Proper care coordination and patient education are essential to the success of delivering chimeric antigen receptor T-cell (CAR T) therapy, particularly in preparing patients for potential adverse events.
A multidisciplinary team approach to education and supportive care, led by a nurse coordinator, was able to successfully implement adverse event management across 22 sites in patients with refractory diffuse large B cell lymphoma (DLBCL) who received axicabtagene ciloleucel as part of the ZUMA-1 trial, reported Alix Beaupierre, RN, BSN, OCN, at the 2017 BMT Tandems Meeting.
In this phase I trial, a subset of 7 patients with refractory DLBCL who received axicabtagene ciloleucel (KTE-C19) demonstrated an overall response rate (ORR) of 71% and a 57% complete response (CR) rate. Grade ≥3 cytokine release syndrome (CRS) occurred in 14% of patients and grade ≥3 neurologic events in 57%.
The latest safety and efficacy data from an interim analysis reported at the meeting showed a 79% ORR and 52% CR in 52 patients overall treated with axicabtagene ciloleucel and who had at least 3 months follow-up at the August 24, 2016 data cutoff. Safety data available for 93 patients overall with at least 1 month of follow-up, showed the rate of grade ≥3 CRS to be 13% and grade ≥3 neurologic events to be 29%. There have been 3 fatal events excluding progressive disease.
All CRS events resolved except for 1 cardiac arrest. Three neurologic events were ongoing at data cutoff (grade 1 memory impairment and 1 each of grade 1 and 2 tremor). No cases of cerebral edema were reported. Two deaths related to axicabtagene ciloleucel occurred: hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of CRS.
Early into the study, it became apparent that care coordination was needed to streamline the process for the healthcare team.
“In treating these patients, nursing was originally not involved,” said Beaupierre, transplant nurse coordinator at the Moffitt Cancer Center. “There was a lot of patient and loved one distress. The patients didn’t have anything concrete to visualize telling them what they’re going to experience.
“I would say that any center considering having a CAR T program needs to make sure from day 1 that there’s a nursing coordination component for the patient. It improves their perception of the outcomes and experience.”
As a result, she and the clinical nurse specialist created an educational folder that patients were instructed to bring to all appointments. The materials in the folder explained clinical events they could expect during the course of therapy, such as central line placement and care, side effects of at-home chemotherapy, CRS, neurologic events, and neutropenic precautions, in addition to how CAR T-cell therapy works, tips for inpatient stay, and discharge planning. The value of a caregiver in the process was also stressed. Additional education along the continuum could be maintained and accessed at any point by the patient, caregiver, and staff.
Involving the caregiver is important to increase education comprehension, to maintain patient safety during the outpatient chemotherapy phase, and to identify early side effects during the post-infusion hospitalization to set in motion the proper course of action, said Beaupierre.
Each patient also received a calendar of appointments for medical testing, apheresis with line placement, and a tour of the outpatient treatment center. “It’s all mapped out; we found that the patient experience is much better with something that’s tangible,” she said.
Vigilant supportive care and tocilizumab and corticosteroids were used to treat grade ≥3 CRS and/or neurologic events. In the overall study population, 38% of patients received tocilizumab, 17% received corticosteroids, and 17% received both.
With these precautions and treatments, “the axi-cel regimen has a manageable toxicity profile,” she said. CRS and neurologic events were self-limiting and reversible in the vast majority of cases. Nurses and caregivers at the bedside played a role in early identification of symptoms.
A second phase of the program has added a classroom setting to patient and caregiver education. “We realize that patient and loved one education is most valuable from the moment of the consent decision to help navigate the patient through the process. That is the key take home,” concluded Beaupierre.
Beaupierre A, Patterson A, Kahle N, et al. Interdisciplinary management of refractory non-Hodgkin lymphoma (NHL) patients treated with Kte-C19 (anti-CD19 chimeric antigen receptor [CAR T] cells) in the ZUMA-1 clinical study. Presented at: BMT Tandem Meetings; February 23-26, 2017; Orlando, Florida.
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