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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.

Baylor Study: Mesothelioma ‘Staged Surgical Approach’ Increases Survival

Select patients diagnosed with mesothelioma cancer in both the thoracic and abdominal cavities still can achieve an extended survival if their treatment center performs the preferred types of aggressive surgery, according to a recent study at Baylor College of Medicine in Houston.

Patients undergoing bicavitary cytoreductive surgery that includes the lung-sparing, extended pleurectomy and decortication had a median survival of 58.2 months, the study found. The Journal of Thoracic and Cardiovascular Surgery published the results online in December.

“Long-term survival can be achieved with an aggressive, staged surgical approach,” study authors wrote. “For patients with localized disease that is amenable to multimodality therapy with resection, prolonged survival can be achieved.”

Mesothelioma is a rare and aggressive cancer that is caused by exposure to asbestos. It typically comes with a poor prognosis and is rarely diagnosed in both the chest and the abdomen.

Aggressive mesothelioma surgery in one cavity can be overwhelming, and having two back-to-back surgeries is almost unheard of outside of select mesothelioma specialty centers such as Baylor.

“Reports of bicavitary CRS [cytoreductive surgery] are limited,” the authors wrote. “Our series is the only non-case report of patients who underwent staged resection of chest and abdominal mesothelioma.”

Mesothelioma Surgeries Produced Different Results 

From 2014 to 2021, 440 patients with mesothelioma were evaluated at Baylor College of Medicine. Only 14 of those (3%) underwent the two-stage chest and then abdominal operations. Of the 14 bicavitary patients, eight underwent the extended pleurectomy decortication and six had the extrapleural pneumonectomy.

For the abdominal surgery that followed, all 14 underwent a standard peritonectomy and hyperthermic intraperitoneal chemotherapy, another specialty procedure known as HIPEC.

Six of the patients received chemotherapy between the two operations and five received adjuvant chemotherapy after each operation.

Median overall survival, for the entire cohort, was 33.6 months, with a five-year survival rate of 20%. 

The objective of the retrospective study was to determine whether the latest extended pleurectomy decortication surgery or the older, lung-sacrificing extrapleural pneumonectomy was more effective as part of bicavitary resection. The results were not even close.

From the date of the second surgery, median overall survival was only 13.5 months for those undergoing the EPP, but 58.2 months for those having the extended P/D. The median progression-free survival was 12.9 months vs. 26.3 months for EPP and ePD groups, respectively, following the first surgery.

Dr. David Sugarbaker Pioneered EPP Surgery

Results of the study are one reason Baylor – like many specialty centers treating mesothelioma –has moved away from the once-groundbreaking EPP surgery that was made popular by the heralded thoracic surgeon and mesothelioma specialist Dr. David Sugarbaker.

Sugarbaker, who became known as Mr. Mesothelioma during his more than two decades at Brigham and Women’s Hospital in Boston, came to Baylor Medical Center in 2014 as director of The Lung Institute. He died in 2018.

“The choice of operative procedure reflects a shift from EPP to ePD in our institution that is similar to many mesothelioma centers,” authors wrote. “EPD is now our standard approach for the majority of patients.”

Earlier studies involving only pleural mesothelioma in the thoracic cavity had shown similar survival times when comparing the two surgeries, but a quicker recovery and a lower morbidity rate with the ePD.

In this study, there were no immediate deaths following the first surgery, and all 14 patients proceeded to the second surgery. There were two patients – both starting with the EPP – who died within 90 days of the abdominal surgery.

“When considering bicavitary cytoreductive surgery for mesothelioma, we would recommend only performing ePD and avoiding EPP in this cohort of patients,” authors concluded.

Baylor Medical Center thoracic surgeon Dr. R. Taylor Ripley was the lead author of the study. One of the co-authors was surgical oncologist Dr. Paul Sugarbaker, brother of Dr. David Sugarbaker and a pioneer in advancing treatments for peritoneal mesothelioma. He last served at MedStar Washington Hospital Center.

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UK Citizens Filing Asbestos Talc Claims In U.S. Courts

Residents of the United Kingdom have been among the growing number of personal injury plaintiffs filing lawsuits in U.S. courts, attributing their diagnoses of mesothelioma cancer to asbestos-contaminated talc.

That should come as no surprise. With the world’s highest per capita incidence rate of mesothelioma, the UK is contributing to the changing face of asbestos litigation in America.

While mesothelioma traced to occupational asbestos exposure among men is dropping, nonoccupational exposure leading to mesothelioma among women is rising.

Asbestos-contaminated talc, sometimes found in health and beauty products, is part of the reason for the growing trend. The burgeoning number of cases linked to talc in recent years  – the first court case came in 2016 – has helped spark the increase in international product liability filings.

Cases Linked to US Products

“You may think that living in the UK, you are not able to file a case within the U.S. court system, but that’s not entirely true,” attorney Daniel Wasserberg, asbestos litigation specialist from New York City, told The Mesothelioma Center at Asbestos.com. “If you have [asbestos] exposure that relates back to American-branded companies or to products manufactured here in the United States, you may be able to avail yourself of a courtroom in the United States.”

Wasserberg has particular expertise dealing with the issue of asbestos-contaminated talc, which has been found in baby powders, body powders, a wide range of makeup, creams and moisturizers. 

Some cases of contaminated talc involve UK residents who bought products while on vacation in the U.S. Others involve American products sold outside the country. Johnson & Johnson, which faces many contaminated talc cases, manufactures its products in several different countries.

According to the UK’s Health and Safety Executive, an estimated 450 to 500 women there are diagnosed annually with mesothelioma. There also is a 7% annual increase projected each of the coming years, much of it stemming from contaminated talc.

“We are seeing more and more talc manufacturers become defendants in the asbestos litigation,” Wasserberg said. “They are very much part of a newer wave of the asbestos litigation. The talcum powder litigation is here to stay.” 

Johnson & Johnson Leads Talc Litigation

Johnson & Johnson is the biggest name in talc litigation, with close to 40,000 talc lawsuits still pending. Although the company has continued to insist its products are safe, litigation from talc lawsuits, in settlements and verdicts, has exceeded $3 billion, according to the company.

J&J announced in August 2022 that it would discontinue selling its iconic talc-based Johnson’s Baby Powder in 2023, and is now using a cornstarch-based formulation. It stopped the sale throughout the U.S. and Canada in 2020, citing the avalanche of lawsuits.

Other cosmetics giants facing litigation include Avon, Chanel, Clinique and Estee Lauder. Avon, for example, was recently ordered by a California jury to pay more than $52 million – $10.3 million in punitive damages, in addition to the $40 million in actual damages – to a woman who said her mesothelioma was caused by asbestos-contaminated talc.

Only a small percentage of contaminated talc cases involve mesothelioma, a rare cancer caused almost exclusively by asbestos exposure. The majority of the cases involve ovarian cancer or other serious health issues. 

The talc contamination stems from where the two naturally occurring minerals are found near the Earth’s surface, often in close proximity to one another. 

Although testing for contamination is done, the different methods of testing have varied widely. Often at issue in court has been the lack of a warning on the products where asbestos contamination is possible.

“Attorneys [including our firm] have had success bringing these cases to American courts and getting good results,” Wasserberg said. “People generally think of personal injury lawsuits as being a local practice, but that’s not always the case with asbestos. A claimant may be surprised that their case can be heard here.”

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Avon Hit With $52.1M Verdict for Asbestos-Contaminated Talc

A California jury awarded $52.1 million to an Arizona woman diagnosed with mesothelioma cancer. The multimillion-dollar verdict combines damages against cosmetics giant Avon and a forklift manufacturer.

Attorneys for Rita-Ann Chapman said she had been using Avon talc products contaminated with asbestos for much of her life. Chapman is 76.

She blamed additional secondhand asbestos exposure on forklift maker Hyster Company. Her husband Gary handled asbestos products while working at Hyster.

Chapman won her case in California Superior Court earlier this month.

Mesothelioma is a rare cancer. Inhalation or ingestion of asbestos fibers is the primary cause of the incurable condition.

Although occupational exposure once dominated asbestos litigation, the field is widely expanding today with the recent discovery of asbestos-contaminated talc products. Chapman’s combined award is a look at the future and past of asbestos litigation.

Avon Kept Asbestos Contamination Secret

Avon, famous for its door-to-door saleswomen known as “Avon Ladies,” sold a variety of cosmetics, including body and face powders.

Jurors concluded Avon management knew of the talc contamination but failed to warn consumers of the serious health risks, and deliberately kept them secret. Actual damages were listed at $40.8 million, with an additional $11.3 million in punitive damages. Jurors blamed Avon for 90% of Chapman’s cancer.

According to court records, Avon faced almost 200 talc lawsuits in 2021. Although the company has continued to say its products are safe, it announced in 2020 that it would stop using talc in its products.

Avon said it will appeal this latest verdict.

“We are disappointed by this verdict and will vigorously pursue all available avenues to appeal,” the company said in a statement. “Avon is confident that it has strong grounds for appeal and will continue to defend its position.”

Secondhand Asbestos Exposure at Hyster

The involvement of Hyster Company in the lawsuit stems from Chapman handling the work clothes of her husband, who worked at a Hyster forklift manufacturing plant.  

He worked with clutches, gaskets and brakes made with asbestos. The naturally occurring mineral strengthens products, but it is also carcinogenic.

Chapman’s husband often brought home the microscopic asbestos fibers on his clothes, which she would regularly wash.

Johnson & Johnson Leads Talc Lawsuits

The verdict against Avon was not a surprise as talc-related cases are becoming more common. Companies such as Chanel, Revlon, L’Oréal and Justice are facing litigation involving contaminated talc.

Johnson & Johnson, with its iconic baby powder, is the giant of the industry. It faces more than 30,000 lawsuits. Most cases involve ovarian cancer. Only a small percentage are mesothelioma legal claims.

The company already has spent more than $3 billion in settlements and verdicts. Johnson & Johnson created a new subsidiary in 2021 that immediately filed for bankruptcy protection to limit its future talc liabilities.

A federal judge in New Jersey approved the controversial strategy, but it’s now in federal appeals court.

J&J, a leader in the field, stopped the sale of its talc-based Johnson’s Baby Powder in the U.S. and Canada in 2020, citing the avalanche of lawsuits.

Talc and asbestos are naturally occurring minerals. Asbestos veins often run through talc deposits, making contamination possible during the mining process.

Although testing for contamination has been done for years, different testing methods have produced varied results.

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Dangers of Legacy Asbestos Detailed in UK Study

A recently published study from the United Kingdom has shown that legacy asbestos lingering in commercial and residential construction is more dangerous than expected. 

In what is believed to be the largest study in the world of legacy asbestos, researchers found that almost two-thirds of it had aged enough, or was damaged enough, for fibers to become airborne and put people at risk.

An estimated 1 million samples were collected in a six-month period across Great Britain as part of the study, completed by the National Organisation of Asbestos Consultants and the trade group Asbestos Testing and Consultancy.

What they found was alarming. The observations were shared at a Parliamentary event in London earlier this month, bringing attention to an asbestos management strategy – similar to what the U.S. has– that is flawed.

“We weren’t looking for this, but when we looked at the data the figures leapt out at us. Asbestos left in the buildings as ‘safe’ was actually now in a damaged state,” said NORAC Chairman Jonathan Grant. “When asbestos is damaged it may create a risk to occupants by releasing fibers which, if inhaled, can lead to irreversible cancer.”

EPA’s Risk Evaluation Key for U.S.

Asbestos can lead to a variety of health problems, including malignant mesothelioma, a cancer with no cure that is caused almost exclusively by the inhalation or ingestion of the toxic fibers.

The UK banned asbestos in 1999, but legacy asbestos remains – like in the U.S. – in most construction that was done before the 1980s.

Although heavily regulated, asbestos is not banned in the U.S. entirely. The U.S. Environmental Protection Agency is in the midst of finalizing its Risk Evaluation for Asbestos as part of the Toxic Substances Control Act.

Part 2 of the Risk Evaluation, which involves legacy asbestos, is expected to be finished by the end of 2023 and could lead to a complete ban of the toxic mineral and a more complete strategy for handling it.

Eliminating Legacy Asbestos

Earlier this year, the UK had discussed a long-term plan that would remove asbestos from all buildings within a 40-year timeframe, but that plan was rejected by legislators as too costly.

“It’s an impossible situation,” said Kevin Bampton, chief executive officer of the British Occupational Hygiene Society in London. “Developers, social housing landlords, schools and hospitals don’t want to have asbestos removed from property [because it is costly], but clearly the management strategies in place are not working.”

An estimated 2,700 cases of mesothelioma are diagnosed in the UK annually, one of the highest per-capita rates in the world. Some European countries that banned asbestos more than a decade ago are moving forward with plans to have it removed from all structures in the future.

Current Asbestos Regulation Falls Short

In the U.S., the mining of asbestos stopped more than two decades ago, and the importation of asbestos has dropped dramatically. 

In recent years, the chloralkali industry has consumed all raw asbestos being imported into the U.S., where it is used for semipermeable diaphragms to make chlorine.

A small number of products made with asbestos are still imported – vehicle friction items, sheet gaskets, brake blocks, etc. – but the biggest threat to the public today is the legacy asbestos.

The general perception, though, is that if left undisturbed, asbestos used earlier in construction is not a threat. That theory is now being seriously challenged in the UK.

There is potential legislation being discussed that would require an asbestos survey of any commercial or residential building being sold, if it was built before 1999. There is currently an ongoing asbestos inspection of all schools in the UK, which is not being done today in the U.S.

“Nobody should be selling a building with a toxic substance hidden in it that the buyer doesn’t know about,” Grant said. “At the same time, when we upgrade our homes and heating systems, we don’t want to expose workers, or the building occupants, to fatal risk. It’s applying the same common sense to asbestos that we do to other hazards.”

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Mesothelioma Surgery With Immunotherapy Proves Effective in Study

An immunotherapy combination given before aggressive surgery has shown impressive effectiveness in extending survival for pleural mesothelioma patients in a recent phase II clinical trial at Baylor College of Medicine.

The combination of immune checkpoint inhibitors durvalumab and tremelimumab showed an ability to effectively alter the intratumoral immune system and make surgery more effective.

This randomized clinical trial compared the use of durvalumab alone – already shown to be effective in other cancers – to both the two-drug combination and to using no immunotherapy before mesothelioma surgery.

Clinical Cancer Research published the randomized trial findings Dec. 5.

“These data indicate that neoadjuvant durvalumab plus tremelimumab orchestrates de novo systemic immune responses that extend to the tumor microenvironment and correlate with favorable clinical outcomes,” study authors concluded. 

Clinical Trial Begun by Dr. David Sugarbaker

The clinical trial opened in May 2016, due in part to the earlier arrival of legendary thoracic surgeon and mesothelioma pioneer Dr. David Sugarbaker as the new director of the Lung Institute at Baylor College of Medicine. Sugarbaker died in 2018 when patients were still being enrolled.

Twenty-four patients who were screened and eligible for either the pleurectomy and decortication or extrapleural pneumonectomy surgery joined the trial. It included both epithelioid and the tougher-to-treat sarcomatoid types of mesothelioma.

Nine were randomized to just durvalumab, 11 to the immunotherapy combination, and four were given no immune checkpoint inhibitors. Evaluation of the randomized patients was at 34.1 months.

Progression-free and median overall survival for those receiving only durvalumab was 8.4 months and 14 months, respectively. Those receiving no checkpoint inhibitors had similar results.

Patients treated with the mesothelioma immunotherapy combination far exceeded both progression-free and median overall survival measurements of the monotherapy group. No survival results were recorded at the time of study publication because three of the 11 patients were still alive.

“In patients with resectable MPM [malignant pleural mesothelioma], we show that a single cycle of durvalumab and tremelimumab delivered in the neoadjuvant setting profoundly reorganizes the immune contexture of MPM tumors,” authors wrote. 

They said the data showing lower rates of recurrence and longer survival are supported by the regimen’s impact on systemic immunity.

Synergy Powers Immunotherapy Combination

The effectiveness of the combination is based on the way the drugs complement one another. Both are created with human antibodies that essentially unmask the cancer cells and allow a patient’s own immune system to attack in different ways.

Durvalumab produces an antibody designed to negate the PD-L1 protein that often blocks the immune system from killing the cancer cells. The drug, also known by the brand name Imfinzi, is approved by the U.S. Food and Drug Administration to treat bladder cancer and certain lung cancers.

Although tremelimumab was ineffective by itself in an earlier trial with mesothelioma, it has shown considerable promise as a complementary agent with other cancers. It works by blocking a protein called CTLA-4, which is something that durvalumab does not do.

In the trial, the combination was administered by intravenous infusion two weeks before surgery was scheduled. Immediately after surgery, patients received intraoperative chemotherapy.

Mesothelioma Study May Lead to FDA Approval

Although immunotherapy has advanced the treatment of pleural mesothelioma, its effectiveness has been inconsistent and minimal.

In 2020, the FDA approved the immunotherapy combination of Opdivo and Yervoy for first-line treatment after it showed a four-month survival improvement over standard chemotherapy.

The most effective treatment is still the multimodal combination of surgery, chemotherapy and radiation, but the majority of those patients still only survive less than two years. Less than a third of those diagnosed with pleural mesothelioma even qualify for surgery.

A potential advancement such as this latest combination of immunotherapy as a pre-surgical treatment has attracted considerable attention, making the next FDA approval a little closer.

“Neoadjuvant ICB [immune checkpoint blockade] appears safe and feasible in patients with MPM. [It] results in pathological tumor responses and has a potentially favorable impact on survival,” authors concluded.

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Study: Early Mesothelioma HIPEC Surgery Extends Survival

Sooner is better when it comes to aggressively treating peritoneal mesothelioma cancer with a combination of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.

Waiting could cost a patient months of survival. Rejecting surgery could cost them years.

The Journal of Gastrointestinal Surgery published a study in November that showed for the first time to what degree a delay in having the mesothelioma surgery, or not getting it at all, can affect overall survival for patients.

Results of the mesothelioma study were presented earlier this year at the annual Society for Surgery of the Alimentary Tract meeting in San Diego.

Surgeons and oncologists from Abramson Cancer Center at the University of Pennsylvania, Sidney Kimmel Medical College in Philadelphia and the University of Colorado Hospital in Aurora co-authored the study.

“These findings reinforce the important role timely surgery can play in patients with peritoneal mesothelioma,” surgical oncologist and co-author Dr. Giorgos Karakousis, of Abramson Cancer Center, told The Mesothelioma Center at Asbestos.com.

Mesothelioma Life Expectancy Rises With Surgery

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, also known as CRS-HIPEC, has become an effective treatment of choice for mesothelioma specialists in recent years. 

This latest life expectancy simulator looked at 1,000 cases of peritoneal mesothelioma in three different categories: timely treatment (fewer than four weeks after diagnosis), delayed treatment (4-24 weeks after diagnosis) and no treatment.

Based on analytic findings, the average life expectancies from time of diagnosis were:

Timely (fewer than 4 weeks from diagnosis) 5.24 years
Delayed (4-12 weeks) 4.8 years
Delayed (13-24 weeks) 4.37 years
No Treatment 2.11 years

Despite the life expectancy differences, authors estimate three out of five patients who are potential candidates for the combination do not receive it. They cited limited access to mesothelioma specialists, or oncologists still not knowledgeable enough about the advantages and eligibility qualifications to recommend it.

“Patients with a new diagnosis of peritoneal mesothelioma should seek early referral for  consideration at a center with specialized expertise,” Karakousis said.

Mesothelioma Specialists Are Crucial

Peritoneal mesothelioma is a rare cancer caused by an ingestion or inhalation of toxic asbestos fibers. It starts in the thin layer of tissue lining the abdomen, but it can take decades before obvious symptoms appear.

The majority of oncologists in the U.S. rarely see cases of mesothelioma. The study highlighted the importance of finding a mesothelioma specialty center for optimal care.

Peritoneal mesothelioma is considered more treatable than pleural mesothelioma, which develops around the lungs and has a shorter median survival. There is no definitive cure for either type of mesothelioma.

An accurate diagnosis is difficult, which often adds to the delay in finding an effective mesothelioma treatment. Early symptoms often are the same as other abdominal issues, including fatigue, fever, loss of appetite, nausea and abdominal pain.

The majority of patients diagnosed with mesothelioma are treated only with standard chemotherapy, followed by palliative care.

Eliminating Missed Treatment Opportunities

The CRS-HIPEC procedure is complex and can last as long as 12 hours. The lengthy, detailed mesothelioma surgery attempts to remove all visible cancer cells, which can be spread throughout the abdomen and involve numerous organs.

HIPEC, which immediately follows the cytoreductive surgery, involves circulating heated chemotherapy throughout the abdominal cavity. The intent is to kill any microscopic tumor cells that evaded the surgeon. The chemotherapy circulates for up to 90 minutes before being drained.

Authors of the recent study concluded that there continue to be missed opportunities to maximize survival with peritoneal mesothelioma, and offered this study to educate patients and clinicians.

“To date, there have been no randomized controlled studies evaluating the surgical management of MPM [malignant pleural mesothelioma], and where such trials do not exist, [this] model may offer utility for clinicians,” the study concluded.

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VA Disability Rates Rise; Veterans With Mesothelioma Benefit

The U.S. Department of Veterans Affairs has increased its monthly payments to disabled veterans by 8.7%, the largest annual increase in 40 years.

Veterans who developed disabilities caused by asbestos exposure during military service – including mesothelioma cancer – are among those receiving the increase, which began on Dec. 1.

VA disability payout increases are based on the latest cost of living adjustment done annually by the Social Security Administration.

Soaring inflation and rising prices prompted the much-needed increase.

“After a year of historic inflation, it’s great to see the federal government recognize this impact on veterans and adjust the VA benefits accordingly,” said Aaron Munz, a former U.S. Army captain and director of the Veterans Department at The Mesothelioma Center.

Veterans Disability Payments Are Tax-Free

With this latest increase, a single veteran with a 100% disability rating will see their monthly payout rise from $3,323.06 in 2022 to $3,621.95 in 2023. Benefits for a veteran with a spouse will go from $3,517.84 each month to $3,823.89 in 2023.

Disability compensation is a tax-free payment made monthly to military personnel who sustained an injury or illness during their time in service. The amount paid is not affected by income level, a VA pension or other benefits.

Disability level, which is interpreted on a percentage scale, determines the amount of compensation. Mesothelioma cancer, if traced to military service and asbestos, is automatically given a 100% rating.

Previous annual increases were 5.9%, 1.3%, 1.6%, 2.8% and 2%, respectively, over the past five years. This latest increase is the largest since it jumped 11% in 1981.

“The increased rates will help veterans who have been injured or have experienced diseases due to toxic exposures during their service. It will provide for their basic needs, as well as those of their family members, who have all made sacrifices for our country,” Munz said. “Most veterans who received 100% disability are not able to work or cannot maintain full employment. VA disability helps close the gap.”

Every Branch of Military Service Affected 

Although veterans with asbestos-related diseases make up only a small percentage of the military population receiving disability payments, it is still very significant.

Asbestos products were commonly used by every branch of the U.S. military due to the mineral’s fireproofing qualities and its heat resistence. Unfortunately, asbestos is toxic, and can it do considerable harm if fibers are inhaled or ingested.

Military personnel comprise a disproportionate number of people in the overall U.S. population who have been diagnosed with mesothelioma cancer, which is caused almost exclusively by asbestos.

According to the VA, veterans who served in the Middle East and Southeast Asia also may have been exposed to asbestos with more than just military equipment. The VA cited older, damaged buildings in those countries that exposed soldiers to toxic minerals such as asbestos.

VA Disability Levels Can Vary

The VA also recognizes several other diseases that have been traced to asbestos exposure in the military. That list includes lung cancer, gastrointestinal cancer, bronchus cancer, pleural plaques, pleural effusion and asbestosis.

Disability levels are not always the same. Noncancerous diseases often warrant less than the 100%, but the 8.7% increase still applies. For example, a veteran and spouse with a 50% rating will go from $1,050.44 each month in 2022 to $1,141.82 in 2023.

The 8.7% increase in benefits also applies to Dependency and Indemnity Compensation, which helps surviving spouses or children of military veterans who have died. Those individuals can now be paid as much as $1,562.74 each month.

Assistance in filing for VA disability compensation is available to all veterans through the Veterans Department at The Mesothelioma Center, which is overseen by Munz. It is a patient advocacy agency and is not part of the VA or any other government agency. Working with an accredited claims agent there can maximize a veteran’s chances of having their claims accepted.

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Honeywell to Fund Asbestos Trust With $1.3 Billion

To eliminate future funding obligations, Honeywell International Inc. has agreed to a one-time, lump sum payment of $1.325 billion to the asbestos trust fund it first established in 2013.

If approved by the U.S. Bankruptcy Court for the Western District of Pennsylvania, the buyout agreement would likely end any additional asbestos-related liabilities for Honeywell.

The payment is a significant investment toward future financial stability for the industrial giant, which is based in Charlotte, North Carolina.

Honeywell’s costly asbestos trust fund obligation stems from North American Refractories Company, which it owned from 1979 to 1986.

NARCO was once one of America’s largest manufacturers of asbestos refractory materials. It created heat-resistant products for Honeywell that were used to line high-temperature equipment .

Although asbestos was once used widely for its strength and heat resistance, its toxicity led to serious health problems – including mesothelioma cancer – for those who worked with the products. It has led to decades of costly legal ramifications.

Honeywell Payout Will Resolve Legal Battle

Asbestos litigation drove NARCO into bankruptcy in 2002, leaving Honeywell responsible for future damages. The North American Refractories Asbestos Personal Injury Settlement Trust was created in 2013. It has paid out an estimated $523 million, periodically funded by Honeywell, to those harmed by NARCO asbestos products.

The harm caused by NARCO asbestos products went well beyond what was used by Honeywell. In the 1970s, for example, NARCO was manufacturing automobile brake pads, also contaminated by asbestos.

Workers in shipyards, power plants, rubber factories, paper mills and railyards also were harmed by NARCO products.

In 2021, Honeywell sued the trust, claiming it was making undeserved payouts to too many claimants. The trust filed its own lawsuit against Honeywell, claiming the company was trying to evade its original obligation, which was estimated at $150 million annually.

This one-time payout is expected to resolve the legal issues between the trust and Honeywell and end future obligations for the company. The current NARCO reserve of $695 million – once projected to cover asbestos-related claims through 2059 – would be removed from Honeywell’s balance sheet.

“Honeywell is hopeful that the bankruptcy court will approve the buyout so that we can permanently extinguish the liability on our books,” the company said in a statement first published by Bloomberg News.

According to the recent regulatory filing with the U.S. Securities and Exchange Commission, Honeywell will still have the right to collect proceeds from its insurance policies related to NARCO. The trust reported legal fees alone at $21 million for 2021.

“Should the Buyout Agreement be approved by the Bankruptcy Court, the Buyout Closing would resolve all outstanding litigation currently ongoing between Honeywell and the trust,” according to the regulatory filing.

Asbestos Trusts Pay Billions to Claimants

The NARCO trust fund is just one of 60 asbestos-related trust funds, worth a combined $30 billion, that exist today. Other companies with asbestos trust funds include Owens Corning Corporation, United States Gypsum, W.R. Grace and Company, Armstrong World Industries, Western MacArthur and Johns-Manville Corporation.

Since the 1980s, they have paid out an estimated $20 billion to claimants. They were created by bankrupt companies, often overwhelmed by the thousands of lawsuits sparked by asbestos contamination.

Trust claim payouts often range from $7,000 to $1.2 million, with a median value estimated at $180,000. Claimants often seek money from more than one trust in a lawsuit.

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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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