Patient education, as well as proper care coordination are essential when delivering chimeric antigen receptor T-cell (CAR T) therapy, especially for patients who may face 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, R.N., B.S.N., O.C.N., at the 2017 BMT Tandem Meeting.
In this phase 1 trial, a subset of seven patients with refractory DLBCL who received axicabtagene ciloleucel (KTE-C19) demonstrated an overall response rate (ORR) of 71 percent and a 57 percent complete response (CR) rate. Grade 3 or higher cytokine release syndrome (CRS) occurred in 14 percent of patients and grade 3 or higher neurologic events in 57 percent.
The latest safety and efficacy data from an interim analysis reported at the meeting showed a 79 percent ORR and 52 percent CR in 52 patients overall treated with axicabtagene ciloleucel and who had at least three months follow-up at the Aug. 24, 2016 data cutoff. Safety data available for 93 patients overall with at least one month of follow-up, showed the rate of grade 3 or higher CRS to be 13 percent and grade 3 or higher neurologic events to be 29 percent. There have been three fatal events excluding progressive disease.
All CRS events resolved except for one 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 one 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 or higher CRS and/or neurologic events. In the overall study population, 38 percent of patients received tocilizumab, 17 percent received corticosteroids, and 17 percent 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.