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Silent no more: Woman lends voice to hope after cancer

Source: health.ucsd.edu
Author: Yadira Galindo

Singing hymns in church has always brought Cynthia Zamora joy. Today, her once sharp intonation has given way to a raspy voice. But Zamora is thankful that she has a voice at all after spending three months without the ability to utter even one syllable.

“I miss going to church and singing with people,” said Zamora. “Although, if I am in the back I’m still singing. I’m just hoping they don’t hear what sounds like a 13-year-old pubescent boy back there, because that’s how I sound. I know God thinks it’s beautiful, so I don’t worry about it. I just go on with life.”

In 2017, Zamora bit her tongue while sleeping, splitting her tongue nearly in half. She was referred to a specialist when her wound would not heal. They found a 5.4-centimeter tumor that enveloped more than half of her tongue. To save her life, her surgeon, Joseph Califano, MD, delivered grim news: Zamora would have to undergo a glossectomy — the surgical removal of all or part of the tongue.

“By the time I saw her she was really having a hard time speaking and swallowing,” said Califano, director of the Head and Neck Cancer Center at UC San Diego Health. “With Cynthia that was a difficult discussion because it was unclear how much tongue we would save and how good the function would be with the remaining tongue that would be preserved.”

A multidisciplinary team of experts that included medical oncology, surgical oncology, reconstructive surgery, radiation oncology, speech therapy, nutrition, psychiatry and a host of others came together to design a comprehensive plan to eradicate an aggressive, stage IV squamous cell carcinoma and deliver the best quality of life for a woman who was about to undergo a catastrophic surgery.

“The tongue is critical. It’s one of the strongest muscles we have in our body. In speech, our tongue is moving so rapidly within the confines of our mouth in order to generate and make certain sounds in conversation that we find it’s hard to grasp how complex that action is,” said Liza Blumenfeld, speech-language pathologist at Moores Cancer Center at UC San Diego Health. “Without a tongue you’re having to compensate for all of that movement with other structures, your lips, your cheeks and your jaw.”

During a 12-hour surgery, Califano would remove a large portion of Zamora’s tongue and place a breathing tube and feeding tube before a reconstructive microsurgeon would step in to replace the portion of tongue that was removed.

“The primary goal of surgery is to remove the cancer as best we can while sparing as much normal tissue as possible,” said Califano. “It was a challenging surgery in that we had to cut just right to save enough tongue so that she would have some function and we could still get well around the tumor. We were able to save less than half her oral tongue. That wasn’t a lot.”

Ahmed Suliman, MD, a plastic surgeon who specializes in reconstruction after cancer treatment, was tasked with reconstructing her tongue.

“When you remove the majority of the tongue you can’t really function,” said Suliman. “You can’t swallow and articulation is limited. We had to rebuild a tongue to provide bulk so that Cynthia could move food in her mouth in order to swallow and to speak.”

He used a method called anterolateral thigh perforator flap (ALT). Suliman cut a 6 by 8 centimeter tissue of skin and fat from Zamora’s leg to shape and create a new tongue. The replacement tongue does not move, but because Califano was able to spare the base of her original tongue, Suliman was able to reconstruct using the remaining tongue base to preserve some movement for Zamora. Suliman sutured the new tongue, attaching one artery and a vein from the neck using a microscope.

The reconstructive surgery and dissection of cancerous tissue in her tongue and lymph nodes left Zamora temporarily unable to walk, talk or eat. One of the advantages of performing an ALT is that minimal thigh muscle, or none at all, is cut when extracting tissue for the new tongue. This allows for a faster recovery because Zamora did not lose leg muscle function, so with physical therapy Zamora was on her feet fairly quickly.

Skin and fat tissue are more resilient to radiation therapy than muscle, said Suliman, making this tissue more ideal for someone like Zamora, who received treatment following surgery.

“The success of management of these advanced cancers rely on the coordinated efforts of a multi-disciplinary oncologic team,” said Suliman. “This leads to better planned surgery, good preoperative and post-operative care, and follow up. The success of complex cases is higher and outcomes are better, as demonstrated by Cynthia.”

While Zamora was undergoing physical therapy and speech therapy, she was also undergoing chemotherapy, radiation and was receiving an experimental immunotherapy called Pembrolizumab (Keytruda), an antibody that inhibits the abnormal interaction between the molecule PD-1 on immune cells and the molecule PD-L1 on cancer cells, allowing the immune cells to recognize and attack tumors. Pembrolizumab is FDA-approved for some cancers, such as melanoma but is still under a clinical trial for squamous cell carcinoma of the head and neck .

While Zamora continued aggressive treatment and attended physical therapy, she also met with Blumenfeld.

“Teaching somebody to regain their speaking and swallowing abilities during head and neck cancer treatment is really difficult,” said Blumenfeld. “Being able to understand what their abilities were like before, and being able to understand what their new normal looks like, helps us play on their strengths and their ability to compensate with other structures.”

Blumenfeld and Zamora worked together targeting the sounds that she had problems expressing. Zamora had to slow her speech and exaggerate each sound, compensating with her vocal chords for sounds she can no longer make with her tongue.

It is a tedious process but in three months Zamora was speaking well again.

“Previously, I was well pronounced with an expansive vocabulary. I had to be patient with myself and use more expressions in my eyes, hands and face. Sometimes I have to pick words I wouldn’t normally use because I can’t use my original vocabulary. Quality is better than quantity,” said Zamora.

“You have to want to be able to communicate in order to talk, and I wanted that more than anything, because I am a person who loves to communicate. I haven’t got singing down yet, but hopefully that will come.”

Zamora’s vocal chords are healthy and with time, patience and modifying her technique, Blumenfeld thinks that Zamora will be singing “proudly, loudly sometime soon.”

“There are people that come into your life as patients and your mind is blown by their strength of character, their humor, their wisdom, and their willingness to fight. Cynthia really embodies all of those things,” said Blumenfeld. “From the first day she was insistent that she was going to come out of this as a stronger, better person. She has really shown me, even in my own personal life, to never give up and to set your mind on a set target, and you simply do not deviate from that.”

In addition to regaining her speech, Zamora would need to relearn to eat. This was her last hurdle to recovery. It was only in early 2018 that she began to eat without a feeding tube.

“I would encourage everybody to think for a moment of what life would be like. Grab your tongue with your teeth and try to talk without a tongue. Try to think about, when you take a bite of a sandwich, everything that’s going on in your mouth,” said Blumenfeld. “In order for us to be able to chew, we have to be able to manipulate food, move it from one side of our mouth to the other side of the mouth. We have to be able to organize all that food on top of our tongue and propel that food backwards in order to swallow it. Without a tongue that becomes almost an impossible task.”

Thankfully, Zamora mastered the ability to eat again and laughs when recalling eating half a lava cake in front of her shocked family during a restaurant outing. She eats crispy fried chicken and just about anything she wants.

“With a little patience and care, and one step, baby steps, along the way, you can do anything,” said Zamora. “Look at me. I had no tongue, and I’m talking. I’m eating. I’m drinking. I’m doing great. There is life after this surgery. Don’t give up. Keep going. Be strong. Be stubborn. You can do it, you can.”

Smoking warning labels could need a refresh to inform public of new health risk discoveries

Source: www.abc.net.au
Author: Tegan Taylor

When it comes to the health risks associated with smoking, most people know about lung cancer and heart disease. But less than a third of Australians realise it can also cause conditions such as acute leukaemia and rheumatoid arthritis, according to a new study, raising the question around whether current graphic cigarette warning labels need to be refreshed.

The study, published in the Medical Journal of Australia, asked 1,800 Australians about whether they thought smoking increased the risk of 23 conditions shown to be associated with tobacco use, such as lung cancer, stroke and diabetes.

While more than eight in 10 participants knew lung, throat and mouth cancers, heart disease and emphysema were linked to smoking, much fewer were aware it was associated with erectile dysfunction, female infertility, diabetes and liver cancer.

The results showed the current warning labels were doing their job, and that it might be time to expand them, said Michelle Scollo from Cancer Council Victoria, which ran the study.

“It was predictable and pleasing that smokers knew about the health effects that have been highlighted in the current sets of warnings and media campaigns,” Dr Scollo said.

“[But] fewer than half realised it could reduce your fertility, and that could have a really major impact on the course of people’s lives … There’s a lot that people need to appreciate.

Part of the reason the link between smoking and some of the conditions surveyed aren’t well known is because research into the health effects of tobacco use has advanced since the time the current warnings were developed, Dr Scollo said.

The current set of graphic warning labels have been in place since 2012.

“In 2014, the US Surgeon-General released a 50-year report — they released a whole updated statement of the diseases caused by smoking. Many more conditions were added to the list in 2014,” she said.

“These health warnings came into effect in 2011-12 and a lot more things have been established. Liver cancer, colon cancer … diabetes, erectile dysfunction.”

Dr Scollo hoped the research would lead to an expanded campaign including new graphic warning labels, showing more of smoking’s health risks.

“People need continuous reminders of these sort of things if they’re going to remember them but I don’t see why we need to be limited to just 14 warnings,” she said.

“I think we need as many warnings as we need to adequately warn people about the risks they face.”

Anti-smoking messaging doesn’t always resonate with people from marginalised groups. (AAP: Dave Hunt, file photo)

There is value in looking at people’s awareness of smoking’s risks, according to Australian National University anthropologist Simone Dennis, who researched the effects of the original graphic warning label campaign.

But she cautioned against automatically reaching for more graphic warning labels as the solution.

Health warnings about smoking were usually framed around a “particular middle-class version of health” and the assumption that more knowledge will change people’s behaviour, said Professor Dennis, who was not involved in the most recent study.

She said the original graphic warnings were effective in reducing smoking, especially among white, middle-class people, but doubted refreshing the campaign would see a similar reduction.

“I don’t know that the constant articulation of danger is doing anything for the people who are smoking,” she said.

The danger, Professor Dennis said, was that people whose behaviour wasn’t changed by the warning labels tended to be from marginalised groups, and pushing the same line risked marginalising them further.

“If you’re marginalised already, that’s a really heavy burden to bear because you’ve done something that’s perceived to be extraordinarily dangerous,” she said.

“[The campaign] missed them last time, they kept smoking, it’s probably going to miss them again. And that’s consequential because those are the people who are going to die.”

11 Things You Need to Know About the HPV/Oral Cancer Connection

Source: thirdage.com
Author: Dr. Susan Maples

Maybe you think that because you’ve been vaccinated against the human papillomavirus (HPV) you’re in the clear when it comes to cervical cancer. Maybe you think that since you don’t drink or smoke that you can’t get oral cancer. Here are some surprising and sobering facts.

  1. So much of what we hear about HPV has to do with cervical cancer;
    however, we have more adults with oral cancer from HPV than cervical cancer.
  2. Oral cancer from HPV affects both women and men.
    By 2020, the number of HPV-related oral cancers in middle-aged men is expected to surpass rates of cervical cancer in women. Both boys and girls should be vaccinated for HPV at age 11 or 12 to not only lower the risk of oral cancer, but also lower the risk of cervical cancer for females and penile cancer for males.
  3. Among newly diagnosed cases of oral cancer, the fastest-growing segment is people under 40 infected with HPV type-16.
    Even with this knowledge, in 2017, vaccination rates only rose to 46% in girls and 26% of boys. It seems that de-escalating this trend will take a very long time.
  4. Just because you’ve been vaccinated against HPV doesn’t mean you are in the clear.
    There are 200 known HPV strains, including the garden varieties that cause warts on your fingers and feet, and 25 types of HPV virus have been associated with oropharyngeal cancer. The most recent Gardasil vaccine (released in 2017) only helps protect against nine of the most dangerous strains. In addition, we don’t know yet when the protection drops off and if re-vaccination will be as effective.
  5. For decades, tobacco (smoking and smokeless) was the leading cause of oral cancer.
    Now, HPV takes the lead, by more than 10 times the risk of smoking. Other causes of oral cancer are alcohol, genetics and being over 40 years old.
  6. An early oral cancer diagnosis is absolutely critical for survival, otherwise you could be left unable to swallow or chew and suffer severe disfigurement from surgery to remove tumors.
    At your next dental checkup, insist that your dentist does an oral cancer screening.
  7. The number of oral cancers has increased over a seven-year period.
    In fact, one person every 20 minutes of every day, all year long, is getting cancer caused by HPV.
  8. Your dentist or hygienist should be checking your mouth for oral cancer, but there is no effective screening for HPV oral cancer.
    It is usually hiding behind the tonsil folds, in the back of the mouth, in the throat or at the base of the tongue. Your saliva can be analyzed for the presence of 51 HPV strains, and if positive you can build an individualized strategy for early clearing of the virus and/or early cancer detection.
  9. Unlike some viruses (like herpes simplex), human beings can “clear” an HPV infection, provided they have good “host immune response,” meaning good overall health.
    Clean living—meaning good sleep, a whole foods diet, hydration, refraining from smoking (of any kind), refraining from heavy alcohol/drugs, losing weight (if overweight/obese) and avoiding undue stress, may eliminate the virus. If your body doesn’t clear the virus on its own, you carry a persistent HPV infection, making you more susceptible to cancer.
  10. The HPV vaccine is covered by health insurance until age 21 in boys and age 26 in girls.
    Contrary to what you may have heard, if you are beyond the covered benefit age for vaccination, you can still act as your own health advocate. If you’re willing to spend $200-$300 out of pocket, you can get vaccinated at a local pharmacy.
  11. The average age of the first exposure to oral sex is now 10 to 13 years old.
    We need to spread the word among children, adolescents, teens and young adults that oral sex is not safe sex and can lead to HPV transmission.

Note:
Dr. Susan Maples is author of “Blabber Mouth: 77 Secrets Only Your Mouth Can Tell You to Live a Healthier, Happier, Sexier Life,” and an expert in the oral health and systemic health connection.

Changes in cancer staging: what you should know

Source: health.clevelandclinic.org
Author: staff

When you learn you have cancer, you want to know what to expect: How will doctors treat your illness? How effective is treatment likely to be?

Much depends on the way doctors first classify, or “stage,” your cancer, using the official staging manual from the American Joint Committee on Cancer. Staging guidelines continue to evolve as knowledge about individual tumor growth and innovative technologies come into play.

An ever-evolving system
“Historically, we staged cancers according to tumor size, lymph node involvement and the presence of metastases,” says oncologist Dale Shepard, MD, PhD.

“The latest staging manual incorporates new findings on the importance of changes in molecular DNA and tumor genomic profiling. This will affect many patients going forward.”

Among those most impacted by changes in staging are people newly diagnosed with breast cancer; head and neck cancer caused by human papillomavirus (HPV); or sarcoma.

How staging works
“Staging allows us to stratify patients into groups based on anatomic and other criteria. It gives us a framework for understanding the extent of disease,” Dr. Shepard explains.

Cancers are staged clinically and pathologically:

  • The clinical stage is determined during the initial workup for cancer.
  • The pathologic stage is determined by studying a surgically removed tumor sample under the microscope.

Adds Tumor Registry Manager Kate Tullio, MPH, MS, “Staging helps physicians and other researchers to compare patients with the same types of cancer to each other in a consistent way — so that we might learn more about these cancers and how to effectively treat them.”

Staging allows doctors to determine the best course of treatment for different types of cancer and helps families to understand the prognosis, or likely outcome, of that treatment.

It also allows doctors to offer patients a chance to participate in clinical trials of new therapies targeting their form of cancer.

The impact of DNA changes on breast cancer
In the past, most breast cancer patients with lymph node involvement were automatically classified as stage II or higher, and were often given chemotherapy.

“Previously, physicians considered only tumor size, lymph node involvement and spread of the cancer to distant areas of the body when staging breast cancer,” says Ms. Tullio.

Today, staging has improved with the addition of advanced multi-gene panel testing and specific information on the biology of the tumor.

“This incorporates what we have found clinically: that some patients previously identified with stage II breast cancer did better than others,” says Dr. Shepard. “In essence, patients with HER2-positive disease were more like patients with stage I disease.”

HPV’s effect on head and neck cancers
The classification of head and neck tumors has changed because of advances in genomic profiling.

“We now have a separate system for classifying head and neck cancer caused by HPV infection because we realize that, clinically, it is a different disease,” says Dr. Shepard.

Ms. Tullio notes that patients with head and neck cancers caused by HPV have a better prognosis — living longer, on average, than head and neck cancer patients without HPV.

“Patients with HPV-positive mouth or throat cancers usually respond well to treatment and may need less aggressive therapy than those who are HPV-negative,” she says.

Also new, adds Dr. Shepard, are separate classification systems for soft-tissue cancers called sarcomas. Doctors have found that, based on the primary tumor’s location, sarcomas will behave and respond to treatment differently.

How will these changes affect you?
The impact of these staging changes will be far greater for patients with cancers diagnosed on or after Jan. 1, 2018.

“If your cancer is new, then changes in classification may affect early decisions about your initial care and likely prognosis,” says Dr. Shepard.

If you received a cancer diagnosis before that date, the stage of your tumor will not change, Ms. Tullio notes. However, new data in the manual may allow your doctors to better assess and treat you.

Adds Dr. Shepard, “Talk to your doctor if you have any questions about the new staging systems. It’s important to be sure all the right tests are ordered to accurately assess your cancer.”

New mouthwash formulation may help to relieve symptoms of dry mouth, study finds

Source: sjogrenssyndromenews.com
Author: Iqra Mumal

Individuals with dry mouth, including those with Sjögren syndrome, may benefit from using a moisturizing mouthwash with cetylpyridinium chloride, a new study shows.

The study, “A randomized controlled study to evaluate an experimental moisturizing mouthwash formulation in participants experiencing dry mouth symptoms,” was published in the journal Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology.

Dry mouth is a common problem and has been reported by up to 47 percent of people at some point in their lives. Dry mouth tends to have a higher prevalence in older individuals and is more likely to occur in women.

Many factors can cause dry mouth, including Sjögren syndrome. However, many people, particularly those with Sjögren syndrome, may underestimate their levels of oral dryness and may never seek professional help.

Sipping water can temporarily help patients relieve the sensation, but it has limited effectiveness.

Researchers in this study set out to determine if symptom relief can be obtained from a newly developed moisturizing mouthwash. While the formulation used to make this mouthwash is similar to those previously available, a different preservative system that incorporates cetylpyridinium chloride (CPC) instead of parabens was used.

Researchers recruited patients with self-reported dry mouth, some of whom had Sjögren syndrome. To determine the mouthwash’s effectiveness, researchers used questionnaires both before and after use.

The product performance and attributes questionnaire (PPAQ) previously has been validated as an appropriate tool to determine the efficacy of dry-mouth products. Participants were randomized to receive either the experimental mouthwash or water only. For eight days, the mouthwash group used 1-2 doses per day at home. Both groups were allowed to sip water if needed.

Supervised treatment took place on days 1, 3, and 8. During treatment, before and after administration, participants completed the PPAQ, parts 1 through 4.

The primary endpoint of the study was relief of dry mouth symptoms, as determined by question 1 of the PPAQ3 — “Relieving the discomfort of dry mouth” — at 120 minutes after use of the experimental mouthwash or water, after eight days of treatment.

Researchers found that individuals in the mouthwash group had significantly more relief of dry mouth symptoms versus participants in the water-only group. Patients without Sjögren syndrome seemed to favor the mouthwash, but this was not the case in patients who had the syndrome. Regarding safety, eight non-serious, treatment-related adverse events were reported by the mouthwash group.

“The findings of a subjective questionnaire showed that an experimental moisturizing mouthwash provided greater relief than water only from dry mouth symptoms over 8 days,” investigators concluded.

“The study shows that efficacy and oral tolerance are retained with the use of CPC as a preservative and adds weight to the use of PPAQ as a measure to distinguish dry mouth remedies,” they added.

Aussie researchers discover way to reverse drug resistance in major cancer

Source: www.xinhuanet.com
Author: staff

Australia’s University of Queensland researchers on Thursday said they have discovered a way to reverse drug resistance in skin and mouth cancers, by adding a new drug to an existing treatment.

The squamous cell carcinoma form of skin and mouth cancer “was curable when diagnosed early but difficult to eradicate once the cancer spread,” the university’s Associate Professor Nicholas Saunders said in a statement. The cancer kills about 1,400 Australians each year, he said.

“The drugs used to treat squamous cell carcinomas that have spread to other parts of the body only work for a small fraction of patients.

“In our study, we successfully added a new drug to an existing treatment to make squamous cell carcinomas responsive to treatment,” said Saunders.

The researchers found that a particular protein was controlling drug resistance in the affected cells and by administering a drug that helps keep it in the relevant cell nucleus, the cancer cells would react to existing chemotherapeutic treatments, said Saunders.

Another way to diagnose head, neck cancer

Source: www.business-standard.com
Author: staff

It is quite common that head and neck cancers are often diagnosed late. However, with the new research conducted in Germany, it is now possible to detect and diagnose the oral squamous cell carcinomas (OSCCs), most common head and neck cancers, at an earlier stage.

The researchers, who tested mechanical properties of OSCC cells, found them to be ‘softer’ than benign cells.

Lead authors Josef Kas and Torsten W. Remmerbach said, “Early diagnosis and treatment of OSCCs is essential to enabling recovery. But in up to 60 percent of cases, the diagnosis is late because the growth has not been recognised, or has been mistaken as harmless.”

The research team examined if cells’ mechanical properties could be used as a marker for malignancy. As well as being softer than benign cells, the team saw that cancer cells exhibited a faster contraction than their benign counterparts when testing the relaxation behaviour after stress release.

Remmerbach added, “This new way of drawing distinction between malignant and benign cells could enable an early confirmation of cancer diagnoses, by testing cell samples of suspect oral lesions.”

The researchers used an optical stretcher to analyse the properties of the cells. Their experiments revealed that cells of primary OSCCs were deformed by 2.9 percent, rendering them softer than cells of the healthy mucosa, which were deformed only by 1.9 percent.

Co-author Jorg Schnauß said, “What we found also has implications for the way studies in cancer research are carried out. Many studies are performed with cancer cell lines rather than primary cells. When comparing the mechanical properties of both, our results showed that longtime culturing leads to softening of cells.

“This softening in the culturing process could potentially affect the significance of test results. Because of that, we suggest that future research uses primary cells to ensure accuracy.”

The study appears in the journal Convergent Science Physical Oncology.

Doctors push HPV vaccine, Merck asks FDA to expand Gardasil 9 age range

Source: www.drugwatch.com
Author: Michelle Llamas, Emily Miller (editor)

Doctors, national cancer organizations and 70 nationally recognized cancer centers banded together in June to increase HPV vaccinations and improve cervical cancer screening. But they’re not the only ones pushing for more vaccinations.

HPV vaccine maker Merck requested the FDA expand the recommended age range for Gardasil 9. Gardasil 9 is currently the only HPV vaccination available in the U.S.

Nearly 80 million Americans get HPV infections each year. Of those people, about 32,500 get HPV-related cancers, according to the CDC.

Studies show the HPV vaccine is effective in protecting against the human papilloma virus. The virus can lead to several cancers. These include cervical, vaginal, vulvar, anal, penile or throat cancers.

HPV vaccination rates in the U.S. remain low. Doctors and cancer centers say low vaccination rates are a public health threat.

“HPV vaccination is cancer prevention,” Dr. Deanna Kepka, assistant professor in the University of Utah’s College of Nursing, said in a statement. “It is our best defense in stopping HPV infection in our youth and preventing HPV-related cancers in our communities.”

Right now, the vaccination rate among teens ages 13 to 17 is 60 percent. Doctors are pushing for an 80 percent HPV vaccination rate in pre-teen boys and girls.

“[Vaccination] combined with continued screening and treatment for cervical pre-cancers … could see the elimination of cervical cancer in the U.S. within 40 years,” Dr. Richard Wender, chief cancer control officer for the American Cancer Society, said in a news release. “No cancer has been eliminated yet, but we believe if these conditions are met, the elimination of cervical cancer is a very real possibility.”

Gardasil 9 requires two to three doses to be complete. Only 43 percent of teens get all required doses.

Studies show the vaccine is safe for most people. The most common side effects are headache, nausea, vomiting and fever.

But, the HPV vaccine may cause rare but serious side effects. The FDA’s Vaccine Adverse Event Reporting System has reports of autoimmune diseases, deaths and premature ovarian failure linked to the vaccine.

The National Vaccine Injury Compensation Program (VICP) has paid out millions to a few people who said the vaccine injured them. Since 2006, VICP has paid out or settled 126 HPV claims and dismissed 157.

Current campaigns urge pre-teens and teens to get the HPV vaccine. Merck wants more adults to get the vaccine, too.

At the beginning of June, the FDA accepted Merck’s application to expand the age range for Gardasil 9. The agency granted it priority review. The FDA originally approved Gardasil 9 for people ages 9 to 26. But Merck wants that age range expanded to include adults ages 27 to 45.

“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases,” Dr. Alain Luxembourg, Merck Laboratories’ director of clinical research, said in a statement.

HPV is a group of about 150 related viruses. Gardasil 9 protects against nine strains. The FDA hopes to reach a decision on the application by Oct. 2, 2018.

State not allowed to investigate death at cancer center

Source: kdvr.com
Author: Rob Low

Lakewood, Colo. – When 80-year-old Virginia Cornelius died at a Rocky Mountain Cancer Care Centers’ location in Lakewood on February 27, the on-site doctor insisted it must’ve been a heart attack.

But the adult children of Cornelius aren’t convinced and tell the FOX31 Problem Solvers their efforts to find the truth have been stymied, partly because cancer centers generally aren’t regulated by the Colorado Department of Public Health and Environment.

Cornelius was receiving radiation treatment for cancer of the larynx in her throat. But her daughter, Susan Hutt, says her mother’s general health on February 27 was fine.

“They took her vital signs. They were better than mine,” Hutt said.

She said she was later told by a radiation tech that her mother was having trouble swallowing just before the procedure began but the treatment was allowed to continue anyway, when something went very wrong inside the patient room.

“All the sudden the door flies open and a curtain and the therapist is screaming in the hall, somebody call 911, somebody find the doctor,” remembered Hutt.

Hutt and her brother Gary Cornelius always sat in a waiting area next to the radiation room for all of their mother’s treatments having no idea that during every procedure their mother’s hands were strapped to a bed.

“We walk in and there is our mother on the table, hands restrained, the mask for radiation therapy with the oxygen that goes into it is up on a table, is hanging up above her. And there is no one in there. She is not responsive, but no one is doing CPR,” said Hutt.

Hutt said it appeared the radiation tech ran out of the room without ever performing CPR.

“Minutes are passing before the tech returns with not a code cart, which I would expect as I’m a nurse in a hospital and they are readily available, but what looked like a fishing tackle box. She puts it on the floor and can’t open it,” Hutt said.

By the time paramedics arrived her mother was dead.

According to the 911 call obtained by the Problem Solvers, a dispatcher is heard advising paramedics, “They (Rocky Mountain Cancer Care Centers) are asking that you not walk through the main lobby, they don’t want that, they want you to go through the back door. I’m not sure why.”

Hutt says she found that suspicious but what she said was even more concerning was learning the “Code Blue” panic button on the wall, which meant to summon emergency help, didn’t work. Plus, the radiation tech who had been treating her mother left before the Jefferson County Coroner arrived.

“Extremely suspicious, that the person present that finds a person down is not able to be interviewed by the coroner,” said Hutt.

The coroner’s report listed the final cause of death as “Acute Heart Failure.” But no autopsy was done.

Minutes after their mother’s death and in a state of shock, Hutt and her brother Gary Cornelius said the cancer care center’s on-site doctor convinced them no autopsy was needed. It’s a decision they now regret.

Several weeks after their mother’s death, Hutt and her brother were able to obtain their mother’s radiation logs.

According to the logs shared with the Problem Solvers, Virginia Cornelius’ treatments normally lasted three to four minutes. But on the day of her death, the treatment appeared to have lasted ten minutes.

Hutt and her brother wonder if their mother received too much radiation at once, or worse was forgotten about and possibly left to choke to death, unable to sit up and remove her oxygen mask.

“A side effect of head and neck radiation is a mucus that is so thick you don’t just clear your throat and get rid of it,” said Hutt.

More than three hours after Virginia died, her radiation log shows someone made new entries at 6:03 p.m., 6:05 p.m., and 6:07 p.m.

Hutt and her brother wonder if someone was attempting to recreate their mother’s chart after the fact. The siblings filed a complaint with the Colorado Department of Public Health and Environment but were shocked to learn the agency was powerless to investigate.

“We have no jurisdiction,” confirmed Dr. Randy Kuykendall. He’s the Director of Health Facilities and Emergency Medical Services for CDPHE.

Dr. Kuykendall says the state can investigate potential wrong-doing inside a hospital because CDPHE licenses hospitals. But he admits all 20 Rocky Mountain Cancer Centers in Colorado aren’t licensed or accredited by anyone.

It’s easy to be confused.

After all there’s a sign outside St. Anthony’s Hospital with an arrow that states “St. Anthony’s Cancer Center,” but it’s really pointing to Rocky Mountain Cancer Centers which isn’t owned or operated by the hospital even though they’re physically connected.

Rocky Mountain Cancer Centers is owned by U.S. Oncology and leases space inside the medical complex but faces none of the regulations of an actual hospital, like having a cardiac crash cart on site or a defibrillator.

“So this cancer care center doesn’t have to have a panic button, doesn’t have to have any of these emergency procedures or policies in place?” asked investigative reporter Rob Low to Kuykendall, who responded, “That would be correct, Rob.”

“We cannot allow these centers just to focus on profits over patient safety. Unfortunately, that`s a real concern,” said Hollynd Hoskins a medical malpractice attorney, who added, “If you have a facility that is not accredited and has no oversight by the state, they could be cutting corners and they could be hiring just techs at a cheaper wage rate than you would have to pay a qualified registered nurse and unfortunately that is a threat to patient safety.”

The Problem Solvers had lots of questions for Rocky Mountain Cancer Centers but Executive Director Glenn Balasky would only release a statement, that reads in part, “For a number of reasons, we cannot discuss the care provided to any particular patient treated at Rocky Mountain Cancer Centers. We can however assure you that patient care remains one of our highest priorities.”

Hutt finds it curious that Rocky Mountain Cancer Centers won’t discuss her mother’s care with the Problem Solvers when she’s willing to sign a consent form releasing RMCC from patient confidentiality restrictions.

“What’s really hard for me, I picture my mother restrained on a table with no monitor, choking to death and they brush it off like she was 80 she had a heart attack. It`s over and done. We`ll report what we want to,” said Hutt.

After repeated phone calls from FOX31, Rocky Mountain Cancer Centers had its attorney call Hutt and her brother Gary Cornelius.

The siblings told the Problem Solvers the attorney and an office manager for the cancer center told them safety changes have been made because of their mother’s death.

As for regulating cancer centers, that would take state legislation and so far lawmakers have no appetite to regulate them.

Praised West Palm attorney fought for many, but is now fighting for his life

Source: www.mypalmbeachpost.com
Author: Daphne Duret – Palm Beach Post Staff Writer

A knock on a door stopped Richard Tendler mid-sentence. His back straightened almost instinctively in his chair, just as it has at the first sign of every verdict. Two decades as a criminal defense attorney in Palm Beach County have taught the 51-year-old West Palm Beach man to never predict how things will go.

“I’ve had cases I thought I won come back guilty,” Tendler had said hours earlier. “Then there were cases I was sure I lost, and the jury would come back not guilty.”

Another certainty: Tendler knew was that he would go home a free man that night, regardless of his client’s fate. This time was different.

Tendler was seated in an examination room at Moffitt Cancer Center in Tampa, where he is one of 10 patients in an exclusive clinical trial for cancer patients whom other doctors have told to prepare to die. Knocking on the door was Dr. Christine Chung, who is treating Tendler and nine others with an immunotherapy regimen as part of a trial that includes 500 patients in the U.S. and around the world.

Chung, the chief of head and neck oncology at Moffitt, was ready to deliver her own verdict — on the results of Tendler’s third six-week cycle. She greeted Tendler’s larger-than-usual entourage that day with polite handshakes and a tight smile.

After the first two cycles, she said, the treatments have cut in half the size of one lesion on Tendler’s lung and slightly shrunk another. A pair of smaller lesions on his liver remained the same size. That much was welcome — though it’s still early in the treatments.

Regardless of whether it’s good or bad news, Tendler has been here before.

By the time he first felt a lump in his throat in December 2015, Tendler was just several months past one of his most high-profile cases. It ended with what was widely considered a great plea deal allowing Boynton Beach mother Heather Hironimus to escape criminal charges for running away with her then-4-year-old son to prevent his father from having him circumcised.

His previous cases ranged from the most tragic to the most bizarre, earning Tendler a reputation as a survivor of the grueling grind of private practice. Among his clients: People involved in deadly car wrecks, a university gunman in the wake of another college shooting, and a teenager charged with killing a goose.

Comforting his mother
Two weeks before Tendler discovered the lump in his throat, he had consoled his mother, Sonia, through a doctor’s tragic prognosis giving her just two months more to live with end-stage pancreatic cancer.

Her sister, his aunt Vera Muller, noticed the lump when he came to visit his mother at her Miami apartment.

“I said, ‘Oh, my God, Richard’ and he said ‘Shhh!’” she said before Tendler’s visit to Moffitt last month, putting her finger to her lips to mimic the gesture her nephew made back then. “He didn’t want his mother to worry.”

Doctors by then had confirmed Tendler’s suspicion. The lump was cancer, brought on by an illness Tendler didn’t know he, too, would soon be diagnosed with.

According to the Centers for Disease Control and Prevention, 79 million Americans had been infected with human papillomavirus, or HPV, as of last year. With 200 strains, most of which carry no symptoms and go away on their own, HPV is the most common sexually transmitted infection in the nation.

The strain Tendler contracted at some point in his life was the rare variety that caused his cancer, his doctors informed him. Although there now exists a vaccine for the virus that is recommended for teenage girls and boys alike, no such prevention existed when Tendler was growing up.

On Jan. 25, 2016, Tendler’s 49th birthday, he underwent a nine-hour surgery to remove the cancer from his throat. He had to be on a feeding tube for a month and recovered at his mother’s Miami apartment, with aunt Vera playing nurse to both her sister and her nephew.

Now 75, and moving to South Florida from Tendler’s native Venezuela, Vera Muller remembers her sister died six weeks into Tendler’s recovery. She was 68.

With his grief still fresh, Tendler then went through a grueling round of radiation and chemotherapy, which required him to live on the feeding tube for another four months.

“It was worse than the surgery,” Tendler remembered. “I couldn’t drink water. I couldn’t even swallow a pill.”

Three months later, Tendler returned to the courthouse much thinner and scarred from his surgery, but cancer-free according to his tests. His doctor reassured him that the worst was behind him.

“He told me ‘I’ve never had one come back,’” Tendler remembers.

His did.

In May 2017, doctors noticed a spot on his chest, and eventually discovered three cancerous lesions on his liver. The cancer had spread, or metastasized, the doctors told him.

Tendler remembers one oncologist telling him he only had months to live. The doctor suggested, matter-of-factly, that he prepare for his death.

“That oncologist talked to me like a piece of dirt,” Tendler said.

He visited several others, and although they were more gentle in their delivery, their news was largely the same. The sentence for the defense attorney was death, they told him, and it would be coming soon.

A doctor offers cautious hope
That summer, Tendler visited Chung at Moffitt. Having immigrated to the United States from Korea with her single mother and two brothers as a child, Chung went to medical school and decided she wanted to be an oncologist.

Tendler and Chung soon learned that, while in different professions, they shared similar views and experiences. Like Tendler’s clients, Chung’s patients are a varied group, including former smokers and people like Tendler, who contracted throat cancer from a rare strain of HPV. The common denominator: They all have a right to treatment.

“None of us is guaranteed good health tomorrow. It is a gift,” Chung said.

Tendler, like most criminal defense attorneys, believes every person accused of a crime, no matter how heinous, is entitled to a fair and just journey through the legal system.

Chung received grants from a pair of foundations that paid off all her medical school loans, a fact she says makes her believe her work is to serve the public. Tendler, who started his career as a public defender, understands.

And with Chung, he found not just an advocate for his life but a doctor who Tendler said was the first to really treat him like a human being. Tendler says her presence in his life tops the list of blessings he makes a habit of thanking God for daily.

Chung told him they would fight the three lesions with CT ablation, a form of targeted radiation that successfully obliterated the three spots. But soon afterward, two more lesions appeared on his liver, and another pair of cancer lesions were now in his lungs.

Chung is clear, both in her conversations with Tendler and in an interview on the day he receives his test results, that there is currently no cure for Tendler’s cancer. She calls the current clinical trial a form of palliative care, meant to reduce the cancer’s severity and alleviate Tendler’s symptoms in hopes of keeping him healthy long enough for researchers to find a cure.

The clinical trial, sponsored by Bristol-Myers Squibb, is a blind study in a treatment that involves immunotherapy, a process that stimulates parts of the patient’s own immune system to fight the cancer.

All patients in the study receive doses of the immunotherapy agent Nivolumab. Two-thirds of the patients also receive a second drug, and the others receive a placebo.

No one — not even Chung — knows which patients are receiving the second agent, a secret she says is vital to the research to see if the two agents together work better than the single Nivolumab treatment alone.

Tendler’s lesions are not as severe as some of her other patients, Chung says, and after two cycles, the results are promising.

Although he is on pain medication, his treatment has been a breeze compared to his radiation, he said. And the fight for his life has brought with it an unanticipated life lesson.

Tendler, who for 20 years poured his life into his work, is learning how to celebrate.