Immunotherapy Clinical Trial Showing Promise in Stopping Mesothelioma Recurrence

Even after the best multimodal treatment approach â€" a combination of two or more therapies (chemotherapy, surgery and radiation) â€" the probability of mesothelioma cancer recurrence remains high because of the diffuse nature of the disease.

Researchers are moving closer to fixing that dilemma.

Doctors currently are testing a Wilms’ tumor 1 (WT1) peptide vaccine for its ability to halt mesothelioma recurrence in a Phase II clinical trial conducted at the MD Anderson Cancer Center in Houston.

MD Anderson still is accepting new participants for this randomized study that began in 2013. The expected completion date is 2017.

"To this point, it looks very promising," Anne Tsao, M.D., director of the Mesothelioma Program at MD Anderson, told Asbestos.com. "We've been encouraged with what we've seen."

Immunotherapy Is the Key

The vaccine is a form of immunotherapy designed to trigger the body's own immune system into preventing any new growth of the tumor. Tsao said the vaccine has been well tolerated by patients and shown no serious side effects.

It is one of several immunotherapy agents researchers are exploring in the fight against mesothelioma, an aggressive cancer which has no definitive cure and is caused by exposure to asbestos fibers.

Mesothelioma tumors typically have high levels of WT1, a protein that causes cell growth and regulates gene expression. When it becomes abnormal, it can lead to the development of cancer. The vaccine is given in combination with drugs GM-CSF and Montanide, which together are designed to cause white blood cells to grow and encourage an immune response.

The addition of the analog peptide vaccine helps direct the response to any mesothelioma cells that remain.

"After treatment [surgical resection and radiation], the premise here is that the immune system can then prevent recurrence from any microscopic disease that was left behind," Tsao said. "So far, that's our hope."

Getting Into the Trial

To qualify for the trial, patients must have finished a multimodal therapy that included a complete surgical resection through either a pleurectomy/decortication (P/D) or an extrapleural pneumonectomy (EPP).

They must test positive for high levels of the WT1 protein and have received either chemotherapy or radiation within the previous 4-12 weeks.

As part of the trial, patients will be given six injections over a 12-week period. All will receive GM-CSF and Montanide. As a random trial, though, only half of patients actually will be receiving the WT1 peptide.

Researchers will be looking for one-year progression-free survival calculated from the date of randomization to date of progression, death or the last follow-up.

MD Anderson Recruiting Patients

Tsao said centers involved in the study are actively recruiting new patients for the trial. She also talked about how much patients can be helped at a specialty center like MD Anderson, along with the importance of enrolling in a clinical trial to advance the goal of eventually finding a cure.

"It's absolutely essential to have patients enrolled in clinical trials to move forward with this disease," she said. "It's important to identify which of these immunotherapy agents work the best."

Most mesothelioma experts agree that immunotherapy may offer the best hope for the future, moving away from the toxicity of traditional chemotherapy and radiation, which can scare off many patients.

"I think there are several promising treatments out there now," she said. "Advancements are being made, both for patients and for research."

Author: Tim Povtak

Tim Povtak is an award-winning writer with more than 30 years of reporting national and international news. His most recent experience is in researching and writing about asbestos litigation issues and asbestos-related conditions like mesothelioma.

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Study: Higher Survival Rates for Women Could Lead to New Treatment Options

A recent study, the largest ever about the effect of gender on the asbestos-related cancer, proved definitively what doctors have suspected for years: women have an advantage over men when it comes to living longer after a diagnosis.

"This is very exciting," said Andrea Wolf, M.D. of the Division of Thoracic Surgery at Mount Sinai Medical Center in New York, an assistant professor who worked on the study. "It's great news for women, yes, but the goal now is to take what we've learned and use it to benefit both men and women."

Published in the Annals of Thoracic Surgery, the study did not examine why women survived longer, but it forwarded the theory that the protective effects of estrogen in a woman could be key to developing better therapies for both sexes.

"The obvious suspicion is that this is a hormonal phenomenon," Wolf told Asbestos.com. "It tells me that next there should be some sort of trial looking into a hormonal modification in treating this disease."

The study included 14,228 pathologically confirmed American mesothelioma cases in the national Surveillance, Epidemiology and End Results (SEER) data base, ranging from 1973 to 2009.

About 22 percent of the cases involved women patients. Despite similar baseline characteristics, the five-year survival for women was 13.4 percent compared to 4.5 percent for men. For women who were diagnosed before they turned 50 years old, the survival rate was 38.6 percent. For men under 50, the rate was 17.3 percent.

Survival Advantage Decreases With Age

Although females had a survival advantage in all age groups, the difference between the two groups grew smaller as they grew older. And the difference was not as dramatic among those who did not have surgery. Some 32 percent of men survived at least one year without surgery or radiation. That compared to 35 percent of the women in the same category.

The stage of diagnosis and treatment options for men compared to women was similar in the study, but the percentage of women opting for surgery was higher.

The effect of gender on survival was consistent across all other categories, including age, race and stage of disease. It differed depending upon treatment received.

"The fact that even older women have better survival rates than men suggests that there may be more than just hormones involved," Wolf said. "Younger women seem to do great, and it gives us good reason to be more aggressive in treating them."

The SEER database is a program run by the National Cancer Institute and the most authoritative source on cancer incidence and survival in America. It includes cancer-based registries that cover approximately 28 percent of the United States populations.

This study included cases from Georgia, Connecticut, Michigan, Hawaii, Iowa, New Mexico, California, Washington, Utah, Alaska, Kentucky, Louisiana and New Jersey. Researchers worked at Mount Sinai Medical Center and the North Shore/Long Island Jewish Health System-Hofstra School of Medicine.

Study Confirms Earlier Findings

The low incidence of women with the disease is mostly related to occupational exposure to asbestos, the primary cause of mesothelioma. It is normally associated with blue-collar professions, which traditionally have a smaller percentage of women.

Although the use of asbestos dropped dramatically in America over the past three decades, it still might be many years before there is an equally-dramatic drop in mesothelioma rates. The latency period between exposure to asbestos and diagnosis of mesothelioma can range from 20 to 50 years.

"There could be many factors in why women seem to do better with this disease. It could be different types of exposure, for example. Historically, women were not working in the shipyards with all the asbestos, but they were cleaning the clothes of workers who did work there.

Wolf previously was involved in similar studies when she worked at Brigham and Women's Hospital in Boston, but those studies carried a much smaller scale.

The small scale of those studies made it difficult to draw any strong conclusions from a single-center database. The findings of the more sweeping recent study confirmed what she already suspected.

"This study really supports some of the earlier findings," Wolf said. "There is something very real here. This could lead to a whole different route in treating the disease."

Author: Tim Povtak

Tim Povtak is an award-winning writer with more than 30 years of reporting national and international news. His most recent experience is in researching and writing about asbestos litigation issues and asbestos-related conditions like mesothelioma.

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Vietnam Vet Credits Strong Will, Alternative Medicine to Mesothelioma Survival

Doctors told United States Army soldier Billy K. almost 50 years ago that he never would walk again, his left leg irreparably damaged by a spray of bullets when his patrol was ambushed in the jungle during the Vietnam War.

Doctors told him last year he had six months to live, an unfortunate victim of malignant pleural mesothelioma, an aggressive and incurable cancer around his lungs.

He didn't listen either time.

Billy was back home last week cutting grass with a push mower, making plans to go camping with his wife and best friends.

A proud military veteran and mesothelioma survivor doing surprisingly well today, Billy, 72, is doggedly stubborn in his belief that he can overcome any obstacle in his path, still living life on his terms.

"I went to Vietnam knowing I might never return home alive â€" but I did. I'm a fortunate guy. I'm a determined guy, too," he said by phone from his home in southwest Ohio. "If someone tells me I can't do something, I make sure I do it. I've always believed you can beat anything if you put your mind to it."

Billy spent more than six months in two different hospitals recovering from his war wounds. He worried more about his friends who never made it back alive. He received the Purple Heart medal for his combat service, slowly but surely working his way out of the wheelchair he used initially.

His crutches soon disappeared, too, and the harder he worked in rehabilitating his leg, the less he limped. He moved to Arizona, Colorado and other places over the next 40 years working different jobs before He retired 10 years ago and moved back to Ohio to be nearer to his close-knit family.

To him though, retirement meant at least a part-time job, which became a lawn service business that included cutting 10-15 yards around town each week. A little limp never stopped him from doing anything, but he knew something was wrong when it got tougher and tougher to catch his breath between lawns.

When it became almost unbearable, he finally went to a doctor. That eventually led to his diagnosis of pleural mesothelioma, confirmed by both the Ohio State University Comprehensive Cancer Center and then the Mayo Clinic in Rochester, Minn.

Billy knew little about this rare and deadly disease, but he approached it with the same hard-headed determination that he takes with anything that stands in his way.

"I told every doctor I saw, `I'm going to beat this cancer,' " Billy said. "They didn't say much back."

Still Camping and Fishing

Billy is the fifth of eight brothers and sisters, but the oldest of the four still living. He and wife Sharon are regulars at church each Sunday but even more regulars at camping, where they spend considerable time on the water, fishing and boating.

They have traveled numerous times to Washington, D.C., to visit the Vietnam Veterans Memorial, which honors all who served and the more than 58,000 Americans who died during that war. Billy is proud of his country. He is proud to have served it.

"He doesn't talk too much about (his time served in Vietnam) unless you ask him. It's still very emotional for him," said Billy’s nephew Dennis, who lives nearby and has helped educate his uncle about mesothelioma. "But I can tell you he's a very determined guy."

Billy was diagnosed in October of 2013 and hospitalized briefly. He underwent three rounds of chemotherapy but opted against major surgery and radiation. Instead, he became a believer in alternative medicine and two particular health and wellness products.

Moringa Tree Has Medicinal Powers

He credits his good health today to the medicinal powers of Moringa, a tree grown in tropical climate and native to parts of Africa, South America and India. The leaves of the tree are rich in vitamins, nutrients and a variety of antioxidants, delivering anti-inflammatory and anti-tumor activity.

Moringa extract has been utilized for centuries for its health benefits, although never fully accepted by the traditional medical community.

Billy uses the powdered form of Moringa with purified water called Kangen, becoming a believer after seeing the benefits of other family members and friends who had used it before him.

"I just figured I had nothing to lose, so why not try something like this," Billy said. "I feel great, so you could say I'm a believer now. People say I look better now than before I got sick. I'm sure this Moringa had something to do with it."

Billy credits the Moringa for keeping his cancer in check. Yes, he gets tired quicker than before and the nerves in his left leg often flare up, but his lungs feel strong and his last CT scan showed no sign of cancer.

"My last check-up, the doctor couldn't believe how good I looked. He didn't say was totally out of the woods, but I'm in complete remission right now," he said. "I must be doing something right."

Author: Tim Povtak

Tim Povtak is an award-winning writer with more than 30 years of reporting national and international news. His most recent experience is in researching and writing about asbestos litigation issues and asbestos-related conditions like mesothelioma.

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Study: Majority of Peritoneal Mesothelioma Patients Avoid Surgery, Despite Benefits to Survival

Peritoneal mesothelioma patients are neglecting surgery as a therapeutic option - for a variety of reasons - and needlessly losing out on years of survival time, a recently published study from the Medical College of Wisconsin shows.

Even though the benefits are clear, surgery is not being performed on 62 percent of peritoneal patients, according to the study using 1973 to 2010 data from the Surveillance, Epidemiology and End Results (SEER) database.

The Annals of Surgical Oncology published the study in its May journal.

"It's unfortunate, but you can see the missed opportunity here," said Kiran Turaga, M.D., one of the study's co-authors and assistant professor in the division of surgical oncology at the Medical College of Wisconsin. "It's a reason to raise awareness. Surgery is a really good option - most patients can benefit - but I think too often, it's not being offered or recommended."

The SEER data consisted of 1,591 peritoneal patients with a median age of 74, most of whom had metastatic disease. The overall survival rate of those who underwent cytoreductive surgery was an average of 20 months, compared to just four months for those who did not have surgery.

Surgeries Becoming More Advanced

Recent advancements in surgery and other therapeutic options have improved everyone's survival rate. Surgical patients, for example, had an overall survival rate of only 15 months from 1991 to 1995, but they survived an average of 38 months from 2006 to 2010.

While the most recent time period reflected a survival rate that more than doubled, the percentage of patients going without surgery remained almost the same. It was 55.8 percent from 1991 to 1995 and 56.8 percent from 2006 to 2010.

The latest surgical procedures involve a combination of radical resection of the tumor, along with hyperthermic intraperitoneal chemoperfusion (HIPEC), which is a heated chemotherapy bath of the abdominal area.

Peritoneal, which attacks the thin membrane around the abdomen, is a less common form of mesothelioma, which strikes an estimated 3,000 Americans annually. Less than a third of those patients are diagnosed with peritoneal. The majority of the cases are pleural, which starts in the lining around the lungs. The SEER database was not specific regarding why patients were not having surgery, leaving much of it to speculation.

"The reason for this practice pattern could be varied, including nihilism for disease or treatment, misinformation, host of disease characteristics precluding therapy or data collection bias," the authors wrote.

Reasons for Finding a Specialty Center

Turaga told Asbestos.com that perhaps some patients are too weak or just refused surgery, "but it could be the fact there wasn't the proper facility available to do it."

"My bias is that most patients are not referred to a specialty center, where they would see someone who could talk about all the options," Turaga said. "Many medical oncologists out there today don't know enough about it [peritoneal mesothelioma], and just tell a patient, the surgery is not worth it."

Turaga also said it is rare when a pleural patient comes to Medical College of Wisconsin and is not offered at least limited surgery to increase their chances of survival. Without surgery today, the prognosis with peritoneal remains poor, typically between 6-12 months.

"The majority of patients who come to us end up getting surgery," Turaga said. "The bottom line is that patients who undergo surgery can end up living a long time."

When separating the patients in the study by limited/regional disease indicators, the SEER study shows that patients with radical surgery had an overall survival rate of 40 months, but only 27 months with limited surgery and 13 months with no surgery.

The authors also detailed a separate, multi-institutional study involving 405 patients with peritoneal mesothelioma, and those results were even more encouraging for surgical patients. Patients who had both cytoreductive surgery and HIPEC had an overall survival rate of 53 months. There was a five-year survival rate of 47 percent.

There was considerable disparity, though, based on the tumor histology, which was not reported in the SEER data. Patients with epithelial peritoneal mesothelioma who had surgery and HIPEC had a median survival of 63 months. Those with either biphasic or sarcomatoid mesothelioma, with comparable surgery and HIPEC, averaged only 16 months.

"It's not surprising that survival time is greatly improved with surgery," Turaga said. "It's disappointing that more patients are not being given that option."

Author: Tim Povtak

Tim Povtak is an award-winning writer with more than 30 years of reporting national and international news. His most recent experience is in researching and writing about asbestos litigation issues and asbestos-related conditions like mesothelioma.

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New Leadership at Brigham and Women's Bolsters Mesothelioma Care

The departure of renowned mesothelioma specialist David Sugarbaker, M.D. from Brigham and Women's Hospital in Boston earlier this year didn't lessen the hospital's commitment. It made that long-standing promise to patients even stronger.

Raphael Bueno, M.D., is making sure of that.

Bueno, who has replaced Sugarbaker as the chief of the thoracic surgery division, reiterated his pledge recently that Brigham and Women's would remain the country's most prestigious destination for patients with malignant pleural mesothelioma.

"It's even better now," Bueno told Asbestos.com. "Patients understand that it’s the whole program and not just one individual that makes this the place to come." Sugarbaker left after more than 20 years to build the new Lung Institute at Baylor College of Medicine in Houston - bringing his reputation as the well-respected leader in mesothelioma care.

Bueno Wearing Many Hats

Bueno officially assumed the role on June 1, but he has been the acting chief for the last five months, mixing new administrative duties with his surgical and research work. He had been the associate chief of thoracic surgery under Sugarbaker for more than 10 years.

"It's been busy lately, but it's been a very rewarding move," he said. "It's an opportunity to really optimize the care for a lot of mesothelioma patients. We're working to make it the best for everyone."

Since Bueno became chief, Brigham and Women's designated every Friday as the day to handle mesothelioma patients exclusively, making sure the surgeons, oncologists, radiologists and pathologists all can focus together on the rare and aggressive cancer caused by asbestos exposure.

Bueno is a product of the nearby Harvard Medical School and the Massachusetts Institute of Technology. He did his residency at Brigham and Women's and joined the thoracic surgical staff in 1996. He worked closely with Sugarbaker for many years, making him the most logical successor.

Bueno also has been a leader in mesothelioma research for more than a decade, working on the prevention and management of complications following aggressive surgery. He has helped move research to the molecular level, creating newer and better diagnostic and therapeutic tools for the disease.

He is currently one of the lead researchers in a Phase II clinical trial at Brigham and Women's involving neoadjuvant defactinib (VS-6063) treatment for patients with resectable mesothelioma. One of the purposes of the study is to assess biomarker responses from tumor tissue.

Boston Still a Major Destination

"There is much more optimism today about the future of mesothelioma treatment than there was 10 years ago," he said. "We have a much better understanding of the disease at the molecular level. There are better drugs now, and better ones coming down the line."

Brigham and Women's is a partner with the highly rated Dana-Farber Cancer Institute and a part of the greater Harvard Medical School family. They have partnered to be a leading force in cancer care.

Thoracic surgeon and mesothelioma specialist Abraham Lebenthal, M.D., works alongside Bueno at Brigham and Women's. Lebenthal also works with the VA Boston Healthcare System. He has been lauded for his work with military veterans, who comprise an unusually large percentage of mesothelioma victims.

"The great patient care is still here. The volume is still here. Patients know that," Bueno said. "Dr. Sugarbaker has been a great friend and supporter of mine. And don't take this the wrong way, but mesothelioma patients don't have to go to Texas to get great care today."

Author: Tim Povtak

Tim Povtak is an award-winning writer with more than 30 years of reporting national and international news. His most recent experience is in researching and writing about asbestos litigation issues and asbestos-related conditions like mesothelioma.

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Doctors Helping Veterans with Mesothelioma Access the VA Health Care System

The West Los Angeles VA Medical Center can provide some of the finest care in the world for patients with malignant pleural mesothelioma.

The problem is that not enough veterans - or even the doctors throughout the sprawling Veterans Administration health care system - know it's available.

"One of the biggest challenges we face is trying to get the word out, to make people aware of what we have here," said Graciela Hoal, RN, NP, who works closely with doctors and patients at the West Los Angeles VA. "The care we offer can make a big difference for a patient with mesothelioma."

In an effort to spread the word, Hoal will be speaking Saturday afternoon in Santa Monica at the 4th annual International Symposium on Lung-Sparing Therapies for Malignant Pleural Mesothelioma. Her topic is "Mesothelioma Among Veterans: The Benefits and Challenges Experienced at the World's Largest Health Care System."

The catalyst behind the symposium is renowned surgeon Robert Cameron, M.D., director of the UCLA Mesothelioma Comprehensive Research Program, and chief of thoracic surgery at the West Los Angeles VA. Cameron has been a pioneer in the treatment of mesothelioma for the last 20 years.

While the U.S. Department of Veteran Affairs overall is under attack these days for rampant mismanagement and falsified recordkeeping that led to the recent resignation of VA Secretary Eric Shinseki, Cameron's work with patients is one of the shining lights within the system.

Cameron Offers Veterans Hope

"Veterans are very lucky to have Dr. Cameron in the system," Hoal told Asbestos.com. "A lot of doctors have little or no experience with mesothelioma. The life expectancy, where there is not a specialist, can be six to nine months. But we have patients we first saw in 2008 who are living fairly healthy lives today. A great specialist can make a difference."

Mesothelioma is a rare and aggressive cancer diagnosed in an estimated 3,000 Americans annually. It is caused almost exclusively by exposure to asbestos, which once was used extensively by the U.S. Armed Forces for its ability to strengthen and resist heat. That reliance on the toxic mineral is a big reason why a disproportionate number of veterans (almost one-third), compared to civilians, are diagnosed with the disease.

Cameron is one of only two thoracic surgeons within the VA system who specialize in this asbestos-related cancer. Abraham Lebenthal, M.D., in Boston is the other. Both have tried to spread the word of their availability throughout the system, but have been frustrated with the results.

Once in the VA system and in possession of a referral from the local VA office, a veteran anywhere in the country with mesothelioma can travel and receive care from a specialist like Cameron or Lebenthal.

The West Los Angeles VA approved the Admiral Zumwalt Mesothelioma Specialty Program in 2013. Yet very little has been done nationally by the VA to promote the program. There are more than 150 hospitals and almost 1,000 clinics within the VA system, but only a fraction know how to handle or where to refer a patient diagnosed with the disease.

Cameron has seen mesothelioma patients at the West Los Angeles VA from California, Oklahoma, Arizona and Iowa, but not as many as he would like - and not nearly as many who could use his help. Cameron is the foremost expert on the lung-sparing, pleurectomy/decortication surgery, developing a multimodality treatment plan that incorporates resources from the Pacific Meso Center, the UCLA Research Program and his local VA.

New Therapies Are Helping Veterans

At the West Los Angeles VA, Cameron utilizes mesothelioma specialists in radiology and chemotherapy. He's had considerable success with novel interventions like Betadine Lavage Therapy, immunotherapy and cryoablation, a minimally invasive procedure that uses controlled freezing to dissipate small cancer tumors.

Cameron has examined records and made recommendations virtually via computers for patients and physicians outside his area, but can only do so for those who are aware of his services. "This is not a situation unique to the VA System," Hoal said. "A lot of times, oncologists and pulmonologists are telling patients there is nothing they can do [for mesothelioma patients]. Patients are just being told to get their affairs in order. But there are new therapies now that can help them if they get to a true mesothelioma care center."

At the Santa Monica symposium, Hoal will be joined by a distinguished international faculty that includes Jan P. van Meerbeeck, M.D., at Antwerp University Hospital in Belgium; Percy Lee, M.D., chief Thoracic Radiation Oncologist at UCLA; Joachim Aerts, M.D., at Erasmus MC Cancer Institute in the Netherlands; Richard Lemen, Ph.D., former Assistant Surgeon General of the United States; and Olga Olevsky, M.D., of the UCLA Medical Center.

The symposium is for physicians, medical students, nurses and other health care professionals wanting to hear about the latest advances in mesothelioma research and therapies. Mesothelioma patients, families and advocates also will be attending.

Author: Tim Povtak

Tim Povtak is an award-winning writer with more than 30 years of reporting national and international news. His most recent experience is in researching and writing about asbestos litigation issues and asbestos-related conditions like mesothelioma.

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