November 2017 VOL 8, NO 11

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Clinical Research

The Chimeric Antigen Receptor T-Cell Treatment Journey: Patient and Nursing Education for Managing the ZUMA-1 Pivotal Trial of Axicabtagene Ciloleucel for the Treatment of Aggressive, Refractory Non-Hodgkin Lymphomas

Kathleen McDermott, RN, BSN, OCN, BMTCN1; Amy Patterson, RN2; Nicole Kahle, RN2; Alix Beaupierre, RN, BSN, OCN2; Maritza C. Alencar, DNP, ARNP-BC, BMTCN3
1Dana-Farber Cancer Institute, Boston, MA; 2Moffitt Cancer Center, Tampa, FL; 3Sylvester Comprehensive Cancer Center, Miami, FL 

Background: Chimeric antigen receptor (CAR) T cells are engineered from a patient’s own immune cells to redirect them to attack tumor cells. ZUMA-1 (NCT02348216) evaluated the anti-CD19 CAR T-cell therapy, axicabtagene ciloleucel (axi-cel; KTE-C19), in adult patients with refractory, aggressive non-Hodgkin lymphoma (NHL). Axi-cel treatment resulted in an objective response rate of 82%, including 54% complete responses (Locke et al. ASCO 2017). Cytokine release syndrome (CRS) and neurologic events (NEs) are potentially life-threatening adverse events (AEs) associated with this class of therapy, with grade ≥3 CRS and NEs occurring in 13% and 28% of patients, respectively. Other common grade ≥3 AEs included cytopenia and encephalopathy. Due to the novelty of the therapy and the multiple touchpoints with the clinic for leukapheresis, conditioning chemotherapy, and infusion of cells, nursing staff and the care team play critical roles in the coordination, management, and education of these patients.

Objective: To describe the role of oncology nurse navigators in educating patients, caregivers, and the multidisciplinary care team to prepare for the CAR T-cell treatment journey.

Methods: Staff was educated on the CAR T-cell process and goal of therapy, including management of AEs. The multidisciplinary care team created reference guides and treatment algorithms to prepare for monitoring, grading, and management of AEs, including those requiring care escalations/transitions. Patient and caregiver education was developed for all stages of the CAR T-cell treatment journey from leukapheresis through discharge. Information was provided in various formats across treatment centers, including fact sheets on CAR T-cells, CRS, and NEs; a treatment flowsheet; a personalized treatment calendar; 1:1 educational meetings; and group classes.

Results: Axi-cel provided significant clinical benefit, with serious but manageable AEs, for patients with refractory, aggressive NHL. While most events of CRS and NEs were reversible and generally manageable with administration of tocilizumab and/or steroids, 13% of patients required vasopressors for CRS-associated hypotension, and 2% required endotracheal intubation, highlighting the importance of multidisciplinary education and coordination of care. Patient and caregiver education through each stage of the journey helped reduce anxiety, increase knowledge, and increase compliance with the CAR T-cell therapy process.

Conclusions: Care team, patient, and caregiver education and communication were key for monitoring AEs and coordinating transitions in acuity of care from leukapheresis to axi-cel infusion and subsequent discharge. Oncology nurse navigators should be familiar with the unique aspects of patient management with CAR T-cell therapies such as axi-cel. A comprehensive education program for educating, coordinating, and collaborating with multidisciplinary care teams, patients, and families can help to optimize the safe implementation of this new treatment paradigm.

Disclosure: Funding provided by Kite Pharma.

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