Sufferers who acquired lymphodepletion within the inpatient setting had a 60-day non-relapse mortality charge of seven.1%.
Sufferers with B-cell acute lymphoblastic leukemia (B-ALL) and mantle cell lymphoma (MCL) skilled related charges of non-relapse mortality and a suitable security profile with outpatient administration of lymphodepletion forward of receiving Tecartus (brexucabtagene autoleucel) compared with inpatient administration of lymphodepletion and Tecartus, outcomes from a retrospective examine introduced on the 2024 ASH Annual Assembly have proven.
Findings confirmed that sufferers administered lymphodepletion within the outpatient setting (28 sufferers) — regardless of the setting for Tecartus infusion — skilled a 60-day non-relapse mortality charge of three.6% versus 7.1% for these given lymphodepletion and Tecartus within the inpatient setting (28 sufferers). The six-month progression-free survival (PFS) charge was 83.3% for the outpatient group versus 71.1% for the inpatient group.
Glossary
Lymphodepletion: chemotherapy administered earlier than CAR-T cell remedy.
Non-relapse mortality: demise with out a recurrence or development of illness after a stem cell transplant.
Development-free survival (PFS): the time sufferers reside with out their illness spreading or worsening.
ECOG efficiency standing: a system of scoring a affected person’s capability to finish day by day duties, with a decrease rating indicating greater operate.
Allogeneic stem cell transplant: the alternative of a affected person’s stem cells with cells from a donor.
Autologous stem cell transplant: when a affected person receives an infusion of their very own wholesome stem cells.
Cytokine launch syndrome (CRS): a situation typically seen after CAR-T cell remedy when there’s a massive launch of cytokines into the blood from immune cells, which can result in signs together with nausea, fever, rash, headache, low blood strain, fast heartbeat and hassle respiratory.
Hypotension: low blood strain.
Dyspnea: shortness of breath.
Full response (CR): the disappearance of most cancers.
Immune effector cell-associated neurotoxicity syndrome (ICANS): A neurological situation that will happen from CAR-T cell remedy brought on by an immune response from the therapy. Signs embrace issue concentrating, confusion, headache, temper adjustments, seizures, muscle weak spot/numbness and imaginative and prescient issues.
“[Tecartus] is secure to manage [in the outpatient setting] with related efficacy and non-relapse mortality,” lead examine writer Dr. Tamer Othman of Metropolis of Hope in Durante, California, and colleagues wrote in a poster presentation of the information. “Future research with [a] bigger pattern dimension and longer follow-up are wanted to verify our findings.”
Investigators performed a retrospective examine of grownup sufferers with B-ALL or MCL handled with Tecartus at Metropolis of Hope between Nov. 1, 2020, and March 31, 2024. Sufferers had been divided into two teams. The primary group included sufferers given lymphodepletion within the outpatient setting, regardless of the setting of Tecartus infusion. The second group featured sufferers given lymphodepletion within the inpatient setting.
Within the total inhabitants (56 sufferers), 66% had B-ALL, and 34% had MCL. The median age was 55 years, and most sufferers had been male (77%), had been Hispanic White (61%), had an ECOG efficiency standing of 0 to 1 (93%), and had greater illness burden (75%). Sufferers acquired a median of 4 prior traces of remedy; 23% of sufferers underwent a previous allogeneic stem cell transplant and seven.1% acquired a previous autologous stem cell transplant.
Within the outpatient group, 82% of sufferers acquired Tecartus within the outpatient setting; all sufferers within the inpatient group had been infused with CAR-T cell remedy within the inpatient setting. Notably, 86% of sufferers within the outpatient group had been admitted to the hospital after beginning lymphodepletion within the outpatient setting at a median of eight days after the beginning of lymphodepletion. Causes for admission included Tecartus-related toxicities similar to fever due to cytokine launch syndrome (CRS) (71%), hypotension as a consequence of poor oral consumption (4.2%) and dyspnea (4.2%). Different causes for admission included high-burden illness (13%), fever throughout lymphodepletion as a consequence of leukemia (4.2%) and ache management throughout lymphodepletion (4.2%). The median time hospitalized throughout the first 100 days from the beginning of lymphodepletion was 10 days within the outpatient group versus 27 days within the inpatient group.
Further knowledge confirmed that sufferers with B-ALL within the outpatient group (20 sufferers) achieved a whole response (CR) charge of 90% versus 88% within the inpatient group (17 sufferers). In sufferers with MCL, the CR charges had been 75% within the outpatient group (eight sufferers) versus 73% within the inpatient group (11 sufferers).
Security knowledge confirmed that any grade CRS occurred in 86% of sufferers within the outpatient group versus 82% within the inpatient group. The charges of grade 3 (extreme) or greater CRS had been 7.1% and 14%, respectively. The respective median durations of CRS had been 4 days and 4 days. Any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 54% of sufferers within the outpatient group versus 61% within the inpatient group. The respective charges of grade 3 or greater ICANS had been 29% and 25%. The median period of ICANS was 4 days within the outpatient group versus seven days within the inpatient group. Actemra (tocilizumab) was given for toxicity to 79% of sufferers within the outpatient group versus 75% of sufferers within the inpatient group. The median variety of Actemra doses was two in each teams.
Steroids got for toxicity to 79% of sufferers within the outpatient group versus 71% of sufferers within the inpatient group; the charges of prophylactic dexamethasone administration had been 32% and 25%, respectively. Prophylactic anakinra was given to 29% of sufferers within the outpatient group versus 7.1% of these within the inpatient group. Remedy anakinra was given to 25% and 18% of sufferers, respectively.
Reference
“Outpatient administration of brexucabtagene autoleucel (brexu-cel) for acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL) is secure and possible” by Dr. Tamer Othman et al., Blood.
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