Tag Archive for: chemoimmunotherapy

How Do Genetic Mutations Impact a CLL Patient’s Prognosis?

How Do Genetic Mutations Impact a CLL Patient’s Prognosis? from Patient Empowerment Network on Vimeo.

What is the best approach for chronic lymphocytic leukemia (CLL) patients with genetic mutations? CLL expert Dr. Seema Bhat shares how mutations impact prognosis and treatment.

Seema Bhat, MD is a hematologist at The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Bhat.

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Transcript:

Katherine:

Okay, that’s great. Here’s one from Phil, “How do mutations affect longevity when surviving CLL? What new treatments help with P53 mutation?”  

Dr. Bhat:

So, there are certain prognostic markers for CLL, meaning certain tests that can tell us how a particular patient is expected to do. Some of these tests detect presence or absence of mutations in certain genes. For example, the IGHV gene can be mutated or unmutated. 

In patients with mutated IGHV, they do well, and patients with unmutated IGHV tend to have a more aggressive disease and may require treatment sooner. Similarly, TP53 mutations also tend to require treatment sooner, and more of these mutations do not respond well to conventional chemotherapy. However, targeted therapy has changed the outlook for these mutations, and it works very well for both these mutations. 

Managing CLL Symptoms and Treatment Side Effects

Managing CLL Symptoms and Treatment Side Effects from Patient Empowerment Network on Vimeo.

Chronic lymphocytic leukemia (CLL) expert Dr. Seema Bhat reviews common CLL symptoms and treatment side effects and approaches for managing them. Dr. Bhat stresses the importance of sharing any issues they may be having with their healthcare teams.

Seema Bhat, MD is a hematologist at The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Bhat.

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Transcript:

Katherine:

Can you please talk about common side effects of CLL – which, of course, we’ve covered already, but both the ones from the disease itself and then ones related to treatment, and what can be done about these? 

Dr. Bhat:

So, disease-related side effects, or we call them disease-related symptoms, include fatigue as a common symptom. Unintentional weight loss can happen. Fevers, chills, or drenching night sweats can happen. We call them, “B symptoms.” Spleen can enlarge, and the enlargement can cause belly pain or feeling of fullness quickly after a meal since spleen is close to our stomach, and as it enlarges, it limits the space stomach can take up in the belly. Lymph nodes can enlarge and can get uncomfortable. So, if any of these symptoms happen, then we have to treat the CLL, and once we start treating the CLL these symptoms should go away. 

As far as treatment-related side effects are concerned, for example, BTK inhibitors are associated with a certain set of side effects. For example, patients can have muscle cramping, muscle pain, joint pain. Patients can have diarrhea. Some of the side effects that we worry about is change in heart rhythm, for example, atrial fibrillation. We talked about that, or increased risk of bleeding.  

Those are some of the side effects we worry about, and if those were to develop, then, of course – for example, a patient has atrial fibrillation, and if it’s symptomatic, we hold the medication. We take care of the atrial fibrillation, usually in collaboration with cardiologists, and once that’s under control, then we have to decide what to do with the treatment. If the atrial fibrillation is under control, we can re-initiate the treatment, or we can go to one of the next-generation BTK inhibitors – the acalabrutinib (Calquence), the pirtobrutinib (LOXO-305), which have less of those side effects. 

Bleeding tends to be a concern, but anything that reduces the risk of bleeding like other medications, aspirin, clopidogrel (Plavix), other blood thinners, we can avoid them, monitor these patients very closely for any of these side effects, so that’s critical. With venetoclax, it’s usually very well-controlled. It’s the initial part of treatment that tends to be a little bit intensive because of the specific side effect called, “tumor lysis syndrome,” which means that the drug works very quickly, and cells die off quickly, they can release stuff in the blood, and things can collect in the blood. 

Uric acid can go up, electrolytes can be up, any number can go up. So, we are aware of this side effect, and we actually pre-emptively have things in place that can prevent this from happening, or if it happens, we manage it right away. For example, venetoclax has a specific dose initiation. For example, it’s called, “dose ramp-up.” We start it at a lower dose, 20 milligrams, for one week. Escalate it to 50 the next week, 100 the third week, 200 fourth week, and 400 the last week, which is the standard dose. They continue on 400 from there onward. 

And even with the slow dose escalation, in the early couple of weeks, we monitor them very closely. Once we initiate a dose, we bring them back to the clinic to recheck their blood work to see if there are any changes. If any changes have happened, we hydrate them, initiate medication for their tumor lysis syndrome. 

If the risk of tumor lysis is very high, then we monitor then admit them to the hospital. Otherwise, long-term side effects of venetoclax, what we have noticed mostly is gastritis, most side effects – mostly diarrhea. But that’s usually well-controlled. We can manage it well with supportive care. 

Emerging CLL Treatment Approaches

Emerging CLL Treatment Approaches from Patient Empowerment Network on Vimeo.

Are there emerging CLL treatments that are showing promise? Dr. Seema Bhat provides an overview of ongoing research and discusses when CLL patients should consider clinical trials. 

Dr. Seema Bhat is a hematologist at The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Bhat here.

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Transcript:

Katherine:  

Dr. Bhat, where do clinical trials fit into treatment? 

Dr. Bhat:  

So, clinical trials play a very important role to advance treatments. Clinical trials for CLL are done to test new treatments, new combinations of treatments, compare different treatments to each other. The goal of these clinical trials is to continue to do better than what we currently have available. This is how treatments improve. Despite all the advancements that we have had in CLL, in the recent years, it continues to be an incurable disease, even today. Our goal as researchers is never to stop until we get to that cure, and clinical trial is that pathway to that cure.

Katherine:

Are there emerging therapies that are showing promise? 

Dr. Bhat:

Yes, of course. There are a number of emerging therapies that are showing promise. So, we all know about ibrutinib and other BTK inhibitors. These work very well, but sometimes the disease can get resistant to these medications, meaning that it stops responding to these treatments. We are excited about this new kind of BTK inhibitor called, “pirtobrutinib,” which has shown great promise in these resistance cases, and we are hopeful that it’ll be approved soon. 

Katherine:

Are there other options that patients have? 

Dr. Bhat:

So, we all hear about what is called, “chimeric antigen receptor T-cell therapy,” or CAR-T therapy. This is studied under clinical investigation for CLL and looks very promising. The therapy uses the person’s own immune cell called, “T cell” to identify and attack cancer cells. 

T cells are taken from the patient’s blood and sent to a specific lab. There, the cells are modified so that they can better find and attack cancer cells. These modified T cells are then re-injected back into the patient to find and fight that cancer, to eradicate the disease. So, this looks very promising.  

How Are Targeted CLL Treatments Administered?

How Are Targeted CLL Treatments Administered? from Patient Empowerment Network on Vimeo.

Chronic lymphocytic leukemia (CLL) expert Dr. Seema Bhat explains how self-administered oral treatments work for CLL patients and what potential side effects doctors are watching out for. 

Dr. Seema Bhat is a hematologist at The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Bhat here.

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Transcript:

Katherine:

How are targeted therapies administered? 

Dr. Bhat:

So, most of the targeted therapies that we have, we are happy to say that these are oral agents. The BTK inhibitors, the three that we have available, are oral agents. Ibrutinib is taken once a day, zanubrutinib and acalabrutinib are twice a day. Venetoclax, similarly, is an oral agent and is taken once a day. Monoclonal antibodies are also considered targeted agents. These are given as infusions in the clinic or in the clinician’s office.  

Katherine:

The oral medications, patients take that at home? They don’t have to go into the hospital?  

Dr. Bhat:

They do not have to go into the hospital. However, venetoclax is associated with a specific side effect called, “tumor lysis syndrome,” where this medication works so well that initially the cells with die off quickly and then things can collect in the blood.  

For example, uric acid can go up, electrolytes can be up, any number can go up. So, we monitor what those initial weeks of starting venetoclax, we monitor patients very closely. We have them come back and forth to the clinic for monitoring, bloodwork, maybe hydration. And sometimes, if we think they’re at a very high risk for this tumor lysis syndrome, we admit them to the hospital.  

After we cross that, those are administered at home. They can take these at home. 

Understanding CLL Treatment Classes

Understanding CLL Treatment Classes from Patient Empowerment Network on Vimeo.

Chronic lymphocytic leukemia (CLL) expert Dr. Seema Bhat explains the different treatment classes available for CLL patients and how the standard of care has evolved.

Dr. Seema Bhat is a hematologist at The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Bhat here.

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Transcript:

Katherine Banwell:

Dr. Bhat, when it’s time to start therapy, what types of treatments are available for CLL patients? 

Dr. Bhat:

So, when we think about treatment for cancer, we think about chemotherapy – the conventional chemotherapy that’s associated with side effects like hair loss, nausea, or vomiting. I’m very happy to say that conventional chemotherapy is no longer the standard of care for patients with CLL. Patients who need treatment for CLL are nowadays treated with what are called, “targeted agents.” 

And we have, in general, two different classes of targeted agents that have been approved for treatment for CLL. We have the BTK inhibitors, Bruton’s tyrosine kinase inhibitors, of which we have three. We have ibrutinib, we have acalabrutinib, and we have zanubrutinib. Then we have BCL-2 inhibitors, of which we currently have one approved, of which is called venetoclax. These treatments can be combined with monoclonal antibodies, which are directed towards the antigen called CD20. For example, rituximab or obinutuzumab. 

Typically, venetoclax is combined with monoclonal antibody as a time-limited therapy. BTK inhibitors usually are not combined with monoclonal antibody. 

Katherine:

What about stem cell transplant, does that fit in there? 

Dr. Bhat:

So, stem cell transplant still has a role for treatment of patients with CLL, but it has moved down the line with such highly effective and well-tolerated oral agents available. 

But, for refractory patients – what we call dual-refractory patients, we definitely are, especially in high – patients who have higher risk features, we do refer them to stem cell transplant. 

Katherine:

And what is a dual-refractory patient, exactly? 

Dr. Bhat:

Dual-refractory patients mean patients who have had a BTK inhibitor, be it ibrutinib, acalabrutinib, or zanubrutinib, and the disease has progressed on that. And then we give them venetoclax, which is a BCL-2 inhibitor. So, these are the two classes of targeted agents that we have available. If they have received ibrutinib, acalabrutinib, or zanubrutinib, and after that, a venetoclax, or venetoclax followed by a BTK inhibitor, and the disease has progressed on both. These patients are called dual-refractory, and currently they tend to be very resistant to whatever treatments we have available. And we looked at other modalities of treatment, be it clinical trials or stem cell transplants for that.  

Should Prostate Cancer Patients Consider a Treatment in Clinical Trials?

Should Prostate Cancer Patients Consider a Treatment in Clinical Trials? from Patient Empowerment Network on Vimeo.

Prostate cancer expert Dr. Andrew Armstrong explains how prostate cancer clinical trials work and discusses why patients should feel confident exploring this option at any stage of their cancer journey.

Dr. Andrew J. Armstrong is a medical oncologist and director of clinical research at the Duke Cancer Institute’s Center for Prostate and Urologic Cancers. For more information on Dr. Armstrong here.

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Transcript:

Katherine Banwell:

At what point should a prostate cancer patient consider participating in a clinical trial? 

Dr. Armstrong:

Sure. If you look at the National Comprehensive Cancer Network, NCCN guidelines, you’ll see that clinical trials should be discussed along all parts of the journey. 

And that’s because clinical trials often can change how we think about cancer, how we treat cancer, can improve cure rates, can improve survival. Most of our drugs and treatments that have been successful in all cancer have been the result of clinical trials. 

And it’s not always appropriate, though. We have very many treatments that can cure patients, and we don’t want to interfere with that, but sometimes a clinical trial can layer on top of that cure rate. 

But many patients, their cancer becomes resistant to proven therapies. That’s certainly an area where clinical trials can make a big difference, either to put off chemotherapy or more toxic therapies, or in patients who have exhausted proven therapies. That’s certainly appropriate. 

But sometimes clinical trials do not involve placebos. They involve combination therapies, they involve layering on top several approaches to try to improve the survival on top of standard of care.  

And so as a director of a research program, we have all sorts of trials. They come in Phase I, Phase II, Phase III. Really only the Phase IIIs involve placebo controlled or controlled trials. Phase II tend to be early studies, where everybody gets a therapy and it’s preliminary to determine efficacy. Phase I is really trying to determine the safety and dosing of an experimental drug. But patients can benefit across the spectrum. 

So, it’s important, particularly if you have advanced disease, to go to a site, like a comprehensive cancer center, for a second opinion to see if there is alternatives to what you might get in the community.  

Katherine Banwell:

Yes. What would you say to someone who might be hesitant to participate in a trial? 

Dr. Armstrong:

Participation in a trial involves shared decision-making, just like being diagnosed, embarking on initial treatment, even embarking on standard of care treatment. Everything is shared decision-making in terms of risks and benefits.  

Sometimes a trial is not in a patient’s best interest, and it’s important for a physician to be upright about that and up front about the risks of a trial. 

I think when patients have exhausted proven therapies, it’s quite appropriate to talk about therapies that might be in the research pipeline that are showing some promise, that have demonstrated at least success in the laboratory or in small numbers of patients coming before.  

For example, in 2022, a brand-new drug just got approved called Pluvicto, or PSMA lutetium. This is a new smart bomb for prostate cancer. Just last year it was a research drug, but this year it’s successful and being used in the clinic. All those hormone drugs I mentioned earlier, those were research drugs five years ago. So, we don’t make advanced, we don’t extend lives without participating in research. We’re not happy with the way things are, we want them to be better. 

And the only way to make them better is by studying them. And not all of these trials are successful, unfortunately, but many are, and that’s why we are seeing men live longer and have better survivorship nowadays. 

An Expert’s Perspective on Emerging Prostate Cancer Research

An Expert’s Perspective on Emerging Prostate Cancer Research from Patient Empowerment Network on Vimeo.

What do prostate cancer patients need to know about emerging research? Dr. Andrew Armstrong discusses developing treatments and their potential impact on prostate cancer care.

Dr. Andrew J. Armstrong is a medical oncologist and director of clinical research at the Duke Cancer Institute’s Center for Prostate and Urologic Cancers. For more information on Dr. Armstrong here.

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Transcript:

Katherine:

Are there any recent developments in treatment and research that patients should know about? 

Dr. Armstrong:

Absolutely. I would say the number one research advance has been the use of these really strong hormonal therapies in earlier and earlier disease setting. So, you may have heard of drugs like Zytiga or abiraterone, or Xtandi or enzalutamide, apalutamide or Errleada, or derolutamide or Nubeqa. Those are mouthfuls. Those are very potent hormonal pills that when used in men with advanced disease improves survival. 

And the data has supported the fact that the early use of those agents extends life even more than waiting until hormone resistance develops.  

So, if you are unlucky enough to have metastatic disease and you’re in need of hormonal therapy, giving injections that lower testosterone, which is the fuel for most prostate cancers, and then blocking testosterone with some of these newer pills extends life by years, not months. And it does so with pretty good quality of life over time.  

Of course, there are negative consequences of having no testosterone, and it’s important as part of shared decision-making to review those side effects and how that can impact quality of life negatively while extending survival.  

So, that’s a major advance. Another major advance is genetic testing and personalized medicine. In men with advanced prostate cancer, it’s now uniformly recommended that all men get hereditary testing to figure out if they inherited prostate cancer risk genes.  

These are genes such as the BRCA I and II genes, BRCA II being the most common. And these are not just breast or ovarian cancer genes. It’s important for men to realize that you can inherit these from a mother or a father, that they can create risks for multiple cancers, not just female cancers, but prostate cancer in particular. 

And now we have guided therapies, targeted therapies that can improve survival in men with these certain mutations, and if you are found to have those mutations, your family members could be tested so that they could be screened, and cancer can be picked up earlier, and perhaps they could be cured rather than suffering the fate of a more advanced diagnosis. So, really important both for yourself and for family members. 

So, those are two major advances. A third one is imaging.  

Imaging keeps getting better and better. We used to just do CAT scans, bone scans, very insensitive tests that in men with advanced disease have a hard time seeing prostate cancer, even when it’s spread. But with the advent of new technologies, like PSMA PET scan, that got approved last year. So, very new technologies. That’s transforming the way we visualize where cancer may be hiding, and for men particularly that have high-risk disease or recurrent disease or even resistant disease, we’re using those scans to guide therapy. 

An Overview of Prostate Cancer Treatment Approaches

An Overview of Prostate Cancer Treatment Approaches from Patient Empowerment Network on Vimeo.

How is prostate cancer currently treated? Dr. Andrew Armstrong provides an overview of treatment options for prostate cancer patients across various stages of the disease.

Dr. Andrew J. Armstrong is a medical oncologist and director of clinical research at the Duke Cancer Institute’s Center for Prostate and Urologic Cancers. For more information on Dr. Armstrong here.

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Transcript:

Katherine:

What are the treatment options that are currently available for prostate cancer patients? 

Dr. Armstrong:

It’s a really important question, and I would say it depends. In early disease, when cancer is picked up early, many patients are cured. Prostate cancer is the number one survived cancer in the United States. It’s important to realize that and kind of take a deep breath and realize that most patients beat prostate cancer. Only about one out of six men will suffer a relapse or develop metastatic disease or Stage IV disease that requires more of a lifelong journey of therapy. 

So, most men come into this because they’ve been screened by their primary care doctor. They had a high PSA, they underwent a biopsy, they were found to have cancer.  

And the first decision, particularly for example at our Duke multidisciplinary clinic, the first decision that we always share with the patient, and as part of shared decision-making, is we give information about prognosis and risk using the PSA level, the biopsy information, staging information if imaging is done.  

And then giving a category or a risk group to that patient can help them decide what are the options that are nationally recommended, internationally recommended by evidence-based guidelines. The most important decision is whether that prostate cancer needs treatment right now at all, and the initial observation or active surveillance is a very valuable “first do no harm” approach for men with very low risk or low risk types of prostate cancer. With a low-grade cancer, low PSA, low stage, and that’s about a third of all patients.  

That’s a huge number of men are told they have cancer, but they actually don’t need initial treatment. 

And they need to be explained to, why we’re not going to treat that cancer, why it’s so safe, and why mortality is not high in that patient population when we don’t treat it, and how we do active surveillance. For example, imaging with MRI, repeat biopsies. And a lot of patients do appreciate that because they’re not undergoing surgery or radiation and they’re not being harmed by those treatments. That would be called overtreatment. That’s not for everybody, though. 

So, just like prostate cancer comes in different flavors, treatments come in different flavors. So, there’s things where the Gleason score is higher, the stage may be higher, the PSA is higher, and the risk to the patient is higher. And when we get into that more intermediate- and high-risk situation, treatment is going to be necessary. But then we’ll have a menu of treatment options that is important to talk through. Typically surgery, radiation, sometimes alternatives to that. 

Sometimes combinations with hormonal therapy, which we call systemic therapy. The drugs that work throughout the body. 

Katherine Banwell:

What about for patients who have advanced disease? 

Dr. Armstrong:

The word “advanced” can mean different things to different people. Advanced can mean metastatic disease. It can mean disease that’s not curable. But advanced can also mean that it’s high risk. That the disease is still confined to the prostate, but it’s aggressive, and that if it’s not handled quickly with a multidisciplinary approach, for example, it has a high risk of occurrence.  

So, advanced disease can mean aggressive, in need of treatment. Sometimes it can be cured if it’s confined to the prostate. Sometimes it requires more than just one treatment modality, such as surgery followed by radiation, or radiation plus some of the newer hormonal therapies.  

For men with stage IV disease, that means disease that has left the prostate and gone to distant sites, we have very effective therapies that can still control this type of advanced disease for many, many years, so it is important to realize how far we’ve come with all of our therapies and to reassure the patient and their family about the good prognosis, even in the worst-case scenario, for many patients. 

Prostate Cancer Shared Decision-Making: How Does It Work?

Prostate Cancer Shared Decision-Making: How Does It Work? from Patient Empowerment Network on Vimeo.

Prostate cancer researcher Dr. Andrew Armstrong describes the benefits of the shared decision-making process and encourages patients to take an active role in their care.

Dr. Andrew J. Armstrong is a medical oncologist and director of clinical research at the Duke Cancer Institute’s Center for Prostate and Urologic Cancers. For more information on Dr. Armstrong here.

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Transcript:

Katherine:

Patients may have heard the term “shared decision-making” Let’s go into – let’s define it, though. What is it, and how does it work? 

Dr. Armstrong:

Sure. So, if you imagine you’re a patient faced with the daunting task of a new cancer diagnosis and trying to navigate decision-making around treatment, or whether you need a certain test, and those tests or treatments have harms and they have benefits, shared decision-making is really the process of communication. You know, open, transparent communication between the doctor or provider and that patient and their family and supportive spouse and others, significant others, so that everybody has complete information around the risks and benefits of a certain treatment course or management course.  

In prostate cancer, this would mean for a newly diagnosed patient, commonly first giving information about what the risks of their cancer might be, but then what the risks and benefits of various treatment algorithms might be, and explaining in ways that a patient can understand those different journeys.  

Dr. Armstrong:

And ultimately the patient makes a shared decision-making with the doctor that’s in their best interest. 

Katherine Banwell:

In your view, what role do patients have in care decisions and why should they feel empowered to speak up and be a partner in their care? 

Dr. Armstrong:

Sure. Just like there’s many different types of doctors, there’s many different types of patients, and you have some patients that have PhDs, you have some patients that are not even sure what cancer is, and it’s really important to empower every patient to understand at a level that will help them make a decision. And some patients wish to have those decisions made for them. I hear that a lot. Some patients really just want to ingest the information, not make a rash decision 

Maybe get three or four second opinions, travel around to really get the right decision. And sometimes it can take a very long time. But every patient has a different journey, and it’s important for the provider, the doctor or the nurse practitioner or the surgeon, to really understand that patient and their values to help them arrive at the decision for themselves. Because sometimes treatment decisions may have equal efficacy but different side effects.  

For example, in prostate cancer, the most common decision is between active surveillance or a radical prostatectomy or radiation of different forms, or the robot versus the open procedure, or intensity modulated radiation or brachytherapy. And these are complex decisions, and I’ve had patients go for months without making decisions. And the shared decision-making approach really can help patients make a decision as quickly as possible. 

So that they can move on and either be cured from their cancer or make the best treatment decision. 

Katherine Banwell:

Dr. Armstrong, why is it so important that patients tell their doctor about any symptoms they’re experiencing? 

Dr. Armstrong:

Certainly symptoms may or may not be related to the prostate cancer, and doctors are well-trained to sift through all of that. You know, back pain could be from a herniated disc or arthritis, but it could be a sign of metastatic disease. Weight loss could be a sign of other metabolic problems, but it can also be a sign of really advanced prostate cancer. Urinary symptoms could just be a sign of a big prostate, may have nothing to do with the cancer, or it could be a big tumor that’s blocking off your bladder.  

So, being transparent and open and just describing what symptoms and letting that physician sort through that with you to help understand what symptoms may or may not be related to the cancer, that’s really important.  

Thriving With Lung Cancer: What You Should Know About Care and Treatment

Thriving With Lung Cancer: What You Should Know About Care and Treatment from Patient Empowerment Network on Vimeo.

What does it mean to thrive with lung cancer? Dr. Jyoti Patel discusses care and treatment goals, reviews current and emerging treatment options, and shares advice for living well and thriving with lung cancer.

Jyoti Patel, MD, is Medical Director of Thoracic Oncology and Assistant Director for Clinical Research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. She is also Associate Vice-Chair for Clinical Research and a Professor in the Division of Hematology and Oncology at Northwestern University Feinberg School of Medicine. Dr. Patel is a leader in thoracic oncology, focusing her efforts on the development and evaluation of novel molecular markers and therapeutics in patients battling non-small cell lung cancer. Learn more about Dr. Patel.

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Transcript:

Katherine:

Hello and welcome. I’m Katherine Banwell, your host for today’s program. Today’s webinar focuses on how patients can aim to live well and thrive with lung cancer. We’re going to discuss treatment goals and the importance of patients playing an active role in their care. Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you. Let’s meet our guest today. Joining me is Dr. Jyoti Patel. Dr. Patel, welcome. Would you please introduce yourself? 

Dr. Patel:

Hi. Thanks so much. My name is Jyoti Patel. I’m a professor in medicine at the Northwestern University Lurie Cancer Center and I’m the medical director of thoracic oncology and the vice chair of clinical research for the Department of Medicine.   

Katherine:

Well, thank you so much for taking the time out of your busy schedule to be with us today. Since this webinar is part of PEN’s Thrive series, I’d like to ask you from your clinical experience and perspective, what do you think it means to thrive with lung cancer? 

Dr. Patel:

I think our definition of that has evolved considerably over the past two decades. The advancements in the lab and in clinical trials have translated to vastly different outcomes from our patients than I ever imagined two decades ago. So, certainly we see a large number of lung cancer survivors, people who have had early disease that has been eradicated and they are living after their lung cancer diagnosis with sequela treatment. And we see an even larger number of patients who are in active treatment, those with more advanced disease.  

When we can minimize the toxicities of active treatment and really focus on quality of life, survival outcomes, then I think we’re really talking about thriving with lung cancer.  

Katherine:

Mm-hmm. Well, thank you for your insights. Of course, an appropriate treatment course is part of thriving. Before we get into treatment though I’d like you to walk us through the types of lung cancer if you would.  

Dr. Patel:

Sure. So, over 200,000 Americans will be diagnosed with lung cancer this year. And we break lung cancer down into two major diagnoses. So, the more common one is non-small cell lung cancer. The less common one, which accounts for 13 percent of diagnoses, is small cell lung cancer. Those are descriptive terms but don’t really go beyond that. It’s, essentially, what do the cells look like under the microscope? We know that these two behave very differently. Small cell lung cancer tends to be a cancer which can move a little bit more quickly. It tends to be more aggressive.  

We have certain treatment regimens that are appropriate. Non-small cell lung cancer is one which we further subdivide into adenocarcinoma, squamous cell cancer, or large neuroendocrine cancer. And we treat those a little bit more similarly with different local therapies and different systemic agents.  

Katherine:

Okay. How would you define treatment goals for people with lung cancer? 

Dr. Patel:

So, we hope that the number of patients that we find with earlier stage disease increases as we now at least have evidence to do screening for people who are at high risk. So, for patients with early-stage disease, which we really define as stage I and stage II – so, cancer that’s limited to the lobe of a lung – our best treatment options are surgery and sometimes radiation in appropriate patients. And for those patients, we think that treatment is discreet and curative.  

For the third of patients who present with stage III disease or locally-advanced disease – and here we’ve seen significant advancements with the integration of immunotherapies, improvements in surgery, and radiation. Their treatment course tends to be a bit longer but, again, our intent is curative. So, the cancer has discreet therapy, we complete it, and then patients are in survivorship mode, in which we’re following them periodically.  

Unfortunately, still, a large number of patients present with more advanced disease. Stage IV disease or metastatic disease. Those are all sort of interchangeable. And treatment for those patients is about controlling the cancer. Often, you’ll hear the word “palliative.” So, the goal of treatment is to control the cancer, to decrease the burden of cancer, and to help patients live longer. Certainly, again, with our advancements of immunotherapies and targeted therapies, patients are living longer than ever before.  

And in some patients, it really becomes a chronic disease in which checkups can be periodically done or patients can be monitored off of treatment for long periods.  

Katherine:

Mm-hmm. Do treatment goals vary by lung cancer type?   

Dr. Patel:

So, the goal of cancer treatment is always to make patients live longer and to make sure that that quality of that survival is the best it can be. So, that’s always our overlying goal. For patients with early disease or early stage – stage I to III non-small cell lung cancer – is something we call limited stage. Small cell lung cancer, the intent is, again, curative. For patients with more advanced disease, we tend to think about the cancer as something that we control, that we see a good response to hopefully, and watch patients over time.  

There are a subset of patients with more advanced disease that have really significantly better outcomes. We call these sort of patients “super survivors.” And we hope to make that number greater as we incorporate new science into their treatment paradigms. 

Katherine:

What is the role of patients in making treatment decisions? 

Dr. Patel:

I think all treatment decisions are patient-focused.  

So, again, understanding someone’s goals of treatment are important. But understanding the context in which the cancer is happening. So, the cancer is part of a patient that has a really full life. Family. Work. Other medical comorbidities. Things that they prioritize. And so, having open discussion about the likelihood of achieving curative therapy or what the risks and benefit ratios are in palliative therapy are absolutely essential to having transparent and honest communication with patients. But it is also optimistic and compassionate.  

Katherine:

You mentioned some treatment approaches a few moments ago, but I’d like to walk through the types of treatments that are used today to treat lung cancer. Let’s start with surgery.  

Dr. Patel:

We think about local therapies as things like surgery. So, surgery has evolved, again, significantly.  

Now with videoscopic approaches and robotic approaches we’re able to remove a tumor either with a larger incision – more traditional incision – or some of the smaller incisions. And the goal of doing the surgery is often to want to diagnosis the cancer. So, to do a biopsy. But when it’s used in terms of cancer treatment, the goal of surgery is to get a complete resection.  

So, we only do surgery if we can remove a tumor and mass with clear margins and not compromise other vital functions. Sometimes we’ll, again, do a more palliative surgery if we need to, if there’s a problem that’s causing significant symptoms. But in that case, the surgery is generally not improving the survival of the patient. It’s trying to palliate symptoms.  

Katherine:

Mm-hmm. What about other types of therapy? 

Dr. Patel:

Other localized therapies predominately include radiation therapy. And, again, radiation has significantly changed over the past years. We’ve been able to incorporate new technologies, truly target tumors, and to minimize toxicity, with two kinds of radiation. Photon therapy, which is more traditional therapy, and proton therapy, which we see administered in a very small subset of patients.  

Primarily, photon therapy, we treat tumors, sometimes over many weeks, to decrease toxicity versus sometimes we give one or two doses of radiation in a high-dose fashion that’s very targeted.  So, often for the chest in stage III cancer, for example, a patient may end up getting six weeks of radiation Monday to Friday with chemotherapy.  

And that, again, is curative intent. It’s to ablate the cancer and to provide the best local treatment. 

Often, we’ll do something called stereotactic radiation therapy. And that is if there is a discreet mass, often that could be if the cancer is metastasized to the brain, we can give very targeted radiation there, again, to ablate the tumor.  

In patients who may not be candidates for surgery because lung surgery is a big deal, right? Removing part of your lung can lead to morbidity in someone with other medical issues. Sometimes we can use pinpoint radiation in the lung and see really good outcomes for patients with good disease control.  

Katherine:

You’re also using chemotherapy still, I would imagine? 

Dr. Patel:

The other part of treatment for lung cancer are systemic therapies. And there a number of systemic therapies. So, I sort of break it down into three major parts. One is chemotherapy. Chemotherapy remains a backbone of treatment for lung cancer.  

It’s a lot more tolerable and much more personalized than ever before. Often chemotherapy can be given to patients without significant toxicities. Not everyone loses their hair. Not everyone has neuropathy. Often, I have patients who are working and taking care of their families on chemotherapy. So, it is a good and very reasonable option. But two things that we’re really most excited about – and I think have changed the field most dramatically – are targeted therapies and immunotherapies.   

Katherine:

Mm-hmm.  

Dr. Patel:

These targeted therapies are rationally-designed molecules or antibodies that block proteins that may be overexpressed in lung cancer.  

So, some of them are the byproducts of mutated genes that are upregulated and causing a cancer to grow. Others may just be that we’re seeing a high level of protein expression on the cancer cell. But these targeted therapies preferentially bind to their targets that are present on cancer cells and not so much normal cells. Because of this, often there is less toxicity to normal cells. But because we can find specific targets – and the best targets are ones that are only expressed on cancer cells.  

But because we can find a direct target, sometimes we’re able to design drugs that may have significant efficacy. So, 80 percent or 90 percent of people who have a particular target and are able to get a targeted therapy may have a response to treatment. Targeted therapy can be great for some patients. And patients may be on oral medications, sometimes for years, to control their cancer.  

The other real game-changer in the past decade for lung cancer has been the integration of immunotherapy. Approved immunotherapies currently are primarily antibodies that we give to patients. And these antibodies block proteins that are expressed by cancer cells which downregulate the immune system. By shutting down these proteins, your own immune system is able to kind of re-see the cancer cell and kill it.  

And so, now we know in patients with more advanced disease that immunotherapy or immunotherapy with chemotherapy leads to better outcomes than we’ve ever seen. We also use immunotherapy for patients with stage III lung cancer after chemotherapy and radiation. And this improves their survival significantly.  

And most recently, we’ve now integrated immunotherapy after surgery for patients with early-staged disease to decrease their chance of relapse from cancer.   

Katherine:

Mm-hmm. That’s excellent. Are some of the targeted therapies taken orally? And if so, are patients in charge of administering them, their own therapies?  

Dr. Patel:

Many of the targeted therapies that are most effective are taken orally. And so, patients take them at home. Often, they’ll have once-daily dosing or twice-daily dosing. The number of pills often depends on the formulation of the drug. So, patients are responsible, I guess, for taking them. That comes with a lot. So, we need to think about, how do we help with adherence? How do we manage toxicity? How are the drugs affected by whether you eat or take the drug on an empty stomach? There are a lot of nuances there.  

Generally, we like to give a lot of information to our patients. So, often, patients will meet with a pharmacist when they’re first prescribed the medication. They’ll meet with our nurses to go over how to take those and how to manage any side effects if they have them or what to do if there are any adverse reactions.  

Katherine:

Mm-hmm. Well, what would happen if a patient forgets to take one of their medications? Does that impact its effectiveness? And then should they get in touch with their healthcare team to let them know? 

Dr. Patel:

So, generally, we like patients to take the medication almost at the same time every day. We sort of think about half-life. So, we want to make sure that that serum level stays appropriate. If someone misses a dose – which happens – and, again the best-case scenario is that people are on these pills for years, right? For several years. So, of course, you’re going to miss a dose.  If that happens, we generally tell people never to double up.  

To let your team know. Often you can just skip that dose and take it in the evening or the next day.  

Katherine:

I’d like to talk about emerging treatments. Are there any therapies in development that patients should know about that you’re excited about? 

Dr. Patel:

There are a number of things that are happening right now in the landscape that is really, again, giving us great optimism about how to move forward. So, areas of active research really concentrate on identification of new targets so that we have identified oncogenes that we’re trying to treat effectively. So, those are things like EGFR Exon 20 mutations or HER2 mutations, as well as some of these new fusions.  

Another area of rapidly growing research is that most patients who have targeted therapies will eventually develop resistance. And so, understanding how to mitigate resistance or how to overcome resistance is important. And we often talk about the different drugs in development as first, second, and third-generation drugs in the EGFR space, which accounts for about 15 percent of lung cancers in the United States. We’re looking at fourth-generation tyrosine kinase inhibitors. They’re certainly very exciting.  

The other piece, I think, of research that is moving and that we are looking forward to understanding why some patients have really robust responses to immunotherapies and others don’t. Or how people become immune to the effects of immunotherapy. And so, understanding the tumor microenvironment, seeing if there are other proteins that we can co-stimulate to cause these robust and durable responses to immunotherapy is an area that we’re working on.  

Katherine:

Mm-hmm. Since no two people with lung cancer are the same, how do you decide which treatment is best for each patient? 

Dr. Patel:

So, the process of evaluating a patient can actually take a little bit of time. So, we first meet a patient, and they may have suspicious findings. We want to understand the full stage of their cancer. And so, in 2022, that’s doing an MRI of the brain, a CT of the chest and abdomen, and often times a pet scan to look for any evidence of distant disease.  

So, once we have radiographic modeling of where we think the tumor is, sometimes we need to do a repeat biopsy to confirm whether or not lymph nodes are involved or the cancer has spread. After we do the biopsy and say that it’s non-small cell lung cancer or small cell lung cancer, we make decisions about looking for genetic markers.  

And so, we’ll often take the tumor tissue and stain for things like PD-L1, which is a marker of response to immunotherapies.  

Very importantly, with all these new targeted therapies, we want to understand the genetic makeup of cancer. So, we want to look for things like EGFR mutations or ALK translocations which are more effectively treated with targeted therapies than chemotherapy or immunotherapy.  

So, those are the two tumor characteristics. But, again, I’ve said before, a tumor exists in a person.  

And so, you need to understand what’s important to the person, what do they prioritize, what’s their health like, what, again, are the preferences, are there other comorbidities that could perhaps make some treatments more difficult? Many people, for example, have autoimmune disease. And so, that can be something that’s relatively minor, like some psoriasis that is well-controlled versus perhaps lupus which can cause organ failure.  

Often with psoriasis there are ways that we can give immunotherapy safely. Sometimes other autoimmune diseases would put patients at very high risk with immunotherapies. And so, again, understanding the overall health, understanding other competing causes of toxicity, are absolutely important as you make decisions together.  

Katherine:

Yeah. It seems like we’re getting closer to personalized medicine. For you, how would you define that term? 

Dr. Patel:

Personalized medicine comes in two forms. So, one is the biologics of the tumor itself. So, what do I understand about the genetic markers, the likelihood of response to the available therapies. The other piece, again, is personalizing it to the person that has the cancer.  

And so, again, what are the preferences? What are the risks they’re willing to take? What are their goals? What are the preferences? 

Katherine:

Symptoms and side effects can sometimes be a burden to patients undergoing treatment. What are the most common issues that patients face? 

Dr. Patel:

So, common symptoms from treatment can include fatigue, lack of appetite, disinterest in the things that made you really excited before. Infrequently now we have severe nausea, because we have such good antinausea medications.  

Sometimes we’ll have problems with blood counts or risks of infection. All of these vary by the treatment that’s rendered. And so, often it may be that you’re on a targeted therapy. Some targeted therapies, for example, can cause swelling in your legs. Immunotherapies are generally well-tolerated but can cause significant side effects in a small minority of people that could include inflammation in the gut, for example.  

So, everything is sort of tailored, I would say. Most frequently, I hear about the fatigue, and then the ongoing stressors of living with cancer. So, the financial toxicity certainly. These drugs are expensive. But not only that, often people have changed the way they work. Their family members have changed how they work to support their loved one. So, bringing people to appointments.  

There’s a lot on someone’s plate. And that can contribute to fatigue and even some anxiety.  

Katherine:

Yeah. What strategies are in place to manage symptoms and side effects? 

Dr. Patel:

So, having a patient who’s knowledgeable about potential side effects and a good advocate for themselves is probably the best way to manage therapy. So, ongoing dialogue with your clinical team, with your nurse, with your physician, are absolutely important. But most of us work with teams of healthcare workers. And so, when I think about our clinic, we have financial counselors, we have social workers, we have dieticians and nutritionists, we work with physical therapists. And importantly, we work with a palliative care team that helps us, again, manage some of the toxicities of therapy.  

We think that they provide a longitudinal assessment of patients and remember what’s most important to a patient over time. Whereas often in the moment there’s this, we want to make the tumor shrink. We think about what we can do immediately. It’s often really helpful to have another team that can provide support over the patient’s journey to help us, again, prioritize what they wanted to do the most.  

Katherine:

Mm-hmm. Dr. Patel, why do you think it’s necessary for patients to tell their doctor about any issues they may be having? Even the little ones.  

Dr. Patel:

I think most of us want to be good patients. And so, we minimize things because we think that, okay, we’re using precious time to talk about things that may seem minor. But, again, all of these add up.  

Even minor symptoms, particularly in the era of immunotherapy, can turn out to be big problems. So, as I say now to my patients particularly on immunotherapy, if something seems a little bit off and you can’t put your finger on it, I just need to know so I can at least do the appropriate workup to make sure that we’re not missing anything. Because symptoms of underlying problems can be very misleading.  

Moreover, I think the cumulative burden of cancer. So, again, we talked a little bit about the financial toxicity, the emotional cost, the time involved in treatment, all of that adds up. And you never want to get it to a breaking point. We want to manage it early on, so we can, again, make decisions together and keep wellness and the quality of survival at the forefront.  

Katherine:

Mm-hmm. You mentioned that sometimes treatment doesn’t work for an individual patient. So, are there options for relapsed patients? 

Dr. Patel:

So, absolutely. Most of our therapies in the metastatic setting work for some time. And then cancer is a difficult adversary. It figures out how to overcome whatever strategy we’re using and becomes resistant. When that happens, often we need to change course. We need to try a new therapy. We have a number of therapies that we’re looking at in the first- and second-line settings. And we’re trying to understand best therapies for subsequent lines of treatment.  

Generally, I say treatment is appropriate if you’re feeling pretty well, right? If you’re able to tolerate treatment, then the likelihood that you would be able to benefit from therapy is significant. How that changes over time weighs heavily on our decision. So, if someone’s having more fatigue or more symptoms from their cancer, it may be that even a little bit of toxicity proves too much.  

Whereas if someone is feeling still really good, we may be willing to say, okay, I’m going to take a little bit more of a risk for the benefit of improved cancer control.  

Katherine:

Mm-hmm. You talked about this a few moments ago, but I would like to talk about self-advocacy. Managing the worry associated with a diagnosis or concerns about progression can lead to anxiety and fear in some patients. So, why is it important for patients to share how they’re feeling with their healthcare team? And who all is in the healthcare team who would be able to help a patient? 

Dr. Patel:

So, the anxiety of cancer therapies, of CT scans, of tumor assessments, can be overpowering. And then the longer-term anxieties. Who’s going to care for me, who’s going to care for my family, am I doing the things that are important to me, are ones that weigh heavily on all of us.  

So, certainly, again, carrying these anxieties over a long time have adverse impacts. So, people who are more anxious may not sleep as well. They may lose weight. They may not be as robust. And so, all of those things weigh into our ability to give more treatment. So, we want people to be psychologically well. We have, generally now in our healthcare teams, a number of people who are there to help.  

And so, we have nurse navigators. Most cancer centers have a number of psychologists and psychiatrists that work with our teams. But more than that, even things like nutritionists and social workers make a significant impact. And then I’m surely lucky to work with a world-class palliative care team. So, these are doctors that really focus on symptoms of cancer, the toxicities of treatment. And we work together to ensure the best outcome for our patients.  

Katherine:

Dr. Patel, we’d be remiss if we didn’t bring up financial concerns.  

Treatment and regular appointments can become quite expensive. So, understanding that everyone’s situation is different, where can patients turn to if they need resources for financial support?  

Dr. Patel:

When your team first talks to you about therapies, it’s important that they have transparency about what something may cost or the risks that you may incur by starting treatment. However, most of us have access to wonderful financial teams and financial counselors that can help you manage this.  

Many of our industry partners and friends are able to have assistance programs to provide oral drugs at discounted rates or to work, again, with organizations in which you may be able to have reduced rates for many of your drugs. Most of the infusional drugs, again, should be covered by insurance. But outside of drug costs, there are a lot of other costs.  

So, parking every time you come for a doctor’s appointment. Time off from work. Time that you’re hiring a babysitter to take care of your children when you’re at treatment. All of those add up. And so, again, perhaps talking to the social worker at your cancer center or talking to the financial counselor, there are often local programs that can help ease some of those burdens. 

Katherine:

Thank you for that advice, Dr. Patel. Before we close, I’d like to ask, are you hopeful about the potential for people with lung cancer to thrive? 

Dr. Patel:

Absolutely. The future is bright after years of working and really developing this great foundational science.  

We are seeing the transformation of cancer care in a way that is faster than I could’ve ever imagined at the beginning of my career. We’re bringing scientific insights to the bedside. And bringing it to the bedside is impacting how patients live with their cancer and thrive with their cancer. They’re living longer and with fewer toxicities and side effects than I ever imagined.  

I’m optimistic about the promise of early detection through blood tests one day, through screening with CT scans to find early-staged disease in which the cancer is the most curable. And then for patients with more extensive disease, to really understand how we can sequence therapies or deescalate therapies when patients have minimal burden of disease, again, to decrease the toxicities.  

Katherine:

Mm-hmm. Dr. Patel, thank you, again, for being able to join us today. It’s been a pleasure.   

Dr. Patel:

Thank you so much for this invitation. I really enjoyed speaking with you.  

Katherine:

And thank you to all of our partners. To learn more about lung cancer and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for being with us.  

Thriving With Lung Cancer: What You Should Know About Care and Treatment Resource Guide

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Thriving With CLL | Tips and Support for Navigating Care

Thriving With CLL | Tips and Support for Navigating Care from Patient Empowerment Network on Vimeo.

What are the key elements that help patients thrive with chronic lymphocytic leukemia (CLL)? In this webinar, Dr. Seema Bhat discusses CLL treatment and research, explains how the side effects and symptoms of CLL are managed, and shares tools for managing daily life with CLL.

Seema Bhat, MD is a hematologist at The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Bhat.

See More from Thrive CLL

Related Resources:

 

Expert Advice for CLL Self-Advocacy

Expert Advice for CLL Self-Advocacy

CLL Treatment Approaches: What Are the Types?

Setting CLL Treatment Goals WITH Your Team

Transcript:

Katherine:

Hello, and welcome. I’m Katherine Banwell, your host for today’s program. Today’s webinar is part of our Thrive series, and we’re going to discuss tools for navigating life with CLL. Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you.  

Let’s meet our guest today. Joining us is Dr. Seema Bhat. Dr. Bhat, welcome. Would you please introduce yourself? 

Dr. Bhat:

Hi, Katherine. Thank you for having me here on the program. My name is Seema Bhat, and I am an associate professor at Ohio State University with expertise in treating CLL.  

Katherine:

Excellent, thank you so much for taking time out of your schedule to join us. 

Dr. Bhat:

You’re welcome. 

Katherine:

Like all of the webinars in our Thrive series, we start with this question. In your experience, what does it mean to thrive with CLL? 

Dr. Bhat:

So, thriving with CLL to me means that we envision our patients with CLL leading normal, functional, and productive lives. You know, when patients hear the word “cancer,” or “leukemia,” it comes as a big shock to them. Cancer is also associated with drastic changing – life-changing experiences. Patients think about their shortened life span, and the difficulties they’ll have to endure in this shortened life span due to the treatments they will be needing for their cancer. But I want to tell my patients that even though they have a leukemia, they have a cancer, they can still focus on their life in general. 

They have – this has been made possible by very effective yet gentle treatments approved for CLL. Patients can have an enjoyable, fulfilling life focusing on their life in general, and thrive. 

Katherine:

Thank you for that, Dr. Bhat. That’s important for patients to know. Let’s move on to treatment and walk through CLL treatment classes and types. Some of our audience members may already know this information, but it’s a good baseline for newly diagnosed patients. First, CLL patients are often put in “watch and wait” when they’re first diagnosed. What does that mean? 

Dr. Bhat:

So, “watch and wait” means observation. CLL is a slow-growing cancer, generally, and one of the few cancers that’s managed by observation if it’s not causing any problems to the patient. These problems could include symptoms in the form of fatigue, unintentional weight loss, symptomatic enlargement of their lymph nodes or spleen, or we could see changes in their blood work in the form of decreased hemoglobin or decreased platelets. 

If this is not happening, observation is still the standard of care. And data from this comes from a number of clinical trials where patients were treated based on just having the disease without having any of the symptoms or signs I just mentioned. 

All these studies had negative results, meaning that starting treatment at diagnosis did not affect the overall survival of these patients. These patients – these studies were, however, done in chemoimmunotherapy era. Now, we have targeted agents. And also, now we are able to define CLL better, which means that we are able to predict who has higher risk disease. 

So, there’s renewed interest in these – what these are called, early intervention studies. But until we have those results are matured and available, “watch and wait” is still the standard approach. And during “watch and wait,” we see patients at regular intervals, we assess them for symptoms, we look at their bloodwork, and one of the main reasons for seeing these patients at regular intervals is to reinforce what symptoms we want them to pay attention to. So, educating patients at each visit is a very important part of these visits. 

“Watch and wait” may be all that 1/3 of our patients may need through their lifetime. They may never need any CLL-directed treatment. 

Katherine:

Dr. Bhat, when it’s time to start therapy, what types of treatments are available for CLL patients? 

Dr. Bhat:

So, when we think about treatment for cancer, we think about chemotherapy – the conventional chemotherapy that’s associated with side effects like hair loss, nausea, or vomiting. I’m very happy to say that conventional chemotherapy is no longer the standard of care for patients with CLL. Patients who need treatment for CLL are nowadays treated with what are called, “targeted agents.” 

And we have, in general, two different classes of targeted agents that have been approved for treatment for CLL. We have the BTK inhibitors, Bruton’s tyrosine kinase inhibitors, of which we have three. We have ibrutinib (Imbruvica), we have acalabrutinib (Calquence), and we have zanubrutinib (BGB-3111). Then we have BCL-2 inhibitors, of which we currently have one approved, of which is called venetoclax (Venclexta). These treatments can be combined with monoclonal antibodies, which are directed towards the antigen called CD20. For example, rituximab (Rituxan) or obinutuzumab (Gazyva). 

Typically, venetoclax is combined with monoclonal antibody as a time-limited therapy. BTK inhibitors usually are not combined with monoclonal antibody. 

Katherine:

What about stem cell transplant, does that fit in there? 

Dr. Bhat:

So, stem cell transplant still has a role for treatment of patients with CLL, but it has moved down the line with such highly effective and well-tolerated oral agents available. 

But, for refractory patients – what we call dual-refractory patients, we definitely are, especially in high – patients who have higher risk features, we do refer them to stem cell transplant. 

Katherine:

And what is a dual-refractory patient, exactly? 

Dr. Bhat:

Dual-refractory patients mean patients who have had a BTK inhibitor, be it ibrutinib, acalabrutinib, or zanubrutinib, and the disease has progressed on that. And then we give them venetoclax, which is a BCL-2 inhibitor. So, these are the two classes of targeted agents that we have available. If they have received ibrutinib, acalabrutinib, or zanubrutinib, and after that, a venetoclax, or venetoclax followed by a BTK inhibitor, and the disease has progressed on both. These patients are called dual-refractory, and currently they tend to be very resistant to whatever treatments we have available. And we looked at other modalities of treatment, be it clinical trials or stem cell transplants for that. 

Katherine:

How are targeted therapies administered? 

Dr. Bhat:

So, most of the targeted therapies that we have, we are happy to say that these are oral agents. The BTK inhibitors, the three that we have available, are oral agents. Ibrutinib is taken once a day, zanubrutinib and acalabrutinib are twice a day. Venetoclax, similarly, is an oral agent and is taken once a day. Monoclonal antibodies are also considered targeted agents. These are given as infusions in the clinic or in the clinician’s office.  

Katherine:

The oral medications, patients take that at home? They don’t have to go into the hospital? 

Dr. Bhat:

They do not have to go into the hospital. However, venetoclax is associated with a specific side effect called, “tumor lysis syndrome,” where this medication works so well that initially the cells with die off quickly and then things can collect in the blood.  

For example, uric acid can go up, electrolytes can be up, any number can go up. So, we monitor what those initial weeks of starting venetoclax, we monitor patients very closely. We have them come back and forth to the clinic for monitoring, bloodwork, maybe hydration. And sometimes, if we think they’re at a very high risk for this tumor lysis syndrome, we admit them to the hospital.  

Dr. Bhat:

After we cross that, those are administered at home. They can take these at home. 

Katherine:

Dr. Bhat, where do clinical trials fit into treatment? 

Dr. Bhat:

So, clinical trials play a very important role to advance treatments. Clinical trials for CLL are done to test new treatments, new combinations of treatments, compare different treatments to each other. The goal of these clinical trials is to continue to do better than what we currently have available. This is how treatments improve. Despite all the advancements that we have had in CLL, in the recent years, it continues to be an incurable disease, even today. Our goal as researchers is never to stop until we get to that cure, and clinical trial is that pathway to that cure.  

Katherine:

Are there emerging therapies that are showing promise?  

Dr. Bhat:

Yes, of course. There are a number of emerging therapies that are showing promise. So, we all know about ibrutinib and other BTK inhibitors. These work very well, but sometimes the disease can get resistant to these medications, meaning that it stops responding to these treatments. We are excited about this new kind of BTK inhibitor called pirtobrutinib which has shown great promise in these resistance cases, and we are hopeful that it’ll be approved soon. 

Katherine:

Are there other options that patients have? 

Dr. Bhat:

So, we all hear about what is called, “chimeric antigen receptor T-cell therapy,” or CAR-T therapy. This is studied under clinical investigation for CLL and looks very promising. The therapy uses the person’s own immune cell called, “T cell” to identify and attack cancer cells. 

T cells are taken from the patient’s blood and sent to a specific lab. There, the cells are modified so that they can better find and attack cancer cells. These modified T cells are then re-injected back into the patient to find and fight that cancer, to eradicate the disease. So, this looks very promising. 

Katherine:

Many CLL community members are interested in learning more about their disease. So, for newly diagnosed patients, what are a few educational resources you recommend to help them learn more about their condition? 

Dr. Bhat:

There are a number of well-established support groups or educational resources for our patients. These include the CLL Society, The Leukemia & Lymphoma Society, Lymphoma Research Foundation, and then we have Patient Empowerment Network, and we have Patient Power. All these resources provide support groups, organize webinars, and have educational material for our patients. 

Katherine:

What about patients who have been living with CLL for many years, or are quite knowledgeable about their disease? Are there more advanced resources for patients to stay up to date on the latest research and treatment? 

Dr. Bhat:

So, for patients who want to search for additional resources, especially looking for clinical trials, going on this website called clinicaltrials.gov, they can first search for CLL-related clinical trials. Also, NCCN, or “National Comprehensive Cancer Network,” has patient resources for each disease, and then they can find information on CLL there, also. I would also like to say that Google is a good resource, as long as you know where it is taking you. 

Katherine:

Exactly. You may not be able to rely on everything you find. 

Dr. Bhat:

Right.  

Katherine:

Yeah. Many people with CLL will experience fear and anxiety, whether it’s the stress of being in “watch and wait” or worrying about regression. Why do you feel it’s important for patients to share how they’re feeling with their healthcare team? 

Dr. Bhat:

So, one of the important things to know about CLL is that CLL, at this point of time, it’s not a curable disease. It is a lifelong disease. Patients will have to deal with CLL for the rest of their life in some form or other, either on watchful waiting, or on active treatment, or if they’ll complete a treatment, they’ll have this lurking fear of relapse at any time. A large part of what I do is to help my patients understand what it means to live with CLL. And, of course, anxiety is a big part of that living with CLL. 

Although at this time, we’re unable to cure our patients with CLL, I want my patients to understand that it’s very treatable, treatments are very well-tolerated with low toxicity, and patients live a long life. They can have good, productive, and active life. They should ask their care team about resources for social, emotional, and physical support. 

They should let them know about their concerns, talk about their feelings. 

Katherine:

That’s my next question, actually. How can a social worker provide support and are there other healthcare team members who might be able to help? 

Dr. Bhat:

So, yes, patients are on a rollercoaster – emotional rollercoaster with this diagnosis. With this diagnosis come lots of unknowns. Worries about possible shortened life span, anxiety over treatment, and effects of treatment. So, there’s lots to deal with, and lot of uncertainty, which causes a feeling of hopelessness for these patients. So, psychological support is very important. That’s where the role of social worker comes in. 

We get them involved to help patients deal with the diagnosis, and social workers – they can provide patients with tools to cope with this life-changing event. They use life tools like encouraging positive thinking, mindfulness, being aware of what the patient can control involving faith and family, and also involving self-care. 

That’s where we see the role of the whole team as such. If patients are having more difficulties, we can have other members of a team, like a mental health provider, connect with our patients. Social workers and other members of the team can help our patients get connected to support groups, or even to other patients who have had similar experiences. 

Katherine:

What about worry and anxiety related to COVID and compromised immunity? What would you like patients to know? 

Dr. Bhat:

So, COVID has become another source of anxiety, unfortunately, for many of our patients, and rightly so. Our patients with CLL are considered immunocompromised, meaning that their immune systems do not work that well, which makes these patients very susceptible to different kinds of infections, COVID being one of them. And this was actually shown by some of the early COVID-related studies that showed a very high mortality in patients with CLL. 

This has improved now, mostly because now we are better equipped to handle COVID. We have COVID-directed medications available, but the major impact has been made by the vaccines. So, we highly encourage our patients to get vaccinated against COVID and keep up to date with the latest CDC guidelines. Also, we have Evusheld available, which is under emergency use authorization, and our patients with CLL, due to their weaker immune system, are eligible to get this, which adds an extra layer of protection for our patients. 

Also, it’s important to know that our test – if our patients test do test positive for COVID, they should let their team of doctors know immediately, since now we have monoclonal antibodies and pills that can be used to treat symptomatic COVID. 

Katherine:

That’s great information, thank you. Financial concerns can be another source of stress for people with CLL. Obviously, everyone’s situation is different, of course, but what resources are available for patients who need financial support?  

Dr. Bhat:

So, financial barriers can be a real concern for our patients. Targeted therapies are very expensive, and although insurances do cover them, the approved FDA drugs, copays can be very high, and this adds on because our patients with – our treatments with CLL, some of them tend to be indefinite. That means patients have to take those medications on an ongoing basis, and when they face such situations, high copays, we look into financial assistance. We look for funding for copay assistance, and funding can be provided by pharmaceutical companies. We can also apply for grants through The Leukemia & Lymphoma Society and other resources to help out our patients with these financial concerns. 

Katherine:

So, does the patient work with the healthcare team to find financial support? 

Dr. Bhat:

Absolutely. We at our institution have what is called, “MAP,” or Medication Assistance Program. 

And when we see that – we run the medications through the insurance, then we see the copay is high, we refer our patients to the MAP program, and then they take over. They find them grants, they find them assistance through be it pharmaceuticals, copay assistance programs. So, invariably, almost all patients who come and see us are helped through that program.  

Katherine:

What about a nurse navigator or patient navigator? What do they do? How can they help? 

Dr. Bhat:

Well, so yes. Nurse navigators and patient navigators are also very important for caring for our patients. So, patients can have, besides our care for our patients which includes caring for their disease, caring for their symptoms, caring for their reduced hemoglobin and reduced platelets, our symptom management, they have psychological needs, they have functional needs, they have needs like family support.  

So, these are all the things that patient navigators can help patients set that up based on their – we have patients who travel from out of state, are from two or three hours away. So, these patient navigators look into what resources they should have available locally. Sometimes, patient navigators help us – some patients cannot do frequent travels back and forth, so we get them connected to local oncologists, also. So, patient navigators look into those appointments, look into those offices, so they provide a lot of help to us manage our patients. So, they provide more of a holistic management, rather than just treatment of CLL. 

Katherine:

Let’s answer a few audience questions that we received in advance of the webinar. This one is from William. Can you please talk about common side effects of CLL – which, of course, we’ve covered already, but both the ones from the disease itself and then ones related to treatment, and what can be done about these? 

Dr. Bhat:

So, disease-related side effects, or we call them disease-related symptoms, include fatigue as a common symptom. Unintentional weight loss can happen. Fevers, chills, or drenching night sweats can happen. We call them, “B symptoms.” Spleen can enlarge, and the enlargement can cause belly pain or feeling of fullness quickly after a meal since spleen is close to our stomach, and as it enlarges, it limits the space stomach can take up in the belly. Lymph nodes can enlarge and can get uncomfortable. So, if any of these symptoms happen, then we have to treat the CLL, and once we start treating the CLL these symptoms should go away. 

As far as treatment-related side effects are concerned, for example, BTK inhibitors are associated with a certain set of side effects. For example, patients can have muscle cramping, muscle pain, joint pain. Patients can have diarrhea. Some of the side effects that we worry about is change in heart rhythm, for example, atrial fibrillation. We talked about that, or increased risk of bleeding.  

Those are some of the side effects we worry about, and if those were to develop, then, of course – for example, a patient has atrial fibrillation, and if it’s symptomatic, we hold the medication. We take care of the atrial fibrillation, usually in collaboration with cardiologists, and once that’s under control, then we have to decide what to do with the treatment. If the atrial fibrillation is under control, we can re-initiate the treatment, or we can go to one of the next-generation BTK inhibitors – the acalabrutinib, the pirtobrutinib, which have less of those side effects. 

Bleeding tends to be a concern, but anything that reduces the risk of bleeding like other medications, aspirin, clopidogrel (Plavix), other blood thinners, we can avoid them, monitor these patients very closely for any of these side effects, so that’s critical. With venetoclax, it’s usually very well-controlled. It’s the initial part of treatment that tends to be a little bit intensive because of the specific side effect called, “tumor lysis syndrome,” which means that the drug works very quickly, and cells die off quickly, they can release stuff in the blood, and things can collect in the blood. 

Uric acid can go up, electrolytes can be up, any number can go up. So, we are aware of this side effect, and we actually pre-emptively have things in place that can prevent this from happening, or if it happens, we manage it right away. For example, venetoclax has a specific dose initiation. For example, it’s called, “dose ramp-up.” We start it at a lower dose, 20 milligrams, for one week. Escalate it to 50 the next week, 100 the third week, 200 fourth week, and 400 the last week, which is the standard dose. They continue on 400 from there onward. 

And even with the slow dose escalation, in the early couple of weeks, we monitor them very closely. Once we initiate a dose, we bring them back to the clinic to recheck their blood work to see if there are any changes. If any changes have happened, we hydrate them, initiate medication for their tumor lysis syndrome. 

If the risk of tumor lysis is very high, then we monitor then admit them to the hospital. Otherwise, long-term side effects of venetoclax, what we have noticed mostly is gastritis, most side effects – mostly diarrhea. But that’s usually well-controlled. We can manage it well with supportive care. 

Katherine:

Here’s another question from Anna. She asks, “What is MRD, and does that mean that the disease is cured?” 

Dr. Bhat:

So, MRD is minimal residual disease, and in CLL is defined as the number of leukemic cells that can be detected in the blood or bone marrow following treatment, meaning how many cancer cells are remaining after treatment? This can be checked by a couple of tests. Most commonly, we use flow cytometry. Undetectable MRD is currently defined as the presence of less than one cell – one CLL cell in 10,000 white cells. 

It’s emerging as an endpoint in a number of clinical trials, and presence of no MRD, also called, “MRD-negative status,” although not considered a cure, predicts better outcomes with longer remission. This is being done in combination treatment, and although it’s part of clinical trials currently, with more data available, we may start using this in clinical practice in the next coming years. 

Katherine:

Sophia wants to know, “Are there any clinical trials regarding Richter’s, or DLBCL, transformation?” 

Dr. Bhat:

So, Richter’s transformation means when CLL, which is a low-grade disease, changes into high-grade lymphoma, and most commonly it’s “diffuse large B-cell lymphoma,” or DLBCL. Currently available treatments for Richter’s transformation are, unfortunately, sub-optimal. So, clinical trials to find better treatments are critical for this division, and there are a number of these currently going on. For example, some trials add targeted agents to the backbone of standard chemotherapy called, “R-CHOP.” 

So, we have one trial where acalabrutinib is being added. There’s another clinical trail where venetoclax is being combined with R-CHOP. One of the problems with Richter’s Transformation is that it tends to be refractory to treatment, and it tends to come back or relapse. So, there are studies ongoing for relapse treatment as well, with combination of targeted agents. And CAR-T therapy, we just talked about that, is also being studied in Richter’s Transformation. So, there’s a lot going on to improve the outcome for this. 

Katherine:

Okay, that’s great. Here’s one from Phil, “How do mutations affect longevity when surviving CLL? What new treatments help with P53 mutation?” 

Dr. Bhat:

So, there are certain prognostic markers for CLL, meaning certain tests that can tell us how a particular patient is expected to do. Some of these tests detect presence or absence of mutations in certain genes. For example, the IGHV gene can be mutated or unmutated. 

In patients with mutated IGHV, they do well, and patients with unmutated IGHV tend to have a more aggressive disease and may require treatment sooner. Similarly, TP53 mutations also tend to require treatment sooner, and more of these mutations do not respond well to conventional chemotherapy. However, targeted therapy has changed the outlook for these mutations, and it works very well for both these mutations. 

Katherine:

Finally, our last question. One audience member would like to know more about how CLL affects the immune system, including wound healing, and how does CLL impact this? 

Dr. Bhat:

So, patients with CLL usually have a weaker immune system. The lymphocyte, which is the white cell, which is affected in CLL, is an important part for an immune system, and due to the presence of disease, these lymphocytes – although there are lots of them in patients with CLL, they tend to be non-functional. 

“Functionally incompetent,” that’s what they’re called. And it leaves the patient’s immune deficient and susceptible to a variety of infections. Also, the lymphocyte is component – the B lymphocyte is one component of immune system. There are other components like T lymphocyte, antibody, MK cell. There’s cross-dock between the B cells and what we call, the “microenvironment,” which is made of the T cells. This cross-dock is deficient in patients with CLL, again making them immune-deficient and susceptible to infection. So, that’s one impact on their immune system. 

Sometimes, there’s something else happening in the immune system where the immune system can go crazy, or wacky, and start attacking the patient’s own blood cells leading to, for example, decrease of hemoglobin or platelets, because these are immune complications. And also, due to a weak immune system, patients with CLL can have delayed wound healing, which also predisposes them to infection. 

So, being aware of these complications is important and using appropriate precautions can be very helpful. Again, because they have a weakened immune system, vaccines are very important. Using all measures to avoid infection, hand washing, staying away from patients, from people who are obviously sick, is very important. Sometimes, patients where we see they’re’ getting frequent infections, we can use what’s called, “IVIG,” intravenous immunoglobulin. These are pre-farmed antibodies which are injected into or infused into the patient at regular intervals before the sixth week, which reduce the chance of these infections. 

Katherine:

Thank you, Dr. Bhat, for all the information. And please continue to send in your questions to question@powerfulpatients.org, and we’ll work to get them answered on future programs. Dr. Bhat, as we close out our conversation, I’d like to get your thoughts on where we stand with CLL progress. Can patients truly thrive with CLL? 

Dr. Bhat:

So, we have made strides in CLL treatment in the past 10 years that really changed the lives of our patients. These treatments work extremely well, and the side effects are gentler than what we used to see with conventional chemotherapy. And it’ll continue to get better with ongoing research, so I will tell our patients to focus on their lives. We know that they have this disease, but we know how to control it well. So, live your life. Enjoy. Be assured that we have all the tools available for you so that you can thrive. 

Katherine:

Yeah. It seems like there’s a lot of hope in the field. Thank you so much for joining us today, Dr. Bhat. It’s been a pleasure. 

Dr. Bhat:

Thank you so much for having me. 

Katherine:

And thank you to all of our partners. To learn more about CLL and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for joining us today. 

Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial

Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial from Patient Empowerment Network on Vimeo

What questions should breast cancer patients ask their healthcare team before entering a clinical trial? Dr. Adrienne Waks shares her advice and key questions that breast cancer patients should ask before participating in a trial.

Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.

See More from Breast Cancer Clinical Trials 201

Related Resources:

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions?

Should Breast Cancer Patients Consider a Clinical Trial?

Hesitant to Join a Breast Cancer Clinical Trial? What You Should Know.


Transcript:

Katherine:

What are some key questions patients should ask their healthcare team about participating in a trial?  

Dr. Waks:

Yeah, I think there’s a couple of major ones. What’s the rationale behind this trial? Why do you think it might be better than the standard? What do I stand to gain in terms of effectiveness? Do you think it could be worse than the standard of care, and why or why not? So, basically, trying to capture well, what’s the rationale and the potential benefit of a trial? We’re always doing trials to try to give the patient some sort of benefits, so very reasonable to ask about that. Number two, of course, is what are the extra side effects that could be associated with participation on this trial, and how much do you know about them? 

Is this a drug that you’ve used for five years in  a different context or is it a pretty new drug and you don’t have a great sense, so number two, what are the side effects potentially associated with participation on the clinical trial? And then the third thing I would say is what is the extra burden on me going to be, not in terms of side effects but in terms of life disruption, time spent and things like that? What are those extra burdens going to be if I participate in a clinical trial will I have to get extra scans, will I have to do extra visits, will I have to get extra biopsies?  

You know, there are a number of clinical trials that require biopsies or have optional biopsies at least because in addition to studying a new drug we’re trying to understand in whom does it work and in whom does it not. And so, we want to have biopsies to help us understand that, but a patient should obviously want to be informed about those biopsies.  

So, what will the extra on me look like? And then, we always try as investigators in a clinical trial to put in place as best we can some ways to sort of mitigate the burden on patients. Like, well if I have to have a biopsy, can my parking be covered that extra day or what accommodations can be made to try to mitigate some of the disruption or the extra time? So, I would say those are sort of the three or four main things to ask about. 

Should Breast Cancer Patients Consider a Clinical Trial?

Should Breast Cancer Patients Consider a Clinical Trial? from Patient Empowerment Network on Vimeo

Dr. Adrienne Waks, a breast cancer expert, discusses why and when patients should consider participating in a clinical trial.

Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.

See More from Breast Cancer Clinical Trials 201

Related Resources:

What Role Do Breast Cancer Patients Play in Care and Treatment Decisions?

Hesitant to Join a Breast Cancer Clinical Trial? What You Should Know.

Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial


Transcript:

Katherine:

Why should a breast cancer patient consider participating in a clinical trial?  

Dr. Waks:

It’s a great question. I always tell patients and, of course, I work at Dana Farber, so we participate and I come to this question with a bias and a huge enormous amount of belief in the importance and the value of clinical research, but I honestly would encourage all patients to encourage clinical trials at all points in their breast cancer care. I think that often patients think that clinical trials are something that your doctor will bring up when you’re scraping the bottom of the barrel in terms of cancer treatment options. 

You know, you’ve exhausted everything that’s good and now we’re going to give you treatments that were given to the mice last week or something like that. But that could not be further from the truth. At every stage of breast cancer treatment whether you have a stage I breast cancer or you have a metastatic breast cancer, all of the current standards for how we treat patients and all of the data that we have to tell us you should use those treatments because they’re beneficial, all of those standards and those data come from patients who came before you who participated in clinical trials. Those were not patients who were at the very last stage of their cancer treatment.  

They were patients who could have been newly diagnosed with a Stage I breast cancer, newly diagnosed with metastatic breast or something like that. We change the standards of how we treat patients at all stages by running clinical trials. 

In breast cancer, we have such effective treatments that it’s virtually unheard of that we would compare something to nothing. There’s almost never a time in breast cancer treatment when it’s ethical to offer nothing as a therapy, so most of our clinical trials are not saying you might get a placebo sugar pill and that’s it. It’s saying either you’ll get Arm A, which is this agent or you’ll get A plus B which is the standard plus something else. So, it’s not like by participating in a clinical trial you’re omitting standard therapy. What we’re generally trying to do is give you standard therapy and something better or replacing a part of standard therapy with something we think is going to do better.  

Every time we design and implement a clinical trial, we’re obviously doing so because we hope that we can improve upon the current standard. So, there certainly isn’t a trial for everybody at every stage in their treatment course, and it’s absolutely fine if there’s no trial ongoing that’s the right fit for you, but I think it’s always a good question to ask. You know, is there a trial I should consider here? 

Hesitant to Join a Breast Cancer Clinical Trial? What You Should Know.

Hesitant to Join a Breast Cancer Clinical Trial? What You Should Know. from Patient Empowerment Network on Vimeo

What do breast cancer patients need to know about clinical trials? Breast cancer expert Dr. Adrienne Waks addresses common concerns and misconceptions about trial participation.

Dr. Adrienne Waks is the Associate Director of Clinical Research at Dana-Farber Cancer Institute. To learn more about Dr. Waks click, here.

See More from Breast Cancer Clinical Trials 201

Related Resources:

How Is Metastatic Breast Cancer Treated?

Should Breast Cancer Patients Consider a Clinical Trial?

Key Questions Patients Should Ask Before Participating in a Breast Cancer Clinical Trial


Transcript:

Katherine:

What would you say to patients who may be hesitant to participate in a trial? 

Dr. Waks:

That’s a great question. I think many patients are at first hesitant to participate in a trial, which is natural. You know, there’s already so many overwhelming and scary decisions to be made when it comes to getting a breast cancer diagnosis or any cancer diagnosis that introduce a whole other set of discussions. Instead of variables, it’s found extremely overwhelming and adds another level of what might feel like uncertainty, so I think that’s a completely natural response is to be hesitant and overwhelmed if somebody brings up the clinical trial. 

But what I would try to address in terms of patient concerns is number one, I think that patients worry that if they are approached about a clinical trial that means there aren’t other good options available to them which not always, but almost always is actually far from the truth. Usually it’s just because we have a standard, we think it’s pretty good but we’d like to do better than the standard and participating in a clinical trial is how we do that. 

So, first I always, of course, assure patients this clinical trial is not like something we’ve never tested before and we know nothing about it, and it’s not because I don’t have other options for you. It’s just because I want to do better than the existing options and often it’s looking at an agent that’s already FDA-approved, but we’re trying to combine it with a different agent or something like that. 

So, obviously, number one try to give patients some reassurance about what we already know about the trial agents and also reassure them about the fact that we don’t anticipate the efficacy of their treatment overall would be compromised. Rather we’re trying to improve upon that. So, I think that’s probably the most common concern that I hear from patients, but, of course, as providers it’s our job to understand from that specific patient who’s in front of you what are your particular concerns about clinical trials in general. And are those misconceptions that I can dispel for you, or are they real things that some women on trials do experience in which case we should talk through them and decide if it’s the right fit for you.  

It’s almost always true that participating in a clinical trial does come with what I always call a few other hoops to jump through, because when you’re participating in a clinical trial we want to learn from your experience. So, we do want women to complete questionnaires about their side effects or have a second appointment one week later so that we can do an extra side effect check-in or something like that. You know, do an EKG that they wouldn’t otherwise need. So, there can be and often are some additional logistical or scheduling components that come with participation in the trial. 

Again, we would want a patient to voice how that might or might not fit into her life and be very up front about what could be expected in terms of additional asks which can be extremely minimal or sometimes more disruptive depending on the trials. So, obviously, we just need to have a conversation about that.