Chimeric antigen receptor (CAR) T-cell therapy is revolutionizing oncology. With two FDA-approved therapies, tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta), some adult and pediatric patients with certain blood cancers have more options for treatment.
This type of therapy, which involves altering a patient's T cells so that they attack cancer cells, is showing great promise. But the benefits also come with high risk for serious, potentially life-threatening, adverse events (AEs).
Oncology nurses play a crucial role in monitoring and managing AEs associated with CAR T-cell therapy, as well as educating staff, patients, and caregivers on what they may experience before, during, and after treatment.
Nurses from Dana-Farber Cancer Institute in Boston, Moffitt Cancer Center in Tampa, and Sylvester Comprehensive Cancer Center in Miami, centers participating in the pivotal ZUMA‑1 trial, assembled practical clinical implications and best practices for implementing CAR T-cell therapy. The findings were presented during a poster session at the Oncology Nursing Society 43rd Annual Congress held in Washington, DC, May 17-20.1
One of the most severe AEs associated with CAR T-cell therapy is cytokine release syndrome (CRS), also known as a cytokine storm, which is caused by a large, rapid release of cytokines from immune cells affected by the immunotherapy.
Common signs include fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and difficulty breathing.
CAR T-cell therapy is also associated with neurologic events (NE) such as seizure and aphasia, as well as other common AEs like cytopenia.
In the ZUMA-1 trial, adult patients with refractory, aggressive non-Hodgkin lymphoma were given axicabtagene ciloleucel. Researchers determined an 82% objective response rate and 58% complete response rate.
The most common AEs of grade 3 or higher during treatment were neutropenia (78%), anemia (43%), and thrombocytopenia (38%).2
Grade 3 or higher CRS and NE occurred in 12% and 31% of patients, respectively.
“The thing that is unique regarding these CAR T therapies is the incidence of cytokine release syndrome and neurologic events that can happen,”
Kathleen McDermott RN, BSN, OCN, BMTCN, Dana-Farber Cancer Institute, said in an interview with Oncology Nursing News.
“It’s the vigilance and close monitoring of the patients that matters, so we can intervene early and pick up subtle symptoms, then treat them appropriately.”
To help the multidisciplinary care team learn about CAR T treatment, the nurses discussed preparations that cancer centers can make. Care teams should undergo educational/training sessions that include the nurse’s role in identifying CRS and NE.
In addition, facilities need to identify key individuals responsible for patients undergoing CAR T, develop continuing education programs, develop CAR T-cell therapy‑specific order sets to ensure quick and safe administration, and place training materials in online repositories and on the nursing unit for easy reference.
Patient Wallet Cards (PWC) list key information, such as the AEs associated with axicabtagene ciloleucel and when a patient should contact his or her oncologist. The card is meant to be given to a physician or emergency room staff if a patient experiences any of the AEs listed. Researchers said staff should decide who should receive a card, such as a family member or caregiver.
“These patients and their families are familiar with chemotherapy, so they know the side effects because they have been through it,” she said. “When CAR T came about, they were like ‘What do you mean I may have a fever of 105 that’s not really related to an infection?’ They also didn’t understand that neurological toxicities may cause confusion or they may be out of it for days. That’s very scary for patients and their families.”
Staff used a number of tools to educate patients and caregivers at their cancer centers including fact sheets and handouts on CAR T cells, CRS, and NE and AE treatment flowsheets. They conducted 1:1 educational meetings and group classes, and developed a personalized treatment calendar for each patient. Staff also referred patients to social services to help with logistical planning.
Staff can take certain safety measures after infusion to help ensure patient safety after infusion. Researchers recommended proactively addressing the logistics of keeping patients safe after infusion and establishing a care transition plan for patients without adequate. Nurses working with these patients should educate family and caregivers in early recognition and reporting of CRS and NE, as well as the risk of late NE and how to intervene.
The researchers also suggested that nurses could start with the medical center’s current post‑transplant patient safety requirements, then modify those requirements for post‑CAR T care as the center gains experience.
In addition, patients should stay close to the treatment center for at least 4 weeks after treatment and avoid driving or operating heavy machinery until at least 8 weeks after resolution.
The researchers also found that education on CAR T-cell therapy reduced patient and caregiver anxiety and increased compliance.
“We can reassure them that this is OK,” McDermott said. “This is to be expected. This is what we want. But we are keeping a close eye on you. That has decreased not only patients’ anxiety but also the families’ anxiety, who sometimes have a harder time because they are watching their family member being so ill in the bed.”
McDermott’s best advice to nurses who will be working with CAR T-cell therapy? “Be educated in the side effects of CAR T, know the grading system, and deliver attentive and diligent care.”
- McDermott K, Kahle N, Beaupierre A, et al. Chimeric antigen receptor T cell treatment for aggressive, refractory non-Hodgkin lymphomas: nursing implications of the ZUMA-1 trial of axicabtagene ciloleucel. Presented at: ONS 43rd Annual Congress; May 17-20, 2018; Washington, DC. Poster IS-18.
- Neelapu SS, Locke FL, Barlett NL, et al. Axicabtagene ciloleucel car T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):2531-2544. doi: 10.1056/NEJMoa1707447.