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«Nashville Patient Forum – March 14, 2015 Page 1 of 51 Speakers: Michael R. Savona, MD Denise McAllister, MS, ARPN, AOCNP ?: Today we have our guest ...»

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Nashville Patient Forum – March 14, 2015 Page 1 of 51

Speakers:

Michael R. Savona, MD

Denise McAllister, MS, ARPN, AOCNP

?: Today we have our guest speakers Denise McAllister, a member of our nurse leadership board

and Dr. Michael Savona, hematologist oncologist here at Vanderbilt. Dr. Savona has dedicated

his career to MDS and transplant research. His post grad training includes a fellowship at the

University of Michigan and other work at the National Institutes of Health in Bethesda, Maryland, The University of California and the United States Air Force. In 2010, Dr. Savona served the US Department of Defense in Iraq as part of Operation Iraqi Freedom joining other physicians in a theater intensive care unit to provide care for coalition forces, contract workers and host nationals. He has earned several awards and grants and has extensive experience writing, teaching and speaking on topics related to the research and treatment of blood cancers.

I’d like you to help me welcome Denise McAllister. She’s donated her time to coming today on a Saturday and I’ll have Dr. Savona come in as well.

Denise McAllister: Good morning everyone and thank you for being here. It’s a pleasure of being part of the MDS Foundation Nurses Leadership Board. It’s also a pleasure for me (inaudible 1:42). Just to go over the agenda. Dr. Savona’s presentation will come first talking about what is myelodysplasia and therapies. Then we’ll take probably just a brief break, maybe five minutes or so to change slides and that’s when we’ll have a quality of life discussion about living with myelodysplasia then we will break for lunch at approximately 12 o’clock and then from 1:00 to 2:00 we’ll finish up with the discussion on tips on how to live each day especially (inaudible 2:20) with myelodysplasia. So, I’m very proud that you’re here. Just housekeeping ideas. There’s restrooms around the corridor. If you have cell phones, will you please put those on vibrate. This is an open discussion. This day is meant for you. It’s devoted to you and we’re here to help and just to give a shout out to the MDS Foundation. I’m very proud (inaudible 2:51) very proud to be a part of this group. This organization is really very (inaudible 2:55) and devoted to the care of patients with myelodysplasia and they’re also very devoted to healthcare providers and sharing that we have what we need to help deliver our care to patients, education support as well as grants, having leaders that have devoted their career to myelodysplasia and talking about the science of the disease and what learn especially each year through the American Society of Hematology (inaudible 3:29). So, thank you very much. Dr. Savona.

(Applause) Dr. Michael Savona: Thank you, Denise. So, I try not to wear a suit and tie much anymore, but I do for this crowd. So, I’m really grateful to be here. It’s real flattering to see you show up on a Saturday during the (inaudible 3:55) tournament listen to me talk about my passion of (inaudible 4:01) and to Denise and to Tracy and Aubrey and Dee from the MDS Foundation. This is a really wonderful group and I’ve worked a lot with them over the years and it’s just been a very

–  –  –

gratifying relationship and I hope you that you find you can take advantage of some of the offerings they have for patients because I think they can really help you and your families.

I had talked to scientists who are developing new therapies and I give talks to my seventh grade science class and so and everything in between and when I speak to people in the community, these groups are always a very wide variety of backgrounds and knowledge that comes into this room. I really expect that both that you interrupt me because I’m going to talk to you about the science behind some of the new therapies and it’s fairly complex, but I find that sometimes patients come with me in understanding everything about new molecules and I certainly don’t want to skip over something for the sake of trying to make it understandable. I think in the course of this talk I can get the point across and hopefully if you are at a point where you are not following, please interrupt.

Denise and I are not going to spend too much time talking about the ideology or pathogenesis of MDS. I’m just going to spend in the beginning a few moments and Denise will follow up some more about how we categories different types of MDS. I’m really going to focus on what the treatment is now and what we’re trying to do in the future. Dr. Mohan is my partner at Vanderbilt and he’s here today and he also takes care of people with MDS and we’re a Center for Excellence for the MDS Foundation. We have many clinical trials with people with MDS and I’ll talk to you about those in a moment.

I do have some disclosures. I sit on several different advisory boards. The reality is 99 percent of the drugs these days are developed in pharma. So, it’s very important to have good relationships with industry and I’m unabashedly participating in such a fashion because that’s what’s important for the patients, but I pursue what’s interesting and if the drug is not interesting, I have no allegiance to working with one group or the other, but they support some of my work and you should know that (inaudible 6:24).





So, what I tell a lot of patients that come into my office for the first time about MDS is the two take home points. One, it’s Myelodysplastic Syndromes. It’s not syndrome. It’s many, many, many diseases and we’re just not smart enough to break it out into what those diseases are yet.

We just say MDS. So, that’s an important first take home point. The second part of that and the corollary to that is that it ranges from something that is annoying enough to bring you into the doctor’s office and something that you’ll die with all the way through acute leukemia where if we don’t do something, it’s something you can die from. So, it’s a real wide variety of different types of diseases. Everyone understands, the heart people have done such a good marketing job.

Everyone understands heart attacks. Everyone understands the idea of your heart not beating.

Some people can understand it very well. Your heart not beating at the right rate. Over your whole life when you run up a flight of stairs, your heart beats faster, you go to sleep it slows down. It’s amazing the heart can figure that out and do that right, but sometimes you need a pacemaker. Sometimes the heart doesn’t quite beat right or sometimes it stops beating. You need the defibrillator and you probably know people that have a defibrillator or a pacemaker in their

–  –  –

chest and that’s to take care of the ticker that’s not quite meeting the demands that it did when the… many years ago.

Well, the bone marrow is much more amazing. The bone marrow can make white cells when you have an infection. It makes more white cells. When you are cut and you’re bleeding, your bone marrow makes more platelets. When you rise up to a high elevation and the oxygen is thin and you have to make more red blood cells to carry oxygen, the bone marrow can do this and it can do the opposite in the reverse situation. In your whole life, your bone marrow is balancing this in homeostasis and sometimes just like people need a pacemaker because their heart is not beating the right way, sometimes the bone marrow stops functioning right. Unfortunately, we don’t have a pacemaker for the bone marrow and what myelodysplasia is, it’s essentially a pacemakerless atrial fibrillation in the bone marrow and sometimes that can spin out and become in your bone marrow’s effort to repair a more aggressive disease like acute myeloid leukemia.

I’ll show you some pictures here. This is an example of (inaudible 8:48) which is where the platelets… what the platelets look like in MDS and the cells that make platelets, that make karyocytes and this erythropoiesis which is the red cells and you’ll take my word for it that these are funny looking cells. You can see this one, the (inaudible 9:03) nucleated cell here, but you can see on this slide with normal granulopoiesis. These are white cells being made in the bone marrow. This is what they should look like. Precursor white cells and in this granulopoiesis over here, you see hyper segmented neutrophils. You see what’s called (inaudible 9:24) cells. You see these multilobulated cells and what happens it just makes total sense. The bone marrow is trying to a job. It can’t do any more so it overdoes the job or it underdoes the job and the assembly line, parts get put on the chassis in the wrong order.

So, the other kind of analogy I tell patients is think of it upper Detroit. So, this works for me, but think of an auto factory. You need iron, you need erythropoietin, you need B6, you need B12, you need AC Delco to send in your spark plugs, you need a batter, you need a windshield. You need all those pieces to make the vehicle. So, all those pieces are there and you still can’t make it. That’s a problem with the factory. So, when you go into your doctor, we’re going to check your B12, your B6, your iron, your folate, your erythropoietin and if all those pieces are there and you still can’t make cells, well that’s a problem with the factory, the bone marrow. That analogy works for me anyway. Sometimes I carry that analogy a little far. In a worst case scenario, that… Here’s an example of that. That factory, all the pieces are there, but there’s only one guy in the assembly line and he’s just slapping pieces on the chassis and in the end the chassis goes off the assembly line with no windshield and no wheels and that is what AML is.

It’s basically an under formed… the precursor cells, unfinished blood cell which has been arrested and replicated by these clonal molecular abnormalities and has no death programming.

So, it lives forever. It’s immortality of the white blood cell.

MDS is typically a disease of those in the mature age category, but I have patients in my clinic, unfortunately, who are 25 years old with MDS and I have patients who are 90 and doing fine

–  –  –

with no treatment in my clinic with MDS. There’s a male preponderance although I certainly have female patients with MDS. Usually, the cardinal feature is anemia, but sometimes people come in with infections and their white cells are low and sometimes people come in with low platelets and they’re bleeding and these have different prognostic ramifications that are nuances that Dr. Mohan and I have to sort out and help us in our planning for therapy.

Everyone asks what causes MDS. We don’t know. We know radiation. So if you worked on a nuclear submarine or you’re exposed to benzene. We know that these things are carcinogenic and can lead to bone marrow changes. We know that from the Hiroshima and Nagasaki in Japan post nuclear explosion radiation therapy science that’s been done there and benzene which most of the people are older than me in this room. So, you probably been exposed to benzene. When I was young, benzene was easy to get and now it’s fairly regulated. So hopefully, the carcinogens associated with benzene is a thing of the past and hopefully people don’t have the exposure, but some of the people in this room who are young in the 30s, 40s and 50s, benzene was available at your hardware store as a solvent and a lot of people were exposed to this. When I was deployed to Iraq, they were using it to wash off the side of buildings. It’s unfortunate that it’s still around and MDS is associated with chromosomal changes and Dr. Mohan and I are used to looking for these things and we know that some of these chromosomal changes are really bad and that will help us adjust our therapy and we know some of these chromosomal changes are actually a good risk. So, that will help us a devise a therapeutic plan as well.

Q1: I have a question. I guess one of the ways to get it is exposure to carcinogens or toxins?

Dr. Michael Savona: Yes.

Q1: And I was also told high dosages of chemo made prior.

Dr. Michael Savona: Yes. Sorry. So, that’s my… I neglected to talk about chemotherapy, but radiation, benzene and chemo and specifically chemo that damages DNA and the typical story is breast cancer and I can’t tell you as a young oncologist and fellow when I would go to these meetings and hear about how we continue to include anthracyclines for the care of breast cancer and how the risk of AML was so low we should still do it. Yet I was the one seeing AML in the clinic for all those people who had cured breast cancer. So, it may be low, but if you get it it’s devastating. So yes, there is a treatment related MDS and AML that could be caused by chemo and it’s specific chemotherapies that damage DNA.

So, this is just kind of an overview slide that talks about our general strategy in MDS. When we think about lower risk disease with low blasts, well, we try to think what’s the least invasive therapy that can guarantee the best quality of life for as long as possible without toxicity and we think growth factors. Sometimes when people have hyper classic MDS, for example, because they have low cell count in their bone marrow we give them steroids or immunosuppression.

That can be very beneficial. For an isolated 5Q-, there’s something called 5Q- syndrome where MDSF2015-Nashville Nashville Patient Forum – March 14, 2015 Page 5 of 51 people have just the 5Q-, just the fifth chromosome is missing a piece and if the fifth chromosome is missing a piece on the bone marrow, those people tend to benefit from this drug called Lenalidomide or Revlimid and Revlimid is a funny drug. It’s an immunomodulatory agent and we’re not sure exactly how it works, which is a little bit scary, but it’s extremely well tolerated in most people and then there’s a small number of people have a lot of trouble with that drug. I don’t know if anyone’s taken Lenalidomide in here before. How did you do with it?

Q2: (inaudible 15:31) short time before I had a bone marrow transplant.

Dr. Michael Savona: You did. So unfortunately, Lenalidomide doesn’t work for a lot of patients and we’ve tried it sometimes in patients who have the 5Q- but also have other abnormalities and for patients who have 5Q- and other abnormalities in their cytogenetics, it doesn’t work as well.



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