Michelle Nadeem-Baker:
Welcome to CALQUENCE Connections. We have a lot to discuss during our program today, including navigating and supporting mental wellbeing with CLL, living with CLL in a COVID world, starting treatment for CLL, staying on a treatment course, and managing side effects, and so much more. I'm Michelle Nadeem-Baker, a CLL patient advocate and your moderator today. I'm excited that today's program will bring forth a lot of dialogue regarding treatment. And that will be between myself and Mark Durant Davis, a physician's assistant. Mark, can you share a bit about your credentials and where you're working?

Mark Davis:
Sure and thank you so much for allowing me to join you today. I've been a physician assistant now for 20 years, all in cancer management. And I've had experiences primarily working in the community setting but also worked in academic cancer centers as well at UT Southwestern and here in North Texas. Of course, throughout those years I've managed a large number of CLL patients.

Michelle Nadeem-Baker:
And Daniel is a CALQUENCE patient. Daniel, would like to share how long you have been living with CLL?

Dan:
Yeah, I've been diagnosed with CLL back in October of 2020.

Michelle Nadeem-Baker:
Thanks to both of you for being with us today. And I just want to let everyone know that this program is made possible by AstraZeneca and Cure magazine. All right. Well, our first session today is going to be covering going through a CLL diagnosis and the considerations behind staying positive. Also, we're going to be talking about addressing diet and physical activity in maintaining your mental health. And just to also share with you, in addition to being a CLL advocate, I am also a CLL patient. So, this is near and dear to me as well. So, in our first poll that I'm going to be throwing out to you, it'll be popping up on your screen, is what are your go tos for managing your own well-being during stressful situations. The choices are maintaining a healthy diet, that's one that I'm not so great at. Usually in stressful situations I'm anything but. But I try hard. Exercising regularly, using stress reducing techniques like meditation, or talking to friends and family or a counselor. So, if you could answer that, what are your go tos for managing your well-being during stressful situations? We'll also be digging deeper into other topics. For example, open communications with loved ones and caregivers, maintaining a healthy lifestyle through diet, exercise, and mindfulness techniques. Also, opening yourself up, how you can let friends and family help you and understanding what is important to you and how to communicate that to your doctor and those around you in relation to your CLL. So, Dan, let's start. Thank you again for joining us. Can you walk us through your CLL diagnosis when it happened?

Dan:
OK. I had COVID in September of 2020. Was supposed to have elbow surgery, did the pre-op and they said, Ooh your blood work. Your white cell count is way too high at 50,000. That was on a Thursday. Monday I go back to hospital for the surgery. They double checked the blood work and go, OK you've got pneumonia. It's more advanced than it was on Friday. But we think you may have some sort of leukemia. Because I had pneumonia, I got to stay in the hospital because I had a fever. I got to stay in the COVID unit as per the protocol back then. And Tuesday morning they said, Yes you definitely have leukemia. We're not sure the type yet but you do have leukemia. And that just kind of puts a stomp on your head right there.

Michelle Nadeem-Baker:
Wow, what were your initial emotions when you heard that?

Michelle Nadeem-Baker: [Inaudible]
Those emotions are something that so many of us go through that at diagnosis time. It's really difficult. Well so, I know in your story that you had little to no watch and wait time. But watch and wait can be anxiety provoking for so many of us. Once you're diagnosed then your- generally for many of us, you're in watch and wait or there are some who go straight into treatment. You're kind of in between there. But it sometimes it feels like no progress is being made to slow or stop your disease and it's progressing and you know it. But- how do you suggest- how did you manage your anxiety at this time? You're diagnosed, you're not on treatment instantly. So, what did you do?

Dan:
Well, I was sitting there in the hospital that Tuesday. COVID unit, the only visitors, the only people I saw were doctors and nurses coming in. I'm sitting there talking about- I'm thinking in my brain about my life. And I remembered stuff my Dad told me when I was 10 years old. He says, Don't worry about it. Put it in your back pocket. If it's a car problem, give it to a mechanic. If it's a house or something, give it to a contractor. If it's a medical problem, give it to a doctor. But he goes, If you can't do anything about it don't worry about it. And 54 years ago when I was told that I'm thinking, Whatever. Sure. Thanks. Yeah, thanks Dad. Now, it, to me, it makes a lot of sense. There's nothing I can do to stop this leukemia other than taking my CALQUENCE and trusting my doctors. So, I can't worry about it. It's not going to do me any good. I don't need the stress.

Michelle Nadeem-Baker:
How long after you were diagnosed did you start treatment?

Dan:
So, I got diagnosed in October. Saw my oncologist and that time he said, hey we caught it early. We're probably looking at five maybe 10 years before you need any treatment. Five months later, March of 2021, I had had two major infections and they said, OK. We're starting you on oral chemo. And to me, that was a relief because something was being done instead of just sitting there for five months getting blood work every week and going up to the cancer center every two months and just try to- something was getting done and that helped my mind a lot.

Michelle Nadeem-Baker:
You're very positive and I can tell you're a pretty positive person from the times that we've spoken. Were you this positive at the very beginning of treatment when you were in the hospital? I know you talked about what your Dad had said to you but did you have a moment, kind of a moment that changed all this to something that happened to you in the hospital?

Dan:
Well, you know, I go up to the hospital, up there right before Christmas wearing my little Santa outfit and making everybody happy because I kind of look like Santa Claus. I go back up for "three days" in January. Go up on January 18th and just for three days. And they said, By the way, you have this infection. You're going to need to be treated here and it's going to take- you're not be able to go home until the value of that infection is zero. And I ended up being there for 34 days. My daughter came up and visited, my wife came up and visited but- and that was before- that was still in my waiting period. So, I'm thinking, "OK. I've got to get this infection out of me. I don't know what caused it, how it happened. And basically it's just one everybody's got but without an immune system it decides to wake up." So, I'm sitting there taking a pill every morning, taking a pill every night, for 34 days and you start thinking, "Is this going to keep happening? Am I going to get an infection every time I turn around." I wasn't liking it, because I'm still on my waiting period and I knew I didn't have an immune system and I just- I was masking up everywhere, extra washing hands, and everything I could do and I still got- had this infection. I didn't like it.

Michelle Nadeem-Baker:
And I seem to remember you received a package of dinner?

Dan:
Yes. The day I got told, yes I do have leukemia. We didn't tell me- they didn't know what kind yet. I did not hide it from the world. I talked to my wife, my daughter, my son, and I put it on Facebook. Said, Hey I'm in hospital with pneumonia. I've also got leukemia. We don't know what kind. A good friend of ours is a chef at my favorite Italian restaurant. Calls my daughter and says, What's your Dad's favorite food here? She goes, The stuff on the menu. I love everything there. you know I'm sitting there talking to my wife, they can't visit. I go to the window. They're out standing by the helipad. We're waving and talking on the phone but I don't have visitors. Six o'clock rolls around, a nurse brings a packet in, a big plastic bag and says, Somebody likes you. One of your friends brought food. And I opened it up. It had- the first thing on top was two big old cannoli, my favorite Italian dessert. And just a bunch of Italian food. Two meals worth in that. And that actually, I'd been in a kind of a funk, but with the chef bringing the food to me, I woke up. I got out of it and decided people do care and I'm glad I share it with my friends. I want them to know. I don't want someone to say, Hey what's going on? And then me tell them, Oh I've have leukemia for two years. If they don't follow me on Facebook, that's their problem. But I never did like saying, Hey how's John doing? You know He broke his leg or he passed. I don't like that. So, I want people to know. I'm not afraid to share my story.

Michelle Nadeem-Baker:
You're a very open person and that's lovely. Not all of us are but a lot are within us. But you know Our poll results have come in and I've been wanting to share them with you all. So, the poll about what are your go tos to help manage your stress during stressful situations? Exercising regularly came in on top at a little over 46%. And then talking to friends and family or a counselor, that follows it next at 28%, a little over that. And maintaining a healthy diet, not sure if Dan's cannoli's fit into that But it was healthy for his mental health at that particular moment.

Dan:
Yes, cannolis, it's Italian food. It's all healthy.

Michelle Nadeem-Baker:
That's at almost 18%. And stress reducing techniques such as meditation, that's at the bottom of the pack here. But still, we have 7.7% of our audience that that's what they go to. So, Mark, coming to you. For patients with a cancer diagnosis, maintaining well-being, especially a positive frame of mind is really important. But a lot of patients ask about natural approaches to help as well, such as meditation and green tea. And we see in our audience here, and I would be- I didn't answer it but I would probably be in that, meditation is probably at the bottom of my list even though I really have tried. But what are your thoughts on all of this, what can patients do?

Mark Davis:
Well, you know really what I remind patients is one of the most natural ways for healing is laughter. And with this group right here in particular Dan, I mean I love his energy. And so, you could clearly tell the importance of laughter in his life. And I just remind patients that it's important to remember to laugh and have fun. That's what life is meant for. And so, yeah there's challenges that people encounter of all sizes and shapes and but don't lose that focus. But things also remind people, recommend to them to help maintain a positive outlook, is in regards to meditation, that can be done in several different ways as well as relaxation breathing is also a very important aspect to help dealing with the stress of it all. Life comes with stress and cancer comes with stress. And so, these are things that are very easily used in your daily routines to help as a coping process, particularly when you're dealing with anxiety or even insomnia. And in regards to meditation, as I mentioned, simple walks can be helpful, reflecting on the nature, just really appreciating life can really change your perspective on your disease state. And then even more physically demanding things like yoga could be very helpful as well. In terms of the supplements, I remind patients really to make sure you discuss that with your healthcare team particularly with the physician or the advanced practice provider because there's always going to be concerns about are there drug interactions and things of that sort but surely there can be a role for that as well.

Michelle Nadeem-Baker:
On supplements then, to just remind everyone that they should really be asking their doctor about them first then. Now, we're about out of time on this particular section but we have a couple of questions that we've got- we received from the audience. So, Mark, here's one of them. I think we have time for this one. What do you feel about naturopathic treatments such as acupuncture?

Mark Davis:
So, in terms of acupuncture, it's something that's been studied in cancer in actually several areas. It can be very helpful in terms of anxiety. It can be helpful for neuropathy, which fortunately in the treatment of CLL is not a common problem. It also could be potentially be helpful in terms of nausea. So, if those are things that patients are dealing with that's certainly something that's worth exploring. There's not much concern in terms of acupuncture and the usage of treatment or being on treatment.

Michelle Nadeem-Baker:
OK. I just heard we have time for one more question. So, you were talking about going for a walk is something that would be good for reducing stress. Is there any other kind of exercise that you would suggest?

Mark Davis:
You know Yoga really, I find, is something that's been researched a lot particularly in solid tumor types. But it's something I've extrapolated in using and recommending for patients with all cancer types. It's something that helps strengthen your core, which is important. And I also, with that meditation part to it, can also be a relaxing experience for patients. So, it really utilizes exercise and meditation together, which I know we'll discuss later on in terms of benefits of exercise. But it really is a combination of things that it could be very helpful for people.

Michelle Nadeem-Baker:
Dan, have you tried yoga?

Mark Davis:
Hahhahahhah

Dan:
No, no no not since the Beatles made it popular. No.

Michelle Nadeem-Baker:
Haha haha Well, I had to ask. I-

Dan:
But I do walk. I do try to walk.

Michelle Nadeem-Baker:
Oo So, it's time for segment two. And in this segment we're going to talking about COVID and CLL and why it's important for patients with a immunocompromised system to follow COVID precautions. Mark, it's back to you. How important is it for CLL patients to get the COVID vaccine? There's so much being asked about this continually.

Mark Davis:
Well, I mean over the course of two and a half years we have seen just the risk associated with COVID for patients who are on treatment, regardless of cancer types. But particularly for patients with blood cancers. And so, anything that can help lower that risk of a severe complication from COVID is welcome. And So, vaccination has been well studied in cancer patients and we see the safety associated with it. And so, it's something I absolutely encourage patients to receive to help really reduce that risk. Because it's such a simple measure for something that potentially has such serious consequences to it.

Michelle Nadeem-Baker:
How does the COVID vaccine impact patients taking BTKi's? That would be Bruton tyrosine kinase inhibitors.

Mark Davis:
So, with COVID vaccination, patients who are on treatment, there's research that's show that there may be attenuation of benefit of the vaccine. This is something that's not just exclusive to BTKis, it's with any type of treatment. And sometimes there's other therapies that it may be more pronounced. And so, there's an impact in terms of the potential immune response. And then, quite honestly, the science isn't fully understood in terms of vaccines, in terms of what should we be looking for immune response. And so, there's other aspects where maybe you don't develop the antibodies that you hope for but it doesn't necessarily mean that the patient hasn't derived any benefit from the vaccine. We know, growing data supports T-cells are a part of the immune response to vaccines as well. So, it's just very important that patients undergo vaccinations for COVID regardless of being on treatment or not on treatment and of course receiving boosters because we again know that every amount of immune response is going to be very important to this patient population because of the natural course of the disease which is associated with increased risk of infections and then on top of that, the CDC is very fluid about the booster protocols. So I think I also want to educate patients and remind them to stay in contact with us or in your case, in contact with their health provider managing their CLL because this is something that changes monthly or quarterly so it is very important to make sure that you're staying up to date on any of the vaccine changes regarding patients who are at risk.

Michelle Nadeem-Baker:
So it'd be remiss if we didn't share this info so here it goes so let's switch this around about BTKi’s and their impact of the efficacy of the COVID vaccines. Mark, take it away on that one.

Mark Davis:
So we do have some literature that exists about the impact of BTKi's as I mentioned before about lowering the efficacy. And little Sadly I sometimes have patients who use this as an argument not to get it you know and I just remind them that any amount of immune response is valuable in this type of situation because of the potential seriousness of COVID in a patient with a compromised immune system. And so Even though there may be patients who have diminished effects whether it's from their treatment or actually from their disease I emphasize that the importance is nonetheless to receive vaccination to help prevent or at least potentially reduce the severity of a COVID infection.

Michelle Nadeem-Baker:
So communication is really important then with your health care provider throughout this whole-

Mark Davis:
Oh absolutely.

Michelle Nadeem-Baker:
OK we have a question that's come in from the audience and it is, what are the best practices for a CLL patient living in a COVID world? I'm thinking that perhaps they're asking maybe for prevention.

Mark Davis:
Right you know there's been a lot of gain since vaccinations have become available as well as the boosters and so you know I think more and more people are becoming comfortable living somewhat of a normal lifestyle as a result of that. So It doesn't necessarily mean we lower our guard to COVID-19 but I do think obviously the vaccines as well as boosters has opened the doors for patients to live a more normal life. But That doesn't mean that you throw away all the masks that you've ever owned. There's still you know a role for that. I encourage patients particularly when they're traveling in close quarters to use masks and of course using antibacterial lotions or creams is something to consider as well when traveling and even when visiting large groups of people and then of course just simply using the screening process of who are you going to be spending time with. Have those groups of persons been sick recently? And So you know take the initiative in those situations, I don't think we're in a place where we can you know dismiss risk completely. It still is something that requires paying attention to your risk factors but fortunately we're no longer required to live in a bubble either and based on those circumstances of course every person is going to be different based on risk tolerance.

Michelle Nadeem-Baker:
Dan?

Dan:
Yes ma'am?

Michelle Nadeem-Baker:
Talk to us here about having CLL during COVID times. What does it feel like to you?

Dan:
It has me a little bit nervous all the time. I mask up anytime I go in public. There's always one in my back pocket. This is my Santa mask but I've always got one with me. If I go into the grocery store or other stories where there's people especially that I don't know I mask up. Even around a group of friends I generally may not mask up but I'll try to keep my distance. You know Getting COVID again is not very high on my wish list but it's a concern. There's so many people out there I'm not saying the vast majority but there's enough people out there that say well it's not real I'm not going to do anything about it. So I just have to make sure you know like we're taught in driver's ed I got to watch out for the other guy.

Michelle Nadeem-Baker:
Do you think people understand your heightened risk to infections?

Dan:
My friends do, you know people on Facebook like I said I'm not afraid to post that on there and let them know what's going on. My family, my friends, my scuba friends they all know and they all understand. If we're going to go over to a friend's house they go well our son was just sent home from school because someone there was sick he's getting tested for COVID I say OK, good, they're letting me know So. The people that I hang with are concerned.

Michelle Nadeem-Baker:
Now you said you carry a mask, now I know that you're traveling soon.

Dan:
Yup.

Michelle Nadeem-Baker:
What will you be doing to take precautions when you're traveling?

Dan:
Even though I hate wearing a mask on the airplane I will be wearing a mask through the airport and on the airplane. I know who's sitting next to me. I don't know who's sitting in front or behind me. Have they been exposed? I don't know. I don't want COVID again so I'm doing what I have to do to not get it again.

Michelle Nadeem-Baker:
Because you had it and you know what it's like.

Dan:
Yes.

Michelle Nadeem-Baker:
So you know we've just asked the audience the same question that I just asked you about how much do you worry about COVID and our audience members we have the majority, 65 percent who have answered saying they're much less concerned now than when it began, 35 percent are still very anxious about it and zero percent said it's hard for me to go about my life. I have to admit it's kind of hard for me to go about my life like it used to be so I probably fit into two of the categories here. But Navigating the risk of COVID for patients with CLL you know it is difficult but talking to your doctor and like Mark was suggesting and eliciting support from friends and family like Dan does, that can help. Mark, what do you suggest to your patients like someone like me who it's hard for me to still go about my life like it was before and being out with people all the time and things like that, I know you said to practice things but what about going inside, into someone's home or out to dinner inside with people when you don't know if they've been vaccinated and what their daily life is like? You're going let's say to an event, a wedding inside or something else that's inside and crowded.

Mark Davis:
You know Some of this anxiety or anxious thoughts are appropriate you know so and I think it would be wrong for any person to dismiss those concerns and just say you know COVID is in the rear view mirror. I think clearly there's risk still associated with it. At the same time we've made substantial progress and so often what I try to do is empathize with the patient and understand you know when you're in a situation that you don't have control over particularly with all the variables around you how do you find peace? You know and So That's where you know I start with our conversation; what is going to give you the level of assurance to allow you to engage in life again because the one thing I don't want to allow patients to do is just become a hermit. You know I mean that's not the acceptable option in my assessment on those things. You know I think we've gone far enough with how to protect patients that it's now just a matter of employing those things so that they go out and enjoy it and if that means wearing a N95 mask in public, you know even if it's somebody who feels like they need to wear latex gloves; I mean if that's what provides peace for you then I You know encourage them. The last thing I want them to do is just to find themselves trapped within their homes when we have these different resources available to help them You know regain a large part of their life. I mean obviously everyone in some form or another has had to make sacrifices and we continue to do so I mean and that's the situation we live in but we still don't live in a world where we have to make huge amounts of sacrifices. Again there may be exceptions but by and large I think most people can still regain a large part of their previous life that they had prior to COVID.

Michelle Nadeem-Baker:
So we're going to switch gears a little here and in this segment we'll be covering beginning treatment for CLL and as a reminder to our audience please submit your questions and we're going to take as many as we can and answer them and like I said we'll try to get through as many as possible but we have a lot of information to get through in this so fasten your seat belts here guys. Mark, we've been talking about CLL for a while now. What are a few key things that people should know about CLL?

Mark Davis:
Well it's worth knowing that chronic lymphocytic leukemia, the other name for it, is a slow growing type of cancer. Obviously there's going to be variability to it based on certain risk factors and it's a cancer that involves white blood cells called B-cells. Unfortunately these cancer cells are dysfunctional and so you actually are more prone to infections and these cancer cells can typically involve the lymph nodes or even bone marrow. So At the time we don't have a cure but there's a lot of research going into making advances in the treatment of patients with CLL. And Majority of the patients well I shouldn't say majority of the patients, about a third of the patients won't actually have symptoms at the time of their diagnosis. It's just an incidental finding, routine lab tests and a physical and potentially may never even need treatment but on the flip side there's patients whose disease gets to a point where the treatment is necessary and it's important to treat the disease until it's put into remission and remain on it for a continuous basis. It's something that's type of treatment being selected. With BTKis obviously it's used on a continuous basis and would be directed by the patient's doctor. But as I mentioned a lot of research is ongoing in CLL, a lot of progress has been made. I imagine CLL based on my observations and so we hope to someday find a cure.

Michelle Nadeem-Baker:
I certainly hope so. I am rooting for that myself. I keep saying if someone says there isn't one I say yet, yet. So let's talk about genetic testing in CLL. So What is it and what are some of those tests called and should patients get it and when?

Mark Davis:
It's a very important part of the management of CLL. Molecular testing or genetic testing is a way of looking at the genetics or protein markers that's related to the CLL and it can help us better understanding your disease. It's a test that can be done either through a peripheral blood draw that's done in your arm or it could be done on the bone marrow biopsy. And The examples of testing that are included in this include things like FISH analysis, flow cytometry or minimal residual disease (MRD), very sophisticated testing and many of these technologies particularly MRD are relatively new and so it's exciting to learn how we use this and incorporate it in the management of patients and what it can tell us about the CLL disease itself. When it should be done is really based on the time of diagnosis or at the time of diagnosis and any time there's a recurrence of the disease it would be helpful to do a genetic testing to see if there's been any changes to help us better understand the course of the disease as well as what might be appropriate treatment.

Michelle Nadeem-Baker:
So basically what you're saying is the results of these tests can help inform you what treatment options may be appropriate?

Mark Davis:
Yes absolutely, the benefits of the testing can provide information on whether or not a patient has mutations that can affect their CLL prognosis so there's some prognostic value. Some are considered to be high risk features of CLL which again goes with the prognostic element to it and then also the mutations can be harnessed in terms of what might be the best treatment for that person as well so very invaluable information you know not just at the time of diagnosis but with each recurrence.

Michelle Nadeem-Baker:
Good info, what treatments are available for CLL?

Mark Davis:
So it's important to recognize that there's a lot of options and there's different ways of doing things so some treatments are fixed duration and some are taken continuously until disease progression or unacceptable toxicity. Historically though CLL was treated with chemotherapy and later chemo immunotherapy and chemotherapy would work by killing rapidly dividing cells which is an accurate description of cancer cells and in comparison to healthy cells they are typically growing at a faster rate which makes them vulnerable. But That doesn't prevent the ill effects of chemotherapy on healthy cells, those are still vulnerable to the effects of chemo and so as a result of this there can be more serious side effects than what you might experience with targeted therapies. In recent years though largely due to the advances to the genome project we have seen really an explosion in targeted-type therapies in all different types of cancer types and this includes Bruton tyrosine kinase inhibitors. So These BTKis actually block an enzyme that helps regulate the growth and survival scale of cancer cells and ultimately what the BTKi does is it helps stop the cancer cells from growing and reduces the number of new cancer cells being made by blocking that enzyme. Nonetheless though even as a targeted therapy it can still cause serious side effects and people should discuss with their doctor what is right for them.

Michelle Nadeem-Baker:
OK so we have a couple of questions here for you that have come in. And please, we have a shy, I think we have some shy viewers this evening. If anyone, or this afternoon depending on where you are in the country, but if anyone has any questions, please don't hesitate to send them in here via the function at the bottom of the screen. So someone has asked, if they're thinking of changing therapies, but they're not saying what they're currently on. Are there any things to keep in mind when switching?

Mark Davis:
Obviously, that would be a conversation with your physician, in terms of changing therapies, because the question really would be, is it because of progression, or is it because of toxicity issues? But ultimately, whenever there's a discussion revolving around the idea of changing therapy, it's important to discuss the potential risks for new types of toxicities that you might encounter with the next type of therapy. And also, I typically try to remind patients to slow down life when you change therapy, because so often we get you know used and acclimated to our prior treatment, that some persons' confidence remains the same, and they might go and start the regular routine of exercise or eating habits and that can be detrimental. So I always encourage patients to slow down life, initially, when they change therapy, and just gradually watch how they tolerate things over those first couple of weeks to assess their tolerance.

Michelle Nadeem-Baker:
Yeah, and I remember myself, even when starting treatment, trying to keep up my gym and running routines right. Doing an hour long workout with heavy weights, and then going and running after, and I just didn't understand – in the beginning I kind of I was trying not to remember that I had started treatment. And I had to get used to that, but one last question here, how long can a BTKi or other treatments keep a CLL patient’s disease from progressing?

Mark Davis:
So this is, it's important to know that there's variable outcomes based on the patient, from patient to patient, so there's not an answer that describes all patients. The good news I also don't have the answers, nor does anyone else when you're discussing frontline therapy with BTKi therapy. Because patients enrolled in the clinical trials over the last five years and longer continue to have a response, so this is very exciting data for patients with BTKi's and seeing these very long remissions. In the second line setting when somebody’s previously been treated with therapy, as you would anticipate the time of remission and recurrence of their disease tends to be shorter than the persons who are newly diagnosed. Usually remissions on average might last three to three and a half years, again, there's a lot of variability based on patient specific factors.

Michelle Nadeem-Baker:
And we have a patient who sent in a question, let's just say someone's currently on CALQUENCE which is a BTKi, what are some of the factors to consider when deciding to put someone on a continuous treatment like a CALQUENCE?

Mark Davis:
So the patient, patients will routinely have a conversation with their medical team is primary the efficacy, You know and efficacy is a way of describing response rates and how long will the CLL respond to treatment? Side effects, is also an important topic of discussion and ability to manage them at home, versus somebody who might have to go into the hospital for management of the toxicity, and so, other aspects you would discuss in terms of the appropriateness of BTKi, is you know discussing the toxicity is what are acceptable and what are unacceptable toxicity. So, as a clinician, you have to consider co-morbidities as well, when starting treatment such as cardiovascular disease, high blood pressure and kidney function, are things of how you might actually choose one treatment over the other. And then patient preferences in terms of oral tablet versus an IV is a point of discussion, as well. And particularly that became very relevant in the times of COVID, and even till now. Whether or not patients want to actually come into the office as frequent to receive IVs, could be a daunting experience for them. And so that certainly can play a role in the decision making of treatment, and then of course one more aspects also is recognizing the limitations of chemo immunotherapy in patients with high risk cytogenetics, is a valuable point to reference and helped us make a decision in terms of the treatments.

Michelle Nadeem-Baker:
Dan.

Dan:
Yes ma'am.

Michelle Nadeem-Baker:
Didn't want to leave you out for too long here, how did you feel during your first few weeks of treatment?

Dan:
Mentally it was great, because I was doing something about by my CLL. Physically, I just say I kept the bottle of anti-diarrheal pills around for the first two or three weeks. But mentally, it made a big difference, because I was actually doing something to treat it instead of just sitting and waiting.

Michelle Nadeem-Baker:
People notice that a poll has come up, but Dan first I want to ask you one last question. How do you act as your own advocate during treatment, like for when let's say you're having, like when you were newly on treatment, and you were having you know a side effect. Did you...how have you self-advocated?

Dan:
Well I was in the cancer center with my second major infection sitting there on an IV, they said we're going to put you on CALQUENCE. OK, so I started reading everything I can about CALQUENCE. I started reading about a, what it was what it did, try to figure out how it worked, when the pharmacist came by and talked to me about it and it goes, "Do you have any questions?" I go, “Yes.” And he and I talked for 45 minutes, because I'd read about it, he answered my questions, and you've just got to make sure you keep taking it.

Michelle Nadeem-Baker:
So, are you seeing our poll? It's really interesting, and I don't know if everyone in the audience can see it as well, but when the numbers come in, it's like you can see the screen light up in different colors. And our poll question for those of you who have not answered is, have you talked to your doctor about treatment using BTKi's? So the answers to choose from are I have and I'm currently not on treatment, I have and I'm currently on a BTKi, I have and I'm currently on a different course of treatment. I haven’t and I'm currently on a different course of treatment, or I haven't and I'm currently not on a treatment. Maybe we can wait another half a minute to see if anyone else who did not notice the poll come up on their screen can answer that. But right now it looks like we do have a trend, and the majority of our audiences is on a BTKi, and that 60, almost 63 and a half percent. Oh, that just went up, over 65% now, we do have more jumping in, this would be Dan – no this would not be Dan, that would be Dan the last one. The other one is I have and I'm currently not on a treatment, that would be almost 19%, and I have and I am currently on another treatment, almost 8%, and then it just goes down, I haven't and I'm currently not under treatment, over 5%. We still have more and more coming in, and we’re at about two and a half percent, I haven't and I'm currently on another treatment. Our numbers just kind of changed a bit, but it's still, the majority is still with, I have and I'm currently on a BTKi at about 65%. OK, we're going to jump to our next section, which is about, we were getting into this a little, managing side effects, and sticking to your treatment. In this segment, we'll be covering taking your CLL treatment, and how to manage side effects of treatment. Dan just shared how he was managing his, and also we'll be digging into deeper topics like the importance of sticking to your medication plan, tips to remember to take your medication, and most common side effects, why they occur, and how side effects can be managed. Just a note for everyone watching, if you are experiencing any side effects, please, please let your healthcare team know. Because our program is not to take the place of your speaking to your own healthcare professionals. Mark, does everyone who's diagnosed with CLL need to be treated, and how do you know when it's time to be treated or not?

Mark Davis:
So again, around a third of the patients actually never need to be treated, but it's a disease that's a spectrum. You may start off initially, with just the elevated white blood cell count is predominately made up of lymphocytes, which is part of the leukemic process, and it may never move much beyond that. And then there's other patients who may develop other disease related complications such as anemia, or low platelets, or swollen lymph nodes that creates discomfort, or drenching sweats, anything that relates to the disease process and symptoms, those would be indications to initiate treatment. As Dan had mentioned from his situation, particularly if recurrent infections, that would be another reason particularly patients who have low neutrophils, which is one of the frontline of defense in fighting infection, is often low in CLL patients. So there's several parameters that might cause you to pull the trigger, and starting treatment versus just simply watching those patients.

Michelle Nadeem-Baker:
So can the treatment be intermittent for patients depending on blood work results?

Mark Davis:
So ultimately, you may need an interruption because of toxicity reasons, but the data for the benefit from treatment with a BTKi specifically is a continuous treatment. And so how long they remain on it, and things of that nature is really dependent on how the disease is responding, and then toxicity as well aspects, but overall when you're discussing the uses of BTKi, the research that we have available is based on continuous treatment, until progression or unacceptable toxicities. But again, these are issues that you're ultimately going to discuss with your doctor, if there is going to be some changes in your therapy.

Michelle Nadeem-Baker:
What if the disease progresses a little, while you're on treatment and then it plateaus?

Mark Davis:
Yes, so this is not an unusual observation, it's actually fairly common, particularly after patients have been on treatment for a while, I mean that's not a concern. We have to remember CLL is a disease not based on white blood cell count itself. There are complications that can happen as a result of elevated white blood cell count, but historically those issues don't arise until the number is quite high, when we start talking about thickening of the blood, or even increased risk for infections. But by and large when you start to you know make a decision about whether or not to change treatment because of progression and white count, that really doesn't move the needle in terms of wanting to change treatment. It's got to be in association, with some other factor associated with the evidence of disease, whether it be an organ impact on an organ involvement, or risk of infections, develop anemia, low platelets, again the things we discussed previously, so not an unusual thing to observe. It really just means monitored them, maybe monitor them a little bit more closely, but certainly no changes in treatment.

Michelle Nadeem-Baker:
What are some of the risks of not adhering to your medication regimen?

Mark Davis:
Well as intuition would imply, all the data that we have about BTKis, is based on continuous treatment. So when we referenced the benefits of treatment, it’s based on that understanding of continuous treatment until disease progression or unacceptable toxicity. So we don't know, we don't have the answer to that, but what we do know is by continuously remaining on treatment that you could potentially reap these benefits based on the clinical research.

Michelle Nadeem-Baker:
And If someone were to- I think this is if they were to not be on treatment, how to stop their treatment, how quickly could disease progression escalate? If they're not, I believe this is in relation to not sticking with the medication regimen.

Mark Davis:
Yes, you know there's a lot of variables to that, there's not a simple answer to that question. I mean, you know if this person is newly diagnosed on the first line of therapy, they potentially could have longer remissions with the interruption in treatment. But again, that's all dependent on their disease behavior, their genetic mutations, where you could even see relapse or remissions being very short, well it may only be a couple of months and then they progress and have active disease. So, there's a lot of factors that play there can actually impact without problems, but you know it can be it can be quite, quite early on after there's an interruption in treatment, where there's recurrence of – but again, depends on the variables.

Michelle Nadeem-Baker:
So this question is really to each of you, and I'm going to start with you Mark, and then go to you, Dan. Mark, what tips or advice do you give patients to help remind them to take their medications for CLL as directed?

Mark Davis:
So this maybe the easiest question of the evening, so thank you Michelle for this one. This is go and buy one of those fancy pillboxes, that comes with alarm and flashing lights that help remind you to take your medication. I mean they can be quite invaluable to remember to take your medication. You know My patients who do use that method, rave about it, about being able to remember to take it, because it's almost impossible to not recognize that something that sounds like a fire alarm is going off in your house. So I think that's probably one of the most beneficial ways to help create a reminder to take your medication.

Michelle Nadeem-Baker:
Dan what about you? How do you – what are some things, how you remind yourself and what you suggest?

Dan:
I try his way, but I’d forget to put batteries in it. What I did, is I went online and I found the seven day pill boxes with morning and afternoon, and I load up, and I actually have forms, so I load up basically a month’s supply at a time. Get up in the morning, I take my pills, at night, I get ready for bed, well there is my pill box and I take them. Occasionally I've taken a nap during the afternoon, and slept past my time, but woke up oh OK, yes Monday nights are still there, so I need to take those. So but having it right there where I could see it every day in a place that I'm always at, I know I'm there in the morning, but I know I'm going to be the right before bed, so it's in that same place every time.

Michelle Nadeem-Baker:
OK, I may have to take Mark up on his suggestion, because I set my alarm, and the funny thing is if your phone battery goes dead, the alarm doesn't go off. So I guess I would have to stock up on batteries, that's the first hint from Dan, and to get that kind of the pill reminder with all the bells and whistles, one other thing to drive everyone crazy within my house, but if it helps it helps.

Mark Davis:
I think you can even plug into the wall nowadays, so you can avoid that issue.

Michelle Nadeem-Baker:
So before we jump into side effects, I was going to check to see if we have any questions, when I see oh my gosh, time flies when you're having fun. Truly, because we're almost at the end of our program, and I just want to get into another question here Mark, and that is what should I do if I forget to take a dose of my treatment? Let's say, Dan didn't wake up and he took a nap and he slept through the night. Or if my alarm doesn't go off, and hours and hours go by, so what should you do if you forget?

Mark Davis:
So if it's within a three hour time period, you can still stay on schedule, otherwise if it is beyond that amount of time, you would just simply skip the dose and resume the following day.

Michelle Nadeem-Baker:
OK, so when using therapies, side effects can occur, doesn't mean they have to, but what are some of the expectations and mutual understanding that you like to establish with people, Mark, when starting them on a new therapy?

Mark Davis:
Well, I try to remind patients that as we go over adverse reactions, which we do prior to starting treatment, and sitting down with them in the office, that not all these toxicities there are something they're going to experience. And most importantly, I rely on them for to maintaining open communication, because I can't help them unless I know about what's happening, and so most of the toxicities that we see with BTKis are something that can be managed at home and that some of the dose interruptions may be required. So I try to you know prepare them mentally for that, to help resolve particular toxicities, but in general, as I've mentioned before, you know encouraged patients to slow down life when they start a new therapy, delay or vacation or anything of that nature, and scale back and some of those unhealthy foods, cannolis as an example. And then just eventually, progressing their daily routines, based on their tolerance, whether it be in terms of exercise, or you know some unhealthy foods, those things are OK, but when they're initially starting treatment, I try to remind them to start slow.

Michelle Nadeem-Baker:
So what are the some of the most common side effects of BTKi's therapies such as CALQUENCE?

Mark Davis:
So things that we have seen with BTKis, include things like headaches and diarrhea or muscle aches and joint pain, even increased risk for respiratory infections in bruising cells. And In regards to serious side effects, you can see serious infections or bleeding problems, or even decrease in blood counts, and there's even been occurrences of other cancers that have been reported, and heart rhythm problems. But as I mentioned before, please note the two things here, is that while these things are time limited, particularly when it comes to headaches, this is often early on in the disease state and can be easily managed with acetaminophen or even caffeine, and then diarrhea itself sometimes can be early on to a few months out, and can also be easily managed typically with antidiarrheals. But again, these are all things, if they occur you definitely want to maintain communication with your doctor and discuss the proper management.

Michelle Nadeem-Baker:
Dan, does being in treatment and taking your medication as directed, does that affect how you feel about taking control of your disease?

Dan:
Oh tremendously, because like you said you know a lot of people are in that waiting period, and I thought five months to me was a long time. I'm that personality that I want, you got something wrong I want it fixed, I want it taken care of. And when I was put on CALQUENCE because of the complicated infections, I know I have to take them, so I make sure I take them, and I think I missed one dose in 18 months of being on it. And I didn't like, didn't like missing that, but taking, having the CALQUENCE, knowing I've taken it twice a day. Knowing I'm doing something, it's brought by my white cell count down to my new normal which is a lot better than it was several months ago. So.

Michelle Nadeem-Baker:
Thank you, that's great to hear. Mark, how do you counsel patients who are experiencing side effects from their medications?

Mark Davis:
So acetaminophen really becomes a popular option for managing some of these toxicities as you mentioned like headache, it can be quite useful for that, or even muscle aches, in terms of the headaches, so caffeine beverages can be helpful, but again in moderation that's not something you want to become use you know frequently, because again, that can increase heart rate which can be unhealthy for you as well. So if somebody is finding benefit in drinking caffeine beverages, you want to do that in moderation of course, and then in terms of diarrhea, it again tends not to be severe, it often can be managed with dietary changes like a low fiber diet, or even over the counter medications like loperamide.

Michelle Nadeem-Baker:
That's so important to keep those lines of communications open. Mark, how can patients know the difference between symptoms of the disease, and side effects of treatment?

Mark Davis:
You know, it can be complicated, and that's why I think for those patients who are engineers or those who have a diary, they can be some of your best patients because they can make your life very easy as a clinician. Because they often have charts or they’ve written a journal about, you know their life prior to treatment, and so it can be very helpful to know what their symptoms were like even beforehand. Because that's where being able to make those distinctions can help ascertain whether it's a treatment related, or is it related to other health problems? Or in other cases, even disease related, so you really can have three factors when you have to tease out which is which, and so when you're looking at from a treatment issue versus disease related, you really can look at other factors like lymph nodes, and white count to really help elucidate what's the underlying mechanism for it.

Michelle Nadeem-Baker:
And are there any support groups or community resources, someone has been asking this in the audience? Are there any support groups or community resources that exist to help manage side effects or in support of each other?

Mark Davis:
A very popular one is the lymphoma & leukemia society, they are very good to generate large numbers at their meetings, and offer assistance by bringing in key opinion leaders on a disease state, and to educate patients as well as family members, and so of course as a result of that, people network and develop a team of support by local people. And so I find that to be a very popular organization and one that I often recommend to patients that they're seeking out that kind of information or support.

Michelle Nadeem-Baker:
I cannot believe that we've run out of time. There's so much more I want to ask both of you. But Dan, thank you thank you so very much for being here, and sharing your personal story to help inspire other patients.

Dan:
My pleasure, I just want, the more you share it, the more people know.

Michelle Nadeem-Baker:
And Mark, thank you for your insights and your knowledge to help educate CLL patients.

Mark Davis:
Thank you for having me.

Michelle Nadeem-Baker:
And thank you, to all of our viewers for welcoming us into your homes and offices today, the team here hopes to see you all again soon. And please continue watching for another minute or so for some important safety information about CALQUENCE. For today, this is Michelle Nadeem-Baker. Have a great day.

Important Safety Information About CALQUENCE^® (acalabrutinib)

What is CALQUENCE?
CALQUENCE is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
It is not known if CALQUENCE is safe and effective in children.

Before taking CALQUENCE, tell your healthcare provider about all of your medical conditions, including if you:

• have had recent surgery or plan to have surgery. Your healthcare provider may stop CALQUENCE for any planned medical, surgical, or dental procedure.
• have bleeding problems.
• have or had heart rhythm problems.
• have an infection.
• have or had liver problems, including hepatitis B virus (HBV) infection.
• are pregnant or plan to become pregnant. CALQUENCE may harm your unborn baby and cause problems during childbirth (dystocia).
  
  
  • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with CALQUENCE
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment with CALQUENCE and for 1 week after the last dose of CALQUENCE
• are breastfeeding or plan to breastfeed. It is not known if CALQUENCE passes into your breast milk. Do not breastfeed during treatment with CALQUENCE and for 2 weeks after your last dose of CALQUENCE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements. Taking CALQUENCE with certain other medications may affect how CALQUENCE works and can cause side effects. Especially tell your healthcare provider if you take a blood thinner medicine.

How should I take CALQUENCE?

• Take CALQUENCE exactly as your healthcare provider tells you to take it.
• Do not change your dose or stop taking CALQUENCE unless your healthcare provider tells you to.
• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking CALQUENCE if you develop certain side effects.
• Take CALQUENCE 2 times a day (about 12 hours apart).
• Take CALQUENCE with or without food.
• Swallow CALQUENCE tablets whole with a glass of water. Do not chew, crush, dissolve, or cut tablets.
• If you miss a dose of CALQUENCE, take it as soon as you remember. If it is more than 3 hours past your usual dosing time, skip the missed dose and take your next dose of CALQUENCE at your regularly scheduled time. Do not take an extra dose to make up for a missed dose.

What are the possible side effects of CALQUENCE? CALQUENCE may cause serious side effects, including:

• Serious infections can happen during treatment with CALQUENCE and may lead to death. Your healthcare provider may prescribe certain medicines if you have an increased risk of getting infections. Tell your healthcare provider right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms.
• Bleeding problems (hemorrhage) can happen during treatment with CALQUENCE and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or you cannot control, vomit blood or vomit that looks like coffee grounds, cough up blood or blood clots, dizziness, weakness, confusion, changes in your speech, headache that lasts a long time, or bruising or red or purple skin marks.
• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with CALQUENCE, but can also be severe. Your healthcare provider should do blood tests to check your blood counts regularly during treatment with CALQUENCE.
• Second primary cancers. New cancers have happened in people during treatment with CALQUENCE, including cancers of the skin or other organs. Your healthcare provider will check you for skin cancers during treatment with CALQUENCE. Use sun protection when you are outside in sunlight.
• Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with CALQUENCE. Tell your healthcare provider if you have any of the following signs or symptoms: fast or irregular heartbeat, dizziness, feeling faint, chest discomfort, or shortness of breath.

The most common side effects of CALQUENCE include headache, diarrhea, muscle and joint pain, upper respiratory tract infection, and bruising. These are not all the possible side effects of CALQUENCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information.
US-86904 Last Updated 4/24