In 2017, the U.S. Food and Drug Administration approved two chimeric antigen receptor (CAR) T-cell agents, one of which was axicabtagene ciloleucel for the treatment of adults with relapsed/refractory large B-cell lymphoma following two or more prior systemic therapies.
Kathleen McDermott, RN, BSN, OCN®, BMTCN®, of the Dana-Farber Cancer Institute, and coauthors presented the background for axicabtagene ciloleucel’s approval and nursing best practices for managing patients receiving CAR T-cell therapy during a poster session at the ONS 43rd Annual Congress in Washington, DC. The poster was titled “Chimeric Antigen Receptor T Cell Treatment for Aggressive, Refractory Non-Hodgkin Lymphomas: Nursing Implications of the ZUMA-1 Trial of Axicabtagene Ciloleucel.”
The drug’s approval was based on results from the multicenter, phase I/II ZUMA-1 trial, which found that after a median 15.4 months of follow-up, overall response rate was 82% and complete response rate was 58% among the 108 study participants. The median overall survival (OS) was not reached, and the 18-month OS was 52%. Most patients experienced at least grade 3 adverse events ([AEs]; n = 105; 97%), and infections were observed in eight patients.
Because of the novelty of CAR T-cell therapies and concerns with potentially life-threatening AEs (including cytokine release syndrome [CRS] and neurologic events), oncology nurses play an important role in patient care.
Oncology nurses from several centers that participated in the ZUMA-1 trial developed educational tools for nursing staff who were less experienced with CAR T-cell therapies, as well as materials for multidisciplinary teams that involved monitoring, grading, and AE management. They also developed patient and caregiver education materials.
The poster authors said that centers should be prepared for CAR T-cell therapy by identifying and educating multidisciplinary teams and developing a formal cellular therapy team to optimize safe treatment delivery. Areas of education should include screening to follow-up care, the nurse’s role in identifying CRS and neurologic events, processes for care coordination, and the do’s and don’ts of patient care. They also recommended developing continuing nursing education programs specifically focused on CAR T-cell therapies. Specific order sets should also be created, and training materials should be placed in online repositories and on the nursing unit for easy use.
Patient and caregiver education should include topics such as:
- What CAR T-cell therapy is and how it works
- A timeline for procedure steps for successful apheresis
- Outpatient lymphodepleting chemotherapy management
- CRS and neurologic event signs, symptoms, and management
- B-cell aplasia and its management
- Outpatient and home precautions and monitoring post-infusion.
Patients should receive personalized treatment calendars and a referral to social services to assist with logistic planning. Nursing staff can proactively facilitate discussions with patients to ensure adequate caregiver coverage and resources. Another resource is a patient wallet card (PWC) that provides key information for patients regarding when to contact their oncologist. The researchers suggested giving the PWC to a family member or caregiver, as well as providing a copy to the local oncologist at the time of discharge. In case of a lost PWC, there should be a patient portal that can be accessed online; at follow-up visits, the nursing staff should ask to see the PWC and provide a new one if the original is inaccessible.
Finally, safety and planning post-infusion should be addressed. Patients are advised stay close to the treatment centers for at least four weeks post-treatment, and patients should not drive or operate heavy machinery until at least eight weeks after resolution.
Read all of the best practices and educational materials.