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Sentinel node biopsy proves mettle in H&N cancer

Source: www.medpagetoday.com
Author: Ed Susman, Contributing Writer, MedPage Today

Sentinel node biopsy achieved “oncological equivalence” with neck dissection in patients with operable T1-T2N0 oral and oropharyngeal cancer, researchers reported.

In a head-to-head trial, the 2-year neck-relapse free survival (RFS) was 90.7% in the sentinel node (SN) biopsy group versus 89.4% in the neck dissection group, according to Renaud Garrel, MD, PhD, of Montpellier University Hospital Center in France.

That 1.1% difference fell well within the pre-specified 10% difference to determine if there was non-inferiority of SN biopsy to neck dissection, which is considered the standard of care for treatment of early stage head and neck cancers (P=0.008 for equivalence), he reported at the American Society of Clinical Oncology virtual meeting.

At 5 years, 89.4% of the SN biopsy group achieved neck-RFS versus 89.6% in the neck dissection group, he said in a pre-recorded oral presentation on the Senti-MER study.

Overall, there were 14 neck recurrences in 139 patients in the neck dissection group and 13 neck recurrences in 120 patients in the SN biopsy group. Also, overall survival was 82.2% in the SN biopsy group and 81.8% in the neck dissection group.

Hisham Mehanna, MBChB, PhD, of the University of Birmingham and the Warwickshire Head and Neck Clinic in England, commented that “Elective neck dissection is the standard, especially for oral cancer. Sentinel node biopsy is an accepted technique as there have been large series that show benefit, but there has never been a head-to-head study with the standard of care.”

Mehanna, who was not involved in the study, said that several questions remain: “Is sentinel node biopsy as effective as elective neck dissection, is it less morbid, and importantly, is it more cost-effective or as cost-effective, because sentinel node biopsy is resource intensive,” he said.

“The study determined that sentinel node biopsy is non-inferior to elective neck dissection; it has equivalent recurrence-free survival; equivalent locoregional recurrence free survival; equivalent disease-specific recurrence free survival; and equivalent 2- and 5-year survival,” Mehanna added. “It was also less morbid at the 2-, 4- and 6-month assessment point, but showed the same morbidity at 12 months. It also showed better function and less physiotherapy up to the 12-month assessment point and then it was the same as elective neck dissection.”

He called the study a ” significant achievement. We have been talking about it for a long time. So sentinel node biopsy should be considered a standard of care. It should be offered as an option alongside, or instead of, neck dissection.” Mehanna added that “really data on cost-effectiveness will be important if this is going to be adopted widely because sentinel node biopsy is resource intensive and, in my mind, it is much easier just to do an elective neck dissection. Cost-effectiveness will remain an issue.”

Garrel reported that cost-effectiveness is being assessed in an ancillary study.

For Senti-MER, 307 patients at 10 institutions were enrolled. After exclusions, 140 patients had SN biopsy and 139 had neck dissection. Patients were diagnosed with operable cT1-cT2NO oral or oropharyngeal squamous cell carcinomas, and had no history of head and neck surgery, neck surgery, or radiation therapy. Patients had to be able to receive transoral radiotracer injection for lymphoscintigraphy.

Garrel and colleagues found that morbidity was reduced among the patients undergoing SN biopsy. The median hospital stay was 1 day less in the SN biopsy group (P=0.001), while the mean hospital stay also was reduced (P=0.013).

He noted that physical problems in the arm were less common among the SN biopsy patients at the 2-, 4-, and 6-month assessment points, but the differences disappeared at 1 year. Similarly, SN biopsy patients required less physiotherapy at 2, 4 and 6 months, but the differences were not significant at 1 year.

“Senti-MER is a high level of evidence study,” Garrel said. “It establishes that sentinel node [biopsy] is the standard of care among patients with T1-T2NO oral and oropharyngeal cancer.”

Disclosures:
Garrel disclosed relevant relationships with Norgine.
Mehanna disclosed relative relationships with AstraZeneca, Merck, MSD, Sanofi, GlaxoSmithKline, Silence Therapeutics.

Primary Source:
American Society of Clinical Oncology
Source Reference: Garrel R, et al “Equivalence randomized trial comparing treatment based on sentinel node biopsy versus neck dissection in operable T1-T2N0 oral and oropharyngeal cancer” ASCO 2020; Abstract 6501.

Less intense treatment safe for HPV+ throat cancer

Source: www.miragenews.com
Author: public release, University of Pittsburgh School of Medicine

A less intense treatment for human papillomavirus positive (HPV+) throat cancer—using robotic surgery followed by low-dose radiation—could provide as much benefit as standard higher-dose radiation and chemotherapy while preserving a patient’s throat function, and with potentially less toxicities, according to researchers at UPMC Hillman Cancer Center and Yale Cancer Center.

The results of their randomized phase two clinical trial will be presented virtually this week at the American Society of Clinical Oncology (ASCO) annual meeting during the Head and Neck Oral Abstract Session (Abstract 6500).

“These results present a promising deintensification approach that has proven to be safe in patients with intermediate risk, locally advanced oropharynx cancer,” said Robert Ferris, M.D., Ph.D., director, UPMC Hillman Cancer Center and a surgical oncologist specializing in head and neck cancer, who was lead investigator of the trial. The results are not yet published in a peer-reviewed journal.

About 60% of oropharynx cancer, in which cancer cells form in the back of the throat, base of the tongue and tonsils, is associated with HPV infection. The incidence has been increasing in recent years, especially in individuals under the age of 45.

Following robotic surgery, patients with HPV-associated throat cancer would typically undergo high dose radiation and chemotherapy. While robotic surgery allows for more precise and optimal preservation of the organs and surrounding tissue, there is still concern with the toxicities from the chemotherapy and consequences of tissue damage from radiation therapy, particularly in a younger population.

“Most throat cancers caused by HPV have good outcomes, and the cancer doesn’t return or spread to other parts of the body after treatment,” said Ferris, who also is professor, Department of Otolaryngology, of Immunology, and of Radiation Oncology, University of Pittsburgh School of Medicine.

“In this trial, we studied the pathologic features of the tumors obtained at surgery to determine patients’ risk of recurrence—low, intermediate or high—to then administer the right amount of postoperative treatment for each risk group.”

Patients at low risk were observed. Patients at intermediate risk were randomized to two arms of radiation alone, at standard or lower doses of radiation. Patients at high risk were assigned to usual high-dose radiation therapy plus chemotherapy.

For patients at low and intermediate risk, the two-year, progression-free survival rate was approximately 95%, and reducing radiation or chemotherapy intensity did not increase the risk of recurrence.

“The tissue samples and imaging studies collected in the course of this trial are a rich resource for studying the biology of intermediate- and high-risk disease, in work that is ongoing,” said ECOG-ACRIN Head and Neck Committee Chair Barbara Burtness, M.D., professor of medicine, and co-leader, Developmental Therapeutics Program, Yale Cancer Center and Yale School of Medicine.

Note:
The ECOG-ACRIN Cancer Research Group designed and conducted the trial with funding from the National Cancer Institute, part of the National Institutes of Health.

Vaping e-cigarettes could increase the risk of oral disease, study finds

Source: technology.inquirer.net
Author: staff

New American research has found that individuals who use e-cigarettes could be at risk of developing oral diseases in the future, which could range from gum disease to cancer.

Carried out by researchers at The Ohio State University, the new study looked at a group of 123 people with no signs of oral disease. The group included 25 smokers, 25 non-smokers, 20 e-cigarette users, 25 former tobacco smokers who used e-cigarettes and 28 people who smoked both tobacco cigarettes and e-cigarettes.

The team collected plaque samples taken from under the gums of the participants to analyze the bacteria in this part of the mouth; bacteria here is the last line of defense against disease as it is the least likely to be disrupted by environmental changes in the mouth, such as food, toothpaste and tobacco.

The researchers then carried out DNA deep sequencing of the bacteria’s genomes to identify what types of microbes were living in participants’ mouths and what their functions were.

The findings, published in the journal Science Advances, showed that although the e-cigarette users didn’t have signs of active disease, their oral bacteria composition was similar to that of people with severe periodontitis, a severe gum infection that can lead to health problems such as tooth loss, and, if left untreated, is a risk factor for serious conditions such as heart and lung disease.

The effect of e-cigarette smoking was also seen with or without nicotine, which the researchers say suggests that it is the heated and pressurized liquids in e-cigarette cartridges that are making vapers’ mouths a welcoming environment for a dangerous combination of microbes.

Even long-term current and former cigarette smokers had worse oral profiles linked to using e-cigarettes after just three to 12 months of vaping.

“Vaping is such a big assault on the oral environment, and the change happens dramatically and over a short period of time,” said Purnima Kumar, senior author of the study.

“If you stop smoking and start vaping instead, you don’t move back toward a healthy bacterial profile but shift up to the vaping profile,” Kumar explains. “Knowing the vaping profile is pathogen-rich, you’re not doing yourself any favors by using vaping to quit smoking.”

The researchers say this is the first human study on the effects of e-cigarette exposure in the mouth, and like previous research into e-cigarettes, also questions their safety.

Revealed: How cancer unit kept theatres open and saved lives despite coronavirus lockdown

Source: www.sundaypost.com
Author: Janet Boyle

Patients with head and neck malignancies have continued to get vital surgery at Queen Elizabeth University Hospital in Glasgow under strict infection vigilance set up by its maxillofacial surgery unit.

More than 40 patients have been treated for head and neck ­cancer during lockdown. Others have undergone procedures for facial skin cancer and facial injuries.

The Royal College of Surgeons Edinburgh says 87% of its members in cancer surgery had stopped operating altogether or significantly reduced the number of procedures due to the danger of patients contracting the virus. And experts fear deaths from cancer could rise by a fifth over the next year as a result of scores of treatments and consultations being cancelled.

Now it is hoped the protocols ­followed by the Glasgow team can be adopted to allow more surgery to resume. Critical to the safety of the operations is that the patients are tested for coronavirus twice before the procedure – once 48 hours beforehand, and then again immediately before surgery begins.

Patients are also asked to ­self-isolate for two weeks before surgery, the surgical team works in a separate building to the main hospital and some surgical techniques have been modified to reduce the risk of infection.

Operating on head and neck malignancies poses considerable risk to theatre teams because the work is closely associated with patients’ faces and respiratory systems, making the virus easily transmissible.

Further risk lies in the head and neck surgeon having to abandon a face shield to use the operating microscope vital to navigate and sew together tiny nerves and blood ­vessels in the face and throat.

Professor Jim McCaul, a ­consultant maxillofacial surgeon at the QEUH, said: “We never stopped working for our cancer patients. We have been doing major surgery throughout, with massive support from trainees and all of the outpatient, ward and theatre staff and nurses and administration team.

“Recent announcements about introducing a two-week lockdown on patients is what we have been doing from the start. There has been amazing support in theatre and no one hesitated at all about continuing surgery on patients.

“It would not have happened ­without the six other maxillofacial head and neck surgeons, outpatient, ward and administrative staff and many others.

“Our theatre nurses all wear full PPE, even though the patients have tested negative. Some staff are even isolating from their families. I cannot wear a visor at the microscope and that raises the risk, but it is a calculated risk.”

Patients will also need radio and chemotherapy, if the disease is more advanced.

“We also very worried about patients sitting on cancer and ­infection symptoms which will present later. It means more life-­changing treatment and we cannot cure them all,” Professor McCaul added.

Survival from head and neck ­cancer – between 50% and 60% depending on the area of head and neck affected and how advanced when it is diagnosed – has lagged behind other cancers such as breast and leukaemia.

“Cases diagnosed later can need extensive surgery, which can change patients’ appearance and ability to chew, swallow food and speak,” Professor McCaul added.

The Scottish Government is ­working to resume treatment halted during the Covid pandemic.

Discussions are ongoing as to how to take Scotland’s cancer surgery and other operations forward. Surgeons believe the way ahead almost certainly involves continual testing of staff and patients.

Hospitals in other countries have strived to create Covid-free units but emergency admissions of patients with the virus have made that challenging.

Besides operating on cancer patients, the QEUH’s head and neck cancer team has been treating those with facial injuries caused by trauma.

Professor McCaul said: “Only the super-urgent trauma cases have to go to theatre and we can get a test in 24 hours and wear full PPE for that.

“If we need to use plates and screws we use self-drilling screws because the drill generates aerosol.”

Nursery teacher Mandy Peebles was devastated to be diagnosed with mouth cancer at the age of 30.

“Everyone is scared when they are told they have cancer and I was prepared to go to any lengths to get the surgery needed to remove it,” said Mandy, from Cowglen, Glasgow. “I came across the pea-sized lump by accident, while looking for a wisdom tooth coming through. A referral to Glasgow Dental Hospital and a biopsy in December led to an appointment at the maxillofacial unit at the Queen Elizabeth University Hospital in Glasgow.

“Results confirmed it was cancer in January, just as Covid was spreading across mainland Europe to the UK.”

Mandy had two operations, in March and April. She said: “The government warnings about cancer patients being at extra risk made me lock down at home and when I was told by Professor McCaul that I would have to completely isolate I did everything possible to ensure I remained Covid-free. Catching the virus would mean my operation would be cancelled.

“My fiancé Calum is a railways maintenance engineer who works in isolation with PPE so all possible transmission was sealed off.

“I could only see my parents by waving to them when they passed my garden gate and that was heartbreaking.

“Not being able to hug my mum before undergoing surgery was painful for us both. But that’s what it took to get the surgery and I can only thank the surgical team for everything they did.

“I was fully aware that mouth cancer was a hill to climb and early treatment was vital.

“I was isolated in hospital for two days before the op and tested before going into theatre.

“The minutes seemed like hours as I waited for the Covid test results. When they returned negative the feeling of relief was amazing.”

Mandy added: “Calum and I are marrying in exactly a year and I now have everything to live for.”

Study: Regular drinkers can curb chance of getting alcohol related diseases with exercise

Source: www.express.co.uk
Author: Richard Percival

The scientists revealed that heavier drinkers needed to produce greater physical output to offset other deadly diseases associated with drink. Meanwhile, people who recently gave up alcohol could also reduce their chances of getting sick if they exercised more too.

Researchers from the University of Sydney used data from participants aged 30 years and over in ten British population-based health surveys. They then compared this with death rates of alcohol-related cancers which included oral cavity, throat, larynx, oesophagus, liver, colorectal, stomach and additionally pancreas and lung

Using models, they discovered a strong direct association between alcohol consumption and mortality risk of alcohol-related cancers, with a significantly higher risk among ex-drinkers.

They discovered people who drank excessive amounts of alcohol every week (more than 14 units for women and 21 for men) but who did at least seven hours of exercise were less likely to die from these cancers.

The study published in the International Study of Cancer last week added: “Engaging in a recommended level of physical activity attenuated the negative effects of alcohol consumption on alcohol-related cancer mortality.

“This provides valuable evidence of the potential of promoting physical activity as an adjunct risk minimisation measure for alcohol-related cancer prevention.”

It is the first time analysts have looked at the link between exercise and surviving cancers linked with alcohol. Anne McTiernan, a cancer prevention expert at the Fred Hutchinson Cancer Research Centre, said that the evidence between exercise and alcohol “was clear”.

A new tool to predict delays in post-surgical radiotherapy for head and neck cancer

Source: www.eurekalert.org
Author: Medical University of South Carolina news release

More than 65,000 Americans are diagnosed annually with head and neck cancer, which most often occurs inside the mouth and throat. For patients who undergo surgery to treat this cancer, guidelines recommend that prompt initiation of radiotherapy — within six weeks — is critical for best outcomes.

Unfortunately, delays in initiating post-operative radiotherapy (PORT) are far too common. Patients do not always understand the importance of prompt initiation of radiotherapy and may have to overcome other barriers, such as lack of social support and insurance. In addition, health care providers do not always communicate with one another or coordinate care. These avoidable delays have a negative impact on outcomes in a disease that claims almost 15,000 lives in the U.S. each year.

To ameliorate this crisis, a research team at the Medical University of South Carolina has developed and validated tools known as nomograms to help predict treatment delays in high-risk patients based on individualized risk factors. The team was led by Evan Graboyes, M.D., an assistant professor in the Department of Otolaryngology-Head & Neck Surgery at MUSC and a member of the Cancer Control Program at Hollings Cancer Center. The results of the nomogram study were reported in JAMA Otolaryngology-Head & Neck Surgery.

“A nomogram is a graphical representation of a mathematical model that we are using to predict how likely it is that a patient with head and neck cancer may have a treatment delay,” explained Graboyes. “We hope that these nomograms can be used to identify patients at highest risk for treatment delays so that we can target interventions to them to decrease the risk of delay.”

Standard-of-care treatment for patients with head and neck cancer combines surgery, radiation and chemotherapy. However, treatment outcomes remain very poor, and only about 50% of head and neck cancer patients with advanced disease will survive after 5 years.

With the goal of improving the survival rate of patients with head and neck cancer, Graboyes and his team developed and validated two types of nomograms for predicting delays in PORT. The study examined pre- and post-surgical data from 60,766 adult patients with head and neck cancer, grouped into different cohorts.

The first nomogram is based on information available to both the clinician and patient during the surgical consultation. At this point, the patient will know whether he or she is likely going to have surgery followed by radiation therapy. “This type of nomogram will provide a personalized estimate of the risk of delay commencing PORT and can be used to enhance counseling and guide interventions for patients with higher risks of delay,” explained Graboyes.

The findings of Graboyes’ study suggest that stage 4 cancer and oral cavity sites are two of the main variables associated with delayed PORT initiation. Knowing this type of information beforehand will enable patients to obtain pre-surgical dental oncologic treatment referrals and may greatly improve timely PORT introduction.

The second nomogram incorporates information from before and after surgery. According to Graboyes, this nomogram can be used by health care systems to compare their rates of PORT delay in a risk-adjusted fashion that acknowledges differences in the types of patients being treated.

In addition, the nomogram may guide quality improvement initiatives. For example, one of the key factors associated with delayed PORT was prolonged length of stay after surgery. This information may help physicians to reduce the length of time patients stay in the hospital after surgery, eliminating one hurdle to prompt initiation of radiation treatment.

Although the two nomograms were developed in one cohort of patients and validated in a second cohort of patients with head and neck cancer from across the U.S., the study still had some key limitations. The nomogram didn’t account for individual patient education, income, social support, dental disease, smoking or alcohol consumption. Therefore, more research will be needed to understand the degree to which these factors lead to delays in PORT initiation. A future study will help to address some of these limitations.

Graboyes believes that the current study will help head and neck cancer patients get the treatment they need and improve their chance of survival.

“I would love it if patients and clinicians would be able to use the nomogram website to get more precise, quantitative information about the risk of PORT delay and use it to educate patients, counsel them before treatment and communicate risk precisely,” said Graboyes. “We know that getting patients timely head and neck cancer care that follows guidelines is a promising strategy to improve survival among these patients. I hope these nomograms will be a practical and useful tool as we work toward the goal of decreasing treatment delays.”

World-first saliva test detects hidden throat cancer

Source: www.miragenews.com
Author: staff

A simple saliva test developed by Queensland University of Technology (QUT) biomedical scientists has detected early throat cancer in a person who had no symptoms, and no clinical signs of cancer. QUT researchers Associate Professor Chamindie Punyadeera and Dr Kai Tang.

  • A series of saliva HPV tests detected an asymptomatic throat cancer during a trial of a new saliva diagnostic
  • Further validation studies are needed to confirm this finding
  • It is a world-first discovery, previously there was no screening test for HPV-DNA oropharyngeal cancers
  • The patient had surgery in which a 2mm cancer was removed and has had no recurrence of HPV-DNA in his saliva.

In what is believed to be a world-first, the non-invasive test picked up HPV-DNA in a saliva sample from an infected healthy person. Persistent human papillomavirus (HPV) infection is now the leading cause of cancers in the oropharynx (tonsils and tongue base area of the throat).

“The series of saliva tests raised the alert and detected an early cancer before the person had any symptoms,” said QUT Faculty of Health’s Associate Professor Chamindie Punyadeera, who, with Dr Kai Tang developed the test.

“This enabled removal of the tonsil which had a 2mm cancer in it, by straightforward local surgery alone.

“The incidence of high-risk human papillomavirus (HPV)-driven throat cancers is on the rise in developed countries and, unfortunately, it is often discovered only when it more advanced, with patients needing complicated and highly impactful treatment.

“In the US, HPV-driven throat cancers have surpassed cervical cancers as the most common cancer caused by HPV but unlike cervical cancer, up until now, there has been no screening test for this type of oropharyngeal cancer.”

Professor Punyadeera said the discovery was made during an HPV-prevalence study which included 665 healthy individuals.

“To take the test all the person has to do is give a salivary oral rinse sample. When the test shows HPV-16 DNA, it is repeated and if the presence of HPV-16 is persistent over a period of time we would be suspicious that there may be underlying cancer.

“The person whom we reported in this study had been consistently HPV-16 DNA positive for 36 months, with a steadily rising count of HPV-16 DNA after testing at 6, 12 and 36 months.

“The patient was found to have a 2mm squamous cell carcinoma in the left tonsil, treated by tonsillectomy. This has given our patient a high chance of cure with very straightforward treatment.

“Since the surgery, the patient has had no evidence of HPV-16 DNA in his saliva.”

Professor Punyadeera said this was the first-ever case of histologically confirmed diagnosis of an asymptomatic, hidden throat cancer, diagnosed with a saliva screening test and that wider validation studies were required to confirm this finding.

“The presence of this pattern of elevated salivary HPV-DNA must be fully evaluated, as it may provide the critical marker for early cancer detection.

“We now have the promise of a screening test for oropharynx cancer and there is an urgent need to undertake a major study to validate this test and the appropriate assessment pathway for people with persisting salivary HPV-DNA.

This research is part of a collaboration with Royal Brisbane and Women’s Hospital’s Professor Liz Kenny, Dr Sarj Vasani, Dr Touraj Taheri and Associate Professor Brett Hughes and University of Queensland’s Professor Laurence J. Walsh.

Source:
The study, An Occult HPV-Driven Oropharyngeal Squamous Cell Carcinoma Discovered Through a Saliva Test (https://www.frontiersin.org/articles/10.3389/fonc.2020.00408/full), was published in Frontiers in Oncology.

Liquid biopsy accurately detects HPV+ oropharyngeal cancer recurrence

Source: www.medpagetoday.org
Author: Zeena Nackerdien PhD, CME Writer, MedPage Today

In general, HPV-positive OPSCC has a favorable prognosis as compared with HPV-negative disease, which has supported efforts to de-intensify treatment regimens to reduce exposure to potentially toxic therapies. Positron emission tomography/computed tomography (PET/CT) imaging 3 months after definitive treatment is standard for response assessment in many cases.

However, the disease will recur in up to 25% of patients, depending on clinical risk factors and tumor biology. The latency period prior to OPSCC recurrence is 2 years for many patients, but rare case reports have described latency periods exceeding 5 years.

Currently, National Comprehensive Cancer Network (NCCN) guidelines recommend surveillance of patients with HPV-associated OPSCC every 1 to 3 months for the first year, every 2 to 6 months for the second year, every 4 to 8 months for years 3 to 5, and then once a year thereafter.

Because the oropharynx can be a difficult anatomic location to evaluate — a process that may be further obscured by treatment-related tissue changes — radiologic imaging studies have been used in cancer surveillance for this disease.

According to study findings published in the Journal of Clinical Oncology, a blood test for tumor-associated HPV-DNA had near-perfect accuracy for identifying OPSCC patients at high risk of recurrence after treatment.

The findings have clear and immediate implications for clinical practice, including earlier initiation of salvage therapy for patients with recurrent disease, reported Bhishamjit S. Chera, MD, of the UNC Lineberger Comprehensive Cancer Center in Chapel Hill, North Carolina, and colleagues.

The negative predictive value (NPV) of 100% and positive predictive value (PPV) of 99% of recurrence detection by this method compared favorably with alternative and emerging post-treatment surveillance strategies.

The findings extended those of a previous report, which showed that a persistently negative ctHPV-DNA test ruled out disease recurrence.

“With regard to how this is applicable to clinical practice, I think it improves the effectiveness, it improves the efficiency, and it reduces the cost and financial toxicity to patients,” Chera told MedPage Today.

Chera and colleagues prospectively evaluated a ctHPV-DNA liquid biopsy in 115 patients who had completed definitive chemoradiotherapy for HPV-positive OPSCC. Each patient had PET/CT imaging 3 months after finishing treatment. The researchers tested patients for ctHPV-DNA at 6- to 9-month intervals.

During a median follow-up of 23 months, 28 patients tested positive for ctHPV-DNA, indicating a possible recurrence, including 16 patients who had two consecutive positive tests. Also during follow-up, 15 patients developed biopsy-proven recurrence of OPSCC; all 15 had two consecutive positive tests for ctHPV-DNA. The median time from ctHPV-DNA positivity to recurrence was 3.9 months.

Consecutive positive tests had a PPV of 94%. The previous report from the study showed that a negative test had an NPV of 100%.

For the 87 patients who tested negative for ctHPV-DNA, none developed recurrence.

“In this study, we had accumulated enough follow-up data to see who was going to develop recurrence and who wasn’t,” said Gaorav Gupta, MD, PhD, assistant professor in the department of radiation oncology at UNC School of Medicine, in a press release. “That allowed us to determine that the test performs best if you look at two consecutively confirmed blood tests.”

Chera and team did acknowledge that heterogenous clinical factors (intensity of treatment, tobacco pack-years, use of chemotherapy) might have impacted the pattern and frequency of disease recurrence in this study. Other study limitations included the fact that the results for the ctHPV-DNA assay used in this study might not apply to alternative ctHPV-DNA assays.

Since there is no “gold standard” for surveillance imaging, the researchers chose the more stringent criterion of biopsy-proven recurrence to define a change in disease status. They added that a shorter interval between ctHPV-DNA testing (e.g., every 3 months) would more precisely define the extent of earlier detection.

Source Reference: Journal of Clinical Oncology 2020; DOI: 10.1200/JCO.19.02444

    Study Highlights and Explanation of Findings:

While imaging and image-guided procedures play important roles in the screening, diagnosis, and surveillance of cancer, serial monitoring for disease recurrence can be a costly, invasive, and cumbersome process.

“We developed a technology that enabled us to distinguish HPV DNA that came from a tumor from HPV that’s simply related to infection,” said Gupta.

“The way I see this working in the clinic is that if you have a negative test, we don’t do a fiberoptic exam, we don’t order any imaging,” said Chera. “If you have a patient whose surveillance test is positive, we would bring the patient back 2 or 3 months later and repeat the blood test. If it’s positive again, then we would do an in-depth physical examination; we would do a fiberoptic exam and order a total-body PET/CT scan. This test can help us better identify which patients we can omit imaging in and those patients we can do imaging in.”

The test very well could have value in the management of patients with other types of HPV-related cancers, he said. The researchers have already examined the rate of ctHPV-DNA clearance as a biomarker for response to treatment and a possible decision-making tool for treatment de-escalation.

The testing technology has been licensed to Naveris for commercial development, and multiple medical centers have already partnered with the company to conduct studies across a variety of HPV-related diseases, said Chera.
Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College

References:
Chera BS, et al “Plasma circulating tumor HPV DNA for the surveillance of cancer recurrence in HPV-associated oropharyngeal cancer” J Clin Oncol 2020; DOI: 10.1200/JCO.19.02444.

Bankhead C “Blood Test Spot On for HPV Cancer Recurrence”, MedPage Today 2020-4-09.

April, 2020|Oral Cancer News|

Which cancers have increased over the past decade?

Source: www.mdlinx.com
Author: Naveed Saleh, MD, MS, for MDLinx

The incidence of cancers at the level of the oral cavity and pharynx increased between 2007 and 2016, according to a recent report by researchers from the CDC published in Morbidity and Mortality Weekly Report. This rise occurred despite respective decreases in the incidence of cancers at various anatomic sites.

Cancers of the oral cavity and pharynx make up 3% of cancers diagnosed in the United States each year, with risk factors including tobacco use, HPV infection, and excessive alcohol intake.

“The overall increase appears to be driven by increases in cancers of the tonsil, base of tongue, oropharynx, and other cancers of the oral cavity and pharynx, which are HPV-associated, as well as by those of gum and anterior tongue,” wrote the authors.

Breaking down the numbers
On average, the incidence rates for cancers of the oral cavity and pharynx combined increased by 0.6% per year between 2007 and 2016, with specific increases as follows:
Oral cavity and pharynx (3.4%)
Base of tongue (1.8%)
Anterior tongue (1.8%)
Gum (1.9%)
Tonsil (2.4%)
Oropharynx (1.9%)

For the following cancers, however, incidence rates decreased:
Soft palate and uvula (−3.7%)
Hard palate (−0.9%)
Floor of mouth (−3.1%)
Lip (−2.7%)
Hypopharynx (−2.4%)
Nasopharynx (−1.3%)

Of note, the incidence of cheek and other mouth and salivary gland cancers remained unchanged.

April, 2020|Oral Cancer News|

Novel intervention looks to improve timeliness, equity of head and neck cancer care delivery

Source: www.miragenews.com
Author: staff report, Medical University of South Carolina

Many factors go into surviving cancer.

Hollings Cancer Center researcher Evan Graboyes, M.D., specializes in head and neck cancer, a disease with poor survival prospects despite intense therapy with combinations of surgery, radiation and chemotherapy. While head and neck cancer only accounts for 4% of all cancer cases each year in the US, it has a high mortality rate. The American Cancer Society estimates that more than 14,000 patients died from this disease in the U.S. in 2019.

Overall, only 50% of head and neck cancer patients are alive at five years. Unfortunately, the mortality rate is even worse for African American head and neck cancer patients. That’s why researchers are looking for new strategies to improve patient survival and decrease racial disparities in outcomes for these patients.

Graboyes and MUSC Hollings Cancer Center researchers Chanita Hughes-Halbert, Ph.D., Katherine Sterba, Ph.D., Hong Li, Ph.D., and Graham Warren, M.D., Ph.D., have teamed up to develop and test a novel intervention to improve the timeliness, equity and quality of head and neck cancer care delivery, which they think might one day be the key to improving survival for these patients.

Funded by a $1.3 million 5-year grant from the National Cancer Institute, their study – Improving the Timeliness and Equity of Adjuvant Therapy Following Surgery for Head and Neck Cancer-started in September 2019 and built upon important research funded by grants from Hollings Cancer Center.

Graboyes explained that for patients with advanced head and neck cancer who are treated with surgery, national guidelines recommend that postoperative radiation therapy should start within six weeks of surgery.

“However, we know from our research that despite national guidelines, over half of the patients nationally don’t get radiation started in a timely fashion. Patients who have delays with radiation are more likely to die and have their cancer recur,” he said. “We are trying to find new ways to deliver timely head and neck cancer care. It’s an appealing way to help improve survival for this group.”

Innovative approach
The study is designed in three parts. The first part aims to identify the underlying reasons for why delays starting postoperative radiation are so common for this patient population. The researchers then developed a new multilevel health care delivery intervention called NDURE (Navigation for Disparities and Untimely Radiation thErapy), that specifically targets the barriers that lead to delays.

In the second part of the grant, the researchers will pilot the NDURE intervention in a small group of patients to make sure that it’s feasible and acceptable and refine the intervention based on participant feedback. In the third and final part of the study, they will compare NDURE to standard care in a randomized controlled trial to see whether NDURE is effective at decreasing treatment delays.

“This study interests me because it is clinically important. To help patients with head and neck cancer live longer, you don’t need to invent a new drug. All you need to do is get them the treatment they’re supposed to be getting. If we can find a way to deliver timely guideline-recommended care, it could have such a large impact on their survival,” he said

“It’s also a scientifically important study. Head and neck cancer treated with surgery followed by radiation is a great model system for us to understand how we deliver cancer care. Right now, we spend a lot of time and effort helping get people in to initiate cancer care. However, we understand a lot less about how cancer patients move through complicated treatment plans.”

Graboyes said South Carolina is primarily a rural state with some geographic barriers that present obstacles for patients to navigate. “Many of the patients will have surgery at a regional center like MUSC, then because radiation is five days a week for six weeks, they’ll get radiation at a different facility closer to where they live. We have to coordinate cancer care across health care systems, which presents some barriers that can lead to treatment delays.”

Graboyes emphasized that head and neck cancer is a major concern for the state of South Carolina and Hollings Cancer Center, a National Cancer Institute-Designated Cancer Center. The two major causes of head and neck cancer are smoking and human papillomavirus (HPV). The state’s population is affected by both, due to high rates of tobacco use and very low rates of HPV vaccination.

“As a result, Hollings has recognized this issue and has really invested a lot in the clinical enterprise of head and neck cancer because it’s such a problem in South Carolina.”

Hollings also has a strong cancer control program dedicated to reducing issues of health disparities and equity in the state, he explained.

“We think that NDURE, our intervention targeting the multilevel barriers to timely head and neck postoperative radiation, will be an effective way to help improve timely cancer care delivery for these patients, which will lead to higher rates of survival and low recurrence and decrease racial disparities and outcomes. That’s very exciting to our team.”

Did you know?
About 70% of cancers in the oropharynx (which includes the tonsils, soft palate and base of the tongue) are linked to HPV.

Dedicated to the mission of raising HPV vaccination rates for teens and young adults, Hollings Cancer Center has initiated a $700,000 three-year project. The Centers for Disease Control and Prevention recommends speaking with a doctor about the HPV vaccination. The HPV vaccine can prevent new infections with the types of HPV that most often cause oropharyngeal and other cancers.

April, 2020|Oral Cancer News|