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The costs of mesothelioma can be overwhelming. They can include income loss, expensive treatments that may not be covered by health insurance, plus pain and suffering for you and for your family. Because the disease is preventable – and because it is usually caused by someone else’s negligence – legal options may be available to help regain these costs. Asbestos lawyers focus their practice on knowledgeably and effectively bringing to justice companies that exposed employees and the public to asbestos products. A mesothelioma attorney can help you consider your options and file a claim against the company responsible for your asbestos-related illness. More than one company may be responsible. A mesothelioma attorney identifies all companies at fault. Mesothelioma lawsuits have helped thousands of people receive financial assistance. A lawsuit can result in much-needed money to help reduce financial hardships during an illness and can also provide a more stable future for your loved ones. A lawyer specializing in asbestos litigation can help you seek compensation for expenses related to illness caused by asbestos exposure.

Looking Beyond Clinical Trials for Mesothelioma Treatment

Clinical trial results should not always be the guiding force when a mesothelioma cancer patient and their medical team determine what therapy path to take, according to one recent study. A look at real-world populations might be just as important.

A research team at the University of Pennsylvania Department of Medicine has made the point with a retrospective, observational analysis of second-line treatment for pleural mesothelioma.

The analysis came on the heels of a multicenter clinical trial from the European Thoracic Oncology Platform that evaluated the efficacy of pembrolizumab (Keytruda), an immunotherapy drug, when compared to chemotherapy in a second-line setting for mesothelioma.

Despite high pretrial expectations, the use of pembrolizumab showed no survival advantage over the use of chemotherapy for mesothelioma in a second-line setting. Progression-free survival was only 2.5 months with pembrolizumab, compared to 3.4 months for chemotherapy. Median survival was 10.7 months and 12.4 months, respectively.

“Obviously, there is a lot of excellent work being done in the clinical trial space, especially with a rare disease and novel therapies like this,” Dr. Roger Kim, lead study author at the University of Pennsylvania, told The Mesothelioma Center at Asbestos.com. “But it is really important to assess those same kind of treatments in real-world populations. That may be the biggest take-home message from our study.”

Clinical Trials vs. Real-World Results

Mesothelioma clinical trials often involve carefully selected patients, many of whom are in a less-advanced stage of disease, healthier overall and able to meet specific criteria to qualify.

For this latest study, researchers took a multicenter retrospective look at 176 patients with advanced pleural mesothelioma who had received platinum-based chemotherapy initially and at least two lines of systemic therapy.

After relapse, 61 received chemotherapy and 115 received pembrolizumab or nivolumab, similar immunotherapy drugs, also known as immune checkpoint inhibitors. The results were considerably different.

Mesothelioma treatment with the immunotherapy drugs produced a median overall survival of 8.7 months, compared to only five months for those receiving chemotherapy. The estimated 12-month survival rate projection was 36.7% and 15.6%, respectively.

“We were able to demonstrate an increased benefit when compared to chemotherapy,” Kim said. “Patients who received chemotherapy – in our real-world population – fared much poorer than in the clinical trial, which is reflective of the older, generally sicker populations of patients we see in the clinic in the real world.”

Treatments Benefit Patients With Advanced Disease 

In contrast to the European clinical trial, the retrospective study found that the immune checkpoint inhibitors benefited those with a more advanced stage of mesothelioma. Lung Cancer published the study findings in late 2021.

Patients in the latest study – the real-world population – were older (median age 75) than in the clinical trial (70). There also was a much lower percentage of patients with the more treatable epithelioid histology.

They generally had a more limited life expectancy, according to study authors. More than 10% had undergone aggressive surgery before even starting the first-line systemic therapy.

“Different baseline characteristics, different patient populations, may perform differently with the same exact medications,” Kim said. “It’s important to know.”

Prior studies had suggested a potentially larger benefit from the immune checkpoint inhibitor drugs for those with a tougher-to-treat histology.

“That our outcomes differed from those reported in the clinical trial highlights the importance of assessing real-world evidence when evaluating novel therapies in populations that differ from those included in clinical trials,” the study concluded.

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Global Mesothelioma Cases Nearly Double Over 30 Years

The number of people in the world diagnosed annually with mesothelioma cancer has almost doubled in the last 30 years, accentuating the need for more effective and better coordinated efforts to end this preventable, global health problem.

Almost 35,000 people were diagnosed with mesothelioma in 2019, compared to an estimated 19,000 in 1990, according to a study by the Clinical Research Center at Shandong University, Jinan, China.

Critical Reviews in Oncology/Hematology published the study in September. It is believed to be the most comprehensive and recent evaluation of the annual incidence and mortality rate for mesothelioma on a global scale.

Malignant mesothelioma is a cancer without a cure. It is caused almost exclusively by exposure to asbestos, a naturally occurring mineral that was once used ubiquitously worldwide. The median overall survival after a mesothelioma diagnosis is about nine to 12 months.

“There has been no study analyzing the latest mesothelioma burden and trends until now,” study authors wrote. “The aim of this study was to use data to determine the global, regional and national burdens of mesothelioma across 204 countries and territories.”

Mesothelioma Awareness Needed

Researchers intended the study to bring increased attention to the cancer and to help formulate specific strategies to improve policy decisions and resource allocation in various parts of the world.

Although the incidence and death rates from mesothelioma almost doubled during the study period, the annual rate of incident cases, deaths and disability-adjusted life years showed a slight decreasing trend. It also showed that a universal ban of asbestos would only be a starting point. 

The mining, import, use and sale of asbestos has been banned in 62 countries, and its use regulated tightly in 20 more, but the diagnosis of mesothelioma continues to be a major problem. 

One reason mesothelioma remains so ominous is its lengthy latency period – 20 to 60 years between asbestos exposure and diagnosis. There also is legacy asbestos in older structures and the lack of a cohesive strategy to stop it from causing new cases.

Governmental Action Is Key

The study pointed to three significant challenges governments must address in order to reduce the rate of mesothelioma incidence: 

Legacy Asbestos: Governments must remediate asbestos in existing buildings that were constructed or renovated before asbestos bans. 

Disposal: They must better resolve asbestos disposal issues and impacts to the environment. 

Soil Contamination: Governments also need to develop methods to successfully recover soil contaminated by asbestos-containing products.

“The results of our study can be used by policymakers to allocate resources efficiently for improving the early diagnosis of mesothelioma, reducing its modifiable risk factors, and developing novel interventions and treatment strategies to reduce its fatality rate,” the authors concluded.

U.S. Falls Behind With No Asbestos Ban

The banning of asbestos began as early as 1980 in Denmark, Norway, Israel and Sweden, and has spread through various regions, but has been slow to take hold. Too many countries – more than half – still have not banned asbestos, many times because of corporate and legal pressure.

The U.S. Environmental Protection Agency, for example, issued an asbestos ban and a phase-out in 1989, but it was overturned two years later after manufacturers of asbestos products filed a lawsuit.

Russia, India, Thailand and Mexico are other countries that have failed to pass a ban, leaving their citizens more vulnerable today.

By 1990 – the first year of the study – the use of asbestos products in most industrialized countries had been reduced by at least 75% from the peak asbestos consumption of the 1960s. Yet researchers still found the highest rates of mesothelioma in high-income countries and the lowest rates in low-income regions.

In North America, incident cases rose from 3,073 in 1990 to 4,487 in 2019. The increase was much more dramatic in the Asia-Pacific region, which went from 796 cases to 2,102 cases. Western Europe rose from 7,732 cases to 12,080 cases. Central Asia increased from 150 cases to 211 cases.

The highest age-standardized mortality rate was in the United Kingdom, followed by Australia, the Netherlands, the European principality of Andorra and Lesotho in Southern Africa. 

In 2020, an estimated 30,870 new cases of mesothelioma were diagnosed, while 26,278 new deaths from mesothelioma occurred.

Over the 30-year span, the study found fewer cases of mesothelioma for those under age 70, and more cases in patients older than 80, a reflection of an aging population. 

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Latest Study Compares Major Pleural Mesothelioma Surgeries

Mesothelioma patients may benefit more from aggressive extrapleural pneumonectomy surgery than from the lung-sparing pleurectomy and decortication currently being recommended as an alternative by many specialists today.

According to the most recent study from Italy, extrapleural pneumonectomy, or EPP, allowed mesothelioma patients diagnosed with high symptom burden to live a longer, better-quality life than with the more popular pleurectomy and decortication surgery, also known as P/D.

Journal of Clinical Medicine published the latest report on Oct. 29, authored by thoracic oncology specialists at Tor Vergata University Policlinico in Rome.

Extrapleural pneumonectomy demonstrated the most durable effects,” the study authors wrote. “Pleurectomy/decortication achieved some temporary advantages in symptom control, especially in the first months after surgery, but we noticed a more effective, long-lasting pain control after extrapleural pneumonectomy.”

Quality of Life Better With EPP

The study results, which are contrary to earlier reports and a growing trend, were based on 55 pleural mesothelioma patients in Rome who underwent one of the two major surgeries over a 14-year period. They were part of a multidisciplinary treatment plan.

Twenty-nine patients had EPP surgery, and 26 had the P/D surgery. Those with the EPP fared better overall.

Comparison of quality-of-life determinants and symptoms were done before mesothelioma surgery, then again at three months, six months, 12 months and 24 months after surgery.

Measurements included a six-minute walk, body pain, physical functioning, vitality and mental health.

“Improvement in physical, social and pain-related measured parameters lasted for a longer time span in the extrapleural pneumonectomy group,” authors wrote. “Both procedures revealed a three-month improvement in many symptoms and the quality of life.”

No differences between the two surgeries were found in the chemotherapy  and radiotherapy compliance rate that was part of the overall treatment plan.

Median overall survival was 20 months for those having EPP and 13 months for those receiving P/D surgery. At the two-year mark, five of the 26 P/D patients were alive, compared to nine of the 29 EPP patients. At three years, only four EPP patients were still living.

“Given life expectancy is generally low, the quality of life assumes a leading role,” authors wrote. “These results confirm the efficacy of extrapleural pneumonectomy in local control of disease.”

More Precise P/D Less Risky

Study results were in contrast to the growing belief among thoracic oncologists today that the EPP surgery should rarely be used because it is aggressive and has the potential for debilitating side effects.

Mesothelioma, a rare cancer caused by a long-before exposure to asbestos, typically starts in the thin lining around the lungs and metastasizes throughout the thoracic cavity.

The P/D surgery, which is more detailed and precise but less life-altering than the EPP, removes the lining around the lung and all visible tumor cells throughout the thoracic cavity. Surgery can last as long as 10 hours.

EPP surgery can provide a more complete tumor resection. It involves removing the pleural lining, the whole diseased lung and major parts of the diaphragm and pericardium.

Less than a third of pleural mesothelioma patients are even considered for either surgery because most are not diagnosed until the disease is too far advanced.

Most other studies have shown little difference in median survival times between the two procedures – ranging from 15 to 24 months – but most have concluded there is a greater deterioration in quality of life with the more aggressive EPP.

Dr. David Sugarbaker Pioneered EPP

The EPP surgery, which was pioneered by legendary thoracic surgeon Dr. David Sugarbaker almost 20 years ago, is not used as often as it once was. Many surgeons believe the risks of such a major surgery outweigh the benefits, making it less attractive.

There have been wonderful success stories, though, despite its decline in use. One of Sugarbaker’s greatest achievements with the EPP is Tim Crisler of Kennesaw, Georgia, believed to be America’s longest living pleural mesothelioma survivor.

Crisler, 66, recently celebrated his 20th year of post-surgery survival.

Sugarbaker died in 2018, leaving Crisler and his EPP surgery as part of his legacy.

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Congress Resumes Asbestos Ban Efforts After ProPublica Report

U.S. lawmakers and public health advocates have renewed their call for Congress to pass a long-awaited legislative ban of asbestos, sparked by the most recent news detailing the damage still being done by the toxic mineral.

ProPublica, a nonprofit online news organization, chronicled the health effects stemming from an upstate New York industrial manufacturing plant and a nearby chloralkali industry plant that they say carelessly handled large amounts of asbestos

Both plants have closed, but the aftereffects remain. 

“American workers are dying from asbestos. It is way past time to end its use,” U.S. Sen. Jeff Merkley of Oregon said. “This report confirms our worst fears. Workers dealing with asbestos are often left vulnerable to this deadly, dangerous substance.”

Merkley and U.S. Rep. Suzanne Bonamici, also of Oregon, are co-sponsoring the Alan Reinstein Ban Asbestos Now Act of 2022, which would ban any importation or use of asbestos. It is the most comprehensive asbestos ban legislation to come before Congress in more than 30 years. All previous legislative attempts have failed to advance.

Ban Asbestos Now Act Gains Co-Sponsors

This latest bill was filed in May and had one Senate committee hearing in June before it was shelved. Since the publication of ProPublica’s article in October, three more members of Congress have signed on as co-sponsors. They are U.S. Representatives Chellie Pingree of Maine, Adriano Espaillat of New York and Eleanor Holmes Norton of the District of Columbia. Proponents of the ban are hopeful it will be addressed in the next legislative session.

After the report last month, the Asbestos Disease Awareness Organization – America’s most aggressive, independent asbestos awareness organization – sent letters to every member of Congress highlighting the ProPublica findings and calling for their support of a ban.

Exposure to asbestos, which is highly regulated but still being used today, can cause a variety of serious health issues, including asbestosis, lung cancer and malignant mesothelioma.

Linda Reinstein is co-founder, president and CEO of ADAO. The legislation is named after her husband, who died in 2006 from mesothelioma cancer that was caused by asbestos exposure.

Over the years, Reinstein has enlisted public health officials, oncologists, surgeons, advocates and attorneys to urge Congress to enact a ban. Never has she been closer to succeeding than today.

“Asbestos puts workers, their families and the surrounding communities at risk for deadly disease and death from exposure, which is sickeningly frequent and widespread and without consequences for the companies that allow it to continue,” Reinstein said.

Past Asbestos Exposure Sickened Workers

Both chloralkali plants in upstate New York were run by OxyChem Corp., an energy/chemicals producer with a worldwide platform. Its plant in North Tonawanda, New York, which was closed 25 years ago, produced industrial plastics with the use of asbestos.

According to the report, the plant released excessive amounts of asbestos fibers into the air and surrounding neighborhoods, leading to health problems for a number of people.

Almost a dozen different lawsuits were filed alleging that the toxic asbestos from many years before had led to cases of mesothelioma, lung cancer and other health issues. Many of those cases have been settled. At least two of the lawsuits are still pending. 

One woman died after years of washing her husband’s uniform, which was consistently covered with asbestos fibers, according to a lawsuit. Another man who lived near the plant was diagnosed with pleural effusions, which is fluid lining the lungs, after inhaling the fibers.

Many of the lawsuits accused OxyChem of failing to protect its workers inside the plant, and neighbors outside.

Report Says Asbestos Safety Standards Lacking

OxyChem also operated a chloralkali plant in nearby Niagara Falls, New York, where essential chlorine was produced. Asbestos was used extensively there also, to manufacture semipermeable fireproof diaphragms that separated chlorine from sodium hydroxide.

According to the ProPublica report, safety standards were routinely disregarded, resulting in health problems and deaths. The plant closed in 2021.

An estimated one-third of chlorine produced in the U.S. today comes from eight remaining plants spread across the country that are still using asbestos diaphragms. Others are using newer technology that doesn’t require asbestos.

The mining of asbestos, a naturally occurring mineral, stopped in the U.S. 20 years ago. Importation also dropped dramatically in that period. 

In 2021, an estimated 320 tons of raw asbestos was imported and all of it went to the chloralkali industry, according to the United States Geological Survey. Small amounts of asbestos products also were imported, including roofing materials, automobile clutches and brakes, and oilfield brake blocks.

EPA Close to Recommending Asbestos Ban

While the push for a legislative ban of asbestos continues, the U.S. Environmental Protection Agency is moving in a similar direction.

As part of the broader Toxic Substances Control Act, the EPA in 2020 released Part 1 of its Final Risk Evaluation for Asbestos. It found 16 conditions of use that presented unreasonable risks to human health through occupational asbestos exposure or consumer uses.

One of those conditions was the processing and industrial use of asbestos diaphragms in the chloralkali industry.

The EPA is expected to finalize Part 2 of the evaluation by the end of 2023 before announcing its version of an asbestos ban.

Advocates like Reinstein and politicians such as Merkley and Bonamici believe legislation will be more effective, more complete, and less likely to be overturned in court than what the EPA will do eventually.

“What this story highlights is that the only way to ensure the safety of workers, their families and the general public is an outright ban of asbestos,” said thoracic surgeon and mesothelioma specialist Dr. Andrea Wolf of Mount Sinai Hospital in New York City. “These stories are terrifying, but must draw attention and support for the Alan Reinstein Ban Asbestos Now Act.”

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New Research Focuses on Mesothelioma Brain Metastasis

Distant metastasis is common with malignant pleural mesothelioma – more than 60% of patients experience it – but rarely is it found around the brain.

A new study by a team of radiation oncologists in Great Britain, however, suggests that physicians should increase their focus on potential cerebral metastasis in mesothelioma patients.

“Patients will continue to live longer as a consequence of newer, more advanced treatments,” the study authors wrote. “It is critical now to recognize mesothelioma’s metastatic potential, particularly cerebral metastasis, which was previously only an autopsy finding.”

The Cureus Journal of Medical Science published the case study on Oct. 16. It centered around a mesothelioma patient with brain metastasis at University Hospitals of North Midlands in the United Kingdom.

Mesothelioma Brain Metastasis Rare

A diagnosis of intracranial metastasis was made secondary to the pleural mesothelioma of the 67-year-old female patient. Her cancer progression, intolerance to chemotherapy and the multiplicity of the brain metastasis led to a rejection of aggressive therapy. She received only palliative radiation therapy and died eight months later.

Pleural mesothelioma, which is typically caused by the inhalation of asbestos fibers, is a rare cancer that starts in the lining surrounding the lungs and chest cavity. 

“This is a rare case with distant brain metastases, which encourages further radiological investigation in the presence of symptoms,” the authors wrote. “Intracranial metastases are rare to the brain. This is due to short survival with MPM [malignant pleural mesothelioma].”

The lead author was Dr. Cleofina Furtado, a member of the department of diagnostic and interventional radiology at University Hospitals of North Midlands.

According to the study, the most common pleural mesothelioma metastatic locations are the contralateral (opposite) lung, liver, adrenal glands, kidneys and bones. Mesothelioma tumor cells typically spread through the lymph nodes.

In various retrospective studies, brain metastasis ranges from only 2% to 5% of cases, most of which are discovered after death – until recently.

Most patients with brain metastasis leave their cancer center without therapy, or only a palliative treatment. According to the study, options could include whole-brain radiation, stereotactic radiotherapy, resection or systemic corticosteroids.

However, only in very rare instances have any shown a therapeutic response, leading study authors to suggest additional treatment options, including immunotherapy.

Multimodal Approach Could Extend Life Expectancy

Earlier in 2022, a case study done at Drexel University College of Medicine in Philadelphia detailed the brain metastasis of a 72-year-old male with pleural mesothelioma.

His mesothelioma metastasis was diagnosed early and treated more aggressively. He underwent a left frontal craniotomy for resection, which eliminated symptoms. During a one-month follow-up, though, new lesions were discovered, leading to stereotactic radiosurgery and a second resection.

“Through this case, we aim to highlight that despite employment of a multimodal treatment approach, including surgical excision of symptomatic lesions, further metastatic lesions can occur that complicate treatment plans,” the authors wrote.

Another case report done in 2021 involving mesothelioma brain metastasis highlighted the need for radiosurgery “without delay.” The case was found at the National Medical Center in Seoul, South Korea.

That study also identified 12 reports of patients who survived for six months or longer after mesothelioma brain metastasis was discovered. All but one of the cases involved aggressive interventions such as intracranial mass removal or whole-brain radiotherapy.

“A multimodal approach can provide symptomatic relief and extend life expectancy,” the study from South Korea concluded.  “Therefore, clinicians should consider aggressive treatment of a brain metastasis arising from MPM if the patient presents with a stable primary lung lesion.”

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Latest Mesothelioma T-Cell Clinical Trial Moves to Phase II

The most recent T-cell therapy aimed at mesothelioma cancer has advanced to phase II of the clinical trial process, with researchers exploring its effectiveness when combined with an already approved immunotherapy duet.

Investigators are studying the synergistic effect of gavocabtagene autoleucel (gavo-cel) when used with the combination of Opdivo and Yervoy, which was approved by the U.S. Food and Drug Administration in 2020 to treat mesothelioma.

Its earlier phase I results, when used alone, were impressive – 93% of patients experienced tumor regression – raising hopes for a much-needed advancement in mesothelioma treatment. The drug was formerly known as TC-210.

“This is only a baseline for further improvement,” said Garry Menzel, chief executive officer of TRC Therapeutics Inc., which is developing the drug. “We hope to push this further in the phase II strategy. We expect to see deeper and longer responses.”

The clinical trial involves four different, tough-to-treat solid tumors. It includes malignant mesothelioma, non-small cell lung cancer, ovarian cancer and cholangiocarcinoma, but only those expressing mesothelin, a cell-surface protein. It is found in several cancers, but most commonly in mesothelioma.

Study Taking Place at Top Cancer Centers

The phase II clinical trial is hoping to enroll 75 patients in the mesothelioma cohort, along with 20 for each of the other three malignancies. It will be conducted across six of the leading cancer treatment centers in the U.S. 

Clinical Trial Locations
  • Memorial Sloan Kettering Cancer Center, New York City
  • National Cancer Institute in Bethesda, Maryland
  • Penn Medicine Abramson Cancer Center in Philadelphia
  • Sarah Cannon Research Institute, Nashville, Tennessee.
  • University of California San Francisco Comprehensive Cancer Center
  • University of Texas MD Anderson Cancer Center in Houston

The disease control rate in phase I, which involved all four cancers, was 77%  with those receiving the genetically modified T cells.

Median overall survival rate and progression-free survival for the 23 mesothelioma patients was 11.2 months and 5.6 months, respectively. All patients had been heavily pretreated but had regressed.

“We saw patients with a lot of tumor burden and saw very significant tumor regression in this trial,” said Dr. Raffit Hassan, medical oncologist and senior investigator at the National Cancer Institute. “We saw a very nice response.”

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Gavo-Cell Well Tolerated by Patients

Gavo-cell was generally well tolerated and side effects from the treatment have been manageable. Patients with ovarian cancer had median survival and progression-free survival of 8.1 and 5.8 months, respectively.

The mesothelioma cohort in phase II will be randomly assigned to receive either the single-agent gavo-cel,  gavo-cel with Opdivo, or gavo-cel combined with Opdivo and Yervoy. The study will allow for patients to be retreated with additional doses.

Gavo-cel’s success in phase I was particularly notable because, until recently, T-cell therapy had not shown effectiveness with solid tumors in advanced stages. Earlier success had been limited to blood cancers such as lymphoma and leukemia.

The FDA approved the first T-cell therapy for leukemia in 2017.

Modifying T Cells Becomes Personal  

T-cell therapy involves a modification of a patient’s own T cells, a type of white blood cell that is separated from the blood through a process known as leukapheresis. The modification is based upon a patient’s unique genetic profile.

It can take up to four weeks before the cells are reintroduced into the body, hopefully with an ability to identify and kill tumor cells by targeting the mesothelin protein.

Overexpression of mesothelin, the target in this clinical trial, often leads to tumor aggressiveness and cancer cell proliferation. 

To be part of the trial, patients must have received from one to five prior systemic standard-of-care therapies.

“We already have treated several in phase II,” Menzel said. “We are clearly leading the field. With mesothelioma, we are focused on developing a new, front-line setting.”

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Study: Cancer Enzyme Slows Growth of Pleural Mesothelioma

Patients with pleural mesothelioma may extend their survival by an estimated 30% when the latest anti-cancer enzyme is added to standard chemotherapy, according to a recently completed study.

AGI-PEG 20 showed unprecedented effectiveness when treating patients with sarcomatoid mesothelioma and biphasic mesothelioma – the most treatment-resistant subtypes – in an international, multicenter, phase II/III clinical trial known as ATOMIC Meso.

The enzyme works by limiting an amino acid known as arginine that often fuels tumor cells. It depletes its effectiveness in promoting tumor growth, leading to longer survival. 

“The results were astonishing to me,” Dr. Peter Szlosarek, principal investigator and medical oncologist at UK Barts Cancer Institute in London, England, told The Mesothelioma Center at Asbestos.com. “The response was robust from the beginning.”

Anti-Cancer Enzyme Makes Chemotherapy More Effective

The study compared patients being treated with traditional pemetrexed and cisplatin chemotherapy to those using ADI-PEG 20 and the chemotherapy combination.

All patients were previously untreated, unresectable and diagnosed with either sarcomatoid or biphasic mesothelioma. Those patients, typically with a median survival of less than six months, were randomized in a double-blind clinical trial. 

Epithelioid mesothelioma is the most treatable and common subtype of mesothelioma that affects close to 70% of the patients being diagnosed. They were not included in the study.

The trial involved several of the leading cancer centers in the U.S. for treatment, including Moffitt Cancer Center in Tampa, Greenebaum Cancer Center in Baltimore, University of Chicago Cancer Center, Mayo Clinic in Rochester, Minnesota, and M.D. Anderson Cancer Center in Houston.

Those being treated with ADI-PEG 20 in combination with chemotherapy had a median survival of 9.3 months compared to 7.6 months for those receiving just the chemotherapy. 

Progression-free survival was 6.1 months for the ADI-PEG 20 patients, compared to 5.5 months for the placebo control arm.

A few of the patients in the study lived more than three years, an unheard-of result for the subtypes being treated.

There were few dose-limiting toxicities in the mesothelioma clinical trial. Most of the adverse side effects seen were considered mild to moderate and many were related to the chemotherapy and not the ADI-PEG 20.

“The Atomic Meso, without a doubt, offers patients with nonepithelioid mesothelioma a safe and novel triplet chemo regimen,” said Szlosarek, who has been studying the combination with several other tough-to-treat cancers. “This [study] heralds exciting times ahead for patients suffering various cancers.”

Manufacturers Will Seek FDA Approval

ADI-PEG 20 is a product of Polaris Group, a multinational biotechnology company focused on the development of the latest anti-cancer therapies.

Its plan is to proceed with regulatory submissions in the United States and seek U.S. Food and Drug Administration approval for mesothelioma treatment in 2023.

The FDA approved the use of an immunotherapy combination involving Opdivo and Yervoy in 2020, the first approval for first-line pleural mesothelioma treatment in 16 years.

With Szlosarek’s leadership, Polaris is working toward another study that will combine the immunotherapy treatment with ADI-PEG 20. Szlosarek has worked with ADI-PEG 20 for almost two decades as a cancer tool.

“We are pleased to report the phase II/III data showing that ADI-PEG 20 can significantly extend overall survival in patients with MPM [malignant pleural mesothelioma]. ADI-PEG 20 is the first arginine-degrading therapeutic to show positive topline results in a pivotal trial as a combination therapy for the treatment of MPM,” said Howard Chen, chairman of Polaris. “The results pave the way towards our working with the regulators to bring this novel biologic to patients with MPM.”

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Orphan Drug Designation Given to New Mesothelioma CAR T-Cell Therapy

In early 2023, the world-class Hospital of the University of Pennsylvania will open a groundbreaking clinical trial for mesothelioma patients utilizing a next-generation immunotherapy with a novel delivery platform.

The U.S. Food and Drug Administration cleared the path in September by granting orphan drug designation for SynKIR-110, a CAR T-cell therapy designed to target solid tumors expressing a specific protein typically found in mesothelioma cancer.

By granting the orphan drug designation, the FDA can provide financial incentives such as tax credits for clinical trials and seven years of market exclusivity. It is designed to help find answers for treating rare diseases or disorders that affect fewer than 200,000 people in the U.S.

A first-in-human clinical trial, officially known as STAR-101, will be assessing preliminary efficacy, tolerability and safety after showing impressive results – including complete remissions – in earlier murine (rodent) models.

As part of the clinical trial, SynKIR-110 also will be used on patients with bile duct (cholangiocarcinoma) and ovarian cancer, but only those expressing the cell-surface protein mesothelin.

SynKIR-110 is a product of Verismo Therapeutics, a Philadelphia-based biotechnology company that has built the KIR-CAR delivery platform, a modified killer-like receptor designed to improve efficacy and persistence against aggressive solid tumors. It will be the first product to use the KIR-CAR platform.

“There is a high unmet need for a successful treatment option [for mesothelioma],” Dr. Bryan Kim, co-founder and chief executive officer at Verismo, told The Mesothelioma Center at Asbestos.com. “Once we demonstrate this can be used safely in patients, it opens a whole new field of potential targets and diseases we can treat using our novel KIR-CAR technology.”

Researchers Still Looking for T-Cell Therapy Success

Although T-cell therapy has been especially effective with blood cancers such as leukemia and lymphoma, it has been generally ineffective to this point against advanced-stage solid tumors like mesothelioma.

T-cell therapy is often based upon a patient’s unique genetic profile and the laboratory modification of their T cells, a type of white blood cell responsible for protecting the body against disease and infection. 

Some cancer cells, though, avoid the immune response by using surface proteins such as mesothelin to trick T cells into leaving them alone. T cells can be modified in a laboratory to better recognize the cancer and attack it.

“One of the hurdles that T-cell therapies face when treating solid tumors is that T cells become terminally differentiated and more exhausted in the harsh tumor environment,” Kim said. “This exhaustion results in T cell failure. The novel way we’ve gone about addressing the exhaustion is by building the cells with a multichain structure that includes components found on natural killer cells.”

More Effective Mesothelioma Therapies Needed

The need for more effective treatments is obvious for solid tumors expressing mesothelin, the cell-surface protein. The five-year survival rate is 50% for ovarian cancer, just 30% for cholangiocarcinoma and only 10% for mesothelioma, according to Verismo.

Mesothelioma, which is caused almost exclusively by an exposure to toxic asbestos fibers, is diagnosed in an estimated 3,000 people annually within the U.S. Although a multimodality approach that includes mesothelioma surgery often works bests, less than a third of those diagnosed even qualify. Too often, mesothelioma is not diagnosed until later stages, and only chemotherapy is advised.

“This will be the pivot point for over a decade of work that has gone into developing our novel KIR-CAR T platform, where we can finally transition from seeing it work in preclinical models to using it to treat patients in need,” Kim said.

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Rare Mesothelioma Cancer Discovered in Quarter Horse

No one is immune to the effects of toxic asbestos fibers, the primary cause of mesothelioma cancer. Not even horses.

Although mesothelioma is a rare cancer in humans, it is even more rare in animals, particularly horses that spend most of their time grazing outdoors. But it still happens.

Both pleural mesothelioma and peritoneal mesothelioma cancer were identified during the autopsy of a 22-year-old gelding quarter horse that had spent much of its working life in equestrian tourism activities.

Animals, an international peer-reviewed journal devoted to veterinary sciences, detailed the rare mesothelioma case report in its September issue.

“Mesothelioma can affect different species, including dogs, cats, cattle, sheep, goats and horses. The onset in horses is very rare,” the authors wrote. “Ours is a rare case of mesothelioma in the abdominal and thoracic cavities.”

Other Malignancies More Common in Horses  

The horse was from the Lazio region of Italy that includes the capital city of Rome. The autopsy was conducted by doctors from the Department of Veterinary Medicine, University of Bari.

According to an earlier necropsy study done by the University of Kentucky Veterinary Diagnostic Laboratory, malignancies occur in 8% of horses between the ages of 15 and 19, with an increase to 17% in horses aged 30 and above. 

The most common tumors are squamous cell carcinoma, pituitary adenoma, melanoma, sarcomas and abdominal lipoma.

Rarely, though, is mesothelioma cancer ever seen. According to the authors, there have been only 11 reports of mesothelioma in horses since 1976.

“In most cases of equine mesothelioma, the diagnosis is made post-mortem at the slaughterhouse or during a clinical necropsy,” they wrote.

In humans, mesothelioma most often stems from long-ago occupational exposure to asbestos. Otherwise, it mostly is traced to heavily urbanized areas, where aging residential and commercial buildings are filled with legacy asbestos. Neither was the case with this horse.

Veterinarians Were Expecting Colic Syndrome

The horse was brought initially to the veterinary clinic for what was believed to be colic syndrome. It appeared emaciated, with congested mucous membranes and an abdominal region that was enlarged and distended. 

Blood counts and ultrasound examinations were performed, revealing abdominal masses and abundant accumulations of abdominal and pleural fluids

After five days of failing to respond to treatment, the horse was euthanized. The autopsy exam revealed abundant effusion and nodular masses throughout the abdomen and thoracic cavity. 

A diagnosis of the epithelioid type of mesothelioma, the most common type in humans, was made through histopathology and immunohistochemistry, according to the authors. They speculated that the horse’s exposure to asbestos was environmental contamination, and not from nearby aging construction.

More Horses Will Be Checked for Mesothelioma

The authors also pointed out that the horse lived in an area with a very high incidence rate of human mesothelioma, suggesting that other horses nearby should be monitored to evaluate the potential presence of this cancer and the biological indicator of the disease.

The staff at the veterinary clinic had an earlier case that involved both a horse and owner suffering from lymphoma.

“Our study has led us to hypothesize that horses, in the geographical area, could be considered excellent sentinel animals,” the authors wrote, including for air pollutants and asbestos.

Lead study author Dr. Giuseppe Passantino did not respond to a request from The Mesothelioma Center at Asbestos.com to provide additional insight into the findings.

Studying Mesothelioma in Animals

Although rare, the horse was not alone in recent research involving mesothelioma in animals.

In 2021, the Journal of Zoo and Wildlife Medicine published a case report in which a male, wild-caught tiger rat snake in Canada was diagnosed with pericardial mesothelioma, the first documented case of its kind.

It was treated with therapeutic pericardiocentesis, and returned to normal behavior within two weeks. Six months later it was treated again, but it died four days after the second procedure.

Earlier this year, the journal Veterinary and Comparative Oncology published a study from the United Kingdom involving the benefits of chemotherapy in treating dogs diagnosed with mesothelioma cancer.

There were 34 dogs in the study, including 25 that were treated with chemotherapy. Those treated had a median survival of 234 days. Those not treated with chemotherapy had a median survival of just 29 days.

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U.S. Court of Appeals Hears Challenge to J&J’s Bankruptcy Plan

Johnson & Johnson’s controversial bankruptcy filing, designed to limit its soaring talc liabilities, was challenged Sept. 26 before the United States Court of Appeals for the Third Circuit in Philadelphia.

A three-judge panel heard oral arguments on whether Johnson & Johnson should be permitted to shift billions of dollars in mass tort liabilities to a newly created entity, which immediately filed for bankruptcy.

The court’s decision is not expected until later in 2022. Regardless of the outcome, several legal experts believe yet another appeal will be filed with the U.S. Supreme Court.

Attorneys representing a handful of almost 40,000 plaintiffs had asked the appeals court in Philadelphia to overturn a ruling earlier this year by a New Jersey judge who allowed the bankruptcy filing to proceed.

Johnson & Johnson in 2021 had used a restructuring strategy known as the Texas Two-Step that created a subsidiary called LTL Management, which absorbed all of its asbestos-contaminated talc liabilities but few of its assets.

Asbestos-Contaminated Talc Under Scrutiny

LTL Management was originally provided $2 billion to settle all talc claims through a bankruptcy trust.

The bankruptcy filing, at least temporarily, blocked all pending talc lawsuits from moving forward. The majority of the 40,000 cases involved the use of J&J’s talc-based products, including its iconic Johnson’s Baby Powder.

Claimants allege the product contained asbestos-contaminated talc, which caused a variety of serious health issues, including ovarian cancer and malignant mesothelioma.

Johnson & Johnson, one of America’s richest companies, has a market capitalization of an estimated $450 billion. Before the bankruptcy filing it was facing almost $3.5 billion in earlier verdicts and settlements. According to  bankruptcy court records, one verdict that covered 22 plaintiffs was worth $2 billion.

Although Johnson & Johnson continues to say its talc products are safe and has denied any responsibility for health-related issues, it recently suspended all talc-based baby powder sales worldwide.

Johnson & Johnson attorney Neal Katyal said in court that the bankruptcy trust fund would benefit victims by producing faster and fairer settlements.

Earlier this year, the New Jersey court ruled that handling mass tort litigation is a valid purpose for bankruptcy, even when a company’s assets are greater than its liabilities.

Department of Justice Challenging Bankruptcy Ruling

Attorneys for claimants have argued that the bankruptcy court ruling violates the constitutional right to due process and a jury trial. They also believe bankruptcy should be reserved for companies in financial distress.

“J&J is using this bankruptcy as a tactic to force an agreement – an attempt to remove the jury trial,” said attorney Jonathan Ruckdeschel of Ruckdeschel Law Firm LLC, who was present at the hearing.

Personal injury attorneys across the country believe the bankruptcy filing was done in bad faith, denying those harmed from being fairly compensated.

J&J attorneys have previously said the $2 billion set aside by LTL Management for a trust was just a starting point, and the amount was negotiable. Katyl, representing J&J at the hearing, said the trust fund could be worth as much as $60 billion.

The U.S. Department of Justice also has challenged the bankruptcy maneuver of Johnson & Johnson. At the Sept. 26 hearing, an attorney from the DOJ said if approved by the U.S. Court of Appeals, it will lead to other nonbankrupt companies, and even wealthy individuals, using similar strategies to avoid liabilities.

“If Johnson & Johnson can get away with this bankruptcy, what’s to stop any other company in America from doing the same thing?” attorney Sean Janda, an attorney with U.S. Trustee, a division of the Department of Justice that oversees bankruptcy cases.

Bankruptcy trusts often pressure claimants to accept lower settlements than they might expect in a civil case and avoid any excessive payouts, but they also make it simpler for claimants.

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Asbestos Health Screenings in Libby, Montana, Expanding

Highly specialized asbestos exposure health screenings in Libby, Montana, have gone mobile.

In an effort to identify lung abnormalities at their earliest stage, the groundbreaking Center for Asbestos Related Disease – known as CARD – has begun touring the state, offering its services to those unable or unwilling to travel.

The efforts have been well received.

Libby is a small town in rural northwest Montana that is home to one of the largest human-made environmental disasters and longest-running asbestos cleanup project in American history.

Although restoration is all but complete in the scenic and charming mountainside community, the damage done by mining in the area still lingers in many who lived through the toxic times.

Libby has the highest percentage of asbestos-related lung disease – and resulting respiratory disease – in the U.S. The contamination stemmed from 70 years of asbestos-contaminated vermiculite mining that affected people in Libby and throughout Lincoln County.

Asbestos Is Gone but Problems Remain

Although the mining ended in 1990, lingering asbestos remained a serious problem for another 20 years. And those affected by asbestos diseases such as mesothelioma cancer can take 20-60 years to begin showing obvious symptoms.

CARD is a specialized medical center and community nonprofit in Libby that was formed in 2000. It is dedicated to the diagnosis and long-term care of patients with asbestos-related diseases who have been such a part of Libby area health care concerns for decades.

An estimated 800 residents are screened annually at the CARD medical clinic. Of those, health officials say 25% have been diagnosed with an asbestos-related condition. 

The most common diseases are asbestosis, pleural plaques, pleural effusions, COPD, mesothelioma and atelectasis. Asbestos exposure also can lead to lung cancer, laryngeal cancer and ovarian cancer.

In total, more than 2,400 people – about 15% of the total population of Lincoln County – have been diagnosed at CARD with respiratory diseases related to the asbestos contamination. Many of those are still being monitored at the CARD center.

“It’s a long-term issue here,” former CARD medical director Dr. Brad Black told The Mesothelioma Center. “People sometimes forget that, and don’t understand the lag time between long-ago exposure and disease today. It’s something you always have to be aware of here.”

CARD Now Traveling Across Montana

This summer, for the first time, CARD didn’t wait for residents to come to the clinic to be tested. CARD is now on tour, traveling through the state to offer assistance to those who need it, particularly Libby residents who moved away.

For the first mobile clinic in June, CARD went to Billings, Montana – 500 miles away – and screened 13 people. In Missoula, 200 miles away, 33 people came for the testing in July. 

The next mobile clinic is scheduled for Oct. 10-12, in Kalispell, Montana, which is 90 miles from Libby. Future dates in future cities will be announced soon. There is talk of also going out of state.

Free screening is available to anyone who spent at least six months in Lincoln County, at least 10 years ago.

Asbestos-Related Disease Screening Is Extensive

The screening process includes a chest X-ray, spirometry breathing test, full physical exam, a CT scan of the chest if deemed necessary, and a complete blood workup. All tests will be read by a CARD medical provider who is trained in identifying early symptoms of asbestos diseases.

CARD staff includes doctors, physician assistants, nurses, respiratory therapists and researchers, all specialists in asbestos diseases.

The clinic has expanded to include academic research that has led to worldwide diagnostic and treatment advances for asbestos diseases.

An estimated 700 residents from the Libby area have died of asbestos-related diseases during the past half-century, some of whom once worked in the mine and many others who did not.  

This extensive early testing for asbestos diseases is vital to successful treatment. Mesothelioma cancer, for example, often doesn’t show obvious symptoms until in its latter stages when mesothelioma treatment is limited and often ineffective.  

Less than a third of those diagnosed with mesothelioma are even eligible for mesothelioma surgery – which has proven to be the most effective treatment – because the disease is often too far advanced. 

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ADAO Asbestos Prevention and Awareness Conference Runs Sept. 16-17

Medical specialists, environmental experts and mesothelioma cancer survivors will be among those gathering for the 17th annual International Asbestos Awareness and Prevention Conference, to be held Sept. 16-17, at Emory University in Atlanta.

The world is invited to watch and learn with a free livestream, which is once again embracing the “Where Knowledge and Action Unite” theme.

“Our conference is, and always has been, about serving people,” said Linda Reinstein, president of the Asbestos Disease Awareness Organization, which hosts the conference. “There should never be a barrier to education, especially when it comes to lifesaving public health information.”

Reinstein co-founded ADAO in 2004 when husband Alan Reinstein was first diagnosed with malignant mesothelioma, a terminal cancer caused by asbestos exposure.

She has spent the past 18 years working tirelessly toward eliminating asbestos disease and has become one of America’s most persistent voices for asbestos awareness.

“It’s about bringing prevention to the forefront,” she told The Mesothelioma Center at Asbestos.com. “We’re making a difference.”

Asbestos Conference Features Global Experts

More than 40 experts from seven countries will gather throughout the two days – many of them virtually – to discuss preventing and treating asbestos diseases, along with policy efforts around the world to finally ban asbestos.

Among the experts will be highly regarded thoracic surgeons Dr. Raja Flores and Dr. Andrea Wolf, mesothelioma specialists at Mount Sinai Hospital in New York City.

“Over the years, I’ve seen the devastating effects of mesothelioma,” Wolf said. “I am grateful to ADAO for the opportunity to share this on a large scale at this weekend’s meeting.”

Livestreaming the event is free, but registration is required.

Friday features the Arts, Advocacy and Action Festival, focused on the impact storytelling has on raising awareness of toxic asbestos and preventing exposure.

David Boraks, a journalist with WFAE, the National Public Radio affiliate in Charlotte, North Carolina, will deliver the keynote address. Boraks’ reporting has documented higher levels of asbestos exposure in poorer communities.

Others scheduled to speak include Tony Rich, an industrial hygienist and environmental technician; Lee Loftus, a former insulator/asbestos worker; and Fernanda Giannasi, a civil and safety engineer.

Academic Panel Discussions Offer Opportunities to Learn

Saturday will feature an academic conference highlighted by four 90-minute panel discussions that include many of the experts who have gathered for the event.

ADAO Saturday Panel Discussions
Session I

Progress and Challenges from the Frontline, with moderator Dr. Celeste Monforton.

Session II

Medical Advancements: Diagnosing and Treating Mesothelioma and Other Asbestos-Related Diseases, with moderator Dr. Arthur Frank.

Session III

Prevention: Legacy Asbestos: What is it? Where is it? What Do I Do? with moderator Richard Lemen, Ph.D.

Session IV

Global Ban Asbestos Action, with moderator Brent Kynoch.

Wolf, who will be receiving the prestigious Dr. Irving Selikoff Award for her commitment to the cause, will be part of the Medical Advancements session. Dr. Melissa McDiarmid will also receive the Selikoff Award.

Dr. Raja Flores to Speak on Legacy Asbestos

Thoracic surgeon Flores will be part of the Legacy Asbestos session, which is particularly pertinent to ADAO, whose recent lawsuit against the U.S. Environmental Protection Agency is pushing the country closer to an asbestos ban.

The lawsuit led to a court order for the federal agency’s current ongoing evaluation of the risks posed by legacy asbestos, a key topic for Saturday.

With asbestos highly regulated today in the U.S. and no raw asbestos being mined or imported into the country, legacy asbestos in the U.S. is what most people believe is the biggest threat today.

Legacy asbestos is found most everywhere throughout the U.S., particularly in older commercial and residential structures. It becomes a threat as it ages and becomes more brittle, particularly in renovation projects.

The EPA was forced to make legacy asbestos a significant part of its much-anticipated Risk Evaluation for Asbestos Part 2, which must be completed by 2024.

“Legacy asbestos is going to drive the message forward that asbestos is a known carcinogen. There is no safe level,” Reinstein said. “We must ban it now.”

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Asbestos Found in Talc-Based Tiger Brands Baby Powder

Johnson & Johnson isn’t the only market leader struggling with the issue of asbestos-contaminated talc in its baby powder.

Tiger Brands, the largest food producer in South Africa, has recalled its Purity Essentials Baby Powder as a “precautionary measure,” after trace amounts of asbestos were detected in test samples.

The recall was announced Sept. 8, less than a month after Johnson & Johnson informed company shareholders that it was ending the worldwide sale of its talc-based product in 2023.

Tiger Brands, one of the largest packaged goods companies on the continent, is expected to continue selling its talc-based baby powder once the recall has been completed. Its products also can be found in Cameroon, Kenya, Zimbabwe, Nigeria, Chile and Mozambique.

“I can assure you that the testing that we did was unrelated to anything linked to J&J issues,” Tiger Brands Chief Operating Officer Noel Doyle said. “While we found trace levels of asbestos in the raw material, we’ve acted to recall everything that’s on the market, despite the fact that previous testing did not show any trace levels.”

Asbestos in Talc Has Prompted Lawsuits

Asbestos, a toxic, naturally occurring mineral, is found near the Earth’s surface, often close to where talc is mined. Talc is coveted as one of the world’s softest minerals.

Johnson & Johnson stopped selling the talc-based version of its baby powder in the U.S. and Canada after becoming the target of close to 40,000 talc lawsuits, most claiming that use of the product caused serious health problems, including ovarian cancer. A small number of cases claim the asbestos contamination led to mesothelioma cancer.

Although J&J shareholders voted in May against ending the worldwide sale of the talc-based powder, company executives overruled them while continuing to insist the product was safe.

Since 2020, Johnson & Johnson has been transitioning to a cornstarch-based baby powder, which Tiger Brands already is using, along with its talc-based product.

The majority of companies today have moved away from talc-based powders, according to Women’s Voices for the Earth, a nonprofit based in Montana that is focused on toxic chemicals and gender justice.

In recent years, scientific studies of Johnson’s Baby Powder have been mixed. Some have shown that women who use the product regularly increase their risk of ovarian cancer. Other studies have not shown a risk.

Talc Asbestos Lawsuits Continue

The U.S. Food and Drug Administration discovered small traces of asbestos in Johnson’s Baby Powder samples in 2019, which prompted a partial recall and helped fuel the rise in lawsuits.

Less than a year later, Johnson & Johnson suspended sales of the product in the U.S. and Canada, but insisted the stoppage was in response to exaggerated reports of contamination and legal ramifications.

This latest recall by Tiger Brands is expected to accentuate the efforts against J&J, which continues to say its product is asbestos-free.

To fend off the lawsuits and absorb its talc liabilities, though, Johnson & Johnson created a new subsidiary earlier this year, LTL Management LLC, which immediately filed for bankruptcy.

The J&J talc bankruptcy filing, which was approved by a federal judge in New Jersey, was designed to limit legal exposure and includes a trust fund worth an estimated $3 billion.

That filing has temporarily suspended most of the lawsuits but is being challenged in court and looked at by Congress. 

According to its own financial reports, Johnson & Johnson has already spent close to $1 billion in legal fees and $3.5 billion in settlements and verdicts.

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Kaiser Study Shows Benefits of Mesothelioma Specialty Centers

Patients diagnosed with pleural mesothelioma are better managed and survive longer when treated at an integrated specialty center, according to a study by Kaiser Permanente that compared its own performance before and after making the transition to specialty care.

Doctors at the Kaiser Permanente Northern California health care system found a dramatic improvement once more specialized and standardized treatment was established for mesothelioma patients.

The Journal of Thoracic Disease published the results of the findings in August.

Mesothelioma patients at Kaiser were three times more likely to receive treatment for this cancer than before the transition. The rate of aggressive mesothelioma surgery went from 6% of patients to 22%.

After the mesothelioma specialty center was established, patients were evaluated and diagnosed more accurately, understood more clearly and treated more aggressively, according to the study.

Median overall survival rates of those undergoing multidisciplinary therapy increased by an average of 12 months, compared to the majority of patients who opted for a more hands-off, hospice approach before the changes were made.

“The takeaway from this study is that mesothelioma patients today really need to get a medical opinion at a center that has expertise in handling this cancer,” study co-author and thoracic surgeon Dr. Jeffrey Velotta told The Mesothelioma Center at Asbestos.com. “Too many don’t. Too many patients today are just not getting the appropriate treatment, and in this day and age, that’s crazy. It is happening too often.”

Mesothelioma Study Makes Before/After Comparisons

Kaiser’s study involved 368 adult mesothelioma patients from Jan. 1, 2009, to Dec. 31, 2020, some before and some after the regionalization of Kaiser Permanente that involved specialized surgical teams and multidisciplinary reviews of treatment options.

The first group included 171 mesothelioma patients from 2009 to 2014, a period in which a low volume of surgeries were performed at two different sites by two different surgeons.

A second group had 197 mesothelioma patients from 2015 through 2020, which was after the move to one thoracic surgeon, a mesotheliomas specialist, at one site. It included a team of multidisciplinary specialists and a tumor board that met weekly to review cases.

In the first group, just 43.9% of the patients received any treatment at all. Only 10 of the 171 patients underwent surgery.

In the second group, 63% of the patients opted for treatment and 44 of the 197 underwent aggressive surgery.

Median survival of the patients opting for surgery went from 16.7 months to 22.6 months, respectively, in the two groups.

“One of the highlights of our regionalization program was that significantly more eligible patients for multimodality treatment did indeed undergo optimal treatment, compared to preregionalization,” the authors wrote.

Many Mesothelioma Patients Go Without Treatment 

Mesothelioma, which is caused by exposure to asbestos, is a rare cancer with no cure that is often only diagnosed in its later stages. Oncologists rarely see it and generally deliver a grim prognosis without many treatment options. Too often, patients are told that mesothelioma treatment side effects are not worth the little difference they would make.

“That ‘do-nothing’ attitude is all too common. When I came here in 2014, I was shocked. You still see it at a lot of centers today,” Velotta said. “People need to get treatment. You can do well with mesothelioma. You just have to go to a place that knows how to treat it.”

In recent years, Velotta has built a reputation as one of America’s top mesothelioma surgeons. Kaiser Permanente also has become a West Coast leader in the field of mesothelioma, particularly with the specialty center Velotta has helped build at Oakland Medical Center, the flagship hospital.

His success has come as no surprise, having trained at  Brigham and Women’s Hospital in Boston under legendary thoracic surgeon Dr. David Sugarbaker, a mesothelioma treatment pioneer.

“Treatment is not going to be easy, but nothing about mesothelioma is easy. Even if you don’t have surgery, there are other good options today,” Velotta said. “The majority do well with surgery. We’ve had success here. That’s why I still find it hard to believe how many people are still going undertreated.”

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Study: ‘Drug-Factory’ Technology Kills Mesothelioma Tumor Cells in Mice

Tiny, drug-producing beads implanted in the chest cavity could one day provide a powerful platform that would change the way mesothelioma cancer is treated.

In a recent study, researchers from Rice University and the Baylor College of Medicine demonstrated the implants’ impressive effectiveness in mice, raising hopes of a possible breakthrough for this tough-to-treat cancer.

Researchers have already met with the U.S. Food and Drug Administration, and hope to open a clinical trial to begin testing the procedure’s effectiveness on mesothelioma patients by the second half of 2023. Clinical Cancer Research published the latest study Aug. 22.

“There is a lot of work left to be done, but we are definitely excited about the potential and encouraged by the clinical work already done,” Rice University bioengineer Omid Veiseh, whose lab invented the novel technology, told The Mesothelioma Center at Asbestos.com. “This could shift the paradigm [of treatment].”

New Technique Delivers Drugs Directly to Tumors

Drug-producing beads, which are no larger than the head of a pin, can be programmed to produce continuous high doses of genetically engineered interleukin-2, a natural compound that activates white blood cells to fight tumors. Researchers have dubbed the process “drug-factory” technology.

The FDA already has approved the technology with interleukin-2 for a clinical trial involving ovarian cancer. It is scheduled to open near the end of 2022.

For the study of mice with mesothelioma, beads were loaded with thousands of cells and implanted with minimally invasive surgery alongside the tumors and inside the pleural lining that surrounds the lungs.

In the first group, tumor burden was reduced by an average of 80% after only one week of treatment. In more than half of the mice, the implants completely eliminated the tumors.

A second group of mice received a combination treatment of the same interleukin-2 and a checkpoint inhibitor drug, which works by training the immune system to recognize and destroy cancer cells.

In that second group, tumor burden was eliminated in all seven animals, none of which exhibited any recurrence in the following weeks of observation.

“It is very hard to treat mesothelioma tumors in mice, like it is in human beings,” said thoracic surgeon Dr. Bryan Burt, a mesothelioma specialist at Baylor University and the study co-author. “And what our data show is that delivery of these immunotherapy particles, regionally, to these mice that have mesothelioma, has very provocative and very effective treatment responses.”

Continuous Drug Dosage Is Critical

The key, according to authors, is the ability to produce the continuous drug doses alongside the tumors. Immunotherapy drugs by themselves have shown only sporadic effectiveness for patients when given systemically. They have worked especially well only for a small percentage of patients.

“We’ve been working on this technology for a while,” Veiseh said. “This combination does a more effective job of using the immune system to kill the tumors.”

It was Veiseh’s earlier work using his technology with ovarian cancer at Rice University that first caught the attention of Burt and Dr. Ravi Ghanta at Baylor.

“They were really impressed by the preclinical data we had in ovarian cancer,” Veiseh said.  “And they asked the question, ‘Could we actually leverage the same system for mesothelioma?’”

The answer came with the mice model, which is leading to clinical trials.

In addition to showing potential to eliminate tumors, this early study suggests that the drug combination and its delivery method also could be effective at training T cells to reactivate the immune system when mesothelioma recurrence occurs.

“I’ve not seen these mesothelioma tumors in mice be eradicated – with such efficacy – as we have in this mice model,” Burt said. “The local delivery of relatively high doses of immunotherapy to that pleural space is a very attractive way to treat this disease.”

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