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Can Race or Ethnicity Impact CAR T-Cell Therapy Response?

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Can Race or Ethnicity Impact CAR T-Cell Therapy Response? from Patient Empowerment Network on Vimeo.

Can CAR T-cell therapy response be impacted by patient race or ethnicity? Expert Dr. Sikander Ailawadhi from Mayo Clinic discusses some impacts to CAR T-cell therapy response for African Americans and some clinical methods to help reduce impacts to patients.

[ACT]IVATION TIP

“…there is a lot of work happening, research happening around how to predict and prevent side effects from CAR T so that the patients are much more informed, aware, can make an informed decision, and as clinicians, we can do whatever is within our control and is at our disposal to help prevent those side effects and make CAR T an even safer and more beneficial treatment for patients.”

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How Can Equitable CAR T-Cell Therapy Access Be Increased?

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How Can Information Disparities on Emerging Therapies Be Addressed?

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Transcript:

Lisa Hatfield:

Dr. Ailawadhi, is there data around ethnicity and response to CAR T-cell therapy and whether genetic factors may affect treatment outcomes? And can the side effects of CAR T-cell therapy be predicted or prevented?

Dr. Sikander Ailawadhi:

So Lisa, a very important question of whether there are racial ethnic factors that can affect CAR T-cell therapy benefit or side effects, and what are we doing to prevent some of these side effects? We know side effects can happen, what can we do to actually prevent them? So I’ll take this question in two different subgroups. The first one of talking about racial ethnic groups or differences. So we know patients who are African Americans. This is one study reported that African Americans are more likely to have side effects from CAR T-cell therapy.

So while it’s not a specific “genetic factor,” but race ethnicity can sometimes be associated with more side effects, and that is just because these are very inflammatory delivered or inflammatory mediated side effects like CRS. It’s also important to know that there are certain other factors, disease or treatment-related factors, that can help predict potentially more side effects with CAR T. For example, patients who are very heavily pre-treated, patients who have a very high disease burden, patients who did not respond to bridging therapy that was given to them prior to the CAR T.

These are all factors where we know that side effects are going to be more, and the success of the treatment might be lesser. What we are trying to do to mitigate some of these side effects, there are now studies which are giving either some low doses of steroids as a prophylaxis before, right around the time of CAR T, so that side effects may not happen. Studies that are giving a low dose or even standard dose of what’s called tocilizumab (Actemra), toci, or tocilizumab.

This toci drug is an antidote for CRS or cytokine release syndrome. The thought is, well, why wait for the toci to be given after the side effect happens? Why not give it beforehand and prevent the CRS? Historically, there was a concern that steroids or toci given early on could affect the CAR T-cell viability or activity, but that’s not the case. For example, in lymphomas, there are clinical trials that have shown very clearly given prophylactic or preventative steroids could help. Using steroids or toci in a preventative manner is helping mitigate some of the side effects. 

Well, by preventing the side effects, we are being able to give the treatment in a way that the patients may have lesser side effects and can get it done closer to home or at home sometimes, and their time to stay in the hospital is lesser. You can imagine that some of these barriers are being further mitigated.

My activation tip for this question is that there is a lot of work happening, research happening around how to predict and prevent side effects from CAR T so that the patients are much more informed, aware, can make an informed decision, and as clinicians, we can do whatever is within our control and is at our disposal to help prevent those side effects and make CAR T an even safer and more beneficial treatment for patients.

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What Side Effects Are Possible Following CAR T-Cell Therapy?

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What Side Effects Are Possible Following CAR T-Cell Therapy? from Patient Empowerment Network on Vimeo.

Myeloma expert and researcher Dr. Beth Faiman shares an overview of both rare and mild side effects that may affect people who have undergone CAR T-cell therapy. Dr. Faiman also discusses patient monitoring and explains methods to help combat potential issues caused by CAR T-cell therapy.

Dr. Beth Faiman is an Adult Nurse Practitioner in the department of Hematologic Oncology and Blood Disorders at the Cleveland Clinic. Learn more about Dr. Faiman.

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Considering CAR T-Cell Therapy? Key Advice From an Expert

Transcript:

Katherine Banwell:

So, after CAR T-cell therapy is completed, what potential side effects might people experience, and what should they look for?  

Dr. Beth Faiman:

Absolutely. I think of things in short-term and long-term side effects. So, the short term, you’re going to be admitted to the hospital and you have a risk for – when we get those T cells back – that cytokine release syndrome, or it’s abbreviated CRS – where you’re body’s immune system’s fighting.  

I tell folks it’s kind of like if you got a vaccine for a flu vaccine or pneumonia and you had a reaction it’s just way worse. So, you can get a high fever – the big first sign of this CRS. Usually, the providers will jump in with giving you a medication called tocilizumab (Actemra) or a similar drug that blocks IL-6, which is a chemical that is triggered when we get the CRS. And then, it stops those symptoms. And so, most of us know how to do that and will approve your insurance to get access to that tocilizumab or similar drug when we approve your CAR T-cell therapy.  

So, that CRS can get you really, really sick. You can get low oxygen levels in your blood. You can get a high fever and you can drop your blood pressure. But most CAR T-cells centers, the nurses and the staff are very well-trained to monitor this every eight hours, in most cases.  

Another rare side effect we worry about is ICANS, and it’s a neurotoxicity kind of thing.   

It can be with CRS or without CRS. But they’ll ask you to do things like write your name on a piece of paper every eight hours or tell me – draw a clock or count backwards from 100. And so, if you have any deviation, even minor, from what you reported back beforehand then we worry about neurotoxicity. Now, that’s short term but that’s the reason why you can’t drive a car for 30 days is because it could be delayed. 

The CRS can start with the one thing, the Ide-cel usually occurs within one day so most people are admitted to the hospital for that CAR T-cell therapy. The Cilta-cel, it onsets to about seven days. So, some people get the Cilta-cel outpatient and then are monitored daily, whether in person or through virtual telehealth monitoring.  

But at any rate, those are the short-term. Long-term, we worry about low blood counts maybe for the first month afterwards. And then, those will come back to normal. And then, we worry about infection. So, I mentioned the antibacterial, antiviral, which is usually a medicine called acyclovir (Zovirax), which most myeloma patients will have been on anyhow. And then, that IVIG to protect against viruses and bacteria when your immune system is so low. 

But fortunately, if we control the CRS, it usually comes with the CRS, although it can be independent. We try not to give steroids, because we don’t want it to interrupt the CAR T-cell process. But many institutions will give that tocilizumab for ICANS. And if that doesn’t get better then they’ll give you a steroid, such as dexamethasone (Decadron). 

And so, that will usually reverse itself pretty quickly. Longer term, after 30 days, you can get with the Carvykti, particularly something called Parkinsonian things where you can get a little bit shaky or something like that. Again, it’s very rare and I have had hundreds of people who have undergone the CAR T-cell procedure at my institution. And knock on wood, fortunately, I’ve not seen first-hand that side effect. And I think it’s because we’re so good now at treating the – preventing the ICANS and CRS as best as we can while they’re inpatient and doing real close following.  

One other thing I want to note is if somebody who’s watching this does go in the hospital for any reason, get up and walk around and stay strong, as well as you can, during the procedure. You might be bored if you’re in the hospital anyhow, but try to stay as strong as you can in the hospital. It’ll help your post recovery for sure.  

Katherine Banwell:

Well, what about more mild side effects like fatigue and changes in appetite?  

Dr. Beth Faiman:

Absolutely. So, the fatigue and the changes in appetite are generally mild for most but I see it, in my experience, if your myeloma’s acting up really quickly, if you’re having a rapid disease progression, the medications that we give you to control the myeloma during this bridging therapy phase might cause some of that as well, not necessarily the CAR T-cell process. But think about it. We’re using your own cells engineered to be fighters.  

And so, that first month or two is probably when you’re going to be the most tired as your body is being programmed to fight against the myeloma cells. That fatigue tends to get better. And as I mentioned just a moment earlier, the importance of just walking around in the halls, getting out of bed when you’re in the hospital, that can really help your post recovery. It doesn’t seem like much, but there have been many studies about how muscle mass declines, energy declines when you’re hospitalized.  

And we want you to be as strong as you can and thrive as much as you can for when you’re out you can then do the things you want to do at a quicker pace.  

CAR T-Cell Therapy Care Partners: Tools for Accessing Support

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CAR T-Cell Therapy Care Partners: Tools for Accessing Support from Patient Empowerment Network on Vimeo.

How can care partners access support during the CAR T-cell therapy process? Expert Dr. Amitkumar Mehta discusses the support patients may need during CAR T and resources for accessing patient and family support.

Dr. Amitkumar Mehta is Director of the Lymphoma Program and CAR T Program and Medical Director of the Clinical Trials Office at O’Neal Comprehensive Cancer Center at UAB. Learn more about Dr. Mehta.

See More from The Care Partner Toolkit: CAR T-Cell Therapy

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Why Is a Care Partner Essential for Patients Undergoing CAR T-Cell Therapy?

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What Is CAR T-Cell Therapy for Myeloma? 

 How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape?

How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape? 

Transcript:

Katherine:

What support services or resources are available for care partners of patients who are undergoing CAR T-cell therapy?

Dr. Mehta:

Unfortunately, I have to say that there are not that many support systems existing. It depends on the center most of the time. And, remember, that many of the centers – you know, CAR T is not offered at every community center.

Usually, they are certified centers. So, on an average, patients might have to travel to go to the center, right? So, it’s mainly center dependent. Now – and, you know, like, if I talk about my center, as I was mentioning, that I like to have the caregiver as a part of the process so they are aware what the patient is going through. Second person is – or second team person is our clinic nurse or CAR-T coordinator who actually talks to the patient in depth as well as patient’s caregiver.

Now, if you are living farther away from the center, three hours, four hours, five hours, in that case, where do I lodge myself, whether there is any other support system? We are going to stay here. Where I’m going to eat? Where is the center? Where do I have to them, whether I have to take them daily or not? So, those kinds of information is provided mainly by the center.

And centers also have many other support systems that we can tap in. The most important is to highlight is CAR T is not cheap. It’s very expensive treatment, right? So, there’s an extra step of insurance approval. Well, what is your copay? So, financial toxicity so to speak also come in picture and not only for the patients but their caregiver also.

We need to sit down if they need additional help. What other sources? What are the other agencies or maybe a local church or local community it can help? One other thing that our center has done, which has helped quite a bit, we have a patient ambassador. There was a patient who had gone through CAR T, and he had such an experience that he decided to offer his service to other patients who were going through CAR T. And he is always available.

So, he always – whenever he comes for the clinic visit and says “I’ll be happy to talk to anyone including his family, right, his mother and his father. They’re available that if [they support the patient], the caregiver, we would like to talk to them. And we would like to share our experience. And, if they have any questions, we can share the resources available to go through CAR T because, at the end, it’s a potentially curative option.

Why Is a Care Partner Essential for Patients Undergoing CAR T-Cell Therapy?

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Why Is a Care Partner Essential for Patients Undergoing CAR T-Cell Therapy? from Patient Empowerment Network on Vimeo.

How can care partners access support during the CAR T-cell therapy process? Expert Dr. Amitkumar Mehta discusses the support patients may need during CAR T and resources for accessing patient and family support.

Dr. Amitkumar Mehta is Director of the Lymphoma Program and CAR T Program and Medical Director of the Clinical Trials Office at O’Neal Comprehensive Cancer Center at UAB. Learn more about Dr. Mehta.

See More from The Care Partner Toolkit: CAR T-Cell Therapy

Related Resources:

CAR T-Cell Therapy Care Partners: Tools for Accessing Support

 What Are the Risks of CAR T-Cell Therapy?

What Are the Risks of CAR T-Cell Therapy? 

 How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape?

How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape? 

Transcript:

Katherine:

What is the role of a care partner of a patient who is undergoing CAR T-cell therapy?

Dr. Mehta:

CAR T-cell therapy is very important therapy and has evolved as a potentially curative therapy in a relapse setting. It does have a downside. And downside, when I say is side effects, which needs to be monitored closely, and it has to be detected early and intervened early, right? Steroids, as well as tocilizumab (Actemra) or anti-IL-6 treatment, are very, very effective in mitigating some of the side effect of CAR T.

But the whole process is very involved, right? You have a patient identified. Then you go through collection. Some people might get some bridging therapy, then chemotherapy, and then they get admitted. Importantly, after the infusion for two months, some of them could have neurological side effect, and that’s why for label and for safety, the patients cannot drive for two months or operate heavy machinery.

So, the whole process requires a good support. In my opinion, when we screen a patient, that “Okay, somebody’s referred to me, or my patient going through a CAR-T process,” how to make sure that they have a caregiver. And caregiver is immensely important, not only for the safety but also moral support for the patient, right?

Katherine:

Yeah.

Dr. Mehta:

And, importantly, what I make sure is that they’re part of the whole discussion. When we sit down and discuss the whole process, side effects, what’s going to happen, they are there.

They know what their loved one is going to go through. So, caregiver support is immensely important. In some patients, unfortunately, they don’t have a caregiver support. For the sake of safety, we might have to give them opportunity to see whether they can actually secure some sort of support. Maybe their distant family member living in a different state and if they can live with them, or their neighbor, or their close friends. If they can bring them to the clinic visit so that we can also discuss with them the whole process. So, caregiver is a very, very important and vital part of the whole process of CAR T.