key opinion leaders, I think this is seen as practice-changing,” Roy Baynes, Merck SVP and head of global clinical development, said when the data were released. And in addition to shaping opinions on clinical practice, the results also confirmed Keytruda’s place in the second-line setting, where it had previously suffered a narrow trial miss.

If Merck can snag a go-ahead in new patients, it’ll be an option for the more than 65,000 patients diagnosed each year in the U.S., according to the company. It’ll also mean a major leg up on BMS, whose Opdivo only bears a second-line OK. And with untreated patients in line to get Keytruda, the number of patients eligible for Opdivo—because those who used Keytruda first wouldn’t be in line for a second round of PD-1 therapy—will presumably dwindle.

The two drugs have been battling it out in different tumor types since the early days of immuno-oncology, when both started off with FDA nods in melanoma. While Opdivo has held market leads in important areas including kidney cancer, it’s Keytruda that has the No. 1 position, thanks to its dominant status in lung cancer, the biggest arena for the medicines.

February, 2019|Oral Cancer News|

Tumor Mutational Burden Predicts Who Will Respond to Immunotherapy

The advent of immunotherapy has significantly shifted the treatment paradigm and prognosis for multiple advanced-stage cancers. In cancers like metastatic melanoma and non–small cell lung cancer (NSCLC), the treatment class has greatly improved survival rates.

However, not all patients respond to the treatments, highlighting the need for predictive biomarkers to determine which patients will benefit. Early reports and small cohorts have suggested high tumor mutational burden being associated with improved clinical response, and now a large study has confirmed the hypothesis.

“Given the potential toxicities of immunotherapy and the highly variable response to immune checkpoint inhibitors, as well as the significant economic cost of these agents, there is an urgent need for biomarkers that can predict immunotherapy response,” explained the researchers of the study.

Looking at data from more than 1000 patients with stage IV or metastatic disease for which immune checkpoint inhibitors are approved, including NSCLC, melanoma, renal cell carcinoma, bladder cancer, and head and neck cancer, researchers found that higher somatic tumor mutational burden is associated with improved overall survival.

Patients were treated with atezolizumab, avelumab, durvalumab, ipilimumab, nivolumab, pembrolizumab, or tremelimumab. Tumor mutational burden was calculated by normalizing the number of somatic nonsynonymous mutations to the total number of megabases sequenced, and noting that mutational load varies across tumor types, the researchers defined tumor mutational burden within each cancer type.

The authors found that, across all cancers, more mutations translated into improved overall survival. The authors noted that the association remained even when removing NSCLC and melanoma from the analysis.

“Although the effect for some individual cancers did not reach statistical significance, possibly because of smaller sample size, the numerical trend of better overall survival was observed in nearly all cancer types, with glioma the clearest exception,” the authors wrote. These findings mirror real-world evidence, which has shown gliomas to be immunosuppressive and remain difficult to treat.

Of note, what constituted as high tumor mutational burden varied greatly by cancer type, which suggests that there is likely not a viable universal number that could define high tumor mutational burden and be predictive of response to immune checkpoint inhibitors across all cancers. While breast cancers and renal cell carcinomas only need 6 mutations per 1 million DNA to predictably respond well to immune checkpoint inhibitors, melanomas need 30.7 and colorectal cancers need 52.2.

According to the researchers, this can likely be explained by distinct tumor microenvironments as well as other factors that have shown to independently predict response, including clonality, immune infiltration, and immune cell exclusion.

Reference:

Samstein R, Lee C, Shoushtari A, et al. Tumor mutational load predicts survival after immunotherapy across multiple cancer types [publihsed online January 14, 2019]. Nature. doi: 10.1038/s41588-018-0312-8.

January, 2019|Oral Cancer News|

Researchers Uncover Major Clue In Predicting Response To Immunotherapy

Researchers at Memorial Sloan Kettering Cancer Center in New York have discovered that cancer cells with high numbers of faults in their DNA are more likely to respond to immune checkpoint inhibitors (ICI), a major class of immunotherapy drugs, which includes Keytruda.

The study, published today in Nature Genetics adds important pieces to the puzzle as to why some cancer patients respond to immunotherapy whereas others do not. The researchers measured ‘tumor mutation burden (TMB)’, essentially counting how many DNA faults a tumor contains by looking for errors in the DNA sequence.

“People assume that TMB is important in predicting response to immunotherapy in all cancers, but up until now, all we’ve had is data from small studies and clinical trials on mostly lung cancers and melanoma,” said Luc Morris, MD, surgical oncologist at Memorial Sloan Kettering Cancer Center and one of the lead authors of the paper.

The researchers studied the DNA of 1,662 patients with advanced cancer (classified as stage IV or metastatic disease) treated with one or more of several FDA-approved ICI drugs and DNA from 5,371 patients with advanced cancer who had not had ICI. They used a tool called MSK-IMPACT, which looks at just 3% of the coding-regions in DNA, but is correlated to the number of mutations in the genome.

“Is TMB associated with likelihood that immunotherapy has benefit? Is this true in all cancers? We wanted to find out whether TMB had broad applicability,” said Morris.

The researchers found that if they took the 20% of cancers in their data with the most mutations, these people responded better to ICI than those with lower numbers of mutations in their tumors.

However, this correlation did not hold true for all tumors, for example, in people with a type of brain cancer called glioma, those with TMB in the top 20% did no better on ICI than those with lower TMB. Also in breast cancer there was no conclusive evidence that a higher TMB predicted response to ICI, although the study included relatively few breast cancer patients as ICI is not currently widely used for the disease.

Researchers don’t exactly know why high numbers of mutations make cancers more susceptible to immunotherapy, but they do have a very plausible theory. They think that the more mutated a cell is, the more likely it is to produce incorrect, mangled proteins. These displayed on the cell surface are called neoantigens and they are so far from what would be considered normal, the immune system identifies them as foreign and attacks the cells.

This is not a unique study in concept, with previous research on a smaller number of cancers of specific types, notably lung and melanoma, indicating that TMB is likely predictive of immunotherapy response. However, it is the largest and most comprehensive study to date, providing the most persuasive evidence that this is true for a greater number of cancer types.

“Only in lung cancer is TMB being used in a clinical trial. Hopefully this data will give us permission to include it in future clinical trials on other cancer types,” said Morris.

However, some patients with high TMB don’t respond to ICI at all, so there is still work to be done to figure out why high TMB is not a universal predictor of response to ICI.

“TMB by itself is not going to give you a high confidence in predicting whether a patient is going to respond to immunotherapy or not. It is one biomarker for response, but a number of other factors are important. I would not suggest you take the data from this paper and apply it to a patient in the clinic,” said Morris.

January, 2019|Oral Cancer News|

CDC: Top HPV-Associated Cancer Is Now Oropharyngeal

Date: 08/23/18
Source: medscape.com
Author: Nick Mulcahy

Oropharyngeal squamous cell carcinoma (SCC) is now the most common HPV-associated cancer in the United States, according to a new report from the Centers for Disease Control and Prevention (CDC) that covers the years 1999 to 2015.

During that period, cervical cancer dropped from being the top HPV-associated cancer and oropharyngeal SCC took its place.

The transition happened because cervical carcinoma incidence rates decreased 1.6% per year, and oropharyngeal SCC incidence rates increased 2.7% per year among men and 0.8% per year among women.

In 2015, there were a total of 11,788 cervical cancers compared with 18,917 oropharyngeal SCCs.

The decline in cervical cancer is a “continued trend since the 1950s as a result of cancer screening,” write the report authors, led by Elizabeth Van Dyne, MD, MPH, an epidemic intelligence service officer at the CDC.

The uptick in oropharyngeal SCC could be due in part to “changing sexual behaviors,” including unprotected oral sex, especially among white men, who report having the highest number of sexual partners and performing oral sex at a younger age compared with other racial/ethnic groups, the authors say.

Oropharyngeal SCCs include those at the base of tongue, pharyngeal tonsils, anterior and posterior tonsillar pillars, glos­sotonsillar sulci, anterior surface of soft palate and uvula, and lateral and posterior pharyngeal walls.

The new report was published August 24 in the Morbidity and Mortality Weekly Report.

The study authors defined HPV-associated cancer as “an invasive malignancy in which HPV DNA was frequently found in special studies.” In other words, the new study data reveal the total number of certain cancers that are associated with — but not necessarily caused by — HPV.

A total of 30,115 new cases of HPV-associated cancers were reported in 1999 and 43,371 in 2015.

Overall, the rate of HPV-associated cancers dropped among women (change, –0.4%) during the study period and rose among men (change, 2.4%).

The CDC analyzed data from their National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program for all years from 1999 to 2015. “These data cover approximately 97.8% of the US population,” say the authors.

However, these two population-based cancer registries have a limitation: They tally invasive cancers but not the HPV status of cancers.

The authors point out HPV causes cervical cancer and “some oropharyngeal, vulvar, vaginal, penile, and anal cancers.”

Table. Annual Change in Type of Cancer From 1999 to 2015

Cancer Type Average Annual Change (%)
Cervical –1.6
Vaginal –0.6
Oropharyngeal in men 2.7
Oropharyngeal in women 0.8
Anal in men 2.1
Anal in women 2.9
Vulvar 1.3

Penile cancer rates remained stable during the study period.

The study authors say that the public health implication of the study is that HPV vaccination “can prevent infection with the HPV types most strongly associated with cancer.”

January, 2019|Oral Cancer News|

Five Things To Look Out For In Cancer Research In 2019

Date: 12/28/18
Source: Forbes.com
Author: Victoria Forster

2018 was a remarkable year for cancer research, with great strides made in diagnosing and treating various types of cancer as well as important breakthroughs looking at the health of cancer survivors. What can we expect to see from cancer research in 2019? As a cancer research scientist, here are the top five topics that I’ll be looking out for.

1. Immunotherapy. Who will respond, who won’t respond and why?

Immunotherapy is now seemingly everywhere, with several therapies approved for various cancer types, including CAR T-cells and immune checkpoint inhibitors and several more in development such as tumor infiltrating lymphocyte (TIL) therapy. TILs successfully cleared all tumors from a woman with metastatic breast cancer, in a research breakthrough which was one of the most reported in 2018.

Over 2,500 trials are now registered worldwide, but as the use of immunotherapy grows, there are still major questions to be answered. One particularly important to the use of immune-checkpoint blocking drugs such as those which target PD-1 or CTLA-4 is ‘why do some patients respond whereas others do not?’ Several research teams worldwide are currently grappling with this question, which is unlikely to have a single, clear answer, but I expect to see much more research published on this in 2019, which will hopefully start to benefit patients by identifying who will and won’t respond to these expensive drugs.

2. Liquid biopsy tests. More clarity on precisely what they do and more evidence that they do it accurately.

The liquid biopsy industry has exploded in 2018, perhaps unsurprising given the market is expected to be worth over $2 billion annually by 2022. The promise is that eventually, we should be able to diagnose cancer with a simple blood test, earlier, more cheaply and even more accurately than we currently do and even use these tests to monitor response to cancer treatment and when and if a tumor returns.  As a cancer research scientist, the number of research papers, presentations at top conferences and news releases by the dozens of companies currently developing these technologies can make it a little overwhelming to figure out what is going on.

In 2018, two of the top liquid biopsy tests on the market had their efficacy called into question with researchers from Johns Hopkins suggesting that the two competing tests gave different results with the same patient samples. A claim which was then challenged by representatives from both companies.

Liquid biopsy tests undoubtedly have huge potential and may indeed live up to their hype, but currently, the field is a little messy and difficult to understand for scientists, patients and oncologists who are not specialists. The American Society for Clinical Oncology (ASCO) issued a statement in March of this year essentially concluding that for most liquid biopsy tests there is currently not enough evidence to recommend their use in either the diagnosis or monitoring of cancer. Hopefully, 2019 brings greater clarity about how these tests can fit into the diagnosis and care of people with cancer and ASCO will be able to review their stance accordingly.

3. More focus on the side-effects of cancer treatment.

As a cancer survivor myself and an advocate for more research into what happens to cancer survivors past the ‘all clear,’ 2018 has been a remarkable year for research into the numerous and often disabling side-effects cancer survivors experience. For decades, cancer research has understandably been mainly focused on making sure as many people survive the disease as possible, but now with millions of cancer survivors in the world, a new research field looking at what actually happens to cancer survivors as a result of their treatments is growing at considerable speed.

From a study which hopes to have found a solution to male infertility after childhood cancer treatment to work showing that some women with early-stage breast cancer can have less radiotherapy without compromising their chance of survival, 2018 was a good year for cancer survivorship research. The highlight, in my opinion, was work from Stanford University scientists that may have figured out why ‘chemo brain’ happens, one of the most commonly-reported side-effects that cancer survivors experience. Even better, the scientists suggest that it may be treatable.

4. Cancer and the microbiome.

The microbiome has been one of the most talked about topics in medicine in 2018 and shows no sign of slowing down. Amidst the predictable flurry of supplements, fad-diets and blog posts giving scientifically-questionable advice telling you how to cherish and nurture your own gut flora, plenty of solid, evidence-backed research has been published showing that the microbiome is potentially involved in multiple sclerosis, inflammatory bowel disease and even Alzheimer’s disease. But what about cancer?

There are already several studies published showing that the microbiome can influence the response to chemotherapy drugs and even in some cases cause the production of toxic breakdown products of the drug. Earlier this month, work published in Nature Communications showed how a particular bacterial strain common in the human microbiome could influence the immune system to drive the progression of a currently incurable type of blood cancer called multiple myeloma. The study raised the possibility that targeting these bacteria with drugs could halt or slow the disease.

5. Organoids, the new secret weapon in personalized cancer medicine.

Back in November 2017, I wrote about how organoids, tiny lab-grown organs made from patient tissue samples would revolutionize the treatment of cancer by allowing researchers to test drugs on patient tumors before deciding which to give the patient. Several pharmaceutical and biotechnology companies have large-scale programs to commercially develop these technologies for using organoids in drug screening for patients and the increasing accessibility of organoid growing kits from companies which supply academic and hospital research laboratories mean research papers are coming out thick and fast.

But, organoids are by no means a perfect way to test new drugs yet. For example, it is easy and quick to make organoids from certain tumor types-such as colorectal, but very difficult from others such as brain tumors. Organoids grown in the lab also don’t have a blood supply, nor are they connected to other body systems which may influence the response of a patient to anti-cancer drugs. But researchers are making progress in organoid development all of the time, figuring out better ways to make and culture them so they more accurately reflect the tumor they were originally made from.  Expect to see them playing an increasing role in designing personalized medicine approaches for cancer patients as well as being involved in more lab-based cancer breakthroughs.

January, 2019|Oral Cancer News|

Hospitals required to post all prices online beginning January 1

Date: 12/26/18
Source: KATV
Author: Associated Press

 

Medicare will require hospitals to post their standard prices online and make electronic medical records more readily available to patients, officials said Tuesday.

The program is also starting a comprehensive review of how it will pay for costly new forms of immunotherapy to battle cancer.

Seema Verma, head of the Centers for Medicare and Medicaid Services, said the new requirement for online prices reflects the Trump administration’s ongoing efforts to encourage patients to become better-educated decision makers in their own care.

“We are just beginning on price transparency,” said Verma. “We know that hospitals have this information and we’re asking them to post what they have online.”

Hospitals are required to disclose prices publicly, but the latest change would put that information online in machine-readable format that can be easily processed by computers. It may still prove to be confusing to consumers, since standard rates are like list prices and don’t reflect what insurers and government programs pay.

Patients concerned about their potential out-of-pocket costs from a hospitalization would still be advised to consult with their insurer. Most insurance plans nowadays have an annual limit on how much patients must pay in copays and deductibles — although traditional Medicare does not.

Likewise, many health care providers already make computerized records available to patients, but starting in 2021 Medicare would base part of a hospital’s payments on how good a job they do.

Using electronic medical records remains a cumbersome task, and the Trump administration has invited technology companies to design secure apps that would let patients access their records from all their providers instead of having to go to different portals.

Verma also announced Medicare is starting a comprehensive review of how it will pay for a costly new form of immunotherapy called CAR-T. It’s gene therapy that turbocharges a patient’s own immune system cells to attack cancer.

Immune system T cells are filtered from the patient’s own blood and reprogrammed to target and kill cancer cells that had managed to evade them. Hundreds of millions of copies of the revved-up cells are then returned to the patient’s blood to take on the cancer.

Though only a couple of such treatments have been approved for blood cancers, the cost can exceed $370,000 per patient.

“It’s a new area for the agency,” said Verma. “We haven’t seen drugs priced at this level and we’re having to think about our strategy.”

January, 2019|Oral Cancer News|

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|