Tag Archive for: targeted therapy

Renal Cell Carcinoma Clinical Trials | A Deep Dive into the Latest Advancements

Renal Cell Carcinoma Clinical Trials: A Deep Dive into the Latest Advancements from Patient Empowerment Network on Vimeo.

What’s the latest in renal cell carcinoma clinical trial news? Expert Dr. Moshe Ornstein from Cleveland Clinic discusses updates on antibody drug conjugates, targeted therapy, checkpoint inhibitors, bispecific antibodies, vascular endothelial growth factor inhibitors, and CAR-T cell clinical trials.

Download Resource Guide

See More from START HERE Renal Cell Carcinoma (RCC)

Related Resources:

How Is Advanced Renal Cell Carcinoma Patient Care Managed?

How Is Advanced Renal Cell Carcinoma Patient Care Managed?

Diagnosed with Renal Cell Carcinoma? Start Here

Diagnosed with Renal Cell Carcinoma? Start Here

Expert Insights into Kidney Cancer Risk Factors and Genetic Testing

Expert Insights into Kidney Cancer Risk Factors and Genetic Testing

Transcript: 

Lisa Hatfield:

So can you talk about any clinical trials you are excited about, both in the newly diagnosed setting and then the metastatic or recurring setting for kidney cancer, specific clinical trials, and then some of the medications that you had mentioned, are those FDA-approved right now or are those also in clinical…are most of those in clinical trials at the moment?

Dr. Moshe Ornstein:

I think what this goes to show is that, here I am talking to you, and sometimes some of the words are hard to understand. You can imagine a patient with a newly diagnosed kidney cancer, how confusing a lot of this can be. So I’m really happy we’re having this discussion. Everything I had mentioned up until this point is FDA-approved.

And if I am to mention something that is non FDA-approved, I’ll make that caveat. And while we’re talking about non-FDA-approved therapies, let’s talk about some of those new and exciting clinical trials. The way I look at clinical trials, whether it’s in the treatment naive, so a patient who has a newly diagnosed cancer, or in a patient with refractory cancer, meaning cancer that has gotten worse despite some treatment already.

So I look at clinical trials, and I tend to divide them into two different main categories. And I think for patients, this sort of helps categorize them in a neat fashion. One, is looking at those trials that are investigating novel therapies. So we spoke about those immunotherapy checkpoint inhibitors, we spoke about those vascular endothelial growth factor inhibitors, in other words, targeted therapy.

We spoke about this HIF-2α, those are all therapies that we understand the mechanism of action, we understand how they work. So one kind of clinical trial is saying, what’s next? What’s down the road? What’s not an irregular immunotherapy? What’s not a regular targeted therapy? What’s not another HIF-2α drug? What are the novel therapies being investigated? So some of those trials that I’m interested in are trials that are looking at something called bispecifics. So these are singular drugs that sort of have two different targets. We’re looking at cellular therapies. We know these things called CAR-T cells work well in some of other cancers like lymphomas, but is there a role for using this type of novel mechanism in kidney cancer?

Drugs looking at things called antibody drug conjugates, which again, these types of therapies are available in breast cancer, in bladder cancer, in other types of cancer, but not yet in kidney cancer. And that’s kind of the one category of novel mechanisms, novel agents. That’s one class of clinical trials. And the other class of clinical trials is really sort of optimizing the drugs we already have.

So we know that as a general rule, giving immunotherapy plus targeted therapy is better than giving immunotherapy alone. But what about trials looking at giving two immunotherapies plus a targeted therapy? We know that patients either get immunotherapy and immunotherapy, or an immunotherapy and a targeted therapy. What about if we gave two immunotherapies and a targeted therapy? Can three be better than two? So there are trials both in the front-line setting and in the refractory setting, looking at these novel therapies in the one bucket. And then there are also trials looking at these combinations and different ways of mixing and matching therapies that we already have to optimize patient outcomes. 


Share Your Feedback

Create your own user feedback survey

Kidney Cancer Patient Expert Q&A: Dr. Moshe Ornstein

Kidney Cancer Patient Expert Q&A: Dr. Moshe Ornstein from Patient Empowerment Network on Vimeo.

START HERE bridges the expert and patient voice, enabling patients facing a kidney cancer diagnosis to feel comfortable asking precise questions of their healthcare team.

In this program, Dr. Moshe Ornstein offers invaluable insights into renal cell carcinoma (RCC), equipping newly diagnosed patients with essential information on treatment priorities, as well as strategies for managing progression and recurrence.

Download Resource Guide

See More from START HERE Renal Cell Carcinoma (RCC)

Related Resources:

Exploring Renal Cell Carcinoma Research | Expert Insights on Immunotherapy and Targeted Therapy

Exploring Renal Cell Carcinoma Research | Expert Insights on Immunotherapy and Targeted Therapy

Renal Cell Carcinoma Clinical Trials | A Deep Dive into the Latest Advancements

Renal Cell Carcinoma Clinical Trials | A Deep Dive into the Latest Advancements

Diagnosed with Renal Cell Carcinoma? Start Here

Diagnosed with Renal Cell Carcinoma? Start Here

Transcript: 

Lisa Hatfield:

Hello and welcome. My name is Lisa Hatfield, your host for this Patient Empowerment Network START HERE program, where we bridge the expert and patient voice to enable you and me to feel comfortable asking questions for our healthcare team. The world is complicated, but understanding your kidney cancer doesn’t have to be. The goal of this program is to create actionable pathways for getting the most out of treatment and survivorship. 

Joining me today is Dr. Moshe Ornstein. Dr. Ornstein is a respected kidney cancer physician and researcher from Cleveland Clinic. Dr. Ornstein’s clinical practice and research are focused on cancers of the genitourinary system, specifically kidney, bladder, and prostate cancer. He has published multiple research articles and presented his research at a variety of national medical meetings. He’s actively involved in multiple clinical trials. Dr. Ornstein, it’s such a pleasure having you today, and thank you for joining us. 

Dr. Moshe Ornstein:

Thanks for having me, Lisa. Pleasure to be here.

Lisa Hatfield:

So before we dive into today’s discussion, please take a moment to download the program resource guide using the QR code. This guide contains pertinent information to guide you both before and after the program. In this program, we’ll provide you with a comprehensive update on the latest kidney cancer news, and its implications for you and your family. Following that, we’ll launch into questions we have received from you.

So let’s start here. Dr. Ornstein, the treatment landscape of renal cell carcinoma, also known as kidney cancer, has evolved significantly over the past three decades, leading to improved therapeutic options and prolonged survival. That said, we also recognize that there are unmet needs to improve outcomes in kidney cancer. Today, we are privileged to have your expertise to help us decipher these developments and shed light on the advancements shaping the landscape of kidney cancer care. Dr. Ornstein, can you speak to the latest news in renal cell carcinoma?

Dr. Moshe Ornstein:

Sure, Lisa. It’s a great question. But before I start with the most recent updates and the latest news, I just want to clarify something. I think for you, Lisa, as you say the words kidney cancer and renal cell carcinoma, it’s indeed a mouthful. And for our patients, it can be very confusing as they sometimes hear kidney cancer, they sometimes hear renal cell carcinoma, they sometimes hear RCC, and it can be really hard to digest and understand what their diagnosis is, or if they see a presentation or a talk on kidney cancer, what that means.

So kidney cancer just means any cancer that arises in the kidney. There’s lots of different types of kidney cancer. For the purposes of today’s discussion, we’re really talking about renal cell carcinoma or RCC, which is the most common type of kidney cancer. And within RCC, the most common subtype is clear cell renal cell carcinoma.

So today, when you hear us talk about kidney cancer, RCC, renal cell carcinoma, clear cell RCC, just know that we’re referring to the most common type of kidney cancer. But it is a really important thing to talk to your doctors about, and for patients to talk, and their families to talk to physicians about to understand the subtype. We’ll use colloquially kidney cancer and RCC for today’s discussion. So just by way of a 30,000 foot view, when it comes to renal cell carcinoma, approximately two-thirds of patients are diagnosed when the cancer is in a localized stage, where the cancer is treated with curative intent, generally with surgery.

For patients who present with metastatic kidney cancer,  in other words, kidney cancer that has spread beyond the kidney, or for patients who had their kidney removed and then developed a recurrence or the cancer had come back to the lungs or the bones or anywhere beyond the kidney, those patients are treated with what’s called systemic therapy. Those are medicines that really cover head to toe, not a specific area, but head to toe.

And when we think about treatment options in kidney cancer, there are two main treatment options. One is immunotherapy. Immunotherapy is generally what’s called checkpoint inhibitors. And these are therapies that “release the brakes” on the immune system, and allow the body’s immune system to be activated to target the cancer. And the other type of medicine is called targeted therapies. And these for the most part, are vascular targeted therapies, and the way I describe it is they shrink the blood supply to the tumors. So again, you have those tumors that are diagnosed at a local stage. You have those tumors that are metastatic or advanced beyond the kidney. And the main treatment paradigms have to do with immunotherapy and targeted therapy.

So we just had the ASCO GU meeting, and I just want to describe the updates and how they fit into sort of the overall treatment paradigms across the different treatment sections, in other words, localized and metastatic. So for a patient who presents and comes in with just a kidney mass, that’s a kidney cancer, generally that patient’s going to be treated with surgery.

In general, there’s no rule for therapy before surgery. For many years, for that patient who had their kidney cancer removed from the kidney, either part of the kidney or the whole kidney removed, we really didn’t know what to do with those patients, and the standard of care was just to watch those patients. And we’ll get into a discussion about what watching the patient means. But one of the updates from the recent meetings has been that for patients who have their kidney removed because of kidney cancer, there is now a rule in some patients, this has to be a discussion with the doctor, to use immunotherapy to help prevent or delay the cancer from coming back. It’s a personal discussion.

We have a lot of data to support the use of a medicine called pembrolizumab (Keytruda), which is an immunotherapy that patients would get for a year after their kidney surgery. So that’s really the big recent update in the localized kidney cancer world, where the kidney cancer has been removed by surgery, and there’s now a treatment option, a year of immunotherapy after surgery for the right patient. So now, we move to the metastatic patient.

So again, the patient who has metastatic disease, either comes in with metastatic disease upfront, meaning the kidney’s there, the tumor’s in the kidney, and there’s advanced disease. And the other type is the patient who had their kidney removed a year ago, two years ago, sometimes five years ago, and now shows up with new spots in the lungs or the bones or elsewhere in the body. And that is metastatic or advanced kidney cancer.

So by in large, the overwhelming majority, and in my clinical practice, 95 percent of these patients are going to get an immunotherapy-based regimen as the first treatment for advanced kidney cancer. And there are different types of immunotherapy-based regimens. There’s an immunotherapy in combination with immunotherapy, and that’s called ipilimumab (Yervoy) and nivolumab (Opdivo), so double immunotherapy, or an immunotherapy plus a targeted therapy.

Lisa, we spoke about the targeted therapy cutting the blood supply. So in addition to getting two immunotherapies, some patients won’t get two immunotherapies, they’ll get one immunotherapy in combination with a targeted therapy. And those combinations include axitinib (Inlyta) and pembrolizumab, lenvatinib (Lenvima) and pembrolizumab and cabozantinib (Cabometyx) and nivolumab as the primary combination treatments for the first line of therapy for metastatic kidney cancer.

And the real updates from the recent meetings in this setting is just that with additional follow-up, in other words, we’ve seen follow-up at two years after the trial started, three years, four years, now five years, we’re seeing that there’s a subset of patients that continue to benefit with this combination years down the road. So, encouraging for patients. Again, it’s not every patient, different patients need different things, but just the knowledge that we have long-term follow-up data for patients who have gotten an immunotherapy-based combination for the front-line treatment for their advanced kidney cancer.

And the last update I want to touch on is once we move beyond that first line of immunotherapy-based combinations, we really don’t know exactly what to do beyond that. Meaning, if somebody got an immunotherapy-based combination, and then the kidney cancer got worse, what do we give next? And generally, we’re giving more of these vascular inhibitors, these targeted therapies. And the latest advancement in this area, in the refractory setting, in other words post immunotherapy-based combination is the introduction of a new medicine called belzutifan (Welireg), which is not a classic vascular inhibitor, but is something called the HIF-2α inhibitor. It’s a very well-tolerated therapy in many of the patients. And it does have activity in the right patient. And it’s now FDA-approved relatively recently for patients who have already had an immunotherapy-based combination. So that’s kind of the major update.

The post-surgery treatment with immunotherapy, long-term data for immunotherapy-based combinations in the metastatic setting, and a novel therapy, a new mechanism of action with a pill with a therapy called belzutifan for patients whose kidney cancer is getting worse despite standard treatments upfront.

Lisa Hatfield:

Okay. Thank you so much for that outstanding overview. I had one follow-up question to that overview regarding clinical trials. So can you talk about any clinical trials you are excited about, both in the newly diagnosed setting or in the…I can’t remember what you called it, but the newly diagnosed setting and then the metastatic or recurring setting for kidney cancer, specific clinical trials, and then some of the medications that you had mentioned, are those FDA-approved right now or are those also in clinical…are most of those in clinical trials at the moment?

Dr. Moshe Ornstein:

A great question. I think what this goes to show is that, here I am talking to you, and sometimes some of the words are hard to understand. You can imagine a patient with a newly diagnosed kidney cancer, how confusing a lot of this can be. So I’m really happy we’re having this discussion. Everything I had mentioned up until this point is FDA-approved. And if I am to mention something that is not FDA-approved, I’ll make that caveat. And while we’re talking about non-FDA-approved therapies, let’s talk about some of those new and exciting clinical trials. The way I look at clinical trials, whether it’s in the treatment naive, so a patient who has a newly diagnosed cancer, or in a patient with refractory cancer, meaning cancer that has gotten worse despite some treatment already.

So I look at clinical trials, and I tend to divide them into two different main categories. And I think for patients, this sort of helps categorize them in a neat fashion. One, is looking at those trials that are investigating novel therapies. So we spoke about those immunotherapy checkpoint inhibitors, we spoke about those vascular endothelial growth factor inhibitors, in other words, targeted therapy. We spoke about this HIF-2α, those are all therapies that we understand the mechanism of action, we understand how they work.

So one kind of clinical trial is saying, what’s next? What’s down the road? What’s not an irregular immunotherapy? What’s not a regular targeted therapy? What’s not another HIF-2α drug? What are the novel therapies being investigated? So some of those trials that I’m interested in are trials that are looking at something called bispecifics. So these are singular drugs that sort of have two different targets. We’re looking at cellular therapies. We know these things called CAR-T cells work well in some of other cancers like lymphomas, but is there a rule for using this type of novel mechanism in kidney cancer?

Drugs looking at things called antibody drug conjugates, which again, these types of therapies are available in breast cancer, in bladder cancer, in other types of cancer, but not yet in kidney cancer. And that’s kind of the one category of novel mechanisms, novel agents. That’s one class of clinical trials. And the other class of clinical trials is really sort of optimizing the drugs we already have. So we know that as a general rule, giving immunotherapy plus targeted therapy is better than giving immunotherapy alone. But what about trials looking at giving two immunotherapies plus a targeted therapy?

We know that patients either get immunotherapy and immunotherapy, or an immunotherapy and a targeted therapy. What about if we gave two immunotherapies and a targeted therapy? Can three be better than two? So there are trials both in the front-line setting and in the refractory setting, looking at these novel therapies in the one bucket. And then there are also trials looking at these combinations and different ways of mixing and matching therapies that we already have to optimize patient outcomes?

Lisa Hatfield:

Great. Thank you for that description of clinical trials, too. That’s very helpful.

Okay. Now it’s that time where we answer questions that we’ve received from you. Please remember that this is not a substitute for your medical care. Always consult with your medical team. So, Dr. Ornstein, how do you explain a kidney cancer diagnosis to your newly diagnosed patients, and what are the priorities for those newly diagnosed patients?

Dr. Moshe Ornstein:

When I’m looking at a patient and their family with a newly diagnosed kidney cancer, I’m trying to think to myself a couple of things. Number one, how can I make it as easy to understand without withholding any information? How can I be as encouraging as possible, but at the same time without misleading the patient in terms of what’s to come? The way I break it down is into two main categories. There is the patient that presents with a localized kidney cancer.

So they came to the emergency room because they were having belly pain, and they were found to have a big mass growing in their kidney that is proven to be kidney cancer. And then there’s the patient who has advanced disease, metastatic disease that has spread beyond the kidney. Either they came in with metastatic disease, in other words, their kidneys in place, and they have cancer beyond the kidney. Or they already had a surgery a year or two ago, and now they come back, and the cancer has returned elsewhere in the body.

So for the patient that comes with a localized kidney cancer or kidney cancer limited to the kidney, I talk to them about what the diagnosis means in terms of what subtype of kidney cancer is it, meaning although most kidney cancers are clear cell renal cell carcinoma, there are other types of kidney cancer. And I want them to have a good handle in terms of what they have, both so that they know and they have all the information they need, but also because I understand that most patients, or at least many patients are going to look for more information elsewhere.  And without understanding the histology, the type of kidney cancer they actually have, I worry that they’re not going to get the right information. So I try to be very clear about what stage is it based on the scans or if they’re coming to see me after their surgery, what stage is it after the surgery?

What does it mean when something is a grade 1 versus a grade 2 versus a grade 3 in terms of what the cells look like under the microscope? That’s about the cancer. And then I talk to them about what we’re going to look for in the future. So again, we’re talking now about the patient with localized kidney cancer. I try to go through with them what the risk of that localized cancer is in terms of what the odds are of it coming back. We talk about what kind of surveillance, what kind of watching or monitoring of the cancer are we going to do, how often they’re going to get CAT scans.

So really try to give them the big picture about what cancer they have, what the outlook is, and what we’re going to do to keep a close eye on them. For the patient who has an advanced cancer, in some ways it’s similar. When I say advanced, I mean a cancer that has spread beyond the kidney that’s going to require therapy, immunotherapy, targeted therapy, a clinical trial, whatever it might be.

And again, super important for them to understand, is this a clear cell kidney cancer? Which is the most common? Is it a papillary kidney cancer? Is it something else? Then we talk about what the different treatment options are. What does the short term look like in terms of side effects? What does the short term look like in terms of getting the cancer under control? What does the long-term outlook look like? What are the possible long-term side effects? And then what are we going to do to monitor? Are we doing CAT scans? Are we doing MRIs? Are we doing imaging of their brain?

So again, first and foremost, what’s the nature of the diagnosis, what the treatment options are and likely side effects, what they need to look out for, and then how we as a medical team are going to monitor this over hopefully the long run.

Lisa Hatfield:

We have a patient asking if you can speak to a typical patient history associated with kidney cancer and is there a common factor, or I think that they’re asking is there a cause that you see frequently for kidney cancer?

Dr. Moshe Ornstein: 

Yeah, this is such a common question, Lisa, because patients want to know I have this cancer, what caused it? And generally, we just don’t know the answer to that. And I tell that to patients, it’s generally not something that somebody did that caused this kidney cancer. We do have known risk factors for kidney cancer, whether it’s obesity, smoking, high blood pressure, chronic kidney disease. So there are certain risk factors and associations, but it’s really difficult for a specific patient to be able to pinpoint this caused the kidney cancer. And I think it’s reassuring for patients to know that as a general rule, it’s not something that a patient did that caused the kidney cancer, and it’s not somebody’s fault that they have the kidney cancer.

Lisa Hatfield:

Okay. Thank you for that. What is hereditary renal cell carcinoma, and can you speak to the instance that you’ve seen in your practice? And third part of that question is, how can I protect my family?

Dr. Moshe Ornstein: 

It’s a loaded question, Lisa. And the truth is, you know, patients come in and many patients are not concerned about their well-being, they’re more concerned about their family, and they want to know, “Is this something that’s going to impact my children? Do my children need to be screened for kidney cancer at an earlier age or screened at all?” Because generally we don’t screen people for kidney cancer. 90+, maybe even as high as 95 percent of kidney cancer is what’s called sporadic.

In other words, it just comes out of the blue. I tell patients in some ways it’s just bad luck. It’s not anything they did. It’s not something that they got a gene from their mother or father that caused it, and it’s not something that they’re going to pass down to their children. There’s a very small percentage, maybe about 5 percent or so of kidney cancer that’s hereditary, that does have, you know, a genetic association. That is something that they can potentially pass down, and they may have received that gene from a parent.

It’s exceedingly rare. We think about VHL syndrome, we think about something called hereditary papillary, tuberous sclerosis complex, Birt-Hogg-Dubé, but the overwhelming majority are sporadic, not associated with any specific gene in terms of a gene passed down from parent to child. What I would say is when I start to think about an inherited kidney cancer, I’m thinking more about a very young patient who comes in with kidney cancer, where we don’t expect young patients generally to have kidney cancer, or a patient who shows up with kidney cancer that’s in both of the kidneys. So there are certain unusual features that would lead a doctor to think about a hereditary or genetically associated kidney cancer. But overwhelmingly, it’s sporadic. Children are not necessarily at a higher risk, don’t need to be screened. But for these small features we do in clinic, keep an eye out for that.

Lisa Hatfield:

Okay. Thank you for that. So when you have a patient who comes in with those more unusual presentations, do you recommend that they get some type of genetic testing done, so they can be aware for their family members that maybe they should be screened?

Dr. Moshe Ornstein:

Yeah, absolutely. I mean, if there’s an unusual feature, either a feature associated with tuberous sclerosis complex or something called Birt-Hogg-Dubé, or a young patient with advanced kidney cancer where we don’t expect it, or a patient that shows up with cancer in both of their kidneys and nowhere else, that will trigger us to send the patient to a genetic counselor to do a more thorough family history and talk about what they might be looking for in terms of genetic testing.

Lisa Hatfield:

Okay. Thank you. All right. Another person watching is asking, are there known occupational exposure risk factors for kidney cancer?

Dr. Moshe Ornstein:

This is a great question. You know, we know that with certain cancers, there are classic occupational exposure risks. People want to know, “If I worked in a coal mine, am I more likely to get this kind of kidney cancer? What if I’m a Vietnam veteran and I was exposed to Agent Orange, is this more likely?” Really difficult to find those associations.

I would say that probably the biggest ones are going to be, again, smoking, which I don’t know is so much an occupational hazard, although secondhand smoke is a real risk factor for cancers. Asbestos. So people who worked around a lot of asbestos, that can be a risk factor even for kidney cancer. I know we usually think about it as lung cancer mesothelioma, but definitely for kidney cancer as well in some studies. And then certain forms of gasoline exposure. I will tell you that I’ve taken care of a lot of patients and a lot of people who have kidney cancer and have never been able to isolate an occupational exposure. But looking in the literature, we’re really looking more for asbestos, certain gasoline, secondhand smoke, things like that.

Lisa Hatifeld:

Okay. Thank you. Another patient is asking if there are any specific diets or diet recommendations for kidney cancer patients, especially as they relate to managing side effects of the treatment.

Dr. Moshe Ornstein:

We get asked all the time. And my general answer that I give, and again it’s sort of tongue in cheek, is I tell the patients the same diet that I should be following is the diet that I would recommend to you. I tell patients it’s a well-balanced diet, the right amount of carbs, the right amount of protein, the right amount of Snicker bars. I’m not a get rid of all your sugar or don’t drink any caffeine person. So I think in terms of sort of being data-driven, I would say a generally well-balanced diet.

However, some of these therapies, particularly the TKIs can cause diarrhea. They can cause mouth sores, they might change how you feel. So even though a well-balanced diet is great, we also encourage patients and empower them and their families to follow a diet that’s going to sit well with them given the therapy that they’re on.

So I care about diet much less in the sense of how’s the diet going to affect the cancer and the long-term outcome, and much more in eat the foods that your body will accept. If your body is tolerating more pasta now than it did before, because that helps your gut and therefore you’re able to stay on therapy, wonderful. If you’ve become more of a protein person because that doesn’t instigate the diarrhea, also great. If you need food that has more salt or less spice because of how your mouth feels because of the therapy, then that’s what you need to eat. So really to pay attention to their own bodies and know that whatever they fall on in terms of their diet, again, taking the extremes out of the equation, it’s okay.

Lisa Hatifeld:

You’ve made a lot of patients happy with that response. Thank you.

Dr. Moshe Ornstein:

I think I may have made a lot of spouses unhappy. But again, I think it’s important to work as a team with the medical team and with family.

Lisa Hatifeld:

Great. Thank you. One last question. A patient is asking, “I’m newly diagnosed and my stage of kidney cancer is unclear as I wait for further review. What questions should I be asking my team? It’s very scary to know you have cancer, but unclear of how serious.”

Dr. Moshe Ornstein:

The first thing I would tell this patient is, it’s okay to be scared. And there’s no right or wrong way to feel while you’re waiting for the uncertainty to be settled. Some people have trouble sleeping, some people cry, some people shy away from interacting with their friends and loved ones. And there’s no right and wrong way to respond.

Once you’re comfortable, once a patient is comfortable saying, however I feel emotionally is okay, now we can talk about what you should be asking and what they should be asking. I always try to frame it as what am I looking for in the short term, and what am I looking for in the long term? And I think it’s important to ask the team, ‘Is this cancer something that we’re going to treat with a goal of eliminating it, or is this cancer something that I’m more likely to be on therapy for the long term?”

Again, a short-term question and a long-term question, and the team can give a general overview. I think it’s okay for a doctor to say, I don’t know, or I don’t know yet. I think if you have a doctor that says that, you’re probably very lucky because they’re comfortable being honest and telling you what they know and what they don’t know and what they’re going to do to get the information.

So I would say the questions to ask are, “What’s the next step in the investigations, whether it’s additional scans or additional biopsies? What are the chances that this is something that’s only going to be a short-term issue, and what are the chances that this is something that I’m looking at sort of a chronic condition for the long term?”

Lisa Hatifeld:  

Great. Thank you so much for that answer and showing compassion when you answered that question too. That’s a difficult diagnosis to receive. So thank you for that.

Dr. Ornstein, thank you so much for joining us today. We really appreciate your time and expertise. On behalf of all patients, including myself, a cancer patient, we’re so thankful for the opportunity to listen to your answers, for you to let us ask questions. So we appreciate your time. Thank you so much.

Dr. Moshe Ornstein:

Yep. Really my pleasure to be here and thanks so much for the opportunity.


Share Your Feedback

Create your own user feedback survey

Do Myeloma Treatment Advancements Create Care Challenges?

Do Myeloma Treatment Advancements Create Care Challenges? from Patient Empowerment Network on Vimeo.

Are multiple myeloma treatment advancements creating challenges in patient care? Dr. Craig Cole from Karmanos Cancer Institute and advanced practice provider Charise Gleason discuss advancements in myeloma treatment options and combinations and navigating the rapid pace of new treatment information.

Download Resource Guide  |  Descargar guía de recursos

See More from EPEP Myeloma

Related Resources:

Best Practices: Crafting Myeloma Clinical Trial Conversations to Individual Patient Needs

How Can Myeloma HCPs Overcome Unforeseen Practice Related Barriers?

How Can Myeloma Nurses Start Clinical Trial Conversations at Start of Care?

Transcript:

Dr. Nicole Rochester:

We know that there has been rapid advancement in the myeloma sphere. Can you speak to how the introduction of novel drugs, treatment combinations and therapeutic modalities may pose some challenges for healthcare providers as they attempt to explain the sequence of treatment in relation to available clinical trials?

Dr. Craig Cole: 

Yeah, that’s a really good question, especially because so many things have been changing in myeloma, and such a rapid secession. It really, it’s been kind of not only an incredible transformative past 20 years in myeloma as we’ve moved away from using chemotherapy to using really targeted therapy, but really in the past five to 10 years, and us using immunotherapy and now T-cell directed therapy, it’s been transformative.

And it’s been very, very difficult for myeloma experts to kind of configure how these treatments are sequenced, and how the clinical trials are conducted. But basically, we have gone from using single drug therapies to using combination therapies for refractory patients to using multiple modalities and as upfront therapy for myeloma. Up until today, us using four-drug induction therapies with IMiDs proteasome inhibitors and now immunotherapy with anti-CD38 therapy being used upfront.

 Now, we have…we’re on the fact we are past the horizon of using T-cell directed therapy for relapsed/refractory myeloma. Those are now being put in combinations. And at the last meetings, we saw data in combining talquetamab with the bispecific antibody with pomalidomide (Pomalyst) having incredible response rates to 99 percent to a 100 percent. The combination of using daratumumab (Darzalex) with teclistamab (Tecvayli) at ASCO a couple of years ago having very, very, very high response rates for relapsed/refractory patients. And, of course, the combination of using two bispecific antibodies talquetamab (Talvey) and teclistamab together having, again, in these incredible response rates and for relapsed/refractory myeloma. So in very quick orders, we’re going to see those therapies moving further and further upfront, which is a huge benefit to patients.

But it can be kind of difficult to keep up with all the changes in myeloma, especially as we move from using these drugs as single agents, to using them in combination. And not only to speak to using some of the newer drugs like Mezigdomide in combination with daratumumab, having one of the CELMoDs having very, very high response rates. And so it’s exciting, but it does, it’s a challenge to discuss clinical trials with patients, because so many things have changed. We now have clinical trials across the spectrum of myeloma, using bispecifics as upfront and smoldering myeloma, which was at the last ASH meeting to using again, more novel therapies upfront and relapsed/refractory space and in the maintenance therapy space.

Dr. Nicole Rochester:

Well, that’s all very exciting, and I appreciate you sharing that because as you’ve said, there’s been a really kind of an explosion for lack of a better word, in the numbers of treatments that are available as well as increasing improvements and results. But as you shared, having all of these different modalities available can definitely cause some confusion even among those who do this every day. Do you have anything to add to that, Ms. Gleason?

Charise Gleason:

No, I think, well, I think Dr. Cole described that perfectly. It’s an exciting time, and also a challenging time, which just really brings you back to that team care approach to your patient, and how all of us need to work hard to keep up to date on the latest information. Dr. Cole mentioned quadruplet therapy, and we’ve got two clinical trials that have essentially told us if you add that quadruple therapy and add that antibody upfront, you drive that deeper response. So we change our practice probably sooner in the academic settings. And it’s really how do we get this out to other healthcare providers in our referral basis that send patients to us? And then also, how do we do maintenance? And I think Dr. Cole would agree most of us risk-stratify for that maintenance setting too, whether it’s one drug or multi-drug, depending on our patient’s disease.


Share Your Feedback:

HCP Roundtable: Critical Clinical Trial Conversations in the Expanding Myeloma Landscape

HCP Roundtable: Critical Clinical Trial Conversations in the Expanding Myeloma Landscape from Patient Empowerment Network on Vimeo.

Treatment options for multiple myeloma have increased substantially, mainly attributed to advancements in clinical trials. More than ever, HCPs having conversations about trials is critical. Given that underrepresented communities bear a disproportionate burden of multiple myeloma, it becomes imperative to shift this paradigm.

What are the optimal approaches to initiate these conversations early in the patient journey? How should HCPs effectively communicate information about clinical trials to patients and their families, including care partners? Myeloma experts Dr. Craig Cole and Charise Gleason lend their expertise, offering insights into best practices and guidance on the next steps to be taken.

Download Resource Guide  |  Descargar guía de recursos

See More from EPEP Myeloma

Related Resources:

Evolving Myeloma Clinical Trial Discussions Amid a Dynamic Treatment Landscape

HCP Strategies for Navigating the Pre-trial Eligibility and Informed Consent Process

HCP Roundtable: Best Practices for Talking About Clinical Trials With Myeloma Patients

Transcript:

Dr. Nicole Rochester:

Welcome to this Empowering Providers to Empower Patients Program. I’m Dr. Nicole Rochester, founder and CEO of Your GPS Doc. EPEP is a patient empowerment network program that serves as a secure space for healthcare providers to learn techniques for improving patient-physician communication and overcome practice barriers. In this

Myeloma roundtable, we are tackling critical clinical trial conversations in the expanding myeloma landscape. Some of the things we’ll discuss during this program include, how to explain the sequence of myeloma treatment and how clinical trials fit in. Healthcare provider to healthcare provider, recommended strategies for initiating clinical trial conversations early in the myeloma patient journey, and how to effectively mitigate and manage concerns regarding clinical trials through education, and continuously encourage patients and their care partners to ask questions.

It is my honor and privilege to be joined by Charise Gleason, vice President and Chief Advanced Practice Officer for Emory Healthcare, and adjunct faculty at the Nell Hodgson Woodruff School of Nursing at Emory University. Ms. Gleason leads the physician assistants and nurse practitioners across Emory Healthcare, overseeing clinical practice, quality, safety, and education. Thank you so much for joining us today, Ms. Gleason.

Charise Gleason:

Thank you so much for having me.

Dr. Nicole Rochester:

We’re also joined by Dr. Craig Cole, a board certified hematologist. Dr. Cole leads multiple clinical trials in multiple myeloma, and has worked extensively with patient advocacy groups to empower, educate, and bring equitable care to everyone. Thank you so much for joining us today, Dr. Cole.

Dr. Craig Cole:

Yeah, and thank you for the invitation.

Dr. Nicole Rochester:

While this conversation can be broadly beneficial, in this program, we are speaking to the unique needs of myeloma patients and families. So let’s get started with how to explain the sequence of myeloma treatment, and how available clinical trials fit in. So I’m going to start with you, Dr. Cole. We know that there has been rapid advancement in the myeloma sphere. Can you speak to how the introduction of novel drugs, treatment combinations and therapeutic modalities may pose some challenges for healthcare providers as they attempt to explain the sequence of treatment in relation to available clinical trials?

Dr. Craig Cole:

Yeah, that’s a really good question, especially because so many things have been changing in myeloma, and such a rapid secession. It really, it’s been kind of not only an incredible transformative past 20 years in myeloma as we’ve moved away from using chemotherapy to using really targeted therapy, but really in the past five to 10 years, and us using immunotherapy and now T-cell directed therapy, it’s been transformative.

And it’s been very, very difficult for myeloma experts to kind of configure how these treatments are sequenced, and how the clinical trials are conducted. But basically, we have gone from using single drug therapies to using combination therapies for refractory patients to using multiple modalities and as upfront therapy for myeloma. Up until today, us using four-drug induction therapies with IMiDs proteasome inhibitors and now immunotherapy with anti-CD38 therapy being used upfront.

Now, we have…we’re on the fact we are past the horizon of using T-cell directed therapy for relapsed/refractory myeloma. Those are now being put in combinations. And at the last meetings, we saw data in combining talquetamab with the bispecific antibody with pomalidomide (Pomalyst) having incredible response rates to 99 percent to a 100 percent. The combination of using daratumumab (Darzalex)with teclistamab (Tecvidli) at ASCO a couple of years ago having very, very, very high response rates for relapsed/refractory patients.

And, of course, the combination of using two bispecific antibodies talquetamab (Talvey) and teclistamab together having, again, in these incredible response rates and for relapse refractory myeloma. So in very quick orders, we’re going to see those therapies moving further and further upfront, which is a huge benefit to patients.

But it can be kind of difficult to keep up with all the changes in myeloma, especially as we move from using these drugs as single agents, to using them in combination. And not only to speak to using some of the newer drugs like Mezigdomide in combination with daratumumab, having one of the CELMoDs having very, very high response rates.

And so it’s exciting, but it does, it’s a challenge to discuss clinical trials with patients, because so many things have changed. We now have clinical trials across the spectrum of myeloma, using bispecifics as upfront and smoldering myeloma, which was at the last ASH meeting to using again, more novel therapies upfront and relapsed/refractory space and in the maintenance therapy space.

Dr. Nicole Rochester:

Well, that’s all very exciting, and I appreciate you sharing that because as you’ve said, there’s been a really kind of an explosion for lack of a better word, in the numbers of treatments that are available as well as increasing improvements and results. But as you shared, having all of these different modalities available can definitely cause some confusion even among those who do this every day. Do you have anything to add to that, Ms. Gleason?

Charise Gleason:

No, I think, well, I think Dr. Cole described that perfectly. It’s an exciting time, and also a challenging time, which just really brings you back to that team care approach to your patient, and how all of us need to work hard to keep up to date on the latest information. Dr. Cole mentioned quadruplet therapy, and we’ve got two clinical trials that have essentially told us. if you add that quadruple therapy and add that antibody upfront, you drive that deeper response.

So we change our practice probably sooner in the academic settings. And it’s really how do we get this out to other healthcare providers in our referral basis that send patients to us? And then also, how do we do maintenance? And I think Dr. Cole would agree most of us risk-stratify for that maintenance setting too, whether it’s one drug or multi-drug, depending on our patient’s disease.

Dr. Nicole Rochester:  

Wonderful. So certainly, this conversation alludes to the fact that the clinical trials regarding these medications are also increasingly complex. And so I’m going to go to you, Ms. Gleason, because we know that nurses and advanced practice providers provide understanding of these trials, including potential benefits and risks, and all of the things that are required as they consider participating in a trial. And then, as you all have both shared, there is some tailoring around the treatment with regard to the disease state, whether it’s relapsing, whether it’s refractory. So with that in mind, do you have any best practices around tailoring the trial conversation with regard to specific patient needs and situations?

Charise Gleason:

Well, I’ll start with, we bring that discussion with all of our patients about the potential of a clinical trial from the start. And so we’re all versed on that, we all look to what clinical trial could be available for this patient. So we’re used to having that conversation. So our teams all need to be educated, participate in our research meetings, so we are ready to discuss a trial on that. We sometimes get to spend more time with patients, and we get to know our patients. These are patients we see frequently, and so we can have those conversations.

You might have somebody who’s starting to have a biochemical progression. It’s not time to change their therapy yet, but we’re already thinking about what’s that next line of therapy. And so as we start to approach that with clinical trials and standard of care, and opening that dialogue, so it’s really that communication and that rapport and relationship you have with your patient, and that care partner. So an ongoing conversation about the different treatments that are available to them.

Dr. Nicole Rochester:

So we know that patients with myeloma are living longer lives based on everything that you all have shared, and with that comes a different set of options and challenges.  And you also have alluded to this team-based approach, Ms. Gleason, and we know that there’s a critical role that advanced practice providers play in the myeloma clinical trial setting. So I’d love for you to speak to that..the role that advanced practice providers play in myeloma clinical trials.

Charise Gleason:

Yeah, the advanced practice providers have started specializing like our physicians do, and we have that collaborative relationship, and we are part of that team approach to take care of our patients. So we’re identifying patients for potential clinical trials. Our scope of practice does vary a little bit from state to state. So in some cases, we can also enroll patients. If we’re not able to do that, though, we can already have discussed the trial, discussed side effects, presented them with the consent. So when they do meet with the physician, they’ve already seen a lot of that information, and then they can ask further questions with the physician.

I think the other big role that we play in the clinic setting is we see these patients, we see these patients for follow-up. So we’re doing a lot of management of the side effects, supportive care through the trials. We might be a little more available during the week, so if a patient’s here on another day, and they’ve got something going on, we’re answering those portal questions, and calling patients back and just really collaborating with our physicians and also the research team.

Dr. Nicole Rochester:

Dr. Cole, I’m going to turn the conversation back to you. As a physician, I know that often, there are some barriers just as part of our everyday practice that can hinder our work. And so I’d love for you to speak to any unforeseen or outdated practice related barriers that you feel may hinder your work, and the work of your colleagues specifically as it relates to myeloma trials. And then if you could also share some potential solutions to those barriers.

Dr. Craig Cole: 

Yes, super good question. I love this question. There are a lot that are out there that I…barriers that I hear providers talk about at other academic centers and in the community. One is that patients don’t want to go on clinical trials that they…and some of that is subconscious bias. Sometimes those are true, true bias. We know the FDA knows all the drug companies all, and I think every myeloma provider knows that there have been horrific disparities in the enrollment of patients in clinical trials based on race and age and ethnicity that the FDA looked at some of the data of trials that were going for FDA approval, and found that over the past 10 years, and that in those trials, that only 4 percent of the population of the trials were Black.

While in the United States, the number of Black myeloma patients is about 20 percent, over 20 percent of the myeloma population. So that’s a huge disparity. And what I hear is that while older patients and Black and Hispanic and Asian patients don’t want to go on clinical trials, and that’s not true. That’s been shown in multiple clinical trials that actually, the patients of different ethnicities and races actually are more likely to go on clinical trials than other racial groups. And so I think that it’s really important to keep that in mind that patients really…that really the ownership of getting a patient on a clinical trial is really on us to present the clinical trial option to them with every single conversation that we have.

 Some of the other barriers to clinical trials is, and Ms. Gleason had mentioned this, what they do at through the Emory system is that, well, the nurses and the other staff in the cancer center aren’t aware of the clinical trials, that when a patient goes through the clinic, they talk to more than just the provider. They talk to the treatment nurses, they talk to the intake people, they talked to the MAs, they talked to the scheduling people.

And there was a study that was done a few years ago in looking at patients who were given consent forms and declined clinical trials. And they found that a lot of patients declined clinical trials, well, because they said that, well, their doctor didn’t want them on the trial. And when they looked further into that, they saw that, well, the doctor offered them a clinical trial, but when they discussed the clinical trial with a nurse practitioner, when they discussed that trial with a treatment nurse or the MA or any of the other staff, when they didn’t know about the clinical trial, that was considered well, if you don’t know about the clinical trial, it must not be good for me. And then they withdrew from the trial.

So just like what they do, what Ms. Gleason had said, we have an all-in approach. We make sure that the treatment nurses, the MAs, the intake people know what we’re doing, know about our clinical trials, because that’s the fun part about what we do. The fun part is when we say, look, my goodness, this four-drug therapy had a 100 percent response rate. That shouldn’t be left in the physician compartment. It really shouldn’t be left in the provider compartment. That excitement should be clinic-wide. And when you have that all-in approach where everybody’s involved, everyone’s excited about clinical trials, it produces a culture of clinical trials that everybody wants to be part of, and the patients then can jump on that bus and feel comfortable participating in the trial.

Dr. Nicole Rochester:

Wow. Thank you for elucidating that. Both the issue of the health disparities that we see in clinical trials and the need to diversify that clinical trial patient population, some of those biases that exist, as well as really lifting up this idea of creating a culture of clinical trials. I love the language that you use for that and the idea that everyone throughout the entire clinical encounter needs to be both aware of, and excited about the clinical trials that are underway. So I appreciate that.

That leads us nicely into our next segment, which is really focusing on strategies for fellow healthcare providers for initiating clinical trial conversations early in the myeloma patient journey. So I’m going to go back to you, Ms. Gleason. We’ve been talking about this team-based approach. We know that nurses serve as key coordinators of care in the myeloma trial setting, as well as other members of the healthcare team. So from your perspective, what are some recommended strategies that you can share to encourage advanced practice providers, specifically how to initiate the clinical trial conversation at the outset of care?

Charise Gleason:  

First, we need to educate our advanced practice providers. So for new APPs coming into our system, part of their onboarding is the research mission, exposing them to the clinical trials, exposing them to what we have available. We have a weekly research meeting, I’m sure Dr. Cole has similar practices. And then our group has a separate meeting once a week, where we meet for two hours. The myeloma team, we have APPs who are off that day who call in for this meeting, because we go over our patients, we talk about what’s, clinical trials are available, that’s just how we practice and we think about that.

I would like to add to that, referring to a center early is so essential as well, and for us to start having that conversation. And I’ll talk a little bit to build on something Dr. Cole said with our patient population.  In Atlanta, in our database, 40 percent of our data is based on Black patients. And we enroll about 32% to 33% of Black patients on clinical trials. And what our work on trials has showed us too, if you give the same access to every patient, you have good outcomes and good outcomes for Black patients, if not better, than white patients. So we all need to be versed on that, whether you’re the research nurse, the clinic nurse, the physician, the advanced practice. And so we really do bring that approach to taking care of our patients.

And then, managing those side effects and having that open dialogue. So patients aren’t surprised by things. And I’ll use talquetamab for instance. We have a patient who is still on the original trial, who relapsed on a BCMA targeted therapy. Early on, these side effects were new to everybody. And she wanted to come off the trial month end. And it was that education piece and working with her, holding the drug, that now almost two years later, she’s still in remission, tolerating the drug. And so those are the stories and these are the experiences we have. We’re giving really good drugs on clinical trials and patients are responding well.

Dr. Nicole Rochester:

That’s an amazing success story. Thank you for sharing that. What about you, Dr. Cole, with regard to potential strategies for healthcare providers, what are some things that they can implement for initiating these clinical trial conversations early in the journey, particularly in the current environment?

Dr. Craig Cole: 

Yeah. And Ms. Gleason had mentioned this at kind of the top of our talk about having those conversations on day one. On day one of our patients coming in either as a second opinion, as a new diagnosis, as in whatever setting, we talk about…we have a list that we go through with the patient that talks about their stage or the disease, how we’re going to follow up. And there’s a line that I have to address, which is, clinical trials. So I mentioned our clinical trials, I mentioned on day one. And I think one strategy that other healthcare providers can take is that, even if you don’t have a clinical trial at that time, so right at this moment, we don’t have an upfront clinical trial.

We have one for maintenance therapy, post-transplant, but we don’t have an upfront trial. I mention that. I say that there are clinical trials that are available for your myeloma. Right now we don’t have a clinical trial for upfront myeloma, but we can refer you for a second opinion for an upfront trial if you’re interested or…and we have a clinical trial in maintenance. So that sets the groundwork that we’re going to talk about clinical trials on every visit. And that it doesn’t come as a surprise. Because the last thing you want to do is that someone is having a relapse and you say, “Oh, we’re going to talk about clinical trials today.”  Because then it’s like, “Oh my goodness, this is a desperation.” This is a desperation move, and it puts a lot of anxiety when you frame it, and we need to do this now as opposed to having on day one.

The second thing that I think really helps is getting patients involved in the myeloma community, especially with the support groups having not only the patients, but their care providers and families involved in the myeloma community. Because the myeloma communities through a lot of the support agencies like the IMF, the MMRF, the HealthTree, they have a very strong clinical trial culture. And when patients get involved, not only is that empowering to see other myeloma patients doing well, but to hear other myeloma patients talk about their experiences in clinical trials really, really helps. And I think the last thing that we use to help patients, go through clinical trials, is a couple of other things, is one, every time we talk about treatment options, if that is maintenance, if that is smoldering, if that is a relapsed/refractory therapy, we always put clinical trials in that conversation.

 Again, even if we don’t have that clinical trial at our institution, we talk about this as an option that we could refer you out to. And, and then we always talk about…I think one other little thing is that every visit that patients have, I somehow include some of the new things that are happening in myeloma. Now, my patients kind of expect it. They expect. They know when December and June is because when I see them after ASH and ASCO and sometimes they’re like asking, “So what’s new?” And once we get into that groove, they see, gosh. There are response rates that are off the charts with some of these new things. These patients are involved in clinical trials and the myeloma and multiple myeloma research is progressing at such a rate and things are getting better that patients want to be involved in it.

So we’re always talking about new things. Do I go into depth of detail with talquetamab and pomalidomide. I don’t go into depth of detail. And I say, where I was this clinical trials at our last ASH meeting that combined these two drugs for a relapsed/refractory myeloma, even patients who were refractory to some of the drugs you’re on now. And response rate was like 100 percent. And then when I talk about those clinical trials in the future, they’ll remember, man, that guy was talking, he’s all upset about these clinical trials. Maybe I want to be involved in them. So that’s kind of my few strategies that I use. 

Dr. Nicole Rochester:  

I love that. And what I really hear both of you saying is this idea of normalizing conversations about clinical trials and not introducing them as like a Hail Mary, so to speak, but really from the very beginning, letting patients and care partners know that this is a viable treatment option. So I think that is wonderful. And I can say like, your excitement is contagious for me, so I can only imagine how excited the patients that you work with feel.

So let’s move on to our final topic. How do we mitigate and manage concerns despite all these wonderful things that both of you have shared? I’m sure that patients and family members have concerns about myeloma clinical trials. And so I’ll start with you, Ms. Gleason. And as you hear concerns from patients and families over the years possibly related to fear of randomization, fear of getting the placebo, you all have mentioned some uneasiness about adverse effects. How do you effectively mitigate and manage these concerns with patients and their family members and care partners?

Charise Gleason:

Yeah, you just have to continue to have open communication. And if you’re, if a patient is accustomed to you mentioning clinical trials, then when you present one to them, right? They’re a little more open to it. But not everybody starts with us. And we get referrals in midway and different parts and different paths along the way. But patients we do hear, “I don’t want to get a placebo.” Or you’ll mention a clinical trial and somebody will say, “Am I ready for hospice?”

And it’s, you have to go back and start that education again that, no, you’re getting good treatment on this, a registry trial, for instance, you’re going to get standard of care treatment plus or minus something else, right? And so we really have to go back and educate that you are getting treatment. You’re going to be watched closer than any of our other patients actually.

You’ve got a whole team around you that’s talking about your trial and our patients every week. And so I think that our excitement and our being positive, we can get those patients to enroll on trials. I think something that makes me really happy is, we keep a list of every treatment line, and when you go through and it’s like standard of care, clinical trial, clinical trial, standard…it’s we’ve done the right thing then, right? Our patient has had full advantage of what’s available to them when we do that. 

Dr. Nicole Rochester:

What about you, Dr. Cole? Do you have anything to add with regard to managing the concerns that come up?

Dr. Craig Cole:

Yeah. The one thing that I tell patients, and I tell patients one-to-one, and when I do talks for some of the efficacy groups that I tell lots of patients that. That in 2024, myeloma trials are incredibly competitive. And the only, the best, best drugs, now float to the top as part of our clinical trial portfolio. There were days I remember begging companies for clinical trials saying, “Please, please think about myeloma.” And we were struggling.

Now, it is incredibly competitive, and that competition does a fantastic thing for patients because what we see in the clinical trial portfolio are drugs that are safer and safer and safer, and drugs that are more effective and more effective. When you go to these meetings and the expectation is that our response rate needs to be over 60%, then you know that the clinical trial mail you, that we work with them, is of a super high quality, which you really can’t say for a lot of other types of cancer.

So I tell patients that their fears that they have are absolutely justified. And one thing we teach the fellows, the residents and the medical students, is that you validate those concerns and you listen to those concerns and you don’t ignore it or blow through it. That you absolutely…those are the most important parts of that conversation. And if you don’t validate it, the patient says, “Well, I have a fear of randomization.” And you go, “Hmm, there’s no such thing.” Then that’s not validating. And that’s not even listening. That’s just moving on because you don’t have that concern, but you’re not bringing that, you’re not validating the patient’s concern. And so you have to be very, very careful in doing that because there are multiple studies that have shown those are the big concerns.

Also, bringing up the things that are facilitators for clinical trials, that if there is an opportunity for reimbursement for travel or reimbursement for hotel stays or reimbursement that we say that this trial has a reimbursement program, or if we say that use other things that help facilitate clinical trials like speaking to the family, not just speaking to a patient, but speaking to the caregiver and speaking to the extended family that that patient will have a conversation with are really important conversation because the more people that you can talk to, that’s part of that patient’s decision-making group, which can be very different from patient to patient based on their culture, the more likely you are to get a consensus among that decision-making group for the patient to go on a clinical trial.

Dr. Nicole Rochester:

Those are great tips. Thank you both so much. It’s time to wrap up our roundtable. I must say I have truly enjoyed this conversation as always. I have learned a lot. I’m sure that our audience has learned a lot. In closing, I’m going to go to each of you just to share maybe one takeaway that you’d like to leave with the audience. So I’ll start with you Dr. Cole, one takeaway.

Dr. Craig Cole: 

One takeaway. I actually thought about this, but I think that the biggest takeaway is, if I can squeeze two in.

Is that, is to remember that basically they’re all patients want to be involved in clinical trials and the ownership of having patients on clinical trials is really on us to really talk to them over a longitudinal period, to talk about clinical trials, to have them involved. To not look at a patient saying, “No, they don’t want to be on clinical trial.” That you really engage that patient to tell them about really the incredible progress that we’ve made, how competitive clinical trials are and how exciting it is to be part of that research environment. And that would be my one, my two sort of closing thoughts.

Dr. Nicole Rochester:

Thank you. And what about you, Ms. Gleason?

Charise Gleason:

Dr. Cole said it well. Please discuss this with your patient. Listen to them. Listen to their concerns. Don’t make decisions for them based on bias that maybe you’re bringing in. Don’t make decisions based on maybe it’s too far. Patients drive hours to go on clinical trials, and let’s give them the information and have that conversation.

Dr. Nicole Rochester:

Wonderful. Well, thanks again to both of you, and thank you all for tuning in to this Empowering Providers to Empower Patients program. I’m Dr. Nicole Rochester. Have an amazing day.


Share Your Feedback:

PODCAST: What Non-Small Cell Lung Cancer Treatment is Right for You?

 

What’s the best approach for YOUR lung cancer? Dr. Isabel Preeshagul discusses the importance of engaging in your lung cancer care decisions, shares advice for working with your team to determine a treatment approach, and reviews factors that affect therapy options. Dr. Preeshagul also provides an update on the latest research and clinical trials.

Dr. Isabel Preeshagul is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. Learn more about Dr. Preeshagul.

Download Program Resource Guide

See More From INSIST! Lung Cancer


Transcript:

Katherine Banwell:

Hello and welcome. I’m Katherine Banwell, your host for today’s program. Today, we’ll discuss the latest advances in non-small cell lung cancer care as part of our Insist series, which encourages patients to play an active role and insist on better 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. Well, let’s meet our guest today. Joining me is Dr. Isabel Preeshagul. Dr. Preeshagul, it’s so good to have you with us. Thank you. Would you introduce yourself? 

Dr. Isabel Preeshagul:

Yes. Thank you so much for having me and for the very kind introduction. My name’s Isabel Preeshagul. I am a Thoracic Medical Oncologist at Memorial Sloan Kettering Cancer Center, and it is a huge honor to be here with you today. 

Katherine Banwell:

Well, we’re so glad to have you with us. I’d like to start with a question pertaining to our series title, Insist. Why is it essential for patients to collaborate with their providers on care treatment decisions? 

Dr. Isabel Preeshagul:

So, collaborating is so important, right? I always tell my patients this is not a dictatorship, right? This is a collaborative effort where I’m here to guide you, but you are the captain of the ship. 

You are the one that needs to make all of the decisions, and I’m here to make sure that the ship goes in a smooth direction, so making sure we have open lines of communication that the patients and their caregivers feel comfortable talking to me and my team and also vice versa and that we trust each other. It’s so important because we are going for a marathon, right? We’re not going for a sprint. This is a long-term relationship, whether we’re treating for cure or we’re treating you with palliative intent and it’s treatable but not curable. We’re going to be following with each other for a long time.  

Katherine Banwell:

A lung cancer healthcare team, of course, consists of a number of different providers. Would you tell us about the various members on a team? 

Dr. Isabel Preeshagul:

Sure. So, there is – there are the people that do the scheduling, that make sure that the CAT scan is scheduled, that the MRI is done, your chemo gets scheduled, all of that. The schedulers are super important and an integral part of our team.  

And then we also have our office coordinators  that answers the phone calls and passes along the messages and assists with scheduling and sort of sets expectations and is the face of the practice. Then you have an office practice nurse or an oncology practice nurse who is the doctor’s right hand, making sure that the patients get proper chemotherapy teaches, making sure that they understand about possible side effects, risks versus benefits, making sure medications are up to date, assessing symptoms.  

They are sort of the front line when it comes to any patient call they’re triaging, and they’re escalating or deescalating. That would be the office practice nurse. And then you have an advanced care practitioner, an APP. You either have a nurse practitioner or a PA that’s working with you that’s sometimes seeing patients independently, sometimes putting chemotherapy orders, you know, really serving as almost as another doctor. 

If for some reason there is something that the doctor’s not available to do, the doctor needs in a pinch, or my patients that are almost at long-term follow-up that are doing great that are just kind of coasting, I will share with my NP and make sure that they know her just as well as they know me. And sometimes there’s a fellow or there’s a resident or there’s a med student that’s part of the team as well because see one, do one, teach one. It’s really important to teach those that are coming after you and serve as mentors and really include them in part of the team and part of the decision-making. And then you have the doctor that just kind of oversees everything.  

Katherine Banwell:

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

Dr. Isabel Preeshagul:

So, the goal of treatment, I think, is really contingent upon someone’s stage, but it’s also contingent upon what’s important to the patient, right? So, we have patients that are stage I all the way to stage IIIC that we treat with intention to cure.

And patients that have stage IV disease, it’s treatable but not curable. So, I am very transparent with that as long as I have the information to have that discussion. With that being said, there are some patients with stage IIIdisease or stage I disease that don’t really want treatment and want to focus on quality of life. And that’s okay too. And in which case, you know, at some point, their cancer will likely progress. How quickly or when that will happen, we don’t know. Could they pass from something else? It’s possible. But you really need to talk about what’s important to the patient, because it’s not always cut and dry.  

Katherine Banwell:

As you mentioned, Dr. Preeshagul, there are several different support members on a team. What would you say to patients or even care partners who can sometimes feel like they’re bothering their healthcare team with their questions and comments? 

Dr. Isabel Preeshagul:

So, we do get that concern a lot. And I always say, “I’m here for you 24/7. And, if it’s not me, it’s someone that’s just as qualified to answer your questions no matter what.” 

“And I would rather get a phone call at 3:00 a.m. than get a phone call at 9:00 a.m., and you need to go to the hospital right now or God forbid something happened. I get a phone call from someone in the ICU that you went overnight and terrible things happened. So, I want the phone calls to come through to keep you out of the hospital and keep you from going south. So, call me.” And I never try to – I don’t try to outline contingency plans or criteria of what would warrant a call, because then you end up getting in trouble.  

I always just tell my patient, “Think about how you’re feeling now in front of me. If you’re feeling any different than how you feel at this very moment, call me.”  

Katherine Banwell:

Good advice. I’d like to turn to the clinical side of non-small cell lung cancer. What tests help you identify the type and stage of lung cancer?  

Dr. Isabel Preeshagul:

Obviously, you need a CAT scan. You need a CAT scan of the chest, abdomen, pelvis, and you need an MRI brain and a PET scan.  

Those are really the gold standards for determining clinical staging. In regards to pathologic staging, it’s really important to have tissue samplings. So, you biopsy a site of disease that’s concerning to you. If it looks like there’s only disease in the chest, you want to biopsy the site where there’s the tumor, and then you talk with your thoracic surgery or pulmonary team to determine the best way to sample the mediastinum for full staging.  

Katherine Banwell:

Why is an accurate diagnosis so important?  

Dr. Isabel Preeshagul:

So, an accurate diagnosis is so important because lung cancer is by no means black and white anymore. There are so many histologic subtypes that we are learning about. There are so many different molecular drivers that we are learning about. So, making sure you have the right diagnosis, full and next-generation sequencing testing, all of the imaging that you need could really make or break your treatment plan.  

Katherine Banwell:

Dr. Preeshagul, let’s talk about biomarker testing. How is biomarker testing for lung cancer different from hereditary genetic testing?

Dr. Isabel Preeshagul:

So, we do do hereditary genetic testing for lung cancer patients as well. So, I think let’s backtrack a little bit. When you’re doing on a patient, there’s germline mutations and there’s somatic mutations. And germline mutations are mutations that you might get from Mom and Dad that they got from their parents and so on and so forth that you could give to your children or your brother and sister or whatever. So, that’s germline testing that could be passed along.  

That would be like BRCA or any other APC gene, but we are learning more and more that there are mutations in lung cancer that do have a hereditary aspect to them. So, we are learning now that while we do somatic testing, which is to find a mutation that just spontaneously happened in your tumor all on its own, it’s really important to pair that with germline testing to make sure that there isn’t some kind of heritable mutation that’s also driving this lung cancer.  

Katherine Banwell:

You mentioned hereditary genetic testing. Should family members of people with lung cancer undergo genetic testing then just to be reassured? 

Dr. Isabel Preeshagul:

So, if there is a germline mutation, then they should – the family members should be referred to a geneticist to have that discussion.   

Katherine Banwell:

What are common lung cancer biomarkers? 

Dr. Isabel Preeshagul:

So, we have nine biomarkers within approval right now, but there are so many. There’s more than I could even talk about today. But some of the more common ones are EGFR, ALK, ROS1, MET exon 14. You have KRAS, KRAS-G12C, which is a newer one. We have NTRK. We have RET. The list goes on, HER2. I could talk for – there’s not enough time on this Zoom video to talk about all of the mutations. But there are nine mutations with approvals as of now to date, this very moment. That could change tomorrow.  

Katherine Banwell:

Of course, it could. How do biomarkers in lung cancer affect treatment options for lung cancer patients? 

Dr. Isabel Preeshagul:

So, it used to only be in stage IV, but now we are learning that biomarker testing is really important from the get-go because we have induction or neoadjuvant protocols that are looking at giving targeted therapy before patients go to surgery. 

We know that there’s FDA approval for patients to get targeted therapy after surgery, and there’s a survival advantage there. So, make sure that you have next-generation sequencing testing regardless of your stage.  

Katherine Banwell:

Okay. That’s good advice. So, we’ve heard how testing and a patient’s individual disease can lead to more targeted options. And you just mentioned targeted therapies. How do they work? 

Dr. Isabel Preeshagul:

So, there’s many different targeted therapies that we have. Some of given as an infusion. For HER2, for example, we have TDXD, and we have T-DM1. TDXD is the only drug that’s FDA-approved in this setting. There are clinical trials looking at T-DM1. For EGFR Exon 20, we have another infusional drug called amivantamab (Rybrevant). For EGFR Exon 19 and Exon 21, we have a pill called osimertinib (Tagrisso). For KRAS, there’s a pill. For most of the driver alterations, it’s a pill, but some of them it does require infusional therapy. 

But these are therapies that are targeted at the cells that harbor that mutation.  

Katherine Banwell:

Let’s turn to immunotherapy. What is it, and how does it work? 

Dr. Isabel Preeshagul:

So, immunotherapy is basically teaching your body to recognize cancer as foreign. So, when you have – I always kind of use this hand model. So, basically, a normal cell has, let’s say, three prongs. And then sometimes what happens is cancer will grow a marker called PD-L1 that makes it hide from the immune system. So, the body thinks that this is a normal cell. So, what immunotherapy does is it comes up and it sort of puts a cap on that PD-L1 so that the cell looks foreign again and the body can attack that cell and get rid of it. So, it’s almost like ramping up your immune system to recognize that marker and get rid of that cell. 

Katherine Banwell:

What is the regimen for immunotherapy, and how often is treatment administered? 

Dr. Isabel Preeshagul:

So, immunotherapy is approved in the neoadjuvant setting, which means before chemotherapy. It’s approved after chemotherapy, and it’s approved in the stage IV setting. There are many different regimens and many different dosings and many different drugs. But it’s typically given in your veins, either once every three weeks or once every four weeks for a certain amount of time. If it’s given in a curative setting and it’s given indefinitely or until there’s disease progression or intolerance in the stage IV setting.  

Katherine Banwell:

Okay. Let’s touch upon the side effects of these types of treatment. You’ve mentioned that there are so many, but what are some of the major side effects, and how are they managed? 

Dr. Isabel Preeshagul:

Side effects of immunotherapy can include pneumonitis, which is inflammation of the lungs, any kind of endocrinopathy like issues with your thyroid, issues with your pancreas like diabetes.  

It can cause colitis, which is diarrhea, inflammation of the colon, hepatitis, inflammation of the liver. It can cause cerebritis, inflammation of the brain. It can cause arthritis or arthralgias, inflammation of the bones. And it can also cause rash and fatigue. 

Typically, if it’s the thyroid, it’s managed with thyroid replacement hormone or a drug that would calm down the thyroid if it’s overactive. Pneumonitis is steroids. Hepatitis is sometimes treated with steroids. Colitis, steroids typically. Steroids usually come somewhere in there, usually not with the endocrinopathies, but the other itis’s, it’s typically – we start with steroids and go up from there. And the goal is to really recognize these toxicities before they become a problem and just at the glimmer of them just starting.  

Katherine Banwell:

So, would you consider these treatments to be personalized medicine then? 

Dr. Isabel Preeshagul:

So, it’s personalized in the sense that if someone has a high PD-L1 expression, there may be some data to demonstrate that they may benefit from immunotherapy or have a response. If someone can’t tolerate chemotherapy or is not interested in chemotherapy or has other reasons that may preclude them from getting it, it might be reasonable. So, in that sense, it is considered personalized.  

Katherine Banwell:

How would you define personalized medicine? 

Dr. Isabel Preeshagul:

To me, personalized medicine takes into account the biologic makeup of a patient’s disease like if they have a mutation and what their PD-L1 status is, what the histologic makeup of it. What’s their stage? And then, on the other hand, what’s important to that patient? If they’re a tailor, you want to make sure you’re not giving them a medication that’s going to cause neuropathy, so they can’t use their hands.  

If they enjoy playing the harp or the piano, same thing. If their goal is to continue to run marathons, you may want to avoid something that’s going to cause inflammation of the lungs and risk them for pneumonitis. Tailoring to make sure that the treatment is part of their life but does not become their life. 

Katherine Banwell:

If the test results don’t reveal one of the biomarkers you’ve been talking about, what other treatments are available?  

Dr. Isabel Preeshagul:

So, if I don’t have an FDA approval, then sometimes we look to see if there is a clinical trial in our early phase drug development program, and we talk about a clinical trial. If there’s no clinical trial and I don’t have an FDA approval, then we have to talk about what options are considered standard of care and how to make that work into the patient’s lifestyle.  

Katherine Banwell:

What about surgery? When is it used?  

Dr. Isabel Preeshagul:

Surgery is typically used in the curative setting with early-stage disease. We’re really trying to give patients some kind of chemotherapy or some kind of treatment before they go to surgery. It’s shown to improve outcomes. It just gives us a en vivo view of how the tumor will respond to the treatment. So, we typically use surgery in the curative setting. And, at times, it’s appropriate to use surgery for a metastasectomy when you have one little site that’s growing. Sometimes after a tumor board discussion, it might be reasonable to resect that area.  

Katherine Banwell:

Is radiation still used? 

Dr. Isabel Preeshagul:

Same thing. It can be used in the curative setting, typically for patients with stage IIIB or stage IIIC disease and combined with chemotherapy patients that are not considered surgical candidates, or it’s used in the palliative setting when patients have painful metastases. 

Katherine Banwell:

Would you define the B and C? You’ve mentioned that a couple of times.  

Dr. Isabel Preeshagul:

Yeah. 

Katherine Banwell:

We’re used to hearing Stage 1, 2, 3, 4. But what’s a stage IIIB and a stage IIIC? 

Dr. Isabel Preeshagul:

Yeah. Sure. Sure. So, it does get a little bit into the weeds here about the size of the tumor and the amount of lymph nodes and location of the lymph nodes. But basically, stage IIIA is considered resectable. That means – that could be the size of the tumor with no lymph nodes, or it could be a smaller tumor with a lymph node on the same side as the disease. Stage IIIB would be a lymph node right underneath the windpipe at the station 7. And stage IIIB also includes lymph nodes that have crossed over to the contralateral side. And stage IIIC would be lymph nodes that are maybe up at the contralateral supraclavicular space. 

Katherine Banwell:

Okay. Do treatment options change if the lung cancer returns? 

Dr. Isabel Preeshagul:

Yes, they do change depending on if this is the same tumor type that’s come back. It’s typically a different treatment algorithm, yeah.   

Katherine Banwell:

Okay. And should biomarker testing be done again if a relapse occurs? 

Dr. Isabel Preeshagul:

100 percent. Because it guides everything about a patient’s treatment. It’s super important.  

Katherine Banwell:

Okay. What are you excited about right now in lung cancer research? 

Dr. Isabel Preeshagul:

I am excited and overwhelmed by the fact that we have so many approvals and so much exciting data that was just presented at ASCO and World Lung and ESMO that it’s next to impossible to keep up. And I’m happy that we have that problem, and I’m happy that the patients have – there’s a spotlight on lung cancer when we were in the shadows. And now, I think we have the spotlight. 

And all of these approvals, you know, with it being Lung Cancer Awareness Month as well, I think is just so important. Just to make sure that we get the knowledge of these new approvals out there though, that is another struggle. 

Katherine Banwell:

Well, are there any current clinical trials that look promising to you? 

Dr. Isabel Preeshagul:

Yeah, I think there are many clinical trials. In the induction setting, there was some data that was just presented on ALINA looking at adjuvant alectinib (Alecensa). We just had a – we have approval for adjuvant osimertinib (Tagrisso) and the ADAURA trial.  

But we are learning more and more that as these targeted therapies have approval in stage IV, we’re trialing them in stage III, and then we’re going to trial them in earlier stages and earlier settings. So, this has been the pattern of how drugs get approved. So, yes, there’s lots of exciting data coming through. 

Katherine Banwell:

That’s excellent. Can you talk about antibody drug conjugates and where they fit into lung cancer care? 

Dr. Isabel Preeshagul:

Yeah. That’s a great question. I don’t think anyone knows the answer as to where they fit in just yet. 

We have probably over 300 antibody drug conjugates that are in development right now. And one of the more common ones that we use is trastuzumab deruxtecan (Enhertu), or TDXD, which is used in patients that harbor HER2 alterations in the stage IV lung cancer setting. It is basically almost like a Trojan horse. So, you have this antibody.  

It’s typically IgG1, immunoglobulin. And then you have a linker, and then at the end of that linker is the warhead or the chemotherapy agent. So, the antibody comes in towards the cancer cell looking very innocent. It binds to the cancer cell. And, once it binds, then everyone inside the Trojan horse or this warhead rush into the cell and get to do its damage. So, it’s a totally different mechanism. We’re trying to outsmart some of the bypass mechanisms that cancer cells develop. And this may be the new wave, but stay tuned, more to come.  

Katherine Banwell:

Right. So, it’s promising.  How can patients find out more about current clinical trials? 

Dr. Isabel Preeshagul:

So, you can always ask your healthcare practitioner if there are any clinical trials at the institution that you’re at, but clinicaltrials.gov has all the clinical trials that are available nationally and internationally.  

You just type in your disease type. You can type in a couple keywords, EGFR maybe or ROS1 or stage IV, something along those lines, and then it should populate a list of clinical trials and what institutions have them open, if they’re still accruing or if they’re not, and a contact on that trial.  

Katherine Banwell:

If a patient is interested in a clinical trial, what kinds of questions should they be asking their healthcare about the trial? 

Dr. Isabel Preeshagul:

So, the first question to ask is, “Do we have any clinical trials that are appropriate for me?” If the answer is yes, “Are they appropriate for me now, or are they appropriate for me if what I’m on right now is not working?” 

So, trying to figure out where that will be, and if they are appropriate for you now, how can I get evaluated, and how can we get things underway? 

Katherine Banwell:

Yeah. What would you say to patients who are interested in participating in a clinical trial, but they’re nervous about it?

Dr. Isabel Preeshagul:

I think one thing that I love about being on a clinical trial is that there are more eyes are on you, because we are looking to get something approved, and we are just watching every single little granular detail. In a way, it’s almost like you’re being more micromanaged than if you were on standard of care because of just how many stops and checks there are, how many eyes are looking at your labs after the doctor and the nurse and the nurse practitioner, and the fellow take a look at everything. It’s 10 other people. So, it’s almost like it’s extra safe because of all of that. It’s exciting because you are hopefully getting tomorrow’s treatment today, right? 

You’re trailblazing the way for other people after you. So, I think it’s exciting, but, of course, it’s nerve-wracking. It’s something new. You don’t know if it’s going to work. But I have to believe that the way that clinical trials are designed now and the clinical trials that we choose to open here, we really hope are going to be pushing the space forward. 

Katherine Banwell:

Yeah. I’d like to get to a few questions that we received from audience members prior to the program. How do you help a family member that is an overwhelmed caregiver but refuses help? Any tips on how to provide support to this person?  

Dr. Isabel Preeshagul:

I mean, I think we see caregiver burnout thousands of times a day, unfortunately, and the first thing is knowing how to recognize it. And the second most important thing is taking the time away from the visit with the patient to address the burnt-out caregiver, because there is not enough time in any visit to ever – there’s never enough time in my mind to spend with a patient.  

I’m always pulled in a thousand different directions. And I think we all feel that. But taking the appropriate time to sit down and to say, “Hey. Listen. I recognize that you’re burnt out. I can see it. Who is in your corner helping you?” And just directing focus away from the patient just for a moment and to really focus on that caregiver and to rely on the social work team and the case manager and the support groups that your institution may have and to make sure that they know about those resources. 

Katherine Banwell:

Yeah. Here’s another question we received. “Can you share more information regarding treatments available for stage IV lung cancer and their side effects?” 

Dr. Isabel Preeshagul:

It depends on if this is non-small cell or small cell. It depends on if you have a driver alteration or not. So, I think that is a little bit challenging to talk about in just one session. But basically, you’re probably looking at some kind of targeted therapy if you have a mutation versus standard of care if you don’t have a targeted mutation versus a clinical trial. And I think those are kind of like the big baskets.  

Katherine Banwell:

When is a second opinion necessary? Dr. Isabel Preeshagul: A second opinion is necessary anytime you want a second opinion.  

Dr. Isabel Preeshagul:

There is no right or wrong time, any time. You’re just not jiving with your oncologist after the first day you met them, second opinion. You’re at the end of the line and you really want toknow more, second opinion. You’ve met two other doctors. You’re not jiving, third opinion. It’s always appropriate anytime you want. 

Katherine Banwell:

So, the patient shouldn’t feel obligated to stay with that one provider? 

Dr. Isabel Preeshagul:

Never. Never, never, never, never, never. No. Please don’t feel that way. There are no hard feelings. And, if there are, that’s not the right oncologist for you. It needs to feel like a perfect friendship. And, if it’s not that, it’s not the right thing.    

Katherine Banwell:

Before we close, Dr. Preeshagul, I’d like to get your final thoughts. What would you say to the audience about the future of lung cancer care and treatment? 

Dr. Isabel Preeshagul:

I do think that the future is bright because, as I mentioned, there is now this light that is shining in the lung cancer space. And things are getting approved. and discoveries are getting made faster than we can even keep up, which is exciting and overwhelming and daunting. But I am happy that, finally, this space is taking off, so I feel optimistic.  

Katherine Banwell:

Okay. All right. Well, I wanna thank you so much for taking the time to join us today, Dr. Preeshagul.  

Dr. Isabel Preeshagul:

Thank you so much for having me. These were wonderful questions, and I look forward to many more discussions with you. Thank you.  

Katherine Banwell:

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 today.   

Non-Small Cell Lung Cancer Treatment | Clinical Trials and Research Updates

Non-Small Cell Lung Cancer Treatment | Clinical Trials and Research Updates from Patient Empowerment Network on Vimeo.

What are the latest advances in lung cancer care? Lung cancer specialist Dr. Isabel Preeshagul shares highlights from recent conferences, promising clinical trial updates, and advice for people interested in joining clinical trials.

Dr. Isabel Preeshagul is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. Learn more about Dr. Preeshagul.

See More From INSIST! Lung Cancer

Related Resources:

Understanding Currently Available Non-Small Cell Lung Cancer Treatments

Understanding Currently Available Non-Small Cell Lung Cancer Treatments

Non-Small Cell Lung Cancer Treatment Options | Personalizing Therapy

Non-Small Cell Lung Cancer Treatment Options | Personalizing Therapy

What Essential Testing Reveals About Your Non-Small Cell Lung Cancer

What Essential Testing Reveals About Your Non-Small Cell Lung Cancer


Transcript:

Katherine Banwell:

What are you excited about right now in lung cancer research? 

Dr. Isabel Preeshagul:

I am excited and overwhelmed by the fact that we have so many approvals and so much exciting data that was just presented at ASCO and World Lung and ESMO that it’s next to impossible to keep up. And I’m happy that we have that problem, and I’m happy that the patients have – there’s a spotlight on lung cancer when we were in the shadows. And now, I think we have the spotlight.  

And all of these approvals, you know, with it being Lung Cancer Awareness Month as well, I think is just so important. Just to make sure that we get the knowledge of these new approvals out there though, that is another struggle. 

Katherine Banwell:

Well, are there any current clinical trials that look promising to you?  

Dr. Isabel Preeshagul:

Yeah, I think there are many clinical trials. In the induction setting, there was some data that was just presented on ALINA looking at adjuvant alectinib (Alecensa). We just had a – we have approval for adjuvant osimertinib (Tagrisso) and the ADAURA trial.  

But we are learning more and more that as these targeted therapies have approval in stage IV, we’re trialing them in stage III, and then we’re going to trial them in earlier stages and earlier settings. So, this has been the pattern of how drugs get approved. So, yes, there’s lots of exciting data coming through.  

Katherine Banwell:

That’s excellent. Can you talk about antibody drug conjugates and where they fit into lung cancer care? 

Dr. Isabel Preeshagul:

Yeah. That’s a great question. I don’t think anyone knows the answer as to where they fit in just yet. 

We have probably over 300 antibody drug conjugates that are in development right now. And one of the more common ones that we use is trastuzumab deruxtecan (Enhertu), or TDXD, which is used in patients that harbor HER2 alterations in the stage IV lung cancer setting. It is basically almost like a Trojan horse. So, you have this antibody.  

It’s typically IgG1, immunoglobulin. And then you have a linker, and then at the end of that linker is the warhead or the chemotherapy agent. So, the antibody comes in towards the cancer cell looking very innocent. It binds to the cancer cell. And, once it binds, then everyone inside the Trojan horse or this warhead rush into the cell and get to do its damage. So, it’s a totally different mechanism. We’re trying to outsmart some of the bypass mechanisms that cancer cells develop. And this may be the new wave, but stay tuned, more to come.  

Katherine Banwell:

Right. So, it’s promising.  How can patients find out more about current clinical trials? 

Dr. Isabel Preeshagul:

So, you can always ask your healthcare practitioner if there are any clinical trials at the institution that you’re at, but clinicaltrials.gov has all the clinical trials that are available nationally and internationally.  

You just type in your disease type. You can type in a couple keywords, EGFR maybe or ROS1 or stage IV, something along those lines, and then it should populate a list of clinical trials and what institutions have them open, if they’re still accruing or if they’re not, and a contact on that trial.  

Katherine Banwell:

If a patient is interested in a clinical trial, what kinds of questions should they be asking their healthcare about the trial? 

Dr. Isabel Preeshagul:

So, the first question to ask is, “Do we have any clinical trials that are appropriate for me?” If the answer is yes, “Are they appropriate for me now, or are they appropriate for me if what I’m on right now is not working?” 

So, trying to figure out where that will be, and if they are appropriate for you now, how can I get evaluated, and how can we get things underway? 

Katherine Banwell:

Yeah. What would you say to patients who are interested in participating in a clinical trial, but they’re nervous about it?

Dr. Isabel Preeshagul:

I think one thing that I love about being on a clinical trial is that there are more eyes are on you, because we are looking to get something approved, and we are just watching every single little granular detail. In a way, it’s almost like you’re being more micromanaged than if you were on standard of care because of just how many stops and checks there are, how many eyes are looking at your labs after the doctor and the nurse and the nurse practitioner, and the fellow take a look at everything. It’s 10 other people. So, it’s almost like it’s extra safe because of all of that. It’s exciting because you are hopefully getting tomorrow’s treatment today, right? 

You’re trailblazing the way for other people after you. So, I think it’s exciting, but, of course, it’s nerve-wracking. It’s something new. You don’t know if it’s going to work. But I have to believe that the way that clinical trials are designed now and the clinical trials that we choose to open here, we really hope are going to be pushing the space forward.  

Non-Small Cell Lung Cancer Treatment Options | Personalizing Therapy

Non-Small Cell Lung Cancer Treatment Options | Personalizing Therapy from Patient Empowerment Network on Vimeo.

How does the presence of biomarkers impact lung cancer treatment options? Lung cancer specialist Dr. Isabel Preeshagul discusses how test results may influence treatment options and aid in personalizing lung cancer therapy.

Dr. Isabel Preeshagul is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. Learn more about Dr. Preeshagul.

See More From INSIST! Lung Cancer

Related Resources:

An Expert Explains Predictive Biomarker Testing for Lung Cancer

An Expert Explains Predictive Biomarker Testing for Lung Cancer

What Biomarkers Affect Lung Cancer Care and Treatment

What Biomarkers Affect Lung Cancer Care and Treatment?

Lung Cancer Care Decisions | Advice for Self-Advocacy

Lung Cancer Care Decisions | Advice for Self-Advocacy


Transcript:

Katherine Banwell:

How do biomarkers in lung cancer affect treatment options for lung cancer patients? 

Dr. Isabel Preeshagul:

So, it used to only be in stage IV, but now we are learning that biomarker testing is really important from the get-go because we have induction or neoadjuvant protocols that are looking at giving targeted therapy before patients go to surgery. 

We know that there’s FDA approval for patients to get targeted therapy after surgery, and there’s a survival advantage there. So, make sure that you have next-generation sequencing testing regardless of your stage. 

Katherine Banwell:

Okay. That’s good advice. So, we’ve heard how testing and a patient’s individual disease can lead to more targeted options. And you just mentioned targeted therapies. How do they work? 

Dr. Isabel Preeshagul:

So, there are many different targeted therapies that we have. Some of given as an infusion. For HER2, for example, we have TDXD, and we have T-DM1. TDXD is the only drug that’s FDA-approved in this setting. There are clinical trials looking at T-DM1. For EGFR Exon 20, we have another infusional drug called amivantamab-vmjw (Rybrevant). For EGFR Exon 19 and Exon 21, we have a pill called osimertinib (Tagrisso). For KRAS, there’s a pill. For most of the driver alterations, it’s a pill, but some of them it does require infusional therapy. But these are therapies that are targeted at the cells that harbor that mutation.  

Katherine Banwell:

Let’s turn to immunotherapy. What is it, and how does it work? 

Dr. Isabel Preeshagul:

So, immunotherapy is basically teaching your body to recognize cancer as foreign. So, when you have – I always kind of use this hand model. So, basically, a normal cell has, let’s say, three prongs. And then sometimes what happens is cancer will grow a marker called PD-L1 that makes it hide from the immune system. So, the body thinks that this is a normal cell. So, what immunotherapy does is it comes up and it sort of puts a cap on that PD-L1 so that the cell looks foreign again and the body can attack that cell and get rid of it. So, it’s almost like ramping up your immune system to recognize that marker and get rid of that cell.  

Katherine Banwell:

What is the regimen for immunotherapy, and how often is treatment administered? 

 Dr. Isabel Preeshagul:

So, immunotherapy is approved in the neoadjuvant setting, which means before chemotherapy. It’s approved after chemotherapy, and it’s approved in the stage IV setting. There are many different regimens and many different dosings and many different drugs. But it’s typically given in your veins, either once every three weeks or once every four weeks for a certain amount of time. If it’s given in a curative setting and it’s given indefinitely or until there’s disease progression or intolerance in the stage IV setting.  

Katherine Banwell:

Okay. Let’s touch upon the side effects of these types of treatment. You’ve mentioned that there are so many, but what are some of the major side effects, and how are they managed? 

Dr. Isabel Preeshagul:

Side effects of immunotherapy can include pneumonitis, which is inflammation of the lungs, any kind of endocrinopathy like issues with your thyroid, issues with your pancreas like diabetes.  

It can cause colitis, which is diarrhea, inflammation of the colon, hepatitis, inflammation of the liver. It can cause cerebritis, inflammation of the brain. It can cause arthritis or arthralgias, inflammation of the bones. And it can also cause rash and fatigue.  

Typically, if it’s the thyroid, it’s managed with thyroid replacement hormone or a drug that would calm down the thyroid if it’s overactive. Pneumonitis is steroids. Hepatitis is sometimes treated with steroids. Colitis, steroids typically. Steroids usually come somewhere in there, usually not with the endocrinopathies, but the other itis’s, it’s typically – we start with steroids and go up from there. And the goal is to really recognize these toxicities before they become a problem and just at the glimmer of them just starting.  

Katherine Banwell:

So, would you consider these treatments to be personalized medicine then? 

Dr. Isabel Preeshagul:

So, it’s personalized in the sense that if someone has a high PD-L1 expression, there may be some data to demonstrate that they may benefit from immunotherapy or have a response. If someone can’t tolerate chemotherapy or is not interested in chemotherapy or has other reasons that may preclude them from getting it, it might be reasonable. So, in that sense, it is considered personalized.  

Katherine Banwell:

How would you define personalized medicine? 

Dr. Isabel Preeshagul:

To me, personalized medicine takes into account the biologic makeup of a patient’s disease like if they have a mutation and what their PD-L1 status is, what the histologic makeup of it. What’s their stage? And then, on the other hand, what’s important to that patient? If they’re a tailor, you want to make sure you’re not giving them a medication that’s going to cause neuropathy, so they can’t use their hands.  

If they enjoy playing the harp or the piano, same thing. If their goal is to continue to run marathons, you may want to avoid something that’s going to cause inflammation of the lungs and risk them for pneumonitis. Tailoring to make sure that the treatment is part of their life but does not become their life.  

What Essential Testing Reveals About Your Non-Small Cell Lung Cancer

What Essential Testing Reveals About Your Non-Small Cell Lung Cancer from Patient Empowerment Network on Vimeo.

What do lung cancer test results reveal to your healthcare team about your disease? Dr. Isabel Preeshagul provides an overview of essential testing for lung cancer and explains the difference between germline and somatic mutations.

Dr. Isabel Preeshagul is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. Learn more about Dr. Preeshagul.

See More From INSIST! Lung Cancer

Related Resources:

Insist on Better Lung Cancer Care | Tips for Essential Communication

Non-Small Cell Lung Cancer Treatment Options | Personalizing Therapy

Non-Small Cell Lung Cancer Treatment Options | Personalizing Therapy

Non-Small Cell Lung Cancer Treatment | Clinical Trials and Research Updates

Non-Small Cell Lung Cancer Treatment | Clinical Trials and Research Updates


Transcript:

Katherine Banwell:

I’d like to turn to the clinical side of non-small cell lung cancer. What tests help you identify the type and stage of lung cancer? 

Dr. Isabel Preeshagul:

Obviously, you need a CAT scan. You need a CAT scan of the chest, abdomen, pelvis, and you need an MRI brain and a PET scan.  

Those are really the gold standards for determining clinical staging. In regards to pathologic staging, it’s really important to have tissue samplings. So, you biopsy a site of disease that’s concerning to you. If it looks like there’s only disease in the chest, you want to biopsy the site where there’s the tumor, and then you talk with your thoracic surgery or pulmonary team to determine the best way to sample the mediastinum for full staging.  

Katherine Banwell:

Why is an accurate diagnosis so important? 

Dr. Isabel Preeshagul:

So, an accurate diagnosis is so important, because lung cancer is by no means black and white anymore. There are so many histologic subtypes that we are learning about. There are so many different molecular drivers that we are learning about. So, making sure you have the right diagnosis, full and next-generation sequencing testing, all of the imaging that you need could really make or break your treatment plan.  

Katherine Banwell:

Dr. Preeshagul, let’s talk about biomarker testing. How is biomarker testing for lung cancer different from hereditary genetic testing? 

Dr. Isabel Preeshagul:

So, we do do hereditary genetic testing for lung cancer patients as well. So, I think let’s backtrack a little bit. When you’re doing on a patient, there are germline mutations and there are somatic mutations. And germline mutations are mutations that you might get from Mom and Dad that they got from their parents and so on and so forth that you could give to your children or your brother and sister or whatever. So, that’s germline testing that could be passed along.  

That would be like BRCA or any other APC gene, but we are learning more and more that there are mutations in lung cancer that do have a hereditary aspect to them. So, we are learning now that while we do somatic testing, which is to find a mutation that just spontaneously happened in your tumor all on its own, it’s really important to pair that with germline testing to make sure that there isn’t some kind of heritable mutation that’s also driving this lung cancer.  

Katherine Banwell:

You mentioned hereditary genetic testing. Should family members of people with lung cancer undergo genetic testing then just to be reassured? 

Dr. Isabel Preeshagul:

So, if there is a germline mutation, then they should – the family members should be referred to a geneticist to have that discussion.  

Katherine Banwell:

What are common lung cancer biomarkers? 

Dr. Isabel Preeshagul:

So, we have nine biomarkers within approval right now, but there are so many. There’s more than I could even talk about today. But some of the more common ones are EGFR, ALK, ROS1, MET exon 14. You have KRAS, KRAS-G12C, which is a newer one. We have NTRK. We have RET. The list goes on, HER2. I could talk for – there’s not enough time on this Zoom video to talk about all of the mutations. But there are nine mutations with approvals as of now to date, this very moment. That could change tomorrow.   

Insist on Better Lung Cancer Care | Tips for Essential Communication

Insist on Better Lung Cancer Care | Tips for Essential Communication from Patient Empowerment Network on Vimeo.

How can you advocate for the best lung cancer care? Lung cancer specialist Dr. Isabel Preeshagul provides an overview of lung cancer healthcare team members, reviews how treatment goals are determined, and shares advice for communication with your care team.

Dr. Isabel Preeshagul is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. Learn more about Dr. Preeshagul.

See More From INSIST! Lung Cancer

Related Resources:

Non-Small Cell Lung Cancer Essential Testing | What You Should Know

Non-Small Cell Lung Cancer Essential Testing | What You Should Know

Personalized Lung Cancer Treatment | Key Factors to Consider

Personalized Lung Cancer Treatment | Key Factors to Consider

Understanding Currently Available Non-Small Cell Lung Cancer Treatments

Understanding Currently Available Non-Small Cell Lung Cancer Treatments


Transcript:

Katherine Banwell:

I’d like to start with a question pertaining to our series title, Insist. Why is it essential for patients to collaborate with their providers on care treatment decisions?  

Dr. Isabel Preeshagul:

So, collaborating is so important, right? I always tell my patients this is not a dictatorship, right? This is a collaborative effort where I’m here to guide you, but you are the captain of the ship. 

You are the one that needs to make all of the decisions, and I’m here to make sure that the ship goes in a smooth direction, so making sure we have open lines of communication that the patients and their caregivers feel comfortable talking to me and my team and also vice versa and that we trust each other. It’s so important because we are going for a marathon, right? We’re not going for a sprint. This is a long-term relationship, whether we’re treating for cure or we’re treating you with palliative intent and it’s treatable but not curable. We’re going to be following with each other for a long time.  

Katherine Banwell:

A lung cancer healthcare team, of course, consists of a number of different providers. Would you tell us about the various members on a team? 

Dr. Isabel Preeshagul:

Sure. So, there is – there are the people that do the scheduling, that make sure that the CAT scan is scheduled, that the MRI is done, your chemo gets scheduled, all of that. The schedulers are super important and an integral part of our team.  

And then we also have our office coordinators that answers the phone calls and passes along the messages and assists with scheduling and sort of sets expectations and is the face of the practice. Then you have an office practice nurse or an oncology practice nurse who is the doctor’s right hand, making sure that the patients get proper chemotherapy teaches, making sure that they understand about possible side effects, risks versus benefits, making sure medications are up to date, assessing symptoms.  

They are sort of the front line when it comes to any patient call they’re triaging, and they’re escalating or deescalating. That would be the office practice nurse. And then you have an advanced care practitioner, an APP. You either have a nurse practitioner or a PA that’s working with you that’s sometimes seeing patients independently, sometimes putting chemotherapy orders, you know, really serving as almost as another doctor. 

If for some reason there is something that the doctor’s not available to do, the doctor needs in a pinch, or my patients that are almost at long-term follow-up that are doing great that are just kind of coasting, I will share with my NP and make sure that they know her just as well as they know me. And sometimes there’s a fellow, or there’s a resident or there’s a med student that’s part of the team as well because see one, do one, teach one. It’s really important to teach those that are coming after you and serve as mentors and really include them in part of the team and part of the decision-making. And then you have the doctor that just kind of oversees everything.  

Katherine Banwell:

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

Dr. Isabel Preeshagul:

So, the goal of treatment, I think, is really contingent upon someone’s stage, but it’s also contingent upon what’s important to the patient, right? So, we have patients that are stage I all the way to stage IIIC that we treat with intention to cure.  

And patients that have stage IV disease, it’s treatable but not curable. So, I am very transparent with that as long as I have the information to have that discussion. With that being said, there are some patients with stage III disease or stage I disease that don’t really want treatment and want to focus on quality of life. And that’s okay too. And in which case, you know, at some point, their cancer will likely progress. How quickly or when that will happen, we don’t know. Could they pass from something else? It’s possible. But you really need to talk about what’s important to the patient, because it’s not always cut and dry.   

Katherine Banwell:

As you mentioned, Dr. Preeshagul, there are several different support members on a team. What would you say to patients or even care partners who can sometimes feel like they’re bothering their healthcare team with their questions and comments? 

Dr. Isabel Preeshagul:

So, we do get that concern a lot. And I always say, “I’m here for you 24/7. And, if it’s not me, it’s someone that’s just as qualified to answer your questions no matter what.” 

“And I would rather get a phone call at 3:00 a.m. than get a phone call at 9:00 a.m., and you need to go to the hospital right now or God forbid something happened. I get a phone call from someone in the ICU that you went overnight and terrible things happened. So, I want the phone calls to come through to keep you out of the hospital and keep you from going south. So, call me.” And I never try to – I don’t try to outline contingency plans or criteria of what would warrant a call, because then you end up getting in trouble.  

I always just tell my patient, “Think about how you’re feeling now in front of me. If you’re feeling any different than how you feel at this very moment, call me.”  

What Non-Small Cell Lung Cancer Treatment is Right for You?

What Non-Small Cell Lung Cancer Treatment is Right for You? from Patient Empowerment Network on Vimeo.

What’s the best approach for YOUR lung cancer? Dr. Isabel Preeshagul discusses the importance of engaging in your lung cancer care decisions, shares advice for working with your team to determine a treatment approach, and reviews factors that affect therapy options. Dr. Preeshagul also provides an update on the latest research and clinical trials.

Dr. Isabel Preeshagul is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. Learn more about Dr. Preeshagul.

Download Program Resource Guide

See More From INSIST! Lung Cancer

Related Resources:

An Expert Explains Predictive Biomarker Testing for Lung Cancer

An Expert Explains Predictive Biomarker Testing for Lung Cancer

Personalized Lung Cancer Treatment | Key Factors to Consider

Personalized Lung Cancer Treatment | Key Factors to Consider 

Understanding Currently Available Non-Small Cell Lung Cancer Treatments

Understanding Currently Available Non-Small Cell Lung Cancer Treatments 


Transcript:

Katherine Banwell:

Hello and welcome. I’m Katherine Banwell, your host for today’s program. Today, we’ll discuss the latest advances in non-small cell lung cancer care as part of our Insist series, which encourages patients to play an active role and insist on better 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. Well, let’s meet our guest today. Joining me is Dr. Isabel Preeshagul. Dr. Preeshagul, it’s so good to have you with us. Thank you. Would you introduce yourself? 

Dr. Isabel Preeshagul:

Yes. Thank you so much for having me and for the very kind introduction. My name’s Isabel Preeshagul. I am a Thoracic Medical Oncologist at Memorial Sloan Kettering Cancer Center, and it is a huge honor to be here with you today. 

Katherine Banwell:

Well, we’re so glad to have you with us. I’d like to start with a question pertaining to our series title, Insist. Why is it essential for patients to collaborate with their providers on care treatment decisions? 

Dr. Isabel Preeshagul:

So, collaborating is so important, right? I always tell my patients this is not a dictatorship, right? This is a collaborative effort where I’m here to guide you, but you are the captain of the ship. 

You are the one that needs to make all of the decisions, and I’m here to make sure that the ship goes in a smooth direction, so making sure we have open lines of communication that the patients and their caregivers feel comfortable talking to me and my team and also vice versa and that we trust each other. It’s so important because we are going for a marathon, right? We’re not going for a sprint. This is a long-term relationship, whether we’re treating for cure or we’re treating you with palliative intent and it’s treatable but not curable. We’re going to be following with each other for a long time.  

Katherine Banwell:

A lung cancer healthcare team, of course, consists of a number of different providers. Would you tell us about the various members on a team? 

Dr. Isabel Preeshagul:

Sure. So, there is – there are the people that do the scheduling, that make sure that the CAT scan is scheduled, that the MRI is done, your chemo gets scheduled, all of that. The schedulers are super important and an integral part of our team.  

And then we also have our office coordinators  that answers the phone calls and passes along the messages and assists with scheduling and sort of sets expectations and is the face of the practice. Then you have an office practice nurse or an oncology practice nurse who is the doctor’s right hand, making sure that the patients get proper chemotherapy teaches, making sure that they understand about possible side effects, risks versus benefits, making sure medications are up to date, assessing symptoms.  

They are sort of the front line when it comes to any patient call they’re triaging, and they’re escalating or deescalating. That would be the office practice nurse. And then you have an advanced care practitioner, an APP. You either have a nurse practitioner or a PA that’s working with you that’s sometimes seeing patients independently, sometimes putting chemotherapy orders, you know, really serving as almost as another doctor. 

If for some reason there is something that the doctor’s not available to do, the doctor needs in a pinch, or my patients that are almost at long-term follow-up that are doing great that are just kind of coasting, I will share with my NP and make sure that they know her just as well as they know me. And sometimes there’s a fellow or there’s a resident or there’s a med student that’s part of the team as well because see one, do one, teach one. It’s really important to teach those that are coming after you and serve as mentors and really include them in part of the team and part of the decision-making. And then you have the doctor that just kind of oversees everything.  

Katherine Banwell:

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

Dr. Isabel Preeshagul:

So, the goal of treatment, I think, is really contingent upon someone’s stage, but it’s also contingent upon what’s important to the patient, right? So, we have patients that are stage I all the way to stage IIIC that we treat with intention to cure.

And patients that have stage IV disease, it’s treatable but not curable. So, I am very transparent with that as long as I have the information to have that discussion. With that being said, there are some patients with stage IIIdisease or stage I disease that don’t really want treatment and want to focus on quality of life. And that’s okay too. And in which case, you know, at some point, their cancer will likely progress. How quickly or when that will happen, we don’t know. Could they pass from something else? It’s possible. But you really need to talk about what’s important to the patient, because it’s not always cut and dry.  

Katherine Banwell:

As you mentioned, Dr. Preeshagul, there are several different support members on a team. What would you say to patients or even care partners who can sometimes feel like they’re bothering their healthcare team with their questions and comments? 

Dr. Isabel Preeshagul:

So, we do get that concern a lot. And I always say, “I’m here for you 24/7. And, if it’s not me, it’s someone that’s just as qualified to answer your questions no matter what.” 

“And I would rather get a phone call at 3:00 a.m. than get a phone call at 9:00 a.m., and you need to go to the hospital right now or God forbid something happened. I get a phone call from someone in the ICU that you went overnight and terrible things happened. So, I want the phone calls to come through to keep you out of the hospital and keep you from going south. So, call me.” And I never try to – I don’t try to outline contingency plans or criteria of what would warrant a call, because then you end up getting in trouble.  

I always just tell my patient, “Think about how you’re feeling now in front of me. If you’re feeling any different than how you feel at this very moment, call me.”  

Katherine Banwell:

Good advice. I’d like to turn to the clinical side of non-small cell lung cancer. What tests help you identify the type and stage of lung cancer?  

Dr. Isabel Preeshagul:

Obviously, you need a CAT scan. You need a CAT scan of the chest, abdomen, pelvis, and you need an MRI brain and a PET scan.  

Those are really the gold standards for determining clinical staging. In regards to pathologic staging, it’s really important to have tissue samplings. So, you biopsy a site of disease that’s concerning to you. If it looks like there’s only disease in the chest, you want to biopsy the site where there’s the tumor, and then you talk with your thoracic surgery or pulmonary team to determine the best way to sample the mediastinum for full staging.  

Katherine Banwell:

Why is an accurate diagnosis so important?  

Dr. Isabel Preeshagul:

So, an accurate diagnosis is so important because lung cancer is by no means black and white anymore. There are so many histologic subtypes that we are learning about. There are so many different molecular drivers that we are learning about. So, making sure you have the right diagnosis, full and next-generation sequencing testing, all of the imaging that you need could really make or break your treatment plan.  

Katherine Banwell:

Dr. Preeshagul, let’s talk about biomarker testing. How is biomarker testing for lung cancer different from hereditary genetic testing?

Dr. Isabel Preeshagul:

So, we do do hereditary genetic testing for lung cancer patients as well. So, I think let’s backtrack a little bit. When you’re doing on a patient, there’s germline mutations and there’s somatic mutations. And germline mutations are mutations that you might get from Mom and Dad that they got from their parents and so on and so forth that you could give to your children or your brother and sister or whatever. So, that’s germline testing that could be passed along.  

That would be like BRCA or any other APC gene, but we are learning more and more that there are mutations in lung cancer that do have a hereditary aspect to them. So, we are learning now that while we do somatic testing, which is to find a mutation that just spontaneously happened in your tumor all on its own, it’s really important to pair that with germline testing to make sure that there isn’t some kind of heritable mutation that’s also driving this lung cancer.  

Katherine Banwell:

You mentioned hereditary genetic testing. Should family members of people with lung cancer undergo genetic testing then just to be reassured? 

Dr. Isabel Preeshagul:

So, if there is a germline mutation, then they should – the family members should be referred to a geneticist to have that discussion.   

Katherine Banwell:

What are common lung cancer biomarkers? 

Dr. Isabel Preeshagul:

So, we have nine biomarkers within approval right now, but there are so many. There’s more than I could even talk about today. But some of the more common ones are EGFR, ALK, ROS1, MET exon 14. You have KRAS, KRAS-G12C, which is a newer one. We have NTRK. We have RET. The list goes on, HER2. I could talk for – there’s not enough time on this Zoom video to talk about all of the mutations. But there are nine mutations with approvals as of now to date, this very moment. That could change tomorrow.  

Katherine Banwell:

Of course, it could. How do biomarkers in lung cancer affect treatment options for lung cancer patients? 

Dr. Isabel Preeshagul:

So, it used to only be in stage IV, but now we are learning that biomarker testing is really important from the get-go because we have induction or neoadjuvant protocols that are looking at giving targeted therapy before patients go to surgery. 

We know that there’s FDA approval for patients to get targeted therapy after surgery, and there’s a survival advantage there. So, make sure that you have next-generation sequencing testing regardless of your stage.  

Katherine Banwell:

Okay. That’s good advice. So, we’ve heard how testing and a patient’s individual disease can lead to more targeted options. And you just mentioned targeted therapies. How do they work? 

Dr. Isabel Preeshagul:

So, there’s many different targeted therapies that we have. Some of given as an infusion. For HER2, for example, we have TDXD, and we have T-DM1. TDXD is the only drug that’s FDA-approved in this setting. There are clinical trials looking at T-DM1. For EGFR Exon 20, we have another infusional drug called amivantamab (Rybrevant). For EGFR Exon 19 and Exon 21, we have a pill called osimertinib (Tagrisso). For KRAS, there’s a pill. For most of the driver alterations, it’s a pill, but some of them it does require infusional therapy. 

But these are therapies that are targeted at the cells that harbor that mutation.  

Katherine Banwell:

Let’s turn to immunotherapy. What is it, and how does it work? 

Dr. Isabel Preeshagul:

So, immunotherapy is basically teaching your body to recognize cancer as foreign. So, when you have – I always kind of use this hand model. So, basically, a normal cell has, let’s say, three prongs. And then sometimes what happens is cancer will grow a marker called PD-L1 that makes it hide from the immune system. So, the body thinks that this is a normal cell. So, what immunotherapy does is it comes up and it sort of puts a cap on that PD-L1 so that the cell looks foreign again and the body can attack that cell and get rid of it. So, it’s almost like ramping up your immune system to recognize that marker and get rid of that cell. 

Katherine Banwell:

What is the regimen for immunotherapy, and how often is treatment administered? 

Dr. Isabel Preeshagul:

So, immunotherapy is approved in the neoadjuvant setting, which means before chemotherapy. It’s approved after chemotherapy, and it’s approved in the stage IV setting. There are many different regimens and many different dosings and many different drugs. But it’s typically given in your veins, either once every three weeks or once every four weeks for a certain amount of time. If it’s given in a curative setting and it’s given indefinitely or until there’s disease progression or intolerance in the stage IV setting.  

Katherine Banwell:

Okay. Let’s touch upon the side effects of these types of treatment. You’ve mentioned that there are so many, but what are some of the major side effects, and how are they managed? 

Dr. Isabel Preeshagul:

Side effects of immunotherapy can include pneumonitis, which is inflammation of the lungs, any kind of endocrinopathy like issues with your thyroid, issues with your pancreas like diabetes.  

It can cause colitis, which is diarrhea, inflammation of the colon, hepatitis, inflammation of the liver. It can cause cerebritis, inflammation of the brain. It can cause arthritis or arthralgias, inflammation of the bones. And it can also cause rash and fatigue. 

Typically, if it’s the thyroid, it’s managed with thyroid replacement hormone or a drug that would calm down the thyroid if it’s overactive. Pneumonitis is steroids. Hepatitis is sometimes treated with steroids. Colitis, steroids typically. Steroids usually come somewhere in there, usually not with the endocrinopathies, but the other itis’s, it’s typically – we start with steroids and go up from there. And the goal is to really recognize these toxicities before they become a problem and just at the glimmer of them just starting.  

Katherine Banwell:

So, would you consider these treatments to be personalized medicine then? 

Dr. Isabel Preeshagul:

So, it’s personalized in the sense that if someone has a high PD-L1 expression, there may be some data to demonstrate that they may benefit from immunotherapy or have a response. If someone can’t tolerate chemotherapy or is not interested in chemotherapy or has other reasons that may preclude them from getting it, it might be reasonable. So, in that sense, it is considered personalized.  

Katherine Banwell:

How would you define personalized medicine? 

Dr. Isabel Preeshagul:

To me, personalized medicine takes into account the biologic makeup of a patient’s disease like if they have a mutation and what their PD-L1 status is, what the histologic makeup of it. What’s their stage? And then, on the other hand, what’s important to that patient? If they’re a tailor, you want to make sure you’re not giving them a medication that’s going to cause neuropathy, so they can’t use their hands.  

If they enjoy playing the harp or the piano, same thing. If their goal is to continue to run marathons, you may want to avoid something that’s going to cause inflammation of the lungs and risk them for pneumonitis. Tailoring to make sure that the treatment is part of their life but does not become their life. 

Katherine Banwell:

If the test results don’t reveal one of the biomarkers you’ve been talking about, what other treatments are available?  

Dr. Isabel Preeshagul:

So, if I don’t have an FDA approval, then sometimes we look to see if there is a clinical trial in our early phase drug development program, and we talk about a clinical trial. If there’s no clinical trial and I don’t have an FDA approval, then we have to talk about what options are considered standard of care and how to make that work into the patient’s lifestyle.  

Katherine Banwell:

What about surgery? When is it used?  

Dr. Isabel Preeshagul:

Surgery is typically used in the curative setting with early-stage disease. We’re really trying to give patients some kind of chemotherapy or some kind of treatment before they go to surgery. It’s shown to improve outcomes. It just gives us a en vivo view of how the tumor will respond to the treatment. So, we typically use surgery in the curative setting. And, at times, it’s appropriate to use surgery for a metastasectomy when you have one little site that’s growing. Sometimes after a tumor board discussion, it might be reasonable to resect that area.  

Katherine Banwell:

Is radiation still used? 

Dr. Isabel Preeshagul:

Same thing. It can be used in the curative setting, typically for patients with stage IIIB or stage IIIC disease and combined with chemotherapy patients that are not considered surgical candidates, or it’s used in the palliative setting when patients have painful metastases. 

Katherine Banwell:

Would you define the B and C? You’ve mentioned that a couple of times.  

Dr. Isabel Preeshagul:

Yeah. 

Katherine Banwell:

We’re used to hearing Stage 1, 2, 3, 4. But what’s a stage IIIB and a stage IIIC? 

Dr. Isabel Preeshagul:

Yeah. Sure. Sure. So, it does get a little bit into the weeds here about the size of the tumor and the amount of lymph nodes and location of the lymph nodes. But basically, stage IIIA is considered resectable. That means – that could be the size of the tumor with no lymph nodes, or it could be a smaller tumor with a lymph node on the same side as the disease. Stage IIIB would be a lymph node right underneath the windpipe at the station 7. And stage IIIB also includes lymph nodes that have crossed over to the contralateral side. And stage IIIC would be lymph nodes that are maybe up at the contralateral supraclavicular space. 

Katherine Banwell:

Okay. Do treatment options change if the lung cancer returns? 

Dr. Isabel Preeshagul:

Yes, they do change depending on if this is the same tumor type that’s come back. It’s typically a different treatment algorithm, yeah.   

Katherine Banwell:

Okay. And should biomarker testing be done again if a relapse occurs? 

Dr. Isabel Preeshagul:

100 percent. Because it guides everything about a patient’s treatment. It’s super important.  

Katherine Banwell:

Okay. What are you excited about right now in lung cancer research? 

Dr. Isabel Preeshagul:

I am excited and overwhelmed by the fact that we have so many approvals and so much exciting data that was just presented at ASCO and World Lung and ESMO that it’s next to impossible to keep up. And I’m happy that we have that problem, and I’m happy that the patients have – there’s a spotlight on lung cancer when we were in the shadows. And now, I think we have the spotlight. 

And all of these approvals, you know, with it being Lung Cancer Awareness Month as well, I think is just so important. Just to make sure that we get the knowledge of these new approvals out there though, that is another struggle. 

Katherine Banwell:

Well, are there any current clinical trials that look promising to you? 

Dr. Isabel Preeshagul:

Yeah, I think there are many clinical trials. In the induction setting, there was some data that was just presented on ALINA looking at adjuvant alectinib (Alecensa). We just had a – we have approval for adjuvant osimertinib (Tagrisso) and the ADAURA trial.  

But we are learning more and more that as these targeted therapies have approval in stage IV, we’re trialing them in stage III, and then we’re going to trial them in earlier stages and earlier settings. So, this has been the pattern of how drugs get approved. So, yes, there’s lots of exciting data coming through. 

Katherine Banwell:

That’s excellent. Can you talk about antibody drug conjugates and where they fit into lung cancer care? 

Dr. Isabel Preeshagul:

Yeah. That’s a great question. I don’t think anyone knows the answer as to where they fit in just yet. 

We have probably over 300 antibody drug conjugates that are in development right now. And one of the more common ones that we use is trastuzumab deruxtecan (Enhertu), or TDXD, which is used in patients that harbor HER2 alterations in the stage IV lung cancer setting. It is basically almost like a Trojan horse. So, you have this antibody.  

It’s typically IgG1, immunoglobulin. And then you have a linker, and then at the end of that linker is the warhead or the chemotherapy agent. So, the antibody comes in towards the cancer cell looking very innocent. It binds to the cancer cell. And, once it binds, then everyone inside the Trojan horse or this warhead rush into the cell and get to do its damage. So, it’s a totally different mechanism. We’re trying to outsmart some of the bypass mechanisms that cancer cells develop. And this may be the new wave, but stay tuned, more to come.  

Katherine Banwell:

Right. So, it’s promising.  How can patients find out more about current clinical trials? 

Dr. Isabel Preeshagul:

So, you can always ask your healthcare practitioner if there are any clinical trials at the institution that you’re at, but clinicaltrials.gov has all the clinical trials that are available nationally and internationally.  

You just type in your disease type. You can type in a couple keywords, EGFR maybe or ROS1 or stage IV, something along those lines, and then it should populate a list of clinical trials and what institutions have them open, if they’re still accruing or if they’re not, and a contact on that trial.  

Katherine Banwell:

If a patient is interested in a clinical trial, what kinds of questions should they be asking their healthcare about the trial? 

Dr. Isabel Preeshagul:

So, the first question to ask is, “Do we have any clinical trials that are appropriate for me?” If the answer is yes, “Are they appropriate for me now, or are they appropriate for me if what I’m on right now is not working?” 

So, trying to figure out where that will be, and if they are appropriate for you now, how can I get evaluated, and how can we get things underway? 

Katherine Banwell:

Yeah. What would you say to patients who are interested in participating in a clinical trial, but they’re nervous about it?

Dr. Isabel Preeshagul:

I think one thing that I love about being on a clinical trial is that there are more eyes are on you, because we are looking to get something approved, and we are just watching every single little granular detail. In a way, it’s almost like you’re being more micromanaged than if you were on standard of care because of just how many stops and checks there are, how many eyes are looking at your labs after the doctor and the nurse and the nurse practitioner, and the fellow take a look at everything. It’s 10 other people. So, it’s almost like it’s extra safe because of all of that. It’s exciting because you are hopefully getting tomorrow’s treatment today, right? 

You’re trailblazing the way for other people after you. So, I think it’s exciting, but, of course, it’s nerve-wracking. It’s something new. You don’t know if it’s going to work. But I have to believe that the way that clinical trials are designed now and the clinical trials that we choose to open here, we really hope are going to be pushing the space forward. 

Katherine Banwell:

Yeah. I’d like to get to a few questions that we received from audience members prior to the program. How do you help a family member that is an overwhelmed caregiver but refuses help? Any tips on how to provide support to this person?  

Dr. Isabel Preeshagul:

I mean, I think we see caregiver burnout thousands of times a day, unfortunately, and the first thing is knowing how to recognize it. And the second most important thing is taking the time away from the visit with the patient to address the burnt-out caregiver, because there is not enough time in any visit to ever – there’s never enough time in my mind to spend with a patient.  

I’m always pulled in a thousand different directions. And I think we all feel that. But taking the appropriate time to sit down and to say, “Hey. Listen. I recognize that you’re burnt out. I can see it. Who is in your corner helping you?” And just directing focus away from the patient just for a moment and to really focus on that caregiver and to rely on the social work team and the case manager and the support groups that your institution may have and to make sure that they know about those resources. 

Katherine Banwell:

Yeah. Here’s another question we received. “Can you share more information regarding treatments available for stage IV lung cancer and their side effects?” 

Dr. Isabel Preeshagul:

It depends on if this is non-small cell or small cell. It depends on if you have a driver alteration or not. So, I think that is a little bit challenging to talk about in just one session. But basically, you’re probably looking at some kind of targeted therapy if you have a mutation versus standard of care if you don’t have a targeted mutation versus a clinical trial. And I think those are kind of like the big baskets.  

Katherine Banwell:

When is a second opinion necessary? Dr. Isabel Preeshagul: A second opinion is necessary anytime you want a second opinion.  

Dr. Isabel Preeshagul:

There is no right or wrong time, any time. You’re just not jiving with your oncologist after the first day you met them, second opinion. You’re at the end of the line and you really want toknow more, second opinion. You’ve met two other doctors. You’re not jiving, third opinion. It’s always appropriate anytime you want. 

Katherine Banwell:

So, the patient shouldn’t feel obligated to stay with that one provider? 

Dr. Isabel Preeshagul:

Never. Never, never, never, never, never. No. Please don’t feel that way. There are no hard feelings. And, if there are, that’s not the right oncologist for you. It needs to feel like a perfect friendship. And, if it’s not that, it’s not the right thing.    

Katherine Banwell:

Before we close, Dr. Preeshagul, I’d like to get your final thoughts. What would you say to the audience about the future of lung cancer care and treatment? 

Dr. Isabel Preeshagul:

I do think that the future is bright because, as I mentioned, there is now this light that is shining in the lung cancer space. And things are getting approved. and discoveries are getting made faster than we can even keep up, which is exciting and overwhelming and daunting. But I am happy that, finally, this space is taking off, so I feel optimistic.  

Katherine Banwell:

Okay. All right. Well, I wanna thank you so much for taking the time to join us today, Dr. Preeshagul.  

Dr. Isabel Preeshagul:

Thank you so much for having me. These were wonderful questions, and I look forward to many more discussions with you. Thank you.  

Katherine Banwell:

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 today.   

Expert Perspective | Disease Modification in Polycythemia Vera

Expert Perspective | Disease Modification in Polycythemia Vera from Patient Empowerment Network on Vimeo.

Is it possible to change the course of disease in polycythemia vera patients? MPN specialist and researcher Dr. Lucia Masarova shares an overview of the research in disease modification, discussing her work as the coauthor in an article entitled Moving Towards Disease Modification in Polycythemia Vera, recently published in the journal Blood.

Dr. Lucia Masarova is an MPN Specialist and Assistant Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. Learn more about Dr. Masarova

 

Related Programs:

Are There Predictors That an MPN May Be Progressing

Are There Predictors That an MPN May Be Progressing?

Myeloproliferative Neoplasm News and Research Updates

Myeloproliferative Neoplasm News and Research Updates

How Molecular Markers Affect MPN Treatment | Advances in Research

How Molecular Markers Affect MPN Treatment | Advances in Research


Transcript:

Katherine Banwell:

Dr. Masarova, you are a coauthor in an article entitled Moving Towards Disease Modification in Polycythemia Vera, which was recently published in the journal Blood. Can you share some of the highlights of the article and what it means for PV patients? 

Dr. Lucia Masarova:

Disease modification in polycythemia vera. I’m so excited finally being talking about this because we’ve been really, really, really so hungry for this term, although we still don’t know what it means.  

So, we group together with lots of experts in the myeloproliferative neoplasm field and try to brainstorm and put together, “What does it actually mean?” And to me, and to all of us, it was to offer our patients the normal or not-normal lifespan without the consequences of the disease that they face. Because we historically divided polycythemia vera into high-risk or low-risk disease based on the age or previous history of thrombosis or clotting complications.  

However, there is a huge area of patients that wouldn’t have either, and still suffer tremendously a bad quality of life, and ultimately also face the disease progression to myelofibrosis, which is the most actual complication of long-term polycythemia vera duration.  

So, the concept of disease modification would be to actually prevent the complications to even occur. To allow our patient to live free of having the fear of living with a thrombosis or clotting complication or ultimately progress into myelofibrosis. We have to learn how to get there. What are the relevant endpoints of tools for us to utilize to really understand? We have learned a lot from seeing what we call molecular remissions, or control of the JAK2 mutation with certain medications, for example, interferons or latest ruxolitinib (Jakafi), the JAK inhibition, where the decrease of the allele burden, which represents the disease, is correlated with better outcome.  

So, that is something that we have to be learning down the road with a longer follow-up. But that basically triggered us to focus on what can we do better? How do we prevent this from even happening rather than only controlling the historically main points of the disease which are presented by the blood counts symptoms and display? And where we are actually failing quite a lot of patients because despite them having a control count, they still don’t have a happy life, and lots of them suffer and complain.  

So, this is something to be learned, and this is opening the disease modification not only for polycythemia vera, but also for all patients with myeloproliferative neoplasms, which have a little bit of a different feeling in the whole myeloid malignancies field. Because it is a very long disease, and it could evolve and change, and only now we starting to understand what does actually happen there. Why some people could live for 30 years, and never face any consequences, and the others would progress very fast? 

So, disease modification would normally allow us to develop and learn more tools and better biomarkers, but also focus on drugs that are really needed to help with these long-term outcomes of our patients.  

Choosing a Myelofibrosis Treatment Plan | Key Questions to Ask

Choosing a Myelofibrosis Treatment Plan | Key Questions to Ask from Patient Empowerment Network on Vimeo.

When considering therapy for myelofibrosis, where do you start? Dr. Lucia Masarova shares advice and key questions to ask your provider when making myelofibrosis treatment decisions.

Dr. Lucia Masarova is an MPN Specialist and Assistant Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. Learn more about Dr. Masarova.

See More from Evolve Myelofibrosis

Related Resources:

Myelofibrosis Therapies in Clinical Trials | BET Inhibitors

Myelofibrosis Therapies in Clinical Trials | BET Inhibitors

Is Stem Cell Transplant the Only Curative Option for Myelofibrosis?

Is Stem Cell Transplant the Only Curative Option for Myelofibrosis?

Thriving With an MPN: Advice for Setting Goals and Making Treatment Decisions

Myeloproliferative Neoplasm News and Research Updates

Transcript:

Katherine Banwell:

When considering treatment options, what key questions should patients ask about their proposed treatment plan? 

Dr. Lucia Masarova:

What’s the goal of my therapy? That is one of the most important things to know. Patients don’t even know how long they have to be on the medicines. What to do and how does it look when the medicine is still working? What do I need to be looking for in this medicine? And then what are we going to do if it fails? And what does it actually mean when it fails? What is the schedule? How burdensome the treatment is? How often do I have to come?  

How often and what do I have to pay? Because the financial burden we have to really, really face the truth. It is very, very, very significant and somebody living with this disease predicates. It’s something we cannot take lightly, and we really have to combine our efforts and help with that. There are fantastic patient support organizations, but is not well-known, and is still in the rare – in rarer field. So, there’s more effort that we do. 

When do I need more help? Where to be referred to more experts? What is the role of stem cell transplantations, if ever? So, those are really the key things.  

Where do I find reliable resources to learn about my treatment, to learn about the disease? How do I connect with people from the same community? It is a disease with a lower age in a lot of circumstances and really facing this disease in the 30s or 40s or 50s is a really challenging thing. Although we have more and more medications currently, we really do have now to start thinking about their durability, about the safety for long-term, about their assessments for not performing, and where do we place the ultimate cure for stem cell transplants?  

And how do we make it actually happen in more and more eligible patients? Because we have to face the truth. It is still not utilized to where it belongs. Patients are not being referred. 

Patients are not being transplanted. And they may change with novel therapies. But we have to really consider all of our tools to offer the longest life span and to prevent all the disease trouble that comes with living with MPNs.   

Katherine Banwell:

When it comes to clinical trials, where do they fit in in choosing treatment? 

Dr. Lucia Masarova:

For me, it’s number one., and always number one.  

That’s just the academic centers which are dedicated and focused on developing better and novel and up front and just tailored and customized drugs. But I know that the life is out there and it’s a little bit more challenging for everybody to deal with such a rare disease.  

I would definitely say any patient that does not respond to current therapy in terms of uncontrolled symptoms or spleen, or other concerns should be referred and evaluated for participation in clinical trials. It is the only way we could understand what is driving that this is not responding and how could we help the best?   

For patients with myelofibrosis, which is the most aggressive myeloproliferative neoplasm, I would definitely put it in. If they are not doing well on number  one, JAK inhibitor, whatever is being used, they should be highly encouraged to be referred to centers and evaluated for clinical trials. 

We have been developing as others and own strategies to potentiate the benefit and efficacy of the current treatments, as well as agents in what we call salvage or refractory setting.  

However, I cannot emphasize enough to really focus on the first track that providers choose for their patients and utilize it to the best ability to avoid frequent or quick switching. Because in a salvage or  refractory setting we cannot offer the same benefit we could offer upfront. We are pushing the disease, maybe being less responsive, maybe more refractory, if we don’t handle the medication we have currently on the table to the best ability.  

Those are excellent medications, fantastic drugs, but there are shortcomings in each and every one of them. And we could do better to really start thinking about what has happened with the medication, why is it failing the patient, and what else could we do? And that’s only possible in the clinical trial setting, especially in such a rare disease as myeloproliferative neoplasms are.   

Katherine Banwell:

Why is it important for patients to feel like they have a voice in their treatment options? 

Dr. Lucia Masarova:

Because it’s about the patients. I would say, as I always say to my patients, “Nobody’s a better advocate for you than you.” I really, really, really like working with patients. They are educated. They understand where to find resources. They’re not afraid to ask. That challenges all of my team and everybody to really be engaged. They know when to notify me. Not to be quiet when they need something. And really raise their voice when something doesn’t work.  

Patients know their bodies more than anybody can. And no data, no boxes, no books can ever tell me how it actually is. It’s not by chance we have two ears to listen and one mouth to talk.  

So, we have to really listen what the patient has to say and take all the abilities, the resources, the knowledge, the capabilities to really make the best thing for the patients, because it is ultimately and only about that.  

Personalized Lung Cancer Treatment | Key Factors to Consider

Personalized Lung Cancer Treatment | Key Factors to Consider from Patient Empowerment Network on Vimeo.

How is lung cancer therapy personalized? Dr. Erin Schenk, a lung cancer specialist and researcher, reviews important factors and considerations that affect therapy choices, including lifestyle and patient preference.

Dr. Erin Schenk is a medical oncologist, lung cancer researcher, and assistant professor in the division of medical oncology at the University of Colorado Anschutz Medical Center. Learn more about Dr. Schenk.

See More From INSIST! Lung Cancer

Related Resources:

An Expert Explains Predictive Biomarker Testing for Lung Cancer

An Expert Explains Predictive Biomarker Testing for Lung Cancer

Advances in Non-Small Cell Lung Cancer Testing

Advances in Non-Small Cell Lung Cancer Testing

Lung Cancer Care Decisions | Advice for Self-Advocacy

Lung Cancer Care Decisions | Advice for Self-Advocacy


Transcript:

Katherine Banwell:

Personalizing therapy involves taking into account a number of patient factors. What should be considered when deciding on a treatment regimen for a given patient?   

Dr. Erin Schenk:

Uh-huh, yes. That’s a great question and one that is really important in formulating a treatment plan. So, some patients because of their health status, for example, aren’t able to undergo surgery, and that happens. And so, occasionally sort of their health status maybe their lungs don’t work as well as they used to or the heart doesn’t pump as well as it used to. 

You know, those sorts of health concerns can help us tailor and personalize treatments to what would be the most – the safest but also the most effective approach. Occasionally patients have another long-term chronic disease where using immunotherapy might be more dangerous than helpful because they’re sometimes autoimmune diseases.  

Especially ones that affect the brain, so for example multiple sclerosis can be one of those or disease that affect the lungs, you know, interstitial lung diseases. Those would put a patient at great risk of receiving immunotherapy, but outside of the health status, it’s also important I think to talk about what your preferences are as a patient as well.  

Because sometimes we will come to you and say, “Here are these multiple different choices and what’s important to you or maybe what you’re worried about or what you’re concerned about are considerations that we want to hear about and understand so that we can talk you through the process and help make some of these decisions.” You know, for example, if you’re receiving chemotherapy plus radiation together for your cancer care that can be a huge time commitment.   

What I mean by that is when patients get radiation in certain circumstances, that can be once a day every day, Monday through Friday for six weeks at a time and sometimes patients have challenges with transportation. Or sometimes they have you know, challenges balancing a job or childcare or other things like that. So, these are all part of the – just part of bringing it all together and putting together a treatment plan that makes sense for what we understand about the lung cancer itself, but also what we understand about you as our patient. 

You know, how can we make changes or make suggestions that would best fit for you and your needs?  

Katherine Banwell:

When should patients consider a second opinion or even consulting a specialist? 

Dr. Erin Schenk:

I think any time it’s appropriate. We – at our institution, we’re one of the main lung cancer centers that – you know, within several hundred miles, so we frequently see patients and sometimes it’s just to check in and say you know, the patient says, “Here’s what my team has started me on. You know, what do you think should be the next approach?” and we talk about that, but really anytime I think is appropriate for reaching out for another set of eyes to look at things. I would say perhaps some of those most critical times would be prior to treatment starts especially if – yeah, I would say prior to starting a treatment with that new diagnosis.  

That would be a really critical time because often again, sometimes once we start down a treatment path, we’re in some ways we’re committed, but if that maybe isn’t the optimal treatment path based on, you know, the tumor and the biomarkers and the patient preference starting on that less optimal treatment path could potentially hurt patients in the long run. So, I would say at – you know, potentially at diagnosis when a treatment course is recommended and then if there is a need to change treatments.  

So, for example, especially in the metastatic setting there are certain therapies widely available. People are very familiar with them, can start them no problem, but when those treatments stop being beneficial that might be a time to also meet with a specialist or go to a lung cancer center of excellence to get their opinions on what to do next.  

Understanding Currently Available Non-Small Cell Lung Cancer Treatments

Understanding Currently Available Non-Small Cell Lung Cancer Treatments from Patient Empowerment Network on Vimeo.

What options are available to treat non-small cell lung cancer? Dr. Erin Schenk, a lung cancer specialist and researcher, defines personalized medicine for the audience and discusses lung cancer treatment options, including clinical trials.

Dr. Erin Schenk is a medical oncologist, lung cancer researcher, and assistant professor in the division of medical oncology at the University of Colorado Anschutz Medical Center. Learn more about Dr. Schenk.

See More From INSIST! Lung Cancer

Related Resources:

An Expert Explains Predictive Biomarker Testing for Lung Cancer

An Expert Explains Predictive Biomarker Testing for Lung Cancer

Advances in Non-Small Cell Lung Cancer Testing

Advances in Non-Small Cell Lung Cancer Testing

Personalized Lung Cancer Treatment | Key Factors to Consider

Personalized Lung Cancer Treatment | Key Factors to Consider


Transcript:

Katherine Banwell:

We’re hearing the term personalized medicine a lot these days. Would you define the term for our audience? 

Dr. Erin Schenk:

Absolutely, and I think the treatment of non-small cell lung cancer is one of the poster childs for children – for personalized medicine because based on the result of the biomarker testing that’s what drives my choice of therapy because the biomarkers help to tell me what is this cancer most likely to be vulnerable to and that in my mind that’s a wonderful application of the promise of personalized medicine.   

Katherine Banwell:

Okay. Let’s move on to treatment now, Dr. Schenk. Would you walk us through the current treatments being used to treat non-small cell lung cancer?  

Dr. Erin Schenk:

Absolutely, and there are a broad range of options, and thankfully we have so many choices in how to best help patients. And it’s often why visiting with a center that sees a lot of patients with lung cancer can be beneficial so that you have all of the parties at the table that need to be there as we’re making these treatment decisions. So, I would start thinking about patients with early-stage disease. Often surgery if tumors are small enough and there’s not you know, no lymph nodes are involved with the cancer and it’s not anywhere else.  

Sometimes surgery is all that patients might need in terms of their treatment. Those are for patients with smaller tumors and really early-stage disease. As we move forward in the stages, meaning going from stage one to stage two, so a little bit bigger of a tumor, lymph nodes might be involved.   

That’s when really the multi-disciplinary approach happens, and what I mean by that is for example, at my institution where people like me, medical oncologists, radiation oncologists, and surgeons all sit down together to talk about a patient, their scans, you know, what is their health status, what is their biomarker testing, to try to come together to form a treatment approach. And so, at our institution, you know, frequently in stage two to stage three tumors based on biomarker testing we either select upfront surgery followed by chemotherapy followed by sometimes targeted therapies or TKIs.   

Those are the medicines, the TKI, those are the medicines that are really dependent on the presence of biomarker testing. So, the biomarkers often tell us for example if there’s an EGFR mutation. If that’s present then I would use an EGFR TKI, for example. 

But if those biomarkers don’t show an alteration where I have TKI to use, then we frequently are giving patients chemotherapy plus immunotherapy before surgery. This approach is called a neoadjuvant chemoimmunotherapy approach, and it’s one of the newer changes to lung cancer care within the past year that I think really is going to have a positive impact on outcomes for patients with lung cancer.  

So, just again in broad strokes, and then as we move into stage three patients where we can’t resect the tumor, that’s where we give chemotherapy medicines plus radiation therapy. Oftentimes followed by immunotherapy and then when patients have disease that spread outside of the chest, outside of the lungs, the metastatic setting or stage IV, that’s when we think about the whole host of therapies available through medical oncology, systemic therapies is another way to call them.  

And there we think about immunotherapy-based treatments plus or minus chemotherapy or we think about targeted therapy-based approaches with those TKIs. And again, it’s all based on those molecular markers, those biomarkers. 

Katherine Banwell:

Do clinical trials play a role in lung cancer treatment? 

Dr. Erin Schenk:

Clinical trials are incredibly important for the treatment of lung cancer. These are the tests and the procedures that we do that have continuously advanced our ability to care for patients with lung cancer. You know, it was clinical trial data that helped us get alerted to doing chemotherapy and immunotherapy before surgery really can help patients do better. And similarly, clinical trials have helped us define when do we use TKIs or targeted therapies. 

So, I think that’s another great question to ask your team of, “Based on all of the information you know about me and my cancer are there clinical trials options that are available here where I’m at or ones that are really interesting or appealing elsewhere that might be worthwhile for me to consider?” So, clinical trials are a critical part of how we help patients do better.  

Non-Small Cell Lung Cancer Essential Testing | What You Should Know

Non-Small Cell Lung Cancer Essential Testing | What You Should Know from Patient Empowerment Network on Vimeo.

What tests are needed for a lung cancer diagnosis, and how might the results affect treatment options? Dr. Erin Schenk reviews the most common tests for lung cancer, including biomarker testing, and how the results may be used to determine the most appropriate therapy for your particular disease.

Dr. Erin Schenk is a medical oncologist, lung cancer researcher, and assistant professor in the division of medical oncology at the University of Colorado Anschutz Medical Center.

See More From INSIST! Lung Cancer

Related Resources:

Understanding Currently Available Non-Small Cell Lung Cancer Treatments

Advances in Non-Small Cell Lung Cancer Testing

Advances in Non-Small Cell Lung Cancer Testing

Personalized Lung Cancer Treatment | Key Factors to Consider

Personalized Lung Cancer Treatment | Key Factors to Consider


Transcript:

Katherine Banwell:

What are the various subtypes of lung cancer, and how are they identified?  

Dr. Erin Schenk:

Absolutely. So, there are a number of different subtypes of lung cancer that are important for us to identify, because it helps to stratify or helps to select the right treatment approaches for a patient. So, usually when someone is diagnosed with lung cancer there was a scan done at some point that noticed a mass or masses in the body. 

What happens next is a biopsy happens where a needle is used to sample the tissue, and that could be in the lung, that could be in lymph nodes or other parts of the body and that tissue that’s sampled is first sent to my colleagues in pathology.  

And they’re a group of doctors who look at tissues underneath the microscope and try to identify what those are. And based on that initial pathology analysis, we can identify usually pretty straightforward, what is the type of cancer that they see under the microscope.  

And so, in very general terms there are non-small cell lung cancers, there is a group called small cell lung cancers, and there’s also a group called neuroendocrine cancers as well. Oftentimes, times we’re able to differentiate these types of tumors, these types of lung cancers based on how different markers show up, and these are called stains. 

And these stains can differentiate non-small cell between adenocarcinoma versus squamous cell carcinoma. And then they can also help differentiate small cell lung cancer. And then, of course, they can also help to identify if this is a neuroendocrine tumor. 

Katherine Banwell:

Today we’re going to focus on non-small cell lung cancer. Are there specific tests that patients should ask their doctor for following a diagnosis? 

Dr. Erin Schenk:

Absolutely, and I think it’s sometimes helpful to understand what are all the pieces of information I need when I first meet a patient to make decisions about treatments? So, we just went over the histology or another word, the pathology, what does the cancer look like underneath – under the microscope? That can help and that’s one of the pieces, understanding what type of non-small cell lung cancer is present. 

Additional information that’s needed includes certain tests, and you might hear say like, molecular testing or sequencing.  

Those pieces of information can be really important for treatment selection. So, whether there’s a diagnosis of adenocarcinoma or squamous cell lung cancer, we always try to know the PD-L1 status. And that’s actually a surface marker that’s present on the outside of the cancer cells and is able to help us select immunotherapy treatments as appropriate.  

Oftentimes, patients with lung adenocarcinoma will get further sequencing of the tumor itself. And again, you might hear of this called molecular testing or next-generation sequencing, NGS. There are a lot of terms we use for it, but fundamentally, what we’re trying to do is understand the vulnerabilities of the cancer cells. 

And these vulnerabilities can be identified by these molecular tests. They often are able to recognize mutations or fusions or genetic changes within the cancer cells that are present. This is critically important, because we have a whole number of oral targeted therapies that can go after these mutations or alterations, and in other words, they go after the vulnerability in the cancer cells. That’s the adenocarcinoma histology.  

That’s the majority of non-small cell lung cancer diagnoses but I think also if you have been told your diagnosis is of squamous lung cancer, classically we don’t often think of those driver alterations or those fusions or mutations that I just spoke about. But I think it’s also quite important for patients in that situation to also undergo molecular testing.  

As we learn more and more, sometimes those squamous lung cancers can also bear those same alterations. Not to the same frequency, but they can be present, and I think it’s important as you’re thinking about a patient to try to understand what are all the tools I have for them to do that sequencing just to make sure you’re not missing something. So, that’s a really in-depth look to molecular testing.  

I’d like to transition to some of the other tests that would be necessary to help put that molecular testing in context. Another important piece is something called staging.  And staging is a way to determine if the lung cancer has traveled elsewhere in the body. 

Sometimes it can be involved in the lymph nodes of the middle of the chest. Sometimes it can go outside the chest. For example, to the bones or the liver or the brain, and understanding that information, understanding that lay of the land before we start treatment, is really important, not only for treatment selection, like the treatments, the medicines I would give as a medical oncologist.  

But also, in thinking about which other colleagues of mine who help take care of patients with lung cancer should I also involve in some of these treatment decisions. So, staging can often involve CT scans of the chest, abdomen, pelvis. A PET scan can be done. As well as an MRI of the brain. 

Katherine Banwell:

Dr. Schenk, I just want to confirm that you’ve been speaking about molecular testing, that’s the same as biomarker testing, right? 

Dr. Erin Schenk:

Exactly. Exactly. 

Katherine Banwell:

And how is it performed? 

Dr. Erin Schenk:

So, biomarker testing, molecular testing, NGS, there’s a whole range of synonyms we use, that is done primarily on the tumor tissue.  

So, the first test that usually comes back is a marker on the cancer cell. 

That’s PD-L1. That is an IHC test that is able to be done pretty quickly and we’re able to have a turnaround time of just a few days to understand that first biomarker. But the PD-L1 status does not make sense unless we have all of the other information to get the best context, the best understanding of the tumor and what drives the tumor. That additional testing is actually the next-generation sequencing where the genetic material of cancer cells, the DNA and RNA is sequenced in a laboratory to look for those mutations or fusions or other alterations that can drive the cancer cells. And again, it helps me identify additional vulnerabilities in the cancer cells to allow me to pick the optimal therapy for the patient in front of me.  

The tissue testing is the gold standard and we try to get all of our answers from the tissue. Sometimes we’re also able to get additional information from the blood, and that’s what’s called a liquid biopsy. Cancer cells – in some patients, cancer cells shed their genetic material into the bloodstream.  

And these specialized tests are able to pick up that genetic material, have the sequencing done on that, and then report back to me about what may or may not be found.  

Now, as I mentioned, not all of lung cancers shed this information into the blood, so it’s not – if the blood does not reveal an answer or information, that’s – we still need to look closer at the tissue, but occasionally if the blood reveals certain alterations, that can be acted upon, and we don’t have to wait for the tissue testing. 

I think one of the challenges that I absolutely sympathize with their biomarker or molecular testing is that it can take a series of weeks to really get all of the information necessary to make the best choice for the patient in front of us.  

And I have a – I have a saying I like to share with patients that is really important and I think really fundamental to the treatment choices for patients with lung cancer and that is, it’s better to get started on the right treatment rather than the fast one, and that’s true. We know through a series of clinical trials that if I were to start a patient on a treatment that wasn’t appropriate to their biomarkers I actually hurt them. So, I actually reduce how well their later therapies will work. 

And so, it’s a tough wait and I anxiously wait with all of my patients but it’s a really important – it’s really important to get all of that information together. 

Katherine Banwell:

Well, would the cancer change dramatically over a period of three or four weeks?  

Dr. Erin Schenk:

That’s it, you know, that’s a question I hear a lot from patients, and, again, to empathize with the agony of waiting, it’s hard to wait but I can tell you as a doctor who’s taken care of many, many patients with lung cancer the weeks do not make a difference in terms of will have – will it hurt me? So, it will not in general it does not hurt to wait. It’s better to get started on the right treatment because the right treatment has the highest chance of being effective. 

So, the two to three weeks very rarely in my experience has that changed a situation for a patient, but that’s also why we frequently do the liquid biopsy testing at the same time as the tissue testing, because we too want to try to get the answer as quick as possible. So, we try to exhaust all of the routes that we have to get the answer that we need for our patients. 

Katherine Banwell:

What about the latest advances, is there anything in lung cancer testing that patients should know about?  

Dr. Erin Schenk:

Yes, absolutely. I think more and more we’re using these liquid biopsies in different situations for patients with lung cancer. So, Katherine, you and I have mostly been talking about patients who’ve been diagnosed with metastatic disease or a disease that’s been spread outside of the lungs. The liquid biopsy testing, though we’re starting to use in patients who have tumors we can remove with surgery or tumors we can try to cure with a combination of chemotherapy and radiation therapy. 

And we’re using more as a marker of response, and what I mean by that is let’s say someone with a cancer that can be surgically resected or removed by surgery, we can check their liquid biopsy. And if we see a marker in their liquid biopsy, we can then follow that over time in conjunction with scans to try to understand is the cancer – you know, with all the information we can, is the cancer completely gone or are we starting to see that marker again? Do we need to think about doing different scans or different tests to look for a potential area of recurrence of the cancer? 

Katherine Banwell:

What sort of questions should patients be asking about their test results? 

Dr. Erin Schenk:

Uh-huh. I think there are – I think the primary question is “Have you sent my tissue for biomarker testing?” 

And this is true – in my opinion, this is true regardless of the stage of diagnosis, again in the non-small cell lung cancer space, and that’s because we are starting to use some of our targeted therapies as well as our immunotherapies in patients with cancer that can be resected by surgery or maybe would get chemotherapy and radiation therapy. So, these biomarkers are also important in that decision-making for patients that have an earlier stage of disease. And so, I think the first question is, “Has my tissue been sent for biomarker testing?” because I think that’s a part as a necessary part of care given the advances that we’ve made.  

That’s the first question, two, “When do you expect the results? When did it get sent off?” and then three, you know once that has been sent off and whether that’s tissue testing, liquid biopsy, or both, talking with your doctor and your team about what it means.  

How they incorporate this data into your treatment decisions, and then occasionally, asking about did they get all the information they need? Because while we’ve been able to do this biomarker testing for lung cancer for years now, you know, no test is perfect and sometimes cancer cells aren’t the best material to start with when you’re trying to get a really definitive answer.  

So, occasionally patients might need to be biopsied again to really and truly get the full spectrum of information necessary prior to making treatment decisions.