Pediatric Guidelines for CAR T-Cell Therapy Help Nurses Recognize AEs Earlier

August 23, 2018
Kristie L. Kahl

A year after the first CAR T-cell therapy was approved to treat pediatric patients with relapsed and/or refractory CD19-positive acute lymphoblastic leukemia (ALL), researchers have issued guidelines to help healthcare professionals recognize and treat the associated adverse events (AEs) from this treatment.

A year after the first CAR T-cell therapy was approved to treat pediatric patients with relapsed and/or refractory CD19-positive acute lymphoblastic leukemia (ALL), researchers have issued guidelines to help healthcare professionals recognize and treat the associated adverse events (AEs) from this treatment.

While the guidelines are intended for all healthcare professionalsfrom emergency room and neurology doctors and nursing staff, to medical trainees, pharmacists, and hospital administratorsnurses in particular can benefit from learning to identify these severe AEs earlier on.

“It is important that all providers from a variety of fields be trained to recognize these toxicities because prompt treatment will save lives,” Kris Mahadeo, MD, associate professor of Pediatrics and chief of Stem Cell Transplant and Cellular Therapy at MD Anderson, said in an interview with Oncology Nursing News.

The guidelines were issued to help address patient selection and evaluation, informed consent and assent, bridging from chemotherapy or hemopoietic stem cell transplantation (HSCT), inpatient and outpatient management, CAR T-cell therapy-related AEs, long-term follow-up assessment, and financial and health-system considerations.

In particular, expert consensus focused a section on nursing considerations. The researchers highlighted the importance of communication among coordinators, medical care providers, and nursing administration to ensure that decisions are made as a staff.

For nurses, the researchers recommend for:

  • Available nursing staff that have completed all required competencies to care for patients treated with CAR T cells.
  • Visual cues put in to practice to assist in the rapid recognition of cytokine release syndrome (CRS)/CAR T cell-related encephalopathy syndrome (CRES); and help avoid iatrogenic errors, even during electronic medical record “downtime procedures.”
  • Discharge protocols to ensure comprehensive education has been given to the caregiver and patient about signs and symptoms of CRS and CRES.
  • Giving the patient a wallet or Risk Evaluation and Mitigation Strategies (REMS) identification card for their specific CAR T-cell product.
  • Instruct patients to immediately alert all providers that they have received CAR T-cell therapy, especially if presenting to a facility outside of their original treatment center.

Last year, guidelines were issued for adult patients being treated with CAR T-cell therapy; however, Mahadeo noted there were striking differences between them. In particular, the researchers focused on different ways to identify CRS and CRES.

For example. normal ranges of vital signs such as temperature, heart rate, and blood pressure in pediatrics are more variable compared to adults as they tend to be age dependent, and therefore, cytokine release syndrome (CRS) grading requires attention to normal ranges based on the age of the child, Mahadeo said. He added that a validated pediatric delirium tool (CAP-D) for early CRES recognition among children was also suggested.

“Because of the amount of time pediatric nurses spend at the bedside with their patients, the guidelines provide an algorithm for early recognition of signs/symptoms of toxicity by bedside nurses,” Mahadeo said. “The CAP-D delirium screening, for example, is a validated nursing assessment for pediatric delirium.”

“The guidelines also provide recommendations for nursing communications and provisional orders that allow for rapid escalation of care based on nursing assessments and concerns,” he added.”