Select Topic:
Browse by Series:

CAR T Post-Infusion Care and Transitioning to Outpatient

Insights From: Nilanjan Ghosh, MD, PhD, Levin Cancer Institute; David Maloney, MD, PhD Fred Hutchinson Cancer Research Center
Published: Wednesday, Dec 19, 2018



Transcript: 

David Maloney, MD, PhD:
Most patients receiving axicabtagene ciloleucel [Yescarta] will require the treatment be given in the hospital. We do not attempt to administer this product in the outpatient setting. If you did, you would have to admit the patients immediately thereafter for monitoring per cytokine release syndrome [CRS] and neurologic toxicity. Patients are in the hospital between 7 and 14 days; minimum is generally suggested to be 7 days. In my experience it’s closer to 14 days for nearly all patients.

Other products though do not necessarily have to be given in the hospital and there’s not a requirement for inpatient administration with the axicabtagene ciloleucel. However, we have more experience in the outpatient setting with the new clinical trial agent lisocabtagene maraleucel.

So patients, while they’re in the hospital, require intensive monitoring in a general ward first, and then, if they become unstable and develop severe cytokine release syndrome, at least grade 2, most patients will require ICU intensive care unit care to monitor them for those symptoms. This requires very close coordination between all the people participating in the care of the patient, including the nurses, providers, and physicians, as well as the ICU staff. This is a requirement of the REMS [Risk Evaluation and Mitigation Strategy] programs for both products, which requires extensive training of the multiple people involved. At our center there were over 350 people required to become REMS trained to be able to administer the commercial products. This is a big cost to your institution in being able to provide these products.

Now patients are in the hospital until the resolution of symptoms. If they were outpatients, they get admitted at the first sign of symptoms and then are monitored in the hospital until resolution of those symptoms, and then they’re discharged back to outpatient care. They have varying levels of required care at that point: It could be daily—coming in for count checks if they’re still having persistent thrombocytopenia or pancytopenia. Most patients do have significant count suppression and a need for platelet and red cell transfusions during this whole period. In about 20% of patients this can persist for weeks to months after treatment. This has to be managed in the outpatient setting generally before discharging the patient back to their local oncologist.

It’s very critical that these patients are monitored as inpatients and outpatients for these toxicities. When patients develop cytokine release syndrome they can develop other organ toxicity. Regulopathy is common and patients need to be monitored for this and aggressively transfused to prevent bleeding complications. This needs to be done either in the inpatient or outpatient setting, depending on how sick the patient is.

In most cases, patients in the outpatient setting will require a caregiver to be with them essentially 24/7 in that first 30 days or so since patients can develop the onset of CRS or an infection in an urgent situation, where they may or may not be able to make their own decisions and notify healthcare providers.


Transcript Edited for Clarity
Slider Left
Slider Right


Transcript: 

David Maloney, MD, PhD:
Most patients receiving axicabtagene ciloleucel [Yescarta] will require the treatment be given in the hospital. We do not attempt to administer this product in the outpatient setting. If you did, you would have to admit the patients immediately thereafter for monitoring per cytokine release syndrome [CRS] and neurologic toxicity. Patients are in the hospital between 7 and 14 days; minimum is generally suggested to be 7 days. In my experience it’s closer to 14 days for nearly all patients.

Other products though do not necessarily have to be given in the hospital and there’s not a requirement for inpatient administration with the axicabtagene ciloleucel. However, we have more experience in the outpatient setting with the new clinical trial agent lisocabtagene maraleucel.

So patients, while they’re in the hospital, require intensive monitoring in a general ward first, and then, if they become unstable and develop severe cytokine release syndrome, at least grade 2, most patients will require ICU intensive care unit care to monitor them for those symptoms. This requires very close coordination between all the people participating in the care of the patient, including the nurses, providers, and physicians, as well as the ICU staff. This is a requirement of the REMS [Risk Evaluation and Mitigation Strategy] programs for both products, which requires extensive training of the multiple people involved. At our center there were over 350 people required to become REMS trained to be able to administer the commercial products. This is a big cost to your institution in being able to provide these products.

Now patients are in the hospital until the resolution of symptoms. If they were outpatients, they get admitted at the first sign of symptoms and then are monitored in the hospital until resolution of those symptoms, and then they’re discharged back to outpatient care. They have varying levels of required care at that point: It could be daily—coming in for count checks if they’re still having persistent thrombocytopenia or pancytopenia. Most patients do have significant count suppression and a need for platelet and red cell transfusions during this whole period. In about 20% of patients this can persist for weeks to months after treatment. This has to be managed in the outpatient setting generally before discharging the patient back to their local oncologist.

It’s very critical that these patients are monitored as inpatients and outpatients for these toxicities. When patients develop cytokine release syndrome they can develop other organ toxicity. Regulopathy is common and patients need to be monitored for this and aggressively transfused to prevent bleeding complications. This needs to be done either in the inpatient or outpatient setting, depending on how sick the patient is.

In most cases, patients in the outpatient setting will require a caregiver to be with them essentially 24/7 in that first 30 days or so since patients can develop the onset of CRS or an infection in an urgent situation, where they may or may not be able to make their own decisions and notify healthcare providers.


Transcript Edited for Clarity
View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Publication Bottom Border
Border Publication
x