NCCN patient guidelines provide ‘basic understanding’ of CAR T-cell therapy toxicities
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The National Comprehensive Cancer Network published the latest in its series of guidelines intended to inform patients and their caregivers about adverse events associated with cancer therapies.
“NCCN Guidelines for Patients: Immunotherapy Side Effects Series” — which is supported by the NCCN Foundation and focuses on chimeric antigen receptor T-cell therapy — is freely available for clinicians and patients to download at the organization’s website (NCCN.org/patients).
The document concentrates on the two most common CAR-T treatment-related toxicities —cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) — and includes information about symptoms and management options.
It also contains a list of resources and glossary of common terms associated with cellular therapies.
“This publication is intended to provide patients with information about [the] most significant toxicities that can develop during CAR T-cell treatment so that they have a basic understanding of them before they arrive at the clinic for treatment,” Olalekan O. Oluwole, MD, MPH, MBBS, assistant professor of medicine, hematology/oncology at Vanderbilt University Medical Center and member of the NCCN Guidelines Panel for Management of Immunotherapy-Related Toxicities, told Healio.
‘A key resource’
Patients who receive axicabtagene ciloleucel (Yescarta; Kite Pharma/Gilead) or brexucabtagene autoleucel (Tecartus; Kite Pharma/Gilead) must be evaluated at least once daily by the center that provided the treatment, according to the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program also requires patients who receive commercially approved CAR T-cell therapies remain within 2 hours of the treating facility for up to 4 weeks after infusion. Only a fraction of that time will be spent at the treatment center, Oluwole said. The remainder often is spent with a designated caregiver, typically a spouse or family member.
The NCCN Guidelines for Patients can help these caregivers, as well as patients, identify indicators of CRS or ICANS after CAR-T infusion, Oluwole said.
“This can be a key resource for both the patient and the caregiver,” he added.
Jordan Gauthier, MD, MSc, assistant professor in the clinical research division at Fred Hutchinson Cancer Research Center, concurred with Oluwole and touted the benefits of the guidelines for patients and caregivers alike.
“CAR T-cell therapy is a complicated treatment — there are many steps and potential for treatment-related toxicities,” Gauthier, who also serves as an assistant professor at University of Washington and attending physician with Seattle Cancer Care Alliance, told Healio. “It’s better to be prepared for the worst and have a good understanding of what can happen during the CAR T-cell therapy process.”
Clinical utility
The NCCN’s patient guidelines have value for clinicians in that they convey treatment details in a clear, straightforward manner, according to Oluwole and Gauthier.
“CAR T-cell therapy is still relatively new, and we are still learning about what can happen during the process,” Oluwole told Healio. “These guidelines can help clinicians communicate about aspects of the treatment with their patients and provide them information about what to expect during the process.”
Although the guidelines may lack utility from a patient management perspective, they can be useful for helping clinicians narrow down key pieces of information to discuss with patients who are considering these therapies, Gauthier said.
Patients at Gauthier’s center already receive information related to their treatment, “but a lot of the documents from our CAR-T welcome packet — especially those from the manufacturer — although they are comprehensive, they tend to be a bit dense in the language,” he said.
He called the language in the NCCN patient guidelines accessible and easy to understand.
“I will recommend that my patients receiving CAR T-cell therapy read this document,” Gauthier told Healio.
For more information:
Jordan Gauthier, MD, MSc, can be reached at jgauthier@fredhutch.org.
Olalekan O. Oluwole, MD, MPH, MBBS, can be reached at olalekan.oluwole@vanderbilt.edu.
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National Comprehensive Cancer Network. Immunotherapy side effects: CAR T-cell therapy. Available at: www.nccn.org/patients/guidelines/cancers.aspx. Accessed July 27, 2020.
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