Published on March 24, 2025
Outpatient Monitoring and Community-Based Administration of Lisocabtagene Maraleucel: Insights from Multicenter Studies
by Alex Kadhim
Recent studies from Rutgers Cancer Institute, Mayo Clinic, Swedish Cancer Institute, and multiple community oncology centers have provided critical insights into the feasibility and safety of outpatient monitoring programs for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory large B-cell lymphoma (R/R LBCL). While CAR T-cell therapies have traditionally been administered with inpatient monitoring due to concerns over cytokine release syndrome (CRS) and neurological events (NEs), growing evidence supports outpatient administration as a viable alternative. A multicenter nursing and advanced practice provider (APP) study outlined key elements for successful outpatient monitoring, including phased program implementation, structured adverse event (AE) surveillance, and coordinated multi-institutional collaboration. In this model, patients were discharged on the same day as infusion but remained near treatment centers for at least four weeks, with hospitalization triggered by severe AEs. These findings underscore the importance of nursing and APP involvement in outpatient CAR T-cell programs and highlight cost savings, lower healthcare utilization, and high patient satisfaction associated with outpatient care.
The OUTREACH study, a phase 2 clinical trial, further assessed the safety and efficacy of liso-cel administered in community-based oncology centers across the United States, evaluating 82 patients with R/R LBCL. The study compared outpatient (70%) vs. inpatient (30%) monitoring, with primary endpoints including grade ≥3 CRS, NEs, prolonged cytopenia, and infections. Notably, no cases of severe CRS occurred in either group, while grade ≥3 NEs were observed in 12% of outpatients and 4% of inpatients. Prolonged cytopenia affected 33% of outpatients and 32% of inpatients, and infection rates remained comparable (12% vs. 8%). Importantly, 25% of outpatients never required hospitalization, while another 32% were hospitalized within 72 hours post-infusion. The median initial hospitalization duration was 6 days for outpatients vs. 15 days for inpatients, supporting the feasibility of outpatient administration. Liso-cel demonstrated strong efficacy, with an 80% overall response rate (ORR), a 54% complete response rate (CRR), and a median response duration of 14.75 months.
These studies collectively confirm that liso-cel can be safely administered in outpatient settings with structured monitoring, reducing hospitalization burden without compromising patient safety. The findings highlight the role of nursing and APP-led outpatient programs and reinforce the potential for expanding CAR T-cell therapy access beyond major academic centers into community-based oncology sites. Future research should further refine risk stratification models and identify optimal monitoring protocols to ensure continued safety and efficacy in outpatient settings.
References
McEntee N, Manago J, Lu C, Holmes L. Implementation of a lisocabtagene maraleucel chimeric antigen receptor T-cell therapy outpatient monitoring program: Multicenter nursing/advanced practice provider perspectives. Semin Oncol Nurs. Published online November 22, 2024. http://doi.org/10.1016/j.soncn.2024.151758
Linhares Y, Freytes CO, Cherry M, et al. OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL. Blood Adv. 2024;8(23):6114-6126.
http://doi.org/10.1182/bloodadvances.2024013254
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