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Outpatient Management and Difficulties

Insights From: Nilanjan Ghosh, MD, PhD, Levin Cancer Institute; David Maloney, MD, PhD Fred Hutchinson Cancer Research Center
Published: Thursday, Dec 20, 2018



Transcript: 

Nilanjan Ghosh, MD, PhD:
There have been some centers able to offer outpatient CAR T-cell therapy. What is needed is a good infrastructure for outpatient management where a patient can be seen any day of the week, which means those sites should also have providers available on the weekends to evaluate these patients. Also needed is a way to admit these patients as easily as possible to the inpatient setting if they have any signs of toxicity, such as a fever, which could be a first sign of CRS [cytokine release syndrome], or slight confusion or a headache, which could be a sign of neurotoxicity. The ability to easily move them from the outpatient to the inpatient setting is essential. It is also very important if we offer outpatient CAR T therapy to somebody, that they live close to the center so that they can come in easily and not have too much of a lag between observing a toxicity and getting admitted. These are important considerations for outpatient therapy.

It is also important to decide who may be a candidate for outpatient therapy which, in my mind, would be someone who is very stable, has a good performance status, does not have high disease burden, is reliable, lives very close to the center, and has a good social support system and caregivers who are reliable and can call whenever there is any toxicity.

David Maloney, MD, PhD: Here in Seattle at the Bezos Family Immunotherapy Clinic, we’re very comfortable giving the 4-1BB–containing CAR T-cell products in the outpatient setting. But that’s because we have extensive experience and a very robust clinic wherein we have 24/7 triage and the ability to immediately care for patients in the hospital at the first sign of CRS or other toxicities.

With the 4-1BB CARs as I mentioned earlier, we’ve seen a more gradual onset of symptoms and most patients will present with fevers. They do not require urgent escalation of care into an ICU [intensive care unit], and there’s time to get them directly admitted to the hospital; their care is then assumed by the inpatient team. With the CD28 CAR, such as axicabtagene ciloleucel [Yescarta], that onset is much quicker and I do not believe that it is safe to do that in the outpatient setting. Patients require a more urgent evaluation when they become symptomatic with fevers, because this can quickly escalate to requiring supportive care, oxygen, fluids, and ICU care for blood pressure support.

I believe, ultimately, that this may be doable in the outpatient, or in the community setting, but the community centers really have to be top-notch centers that have experienced groups in the outpatient and inpatient setting, as well as having available emergency departments and ICU care. Recognition of cytokine release syndrome is absolutely critical, and early treatment when indicated is mandatory. I don’t think there are many community centers available that really have that degree of support to be able to do this yet. It could certainly be done the future, but it really requires this 24/7 triage, recognition, and an experienced team to take care of the patients.

Obviously the cost of CAR T-cell therapy is multifactorial. There’s the cost of the drug—which is obviously a large portion of it—but there’s also the cost of the care. This can be broken down into the outpatient care, the restaging, and necessary tests, to make sure that you can do this successfully. Then there’s the supportive care, which is often done in the inpatient setting. Any kind of treatment that can vary the ratio of inpatient-to-outpatient care could potentially reduce the cost. What we are seeing now with the 4-1BB–containing CARs, is that they have a track record of being able to be done in the outpatient setting. In the JULIET trial, about a quarter of the patients were treated initially as outpatients, with hospitalization at the first sign of symptoms.

This will translate potentially into the preservation of resources, which consequently make CAR T-cell therapies more enticing, driving the acceptance of it up in the medical community. Obviously, there are 3 factors that are important to consider with regard to this; the first is efficacy: If the product works more effectively, that’s going to greatly influence the market; so far, however, they look quite similar. The second issue is safety and outpatient administration, which, if streamlined, will further improve the likelihood of increased CAR T-cell therapy availability. Lastly is the cost, which, if reduced, will greatly improve accessibility.


Transcript Edited for Clarity
 
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Transcript: 

Nilanjan Ghosh, MD, PhD:
There have been some centers able to offer outpatient CAR T-cell therapy. What is needed is a good infrastructure for outpatient management where a patient can be seen any day of the week, which means those sites should also have providers available on the weekends to evaluate these patients. Also needed is a way to admit these patients as easily as possible to the inpatient setting if they have any signs of toxicity, such as a fever, which could be a first sign of CRS [cytokine release syndrome], or slight confusion or a headache, which could be a sign of neurotoxicity. The ability to easily move them from the outpatient to the inpatient setting is essential. It is also very important if we offer outpatient CAR T therapy to somebody, that they live close to the center so that they can come in easily and not have too much of a lag between observing a toxicity and getting admitted. These are important considerations for outpatient therapy.

It is also important to decide who may be a candidate for outpatient therapy which, in my mind, would be someone who is very stable, has a good performance status, does not have high disease burden, is reliable, lives very close to the center, and has a good social support system and caregivers who are reliable and can call whenever there is any toxicity.

David Maloney, MD, PhD: Here in Seattle at the Bezos Family Immunotherapy Clinic, we’re very comfortable giving the 4-1BB–containing CAR T-cell products in the outpatient setting. But that’s because we have extensive experience and a very robust clinic wherein we have 24/7 triage and the ability to immediately care for patients in the hospital at the first sign of CRS or other toxicities.

With the 4-1BB CARs as I mentioned earlier, we’ve seen a more gradual onset of symptoms and most patients will present with fevers. They do not require urgent escalation of care into an ICU [intensive care unit], and there’s time to get them directly admitted to the hospital; their care is then assumed by the inpatient team. With the CD28 CAR, such as axicabtagene ciloleucel [Yescarta], that onset is much quicker and I do not believe that it is safe to do that in the outpatient setting. Patients require a more urgent evaluation when they become symptomatic with fevers, because this can quickly escalate to requiring supportive care, oxygen, fluids, and ICU care for blood pressure support.

I believe, ultimately, that this may be doable in the outpatient, or in the community setting, but the community centers really have to be top-notch centers that have experienced groups in the outpatient and inpatient setting, as well as having available emergency departments and ICU care. Recognition of cytokine release syndrome is absolutely critical, and early treatment when indicated is mandatory. I don’t think there are many community centers available that really have that degree of support to be able to do this yet. It could certainly be done the future, but it really requires this 24/7 triage, recognition, and an experienced team to take care of the patients.

Obviously the cost of CAR T-cell therapy is multifactorial. There’s the cost of the drug—which is obviously a large portion of it—but there’s also the cost of the care. This can be broken down into the outpatient care, the restaging, and necessary tests, to make sure that you can do this successfully. Then there’s the supportive care, which is often done in the inpatient setting. Any kind of treatment that can vary the ratio of inpatient-to-outpatient care could potentially reduce the cost. What we are seeing now with the 4-1BB–containing CARs, is that they have a track record of being able to be done in the outpatient setting. In the JULIET trial, about a quarter of the patients were treated initially as outpatients, with hospitalization at the first sign of symptoms.

This will translate potentially into the preservation of resources, which consequently make CAR T-cell therapies more enticing, driving the acceptance of it up in the medical community. Obviously, there are 3 factors that are important to consider with regard to this; the first is efficacy: If the product works more effectively, that’s going to greatly influence the market; so far, however, they look quite similar. The second issue is safety and outpatient administration, which, if streamlined, will further improve the likelihood of increased CAR T-cell therapy availability. Lastly is the cost, which, if reduced, will greatly improve accessibility.


Transcript Edited for Clarity
 
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