Message to Pharma: Large Trials in Mesothelioma are Possible

Dr. Lee Krugby Lee Krug, MD, Memorial Sloan Kettering Cancer Center

This month, a notification was sent to investigators on the DETERMINE Trial that accrual will be completed by the end of October. DETERMINE is an international, randomized trial comparing treatment with an immunotherapy drug called tremelimumab to treatment with placebo as second or third line therapy in patients with malignant mesothelioma. The trial opened in May, 2013, and in just 17 months will have enrolled 564 patients! This is a notable achievement. To put this in perspective, the last phase III of this magnitude testing vorinostat in a comparable group of patients (VANTAGE Trial) took 5 1/2 years to enroll 660 patients. There are differences between these two trials that could have accounted, in part, to the more rapid accrual. In DETERMINE, 2/3 of the patients receive the study drug, 1/3 get placebo, while in VANTAGE it was half and half. Also, immunotherapy drugs such as tremelimumab have garnered tremendous excitement in the oncology field due to their promising results in numerous cancers such as melanoma skin cancer and lung cancer. Yet, despite these differences, this accomplishment of completing a trial of this size in such a short period of time should be a wake-up call to the pharmaceutical industry. Historically, drug companies have been reluctant to undertake large trials in mesothelioma due to concerns about feasibility and slow accrual. But this trial demonstrates the potential. Patients with mesothelioma urgently need better treatments, and with only one chemotherapy regimen approved, there is a tremendous opportunity to impact the outcomes for these patients. So here is the message to pharma: Large trials in mesothelioma are possible, and the community of patients with mesothelioma is eager to participate.

Lee M. Krug, MD, is an Associate Attending Physician in the Division of Thoracic Oncology, Department of Medicine at Memorial Sloan-Kettering Cancer Center in New York, New York where he completed a fellowship and chief fellowship in medical oncology. Dr. Krug is the Director of the Mesothelioma Program at Memorial Sloan-Kettering Cancer Center. Read more about Dr. Krug’s work here.

Bill Ziegler on his Experience as a Survivor Advocate

Bill ZieglerIn June, mesothelioma warrior Bill Ziegler represented the mesothelioma community as a Survivor Advocate at the 7th Biennial Cancer Survivorship Research Conference: Advancing Survivorship Care through Multilevel Collaboration after being nominated by the Meso Foundation.  He was one of twenty survivors accepted out of 100 applications. Survivor Advocates attended the conference to participate in the conversation about the latest advances in survivorship care and how to improve the quality of life for cancer survivors. He wanted to share what he learned with the meso community:

Greetings Meso Community!

A little over a month ago I attended a survivorship conference in Atlanta.  It has taken me a while to formulate my thoughts on the overall experience and information I received during the conference.  There were over 500 people in attendance at the conference—20 of whom were survivor advocates.  The advocates represented different cancer support organizations across the US.  On the first day, there were sessions that placed survivor advocates at the tables of researchers.  Every 20 minutes you would switch tables and meet and learn something new.  Every researcher and advocate brought something uniquely different to the table.

I did attend a few breakout sessions.  The sessions I attended ranged from Adolescent and Young Adult (AYA) cancer survivorship to financial impact of a cancer diagnosis.  These were great sessions that provided a lot of relevant information on how much more money cancer patients will spend on healthcare over time to social stigma of a cancer diagnosis within a social group.  Without a doubt, there was a lot of information presented.  But the core reason I wanted to attend the conference was because of the specific nature of the challenges that a diagnosis of mesothelioma presents to patients.

I wanted to understand how, as patients, we can get the best treatment possible, and then continue to be followed over time from cancer care and then transition to primary care.  It was clear that this gap in care was the biggest elephant in the room—and identified repeatedly by a multitude of researchers.  For a lot of mesothelioma patients, as well as myself, this diagnosis of mesothelioma means that you will have to travel to a specific treatment center and have a plan tailored to your own personal needs.  Whether it is to have surgery, chemo, radiation, or trials, a plan is usually made at one of a handful of treatment centers across the US.  After treatment, which is usually hundreds of miles or hours away, patients are sent back home to recover and be followed once every few months back at the specialists office.  Any non-cancer treatment follow up will usually be done with your primary care physician—and it is rare that they have all of your records from your other healthcare providers unless you specifically provide them to your primary care physician.  It is this disconnect that so many of our community members have expressed concern with, as well as myself.

I often reflect on my own adventure and ask myself how I’ve been successful.  I’ve done well because I try to have a resource for everything.  It has become clear to me that patients who have the right resources win.  Whether it be a mental support resource, a doctor resource, a travel resource, or a cancer “best practice” resource, I can always find what I need.

Patient resource management is critical for their success.  At the conference, there was a clear trend towards “nurse navigators.” Nurse navigators help patients find health resources, and guide patients through treatment options.  Nurse navigators are popping up in health organizations across the country to assist patients and providers becoming more aligned.  It’s a good thing for survivorship, and while it’s something that is growing, not everyone has a navigator and there are still a lot of gaps in total care for cancer patients. I was proud to know that the Meso Foundation has been at the forefront of this trend for nearly a decade, providing medical consultations and support, and helping mesothelioma patients, through Mary Hesdorffer, Nurse Practitioner.

I’ve thought a lot about how each patient can manage resources effectively and be organized in keeping those resources and in the way they receive care.  I told this to another advocate and he showed me a portable handbook that he brought with him.  This handbook was standardized for patients, caregivers, and doctors.  It kept all vital information so resources could be available and easily shared.  I thought it was great, and extremely helpful!  I’m going to get a couple copies of the book because I think it would be beneficial for our patients to have.  It will provide a standard handbook for patient resource management.  So, I’m going to talk with Mary on how we can develop something that can be a “patient resource management tool.”

I am extremely happy that we, as mesothelioma patients, have a great cancer community facilitated by the Meso Foundation that allows us to connect and learn from one another.  It is a GREAT resource and wonderful tool!  By attending the conference, I have also learned that there are many different components of survivorship, and that it means something different to everyone.  I would also like to thank everyone in the community for allowing me to participate and be an advocate for our mesothelioma community—attending the conference was just more proof that we have some of the best people and resources available.

-Bill Ziegler

Read more about Bill on our blog.

Summary of Mesothelioma Studies Presented at ASCO

Lee M. Krug, MD shares his annual summary of the mesothelioma research presented at the American Society of Clinical Oncology (ASCO) meeting.by Lee M. Krug, MD, Memorial Sloan Kettering Cancer Center

The American Society of Clinical Oncology meeting was held from May 30 – June 3, 2014 in Chicago. This is the largest oncology meeting each year with around 30,000 attendees from all over the globe who congregate to discuss the latest research in all cancer types. I will provide you with my annual summary of the most prominent studies in mesothelioma.

Randomized trial of arginine deprivation with ADI-PEG20: This abstract was presented by Dr. Szlosarek from the United Kingdom. Arginine is an amino acid that normal cells make using an enzyme called ASS (time to make the joke here!). However, many cancer cells lack the ASS enzyme so they cannot make arginine and they need to get it from outside the cell. ADI-PEG20 starves the cancer cells of arginine. In this trial, patients with mesothelioma were randomized to receive treatment with ADI-PEG20 or just supportive care. In order to qualify, the tumor samples were tested to make sure they had low levels of ASS. Side effects were very mild with this treatment. About half of the patients had stabilization of their disease. The time for cancer growth to occur was longer in the ADI-PEG20 arm, but only by a small margin (1.9 versus 3.2 months). A future study will combine ADI-PEG20 with chemotherapy, and that trial should open later this year.

Phase 2 study with tremelimumab: Probably the hottest drugs in oncology right now are the antibodies that boost the immune system. These types of treatment have shown great benefit in melanoma, lung cancer, and many others. Tremelimumab is one of these drugs, and this trial, conducted in Italy by Dr. Calabro and colleagues, showed that mesothelioma also responds to these therapies. Of the 29 patients, 14% of patients had shrinkage of their mesothelioma and 38% had stabilization. These data support the international, randomized trial with tremelimumab that is currently ongoing that will include 542 patients. If this large trial shows that tremelimumab improves survival, this drug will get FDA approval for mesothelioma.

Anti-mesothelin vaccine CRS-207 plus chemotherapy: Dr. Hassan from the National Cancer Institute reported these results. Mesothelin is a protein on the surface of mesothelioma tumors, and seems to be an excellent target for treatment. CRS-207 is a vaccine that increases the immune response against mesothelin. In this study, CRS-207 was given with pemetrexed and cisplatin. Nearly 70% of patients had shrinkage of their cancer, much more than usual with chemotherapy alone, and the responses seemed to last longer. These results should encourage a larger future randomized study.

Next-generation sequencing in mesothelioma: The report from Dr. Scagliotti at the University of Turin, Italy, described his findings from an analysis of gene mutations in a group of mesothelioma tumor samples. This type of testing has become critical for identifying potential targets in all cancers, and customizing treatment for each patient.


Lee M. Krug, MD, is an Associate Attending Physician in the Division of Thoracic Oncology, Department of Medicine at Memorial Sloan-Kettering Cancer Center in New York, New York, where he completed a fellowship and chief fellowship in medical oncology. Dr. Krug is the Director of the Mesothelioma Program at Memorial Sloan-Kettering Cancer Center. He is also the chair of the board of directors of the Meso Foundation.

GUEST BLOG: Sarah Lackner Attends the Charlie Cole Golf Classic

Lynn Cole and Sarah Lacknerby Sarah Lackner

I spent the third weekend in May in Asheville, North Carolina on behalf of the Meso Foundation at the 3rd Annual Charlie Cole Golf Classic hosted by Lynn Cole, along with her children, Matt and Katie, in memory of her husband, Charlie, who lost his battle with mesothelioma on March 31, 2010 after only 17 months.

I hadn’t met the Cole family prior to this weekend, but what occurred during that quick less-than-48-hour trip is exactly what the Foundation is about. The warmth and strength that the family displayed, their incredibly supportive and loving friends, as well as other local meso community members all contributed to making the day an absolute success.

Not only was I able to thank the Cole family for their commitment, their friends and family for their support, I was able to spend time truly connecting with each of them. Katie and I were the same age when we lost our parent and zipping around on the golf cart gave us a few hours to share our experiences, both of the loss and of life after the loss. Later that evening, Matt and I were able to also have those conversations that only occur with someone who has been through what we as a community go through. C.S. Lewis says that friendship is born that moment when one man says to another “What? You too? I thought that no one but myself…”

Charlie Cole Gold ClassicThis event was, for me, everything that the Foundation works for: supporting research, education, support, and advocacy programs through raising funds and awareness as well as bringing together those affected by mesothelioma. It takes what is often an isolating disease and provides a place where if you want to talk about it, everyone understands, and if you don’t want to talk about it, everyone understands.

Thank you, so much, Lynn, Matt and Katie for allowing me to share the weekend with you. And thank you for believing in and working towards a cure.

Calling Him Dad: What My Father Meant to Me

Jennifer Gelsick dancing with her father, Donald Edward Smitley, who was diagnosed with pleural mesothelioma in January of 2012.by Jennifer Gelsick

When I was asked to write about my Dad, I struggled with it. I wasn’t sure where I should start. My father, Donald Edward Smitley, was born on April 25, 1956. He was diagnosed with pleural mesothelioma on January 30, 2012 and fought as he lived, with faith, grace, and love, until he took his last breath on October 15, 2013 at the age of 57. Mesothelioma ultimately took his life, but it was a beautiful life, and he was so much more than just a disease.

Over these past few months, I’ve been reflecting on what it was like growing up with my Dad. I had told many people that I would have rather had 30 short years with him as my father than 100 with someone else. I mean that from the bottom of my heart. My Dad was the perfect father to me.

Growing up, there aren’t a lot of memories that don’t involve my Dad’s laughter. He had an unfailing knack to make the best of any situation and bring out the best in those around him. People were always drawn to him; he had a magnetic personality that just made people want to be close to him. I was blessed to have him all the time.

Dad was a handyman. He could literally fix anything. In my home, there was never a call to a plumber, contractor, or electrician. Mom and I just told Dad what was broken, and the next thing we knew, it was fixed.

Dad was a musician. He always said he just “played at” the guitar, but he had the most beautiful voice. I remember growing up and sitting with him while he played and sang. He would always sing “You are My Sunshine” to me, and “Rocky Top” became what he called his theme song. Later on, he worked up the courage to begin singing in Church and became a staple at community events; people loved to hear him sing. His love of God and neighbor always shone through. He also joined a bluegrass band called The Dunbar Boys (named after the town where he lived his whole life) and loved being on that stage performing for whomever happened to be around. It didn’t matter if there were 10 people or 300 people there; he always had the best time singing with his friends.

Jennifer Gelsick remembers her father, Donald Smitley, who lost his battle with pleural mesothelioma in October of 2013.Dad was a special kind of dad. He was fun, goofy, and never afraid to look silly to make me smile. We were watching some home movies over Christmas where Dad and I were walking our dogs. Then, of course, I decided to walk Dad. I put the chain around his waist and dragged him all over the place. Some neighbors who were outside asked him what he was doing and he just laughed and said, “I’m getting walked!” He was constantly doing things like this. When he saw that I was happy, he was happy too.

Even though I danced my whole life, Dad wanted me to try out all different sports. Not necessarily by being on an official team, but with him. We spent hours outside playing baseball, kickball, and throwing a football around. I never exceled at any of these activities, but looking back, he was trying to help me become more well-rounded (or maybe to just be able to play games with the other kids). Plus, he liked chuckling at me when I would kick as hard as I could and miss the ball completely.

We were always going on adventures together. Whether it was taking a ride in the mountains or trying to bake cookies at home, he made even the most seemingly ordinary activity special. My Mom worked late one night a week; I was never in bed on time those nights. It became a game to see if I could get ready and be “asleep” under the covers by the time she got home. We never made it.

You would think that these things would have changed a bit as I got older, but they didn’t. Every Saturday morning was our time. Mom would be at work, and we’d be off. We would go out to breakfast, shopping, up to the mountains, for ice cream, do a project at home, and visit family… all in the same day. Those days are such precious memories for me.

Dad was more than just fun. We always had the kind of relationship where we could talk about anything. Dad gave the greatest advice of all time. No topic was off limits for us: school, work, faith – we discussed it all. He always knew exactly what to say. If he wasn’t sure, he would tell me to let him think about it and he would let me know what he came up with later. And he always did.

The day my Dad passed away, a piece of me went with him, but a piece of him stayed here with me. Even when he felt his worst, he wanted to work to help others battling mesothelioma. He believed that if he could help even one person, then what he was going through was worth it. His faith in God always carried him through.

I am honored to continue to work with the Mesothelioma Applied Research Foundation as a part of their Rising Leaders Council to help to eradicate this awful disease that causes so many families to be torn apart. I am also a part of MesoConnect, which allows me to remain in close contact with those in the meso community and do my best to help them heal, vent, and grieve. This organization does so much for so many, and my family and I will be forever grateful to them.

I could write a book, or 50, about Dad and his kindness, generosity, and genuine love for life, God, and his family. He was perhaps the single most powerful influence on my life. He didn’t just tell me how to live a good life, he showed me. This is a true testament of the life of the most amazing person I’ve ever known, and I was blessed to be able to call him “Dad.”