For over 30 years, the law firm of Galiher DeRobertis & Waxman has represented people who have been diagnosed with mesothelioma.  We have worked closely with our clients and their families.  We have also worked with treating physicians, clinicians, world-renowned researchers and scientists, and through our work, we have learned a lot about mesothelioma, and we have seen the evolution of mesothelioma treatment and care over the past three decades.

Today, the treatment and care of mesothelioma patients are often comprehensive and targeted at treating patients as a whole.  The International Mesothelioma Program(IMP) at Brigham and Women’s Hospital in Boston has become an excellent example of a facility that embodies this philosophy and approach to treating mesothelioma patients.  The  IMP offers state-of-the art treatment, cutting edge research, and an extended network of support for patients and families.  In terms of patient support, the IMP recognizes the need that patients have to talk directly with other patients about their experiences.  To meet this need, the IMP has developed a “Patient Matching” program.

Patient Matching Program at the International Mesothelioma Program

Dr. David Sugarbaker is the founder and director of the International Mesothelioma Program in Boston, Massachusetts, and is the Chief of Thoracic Surgery.  He possesses a great understanding of mesothelioma, but he also understands the devastating emotional effects this disease has on patients and their families.  According to Dr. Sugarbaker,  “Mesothelioma takes an emotional toll on patients and their families that cannot be underestimated; it can be nearly as significant as the disease itself.”

We all know that being faced with a serious, life threatening diagnosis such as mesothelioma can be frightening.  Patients begin to wonder what treatments are available to them, how they will respond to treatment, what will the recuperation period be like and so forth.  That is why the IMP has created the Patient Matching Program.
The Patient Matching Program connects current patients of the International Mesothelioma Program with survivors to help provide a more grounded perspective on the difficult and frightening prospects patients have to face when diagnosed with mesothelioma.  We all know how comforting it can be to hear encouraging words from someone who has been in your position before, and the IMP attempts to accomplish that through this program.

The program attempts to match patients by gender, age, state and the type of treatment received; however, many patients connect over the telephone and with patients of either gender and  any age from around the world, and strong bonds are often forged.

Mesothelioma Patient Matching Program Grows Exponentially

Doug Burnett, a farmer in Western Massachusetts, underwent surgery in early February of 2006.  Since then, he has been paired with more than 20 people from Florida to Israel.  He states that he and other patients often compare notes on medications and the symptoms they are experiencing.  Mr. Burnett stated, “We all need to pull together to get through this…I’m happy to do whatever I can to help.”
Mr. Burnett has given new hope and perspective to current or incoming patients who will hopefully give a sense of hope to a new generation of patients as the IMP continues to further its goal to provide mesothelioma patients with longer, healthier lives.

Patients at the International Mesothelioma Program (IMP) at the Brigham and Women’s Hospital in Boston, Massachusetts who have a confirmed diagnosis of malignant pleural mesothelioma routinely undergo a series of tests to determine the type of surgery they need.  One of these tests is called a “cervical mediastinoscopy,” which is used to biopsy the patient’s lymph nodes.  This test helps assess how far the cancer has spread.  This information, in conjunction with other test results, is used to help determine if the patient is a candidate for either a pleurectomy or an extrapleural pneumonectomy.

Cervical Mediastinoscopy Used to Biopsy Lymph Nodes

The International Mesothelioma Program  is one of the leading treatment centers for malignant pleural mesothelioma.  According to Dr. David Sugarbaker, who is Chief of Thoracic Surgery at the Brigham and Women’s Hospital and the founder and Director of the International Mesothelioma Program, the IMP consulted with over 300 malignant pleural mesothelioma patients last year and performed over 160 surgeries.  As part of the screening process for surgical candidates, a cervical mediastinoscopy is performed at the hospital to determine if the cancer has spread to the mediastinal lymph nodes.

A cervical mediastinoscopy is a hospital procedure performed under general anesthesia used to biopsy lymph nodes in patients with malignant pleural mesothelioma.  The surgeon makes an incision in the patient’s neck at the top of the sternum.  The mediastinoscope, which is a thin tube with a light and surgical instruments, is then placed through the incision where tissue samples are taken from the mediastinal lymph nodes.  The patient’s biopsied tissue is analyzed by a pathologist to determine if the malignant mesothelioma has spread to the mediastinal lymph nodes.  The IMP’s surgical team, led by Dr. Sugarbaker, uses this information to determine whether the patient is a surgical candidate and if so, the type of surgery that will be performed.

Published Research on Importance of Cervical Mediastinoscopy

In 1999, Dr. Sugarbaker and his colleagues published an article entitled, “Resection Margins, Extrapleural Nodal Status, and Cell Type Determine Postoperative Long-Term Survival In Trimodality Therapy of Malignant Pleural Mesothelioma:  Results in 183 Patients” in the Journal of Thoracic and Cardiovascular Surgery. Dr. Sugarbaker described the importance of mediastinoscopy as a staging tool for patients with malignant pleural mesothelioma.  A similar conclusion concerning the importance of cervical mediastinoscopy was reached by British physicians in a published article entitled, “The Case for Routine Cervical Mediastinoscopy Prior to Radical Surgery for Malignant Pleural Mesothelioma” in the European Journal of Cardio-Thoracic Surgery in 2004.

Mesothelioma Cytoreductive Surgery at International Mesothelioma Program (IMP) Increases Survivability

Patients diagnosed with malignant pleural mesothelioma are usually given a very grim prognosis, and in the past had very few treatment options.  However, due to the pioneering efforts of Dr. David Sugarbaker at the International Mesothelioma Program (IMP) at Brigham and Women’s Hospital in Boston, patients have a much better prognosis with surgery aimed at removing the tumor, followed by chemotherapy to kill any remaining cells.  These procedures are called cytoreductive (or debulking) surgery and intrathoracic heated chemotherapy administered during surgery.

Surgery to Remove the Tumor

Cytoreductive surgery falls into two categories:  (1) extrapleural pneumonectomy that involves the removal of the affected lung, and (2) pleurectomy and decortication which is the removal of the pleura and as much tumor tissue as possible.  The type of surgery that a patient receives at the IMP depends upon how early the mesothelioma was diagnosed and the extent to which the disease has spread.  It is part of the preoperative protocol at the International Mesothelioma Program to perform a procedure called a mediastinoscopy, to biopsy the patient’s lymph nodes in the  mid-chest area or mediastinum.  This procedure tells the physicians at the IMP the extent to which the malignant mesothelioma has spread.

If the patient’s malignant mesothelioma is discovered early enough, Dr. Sugarbaker may perform an extrapleural pneumonectomy.  Not only is the affected lung removed, but the diaphragm, pleura, and pericardium are also surgically removed.  The diaphram and other structures in the chest are re-built using Gortex, which is a synthetic gas-permeable membrane.   The other surgery, a pleurectomy/decortication is used to removed the diseased pleura and as much of the patient’s mesothelioma tumor as possible.

Chemotherapy Drugs Administered Immediately

At the International Mesothelioma Program, following either the extrapleural pneumonectomy or the pleurectomy/decortication, the patient’s chest cavity is infused with a lavage (washing out the organs) of heated chemotherapy drugs.  Researchers and physicians at the IMP have determined that there is much greater chemotherapy penetration when the drugs are heated and washed directly over the affected area compared to being delivered intravenously.  The purpose of the intracavitary heated chemotherapy lavage is to kill the malignant mesothelioma cells that might be left behind after surgery and that cannot be seen by the surgeon.

Success With Dr. Sugarbaker’s Techniques

Dr. Sugarbaker and his team have been very successful in using cytoreductive surgery and intracavitary heated chemotherapy in prolonging the lives of malignant pleural mesothelioma patients.  Dr. Sugarbaker reports some patients surviving five to ten years using this combination of surgery and heated chemotherapy.

Clinic Trials Recruiting Pleural Mesothelioma Patients

Brigham and Women’s Hospital, in collaboration with the Dana-Farber Cancer Institute in Boston, are currently recruiting patients with malignant pleural mesothelioma for two clinical trials.  The first is a Phase I clinical trial that will study the effects of extrapleural pneumonectomy/pleurectomy decortication followed by a combination of heated chemotherapy drugs Cisplatin and Gemcitabine administered during surgery.  The second is a Phase II clinical trial that will study the effects of pleurectomy/decortication combined with intraoperative heated Cisplatin, then followed by an intravenous administration of sodium thiosulfate to reduce the effects of the Cisplatin.

There once was an asbestos factory in the small town of Casale Monferrato in northwest Italy, known by its townspeople as the “factory of cancer”.  At one time or another, most residents of Casale Monferrato worked in this asbestos factory.  It was built in 1900 and continued in operation for many decades. In this very small town, the incidence of mesothelioma is about 16 times greater than that found in the rest of the country. It is anticipated that there will be a further increase in the incidence of mesothelioma up to 2020.

The factory workers and their families, as well as the rest of the town’s population, were exposed to asbestos from the Eternit Factory. Although work at the factory stopped in the 1980s, Dr. Giovanni Gaudino says that they “have huge environmental exposure to asbestos fibers. We are expecting, sadly, a high number of [mesothelioma] cases because of the long latency period for asbestos disease to develop.”  Thus, it was very fitting that Dr. Gaudino, who is a dedicated mesothelioma researcher, would continue to follow the incidence of disease in this population.  The Hospital of Casale Monferrato is included among several institutions participating in the Italian clinical trial involving use of the combination drug therapy of Gleevac and Gemcitabine.

Asbestos Today

While the sale of asbestos-containing products has been essentially banned in the United States since 1978, asbestos is still in use in much of the world today, with tragic consequences.  As he spoke to attorneys from the Galiher law firm, Dr. Gaudino explained that mesothelioma and other asbestos diseases are a worldwide problem. Due to the widespread use of asbestos all over the world, asbestos cancer has become a truly international problem. Many thousands of cases are expected in the next several years, not only in Italy, but also in Europe, the United States, Australia and other parts of the western world. Dr. Gaudino believes that asbestos disease “is a huge problem for society because there are many thousands of cases expected in the years ahead.”  He refers to the phenomenon as “the European mesothelioma epidemic.”

Like in Casale Monferrato, Dr. Gaudino notes that there are workers all over the world “who are much exposed to fibers.”  He also noted that there are often children who live nearby, and they are often “playing… close to these materials.”

While factories have been closed in Europe and the United States, they have moved to India and other emerging countries. A high incidence of mesothelioma cases is expected around the world, especially in the emerging countries, where asbestos is still legal and is still being used.  This will lead to an “even worse world ‘epidemic.’”

Many of us know that malignant mesothelioma is very difficult to treat.  Dr. Giovanni Gaudino, the prominent Italian medical researcher, talked to Galiher DeRobertis & Waxman about mesothelioma treatment and the hope his research offers.  He said:

“… since this cancer is so aggressive, since the incidence of this cancer is increasing . . . we have to go fast to find new therapies, effective therapies.  And the only way to do that is to foster as much as possible clinical trials.  I know that clinical trials . . . can be seen as an experiment on humans . . . And for individuals this could be hard to accept . . .  to be part of an experiment.  But at this point, clinical trials, I think, are the best way to try something new to get rid of this disease.”

Clinical trials are of paramount importance in the search for a cure for malignant mesothelioma.  There is general agreement that in most cases, conventional therapies are not working.  Time is of the essence, but it takes a very long time for new therapies to be approved by the Food and Drug Administration (FDA) in the United States.  The story is the same in Europe and in India – it takes a long time to approve a new treatment.  Clinical trials are a chance for patients to be exposed to novel therapies.  In some instances, existing, approved drugs are repurposed in new combinations.

To find a list of clinical trials, you can go to the National Cancer Institute’s (NCI) website.  With almost 100 clinical trials listed on this site, all with different drug combinations and approaches, this can be confusing.  How do you decide which therapy is the best?

You may wonder if one clinical trial is better than all others.  This is not the case.  Cancers, and mesothelioma in particular, come in many different forms.  As a result, no one therapy is right for all patients.  One therapy may be effective for one patient, or one population of patients, but not for others who may find other therapies are more effective.

The evaluation and initial determination of whether one qualifies for a particular clinical trial is an important discussion a patient must have with his or her physician.  In general, patients must be carefully selected for these trials.  Patients must meet certain criteria to participate in any given study.  You cannot simply choose a clinical trial.  You must be evaluated by physicians to see  if you have the right “markers” for enrollment in the clinical trial.  While enrollment in clinical trials offers no guarantee that they will work, all patients should be encouraged to consider them.

The Researcher and the Clinician – “Translational Research”

“We are used to work[ing] with molecules, with cells,…with experimental animals, while…physicians are used to work[ing] with real live patients, and of course we use different…[terminology] sometimes…[In] some cases, collaboration is very useful and successful, and we can say, especially for us [who are] used to working in…the labs, [it is exciting] to meet the patients that are surviving or doing better.  Even small improvements are very important to us.  It’s…a very interesting and emotional experience.” – Giovanni Gaudino

Researchers and clinicians inhabit two very different worlds.  The researchers work with cells and molecules in their laboratories, and usually do not see the patients that they are trying to help through their research.  The physicians, on the other hand, care for their patients in clinic and hospital settings, and often get to know their patients intimately.   But communication between these worlds – the world of the researcher in the laboratory and the world of the physician who is caring for their patient – is becoming more and more important.
As researchers become increasingly aware of their role in communicating the results of their research to physicians, the physicians, in turn, can “translate” the results of this research into new and effective therapies.  Thus it becomes “translational research.”  The clinicians’ feedback is also very important to the researchers, who learn how the patients are doing and how they are responding to the new therapies.  This makes it possible for the laboratory researchers to adjust and revise their work.

This communication between researchers and physicians or “bench to bedside” approach is not always easy.  This can be difficult because they sometimes seem to use different languages as they talk in technical terms specific to their field of expertise.  However, the patient is at the very center of this collaboration and is the most important reason that this strong effort toward enhanced communication is being made.  On the occasions when the researcher has the opportunity to meet patients and to know how they are doing, this too can be very inspirational and motivational.

The Researcher and the Mesothelioma Patient

“I saw patients with incredible increasing quality of life…And to see that what we are doing could help individuals to feel…better is something very, very special that I’ve never experienced before.” – Giovanni Gaudino

Most of us do not think of research scientists having any contact with patients.  Ordinarily, research scientists do not have a chance to meet mesothelioma patients during clinical trials.  When clinical trials begin, the researchers “step back.”   However, in some instances, basic scientists do meet these patients.  Dr. Giovanni Gaudino has had this wonderful opportunity.  He describes this as an emotional experience because he saw the improvement in the mesothelioma patients’ quality of life, regardless of whether the therapy was successful in getting rid of the cancer or just stabilizing the disease.  These patients were happy, they were active, and they also recognized the importance of the work going on in the laboratory.  Dr. Gaudino explained that this was a very powerful emotional experience to see that as research scientists, they were helping these patients.

Well known approaches to cancer treatment include surgery, radiation therapy, chemotherapy, immunotherapy, and chemicals.  All of these conventional therapies have been and are still being used to treat mesothelioma.  While some of these approaches have been successful with other solid tumors, unfortunately, this has not been the case with mesothelioma.

“All these agents can kill cells. . . .  Unfortunately, this is not true for mesothelioma, because, as I say, it is a very resistant tumor to … conventional therapy.  So, because of that, we try to find … new therapeutic approaches.” – Giovanni Gaudino

One of these important new approaches is aimed at overcoming chemoresistance and interfering with cell survival.

Overcoming Chemoresistance

Scientists like Dr. Gaudino have been studying how mesothelioma cells develop; in other words, what has gone awry in the normal cell life of growing, maturing and then dying off.  Dr. Gaudino points out that the growth signals that lead to cancer cell proliferation and neoplastic transformation are the result of a series of biochemical reactions that start at the cell’s surface and move down in a multi-step process called “receptor downstream signaling.”  This continues until the signals reach the nucleus of the cell and their final destination, which is the DNA.  The DNA is the “port master” of all that is going on in the cell.  The “big button” on the top of the cell membrane is called the “Receptor Tyrosine Kinases.”  It mediates the process by which cells become resistant to cell apoptosis, or what is known as “programmed cell death.”  Apoptosis is a normal process of getting rid of old cells.  In an average adult human, 50 to 70 billion cells die every day as a result of apoptosis.  In patients with mesothelioma as well as other cancers, there is insufficient apoptosis, and there is cell proliferation of abnormal cells.

“So the rationale of our work was that the Receptor Tyrosine Kinases, which is the big button that you see on top of the handle of the cell membrane, can be a good target, and by inhibiting [the] receptor downstream signaling . . . we could get rid of the tumor chemoresistance.” – Giovanni Gaudino

The purpose of the drugs used to target this button, then, would be to interfere with cancer cell survival and chemoresistance.

Cell Survival

There are many different molecules involved in cell survival and apoptosis.  These molecules are on the surface of the cell, in the interior of the cell, and in the nucleus.  These molecules all have names so that they can be identified.  Thus, if someone is exposed to asbestos, this toxic exposure combines with genetic factors and many other different reactions.  These different reactions are all pathways that determine cell survival and the transformation of normal tissue to tumor cells which results in cancer, in this instance, malignant mesothelioma.

“And, cell survival is a very important step for a cancer, because if [a] cell can survive despite all the DNA mutations, the DNA damage they suffer, it means they have a good chance to become tumor cells and to .. [become] cancer.” – Giovanni Gaudino

As you or your loved one is considering the course of treatment for mesothelioma, you and your physician will need to explore the possibility of enrolling in a clinical trial as a critically important option.  A clinical trial is a study to evaluate new treatments to determine how effective and safe a certain medication, combination of medications, a surgical or radiation procedure or a combination of these modalities might be.  Patients enrolled in clinical trials are monitored closely.  These clinical trials allow medical research to progress, so that diseases once thought to be incurable are now curable.

Misconceptions About Clinical Trials Dispelled

Having never made such a monumental decision, many are concerned about enrolling in a clinical trial.  Some worry that the patient will be treated like a guinea pig or will receive the placebo or sugar pills.  Worse yet, some think that clinical trials should be considered only when there is no hope.  These misconceptions about clinical trials are dispelled at the International Mesothelioma Program (IMP) at Brigham and Women’s Hospital in Boston, Massachusetts.

Dr. David Sugarbaker, the founder and director of the International Mesothelioma Program and the Chief of Thoracic Surgery at Brigham and Women’s Hospital, has been treating mesothelioma patients along with his colleagues at the Dana-Farber Cancer Institute since the 1980s.  In fact, the clinical trials being conducted at the IMP are at the forefront of state-of-the-art mesothelioma treatment and care in the United States.  Each year approximately 160 mesothelioma patients are treated at the International Mesothelioma Program by Dr. Sugarbaker and his team of medical experts.  Twice that number of patients are seen for consultation.

Surgical Clinical Trials Leading to Increased Survivability

In a lecture given in late 2009, Dr. Sugarbaker noted that through his surgical clinical trials, the IMP is seeing a 17 percent survival rate for patients who are four years post-surgery.  This is remarkable when you consider these patients’ original prognosis, which was a mere six to nine months to live.  Dr. Sugarbaker is seeing survivors who are eight to ten years post-surgery and a few others who are living as long as 13 years with no recurrence.

Attorney L. Richard DeRobertis who has represented mesothelioma clients for decades, is very hopeful when he see the results Dr. Sugarbaker has had from his clinical trials.

“I have seen my clients suffer and die from this devastating cancer.  Dr. Sugarbaker’s clinical trials portend much hope and promise that one day in the not so distant future mesothelioma will be a curable disease.”

Clinical Trials at the International Mesothelioma Program

One important mesothelioma clinical trial is Protocol 07-091 for patients with resectable pleural malignant mesothelioma; that is, a tumor that can be removed surgically.  The surgery is followed by heated chemotherapy drugs applied directly into the chest cavity during the surgical procedure.  The drug combination used is Cisplatin along with Gemcitabine.  Amifostine is also used to protect the normal cells.  The patient is then followed weekly.

Of 304 patients screened, Dr. Sugarbaker says 64 were enrolled in this clinical trial.  The study is still open and accepting patients.  The clinical trial requires that certain criteria are met in order for a patient to qualify for enrollment in Protocol 07-091.  Since time is of the essence, it is important that patients discuss this and other possible courses of treatment with their physician right away.   They may also consider calling the IMP directly at phone:  617-732-5922 to get immediate information.

It is clear that through a number of clinical trials, medical advances are taking place at the International Mesothelioma Program under Dr. Sugarbaker’s leadership.  Virtually all advances in cancer treatment involve clinical trials.  These advances translate to hope and a prolonged and enhanced quality of life for mesothelioma patients.

New Clinical Trial Underway

The International Mesothelioma Program will be conducting a new clinical trial for patients with advanced stage mesothelioma.  This new Phase I trial would use the neoadjuvant mTOR inhibitor followed by administering Cisplatin in combination with pemetrexed or Alimta.  After the chemotherapy regimen, depending on the patient’s response, an extrapleural pneumonectomy could then be performed.

Over the years through the clinical trials, the IMP has been able to increase the dose of chemotherapy drugs to the maximum tolerable amount.  Additionally, because of Dr. Sugarbaker’s experience treating so many mesothelioma patients, he and the IMP have learned the site of recurrence of the cancer is usually in the chest or abdomen where the original tumor appeared.  Dr. Sugarbaker explained that he and his medical team have observed over the last 15 years that, even after surgery, microscopic cells are present and thus he developed the in vivo model, as he calls it, of administering the heated chemotherapy in the maximum tolerable dose into the open chest cavity.

His patients have words of praise and gratitude as they speak of Dr. Sugarbaker being a hero and a pioneer in mesothelioma research with the clinical trials which the International Mesothelioma Program is conducting.

When faced with a life-threatening diagnosis of malignant mesothelioma, the patient and his or her loved ones will certainly seek the most advanced medical care to ensure the best possible outcome.  Memorial Sloan-Kettering Cancer Center is at the forefront of such cutting-edge medical research and care for mesothelioma patients.  Dr. Lee M. Krug, a thoracic oncologist, is the Director of the Mesothelioma Program at Memorial Sloan-Kettering Cancer Center (MSKCC).  With its main campus and inpatient hospital located in Upper East Side Manhattan, Memorial Sloan-Kettering also has about a dozen outpatient clinics in New York City, Long Island and New Jersey where mesothelioma patients can receive their chemotherapy and radiation treatments at these community-based locales.

Multi-Disciplinary Team Serves Mesothelioma Patients

If you decide to contact Sloan-Kettering, you may want to consider the option of entering one of several mesothelioma clinical trials for treatment and care.  This consideration will be carefully discussed with a physician or nurse clinician at Sloan-Kettering who is part of a multi-disciplinary team.  This team of specialists will be there to serve you and meet your medical needs, as well as your emotional and other needs, as you go forward with your treatment and care for mesothelioma.

Consider Entering A Mesothelioma Clinical Trial

Under Dr. Krug’s leadership, there are presently at least three open mesothelioma clinical trials being conducted at Sloan-Kettering.  One trial utilizes an investigational drug known an CBP 501, a stable peptide, which is an enzyme that works on cancer cell division.  Along with CBP 501, the standard mesothelioma therapy of Alimta and Cisplatin is used.  In order to participate in this particular study, the mesothelioma tumor must be unresectable and untreated.  The mesothelioma patient must also be able to be up and about for half of his waking hours.

Another clinical trial involves the use of Everolimus (RAD 001).  Everolimus inhibits the molecule mTOR which helps cancer cells grow.  Even if a mesothelioma patient has had prior chemotherapy treatment, he or she can still participate in this study.  The patient will need to have adequate pulmonary function however.

Finally, another trial is a toxicity study utilizing chemotherapy followed by Intensity Modulated Radiation Therapy (IMRT), which is targeted radiation.  To participate, the mesothelioma patient must have an unresectable tumor and not have had any prior chemotherapy or radiation treatment.  Usually standard radiation therapy does not work well for mesothelioma patients.  Some radiation oncologists liken it to attempting radiation on the apple peel without radiating the apple itself.  IMRT obviates this problem of standard radiation therapy.

Of course eligibility for any of these mesothelioma clinical trials will be decided in close consultation with the multi-disciplinary team who will review each individual mesothelioma patient’s medical records, test results and situation very carefully.

Be Proactive – Explore Sloan-Kettering’s Mesothelioma Program

As you can see, if you intend to explore the possibility of participating in any of these mesothelioma clinical trials, the sooner you contact the Sloan-Kettering Mesothelioma Program, the better it is for you.  More options may be available.

Attorney Richard DeRobertis, who has represented many mesothelioma clients over three decades, remarks that, “from a scientific point of view, what is happening at Memorial Sloan-Kettering is exciting and encouraging.  But more importantly, from seeing what my clients and their families have gone through over the years, I encourage anyone who has been diagnosed with mesothelioma to be proactive and explore what is available at leading cancer centers such as Sloan-Kettering.”