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«New York Forum Part 1 September 20, 2014 Page 1 of 30 Speakers: Virginia Klimek, MD Boglarka Gyurkocza, MD Simon Yeung, PharmD, MBA, Lac Jayshree ...»

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New York Forum Part 1 September 20, 2014 Page 1 of 30

Speakers:

Virginia Klimek, MD

Boglarka Gyurkocza, MD

Simon Yeung, PharmD, MBA, Lac

Jayshree Shah, APN-C, MSN, RN, BSN, BS

Jayshree Shah: … first and my name is Jayshree. I’m a nurse practitioner. I work in Hackensack

University Medical Center at John Theurer Cancer Center. I have been a nurse practitioner for

over 11 years and I started my career in GY and oncology taking care of women and gynecological type of cancers. Shifted gears to hematology and recently shifted gears to medical/hem/phase one. So, (inaudible 0:28). It’s quite exciting. So, I’m here today to be just a moderator, a nurse lead discussion in conjunction with other people that are here and starting with Dr. Klimek. Her team, Debra, Colleen. We also have a couple other representatives. So, I just want to introduce them so that you know who they are. We have Steve. We talked about Vince. Steve from Celgene and we have a representative from Onconova, Scott, and we also have Dr. Yeung and we also have a transplant physician also presenting right after Dr. Klimek.

So, I want to stay on cue because we have lots to discuss and it’s getting quite exciting. Feel free to get up when you feel like you need to stretch your legs. We have some pastries and it looks like some water and drinks and stuff. If you have any questions, I’m going to pass around or go around with this mic to go to you to ask a question. Let the presenter please finish. If you can, write down your questions please so that we can go person by person and do so. Again, I want to stay on cue with the timing because we are on cue from 10:00 to 2:00 and I want to make sure that everybody gets to do what they or the questions get answered. Also, I think there is a survey for you guys to fill out in the back. So, if you get a chance if you can, please when you take a few minutes here and there to fill it out to hand it back to us. Debra and Audrey from MDS Foundation are outside. So feel free to ask them any questions or any information about how to join or get information, how to give your E-mail and contact information for updates. Anyway, let’s start the day. We’re going to begin with Dr. Klimek. You guys are welcome to (inaudible 2:25) with her. She is renowned physician specializing in MDS and she’s going to start with her presentation. Thank you.

(Applause) Virginia Klimek, MD: I also would really like to thank everybody for coming making the trip into the City. I know it’s not easy to come in and I know some of you came from quite a distance. So, we really appreciate you coming and I hope you have a good day and learn something that will help you and your loved ones with this disease. Jayshree introduced you to some of my staff at Sloan Kettering. I just want to mention them again. Debra O’Shea if you can raise your hand and Colleen Branigan, a nurse and nursepractitioner who work with us and anybody who comes to see us at Sloan Kettering knows how integral they are to our team and that we can’t… no physician can do it alone.

–  –  –

So, and also to emphasize, I know that there’s going to be a lot of questions. We’re going to try to build in time for questions, but we also have a couple talks we want to make sure we get in.

So, we’ll try to have time during each speaker’s session for questions and then they’ll be opportunities during lunch time for questions. I’ll be here all day as well. So, I’m going to talk from this mic because the sound is better, but the angle is a little tough for me. So, I’ll do my best to use the pointer. Just let me know if you have any questions about what I’m referring to on the screen.

So, what I wanted to go over was just a general discussion about what MDS is and some general treatment strategies and I just want to preface my talk by saying that I think I could probably talk to every person in this room who has MDS and if you were sitting in front of me in my clinic and I was talking to you about your disease, it would probably be a different discussion with almost every one of you. So, it’s a very heterogenous disease. So, I’m going to try to approach this generally and I understand that there’s questions and maybe not everything I tell you is applicable to every one of you, but I’m going to do my best to sort of get across some general principles.

So, what is MDS? So, MDS is a… stands for Myelodysplastic Syndrome. I think everybody in this room probably knows that, but they may not know where this comes from. So, myelo is just a scientific word for the bone marrow which is where your blood cells are made. Dysplastic just means that the cells in your bone marrow are abnormal. They look abnormal under the microscope. They don’t work normally. So, it’s a disease of the bone marrow that causes a decrease in blood cell production and as a result you have low blood counts and over time this can change into something that we call acute leukemia. So to better understand MDS, I just wanted to talk a little bit about what the bone marrow is and does and what blood cells are.

So, bone marrow is a material inside of your bones and for the most part as adults we make blood in the bone marrow in our spine and in our hip bones and in our legs and I always talk to my patients about how the bone marrow is essentially a blood cell factory and when you develop MDS that factory is not working so well. It’s inefficient, it produces defective cells and it produces insufficient numbers of cells. This is just a picture of the bone and you can see the bone marrow inside the bone and all the different types of cells that are produced. So, the bone marrow produces the red blood cells. It produces a variety of different types of white blood cells and cells called platelets. Whenever I talk to patients and whenever your doctor talks to you about blood cells, these are the three main types of cells they focus on. We have the red blood cells. The red blood cells are cells that are filled with something called hemoglobin and the job of the hemoglobin is to carry oxygen to all your vital organs, to your brain, your lungs, you muscles, your joints and so that explains why when your hemoglobin levels are low when your red cell levels are low you don’t feel well. You feel tired, you feel short of breath, you feel dizzy, weak, you can’t think right. So, it’s important that we be aware of and we monitor the red blood cell levels. The neutrophils are one of the white blood cells that we use to fight off infection. So, that’s another important cell that we keep an eye on with this disease. The platelets are cells that

–  –  –





you produce that can stop bleeding or prevent bleed. So obviously, important for us to keep any eye on those as well.

So when is MDS suspected? Most of the time when people are diagnosed with MDS, it’s because to the doctor for some other reason and they have a blood test done. Maybe they’re having a surgical procedure, maybe they’re going to the doctor because they feel fatigued or they had some bleeding or they had a bad bronchitis and pneumonia and the blood work is done and you can find a low blood count to that time. Sometimes people come to me with a diagnosis of MDS because they had a bone marrow procedure done for something completely unrelated maybe another cancer even and they find MDS at that time when it wasn’t suspected. We sometimes pick up abnormal bone marrow by x-ray studies. So, sometimes people will have an MRI, for example, after they have a car accident and the radiologist can see that the bone marrow in the bone looks abnormal and that leads to a bone marrow test and a diagnosis of MDS. We also suspect MDS more commonly in people in their 60s, 70s and 80s and the average age of MDS is around 70.

So, the symptoms of MDS that bring people to their doctors are fatigue, shortness of breath and weakness and, again, that’s primarily from the anemia, the low red blood cell counts, or if they’re having frequent or prolonged infections or bleeding problems. The problem is that a lot of these symptoms can be caused by other things. You could talk to anybody who’s had fatigue and you can know that that it could be from thyroid disease, heart disease, diabetes, a lot of other medical conditions can cause some of these symptoms. So, MDS can mimic a lot of other medical problems. So that’s why when MDS is diagnosed it’s so, so very important that your doctor obtains a good history, they do a physical exam and they do a lot of basic bloodwork to make sure you don’t have some of these other disease that can cause these same symptoms which can also cause low blood counts. So, the low blood count brings you in. You have these symptoms, but it doesn’t necessarily mean that you have MDS. You can have something else or you can have MDS and another medical condition. So, it can get a little complicated.

We diagnose MDS by looking at the blood work, by looking at your blood cells under the microscope and then, of course, by doing the bone marrow test. Most of the people in this room probably cringe when you see this picture. This is a cartoon of somebody undergoing a bone marrow biopsy and aspirate. We take the bone marrow samples from inside the bone because remember I told you that’s the factory, where that’s where the blood cells are made inside the bone and we look… we do a lot of different tests on both the liquid from the bone marrow and we also go back in and we take a little piece of the bone and I’ve listed some of the tests that we do on these samples. All of these tests are really done and needed to make and establish a diagnosis of MDS and to find out what type of MDS somebody has.

So, there’s really no single test that shows somebody has MDS. Remember, I said you have to eliminate a lot of other problems that can cause symptoms and low blood counts. You need to do a bone marrow that shows typical findings that we see in MDS and even then even if somebody

–  –  –

has low counts they have some symptoms of MDS. If we really can’t be sure about it based on how the bone marrow looks, sometimes we have to take a watch and wait approach and I’m going to bet there’s at least a few people in this room have been down that road where the doctor says I’m not quite sure. We need to follow your blood work and maybe have to repeat another bone marrow even to confirm the diagnosis.

This is a just a list of some of the other causes of low blood counts I talked about. So, people can have low levels of vitamins. Sometimes medications can cause low blood counts and even some of the symptoms of MDS, other cancers and then there’s a lot of other bone marrow disorders that we have to think about when somebody walks in the door and to be evaluated for these low blood counts. This cartoon looks complicated and it would probably take about an hour to explain this, but this is what goes through my head when I sit down with somebody and I’m trying to think of everything that can go along with the symptoms and the blood counts and the medical history of that patient. We have MDS in the middle in that yellow circle, but there are a lot of other diseases that sort of overlap with and can look like MDS including PNH, paroxysmal nocturnal hemoglobinuria. It’s a mouthful. Other bone marrow diseases like myeloproliferative disorders, for example. Aplastic anemia which is a related disease that you may have heard of and, of course, leukemia. So, a lot of… So even once you have a bone marrow that looks like MDS, you have to still have to make sure that you’re not dealing with one of these other conditions as well.

So just as a summary, in Myelodysplastic Syndromes you have an abnormal bone marrow. You have low blood counts because the bone marrow is not producing enough cells. Unfortunately, some patients… fortunately, actually, a minority of patients, but some patients can develop leukemia as part of their MDS disease course and just to emphasize a point I made earlier, it’s a very heterogenous disease. A lot of different types of MDS, different approaches to managing it depending on the individual.

So, I think I wanted to build in a little bit of break for just a couple questions. If not, we can just continue to move on. Let’s move on.

So, this is a really common question I get from patients and their families. Never heard of MDS before I was told I had it. Does that sound familiar to people here in this room? Yeah. I see a lot of heads nodding. It’s not a common disease. So, it’s not surprising that people have never heard of this. This is not something you hear about on the news. Although with some… people coming forward more recently… recent time about their disease now there’s some more public awareness about this disease. Instance increases with age and what I was trying to show with this graph if you can see the pointer. Although we see MDS diagnosed in people in their 40s and 50s, you can see that as your age goes up to the 60s, 70s, 80s and beyond the incidence of MDS goes up and the median age is right around 70 and although this graph looks like it’s a lot of patients, it is and I’m trying to show the relative increase in people as we get older. So, it’s still a rare disease and I put a little comparison on the bottom where in the United States alone over 200,000

–  –  –

people are diagnosed with breast cancer each year. For MDS, we’re talking about between 10,000 and 20,000. So compared to other cancers that you hear a lot about, MDS is a rare disease.

Another common question people have is how did I get this? Is it something I did? Is it something I ate? What do you do? And what we think is that the cause of MDS is probably a combination of changes in our bone marrow as we get older because we see it mostly in people in their 60s, 70s and 80s. There may be some exposures that people have to certain chemicals.



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