Abstract
Cellular therapy has made a landmark change within the treatment paradigm of several solid and hematologic malignancies. Novel cellular therapy products, such as chimeric antigen receptor (CAR) T-cell, have demonstrated impressive efficacy and produced durable responses. However, cellular therapies have been associated with significant toxicities as well as financial burden. Most of these therapies have been administered in the inpatient setting due to their toxicity profile particularly with cytokine release syndrome and neurological complications. Improved toxicity management strategies and better understanding of cellular therapy processes have been recently established. Therefore, efforts to transition cellular therapies to the outpatient setting are warranted with the potential to translate into enhanced patient quality of life as well as cost-savings. A successful launch of outpatient cellular therapies requires several components including a multidisciplinary cellular therapy team, and an outpatient center with appropriate clinical space and personnel. Additionally, a plan for patient workflow, criteria for admission upon clinical decompensation, toxicity management guidelines, and incorporation of telemedicine should be implemented. Effective education about cellular therapy and toxicity management is imperative especially for the Emergency Department and Intensive Care Unit teams. This information will be discussed to support patients as cellular therapy programs transition to outpatient treatments.
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Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene Ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377:2531–44.
Schuster SJ, Bishop MR, Tam CS, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380:45–56.
Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382:1331–42.
Sarnaik AA, Hamid O, Khushalani NI, et al. Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma. J Clin Oncol. 2021;39(24):2656–66.
Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transpl. 2019;25:625–38.
Corp. NP. Tisagenlecleucel (Kymriah) [prescribing information]. East Hanover, NJ2020.
Juno Therapeutics I, a Bristol Myers Squibb Company. Lisocabtagene maraleucel (Breyanzi) [prescribing information]. Bothell, WA2021.
Kite Pharma I. Axicabtagene autoleucel (Yescarta) [prescribing information]. Santa Monica. CA2021.
Owattanapanich W, Suphadirekkul K, Kunacheewa C, Ungprasert P, Prayongratana K. Risk of febrile neutropenia among patients with multiple myeloma or lymphoma who undergo inpatient versus outpatient autologous stem cell transplantation: a systematic review and meta-analysis. BMC Cancer. 2018;18:1126.
Tan XN, Yew CY, Ragg SJ, Harrup RA, Johnston AM. Outpatient autologous stem cell transplantation in Royal Hobart Hospital, Tasmania: a single-centre, retrospective review in the Australian setting. Intern Med J. 2021;
Dhir V, Zibdawi L, Paul HK, et al. Quality of life and caregiver burden in patients and their caregivers undergoing outpatient autologous stem cell transplantation compared to inpatient transplantation. Blood. 2019;134:62.
Schulmeister L, Quiett K, Mayer K. Quality of life, quality of care, and patient satisfaction: perceptions of patients undergoing outpatient autologous stem cell transplantation. Oncol Nurs Forum. 2005;32:57–67.
Summers N, Dawe U, Stewart DA. A comparison of inpatient and outpatient ASCT. Bone Marrow Transplant. 2000;26:389–95.
Brudno JN, Kochenderfer JN. Toxicities of chimeric antigen receptor T cells: recognition and management. Blood. 2016;127:3321–30.
Alexander M, Culos K, Roddy J, et al. Chimeric antigen receptor T cell therapy: a comprehensive review of clinical efficacy, toxicity, and best practices for outpatient administration. Transpl Cell Therpy. 2021;
Company BMS. Idecabtagene vicleucel (Abecma) [prescribing information]. Summit, NJ2021.
Kite Pharma I. Brexucabtagene autoleucel (Tecartus) [prescribing information]. Santa Monica, CA2021.
Maus MV, Alexander S, Bishop MR, et al. Society for Immunotherapy of cancer (SITC) clinical practice guideline on immune effector cell-related adverse events. J Immunother Cancer. 2020;8
Cell Therapy 360. 2021. https://www.breyanzi.com/support/cell-therapy-360/. Accessed 25 May 25 2021
Dulan SO, Viers KL, Wagner JR, et al. Developing and monitoring a standard-of-care chimeric antigen receptor (CAR) T cell clinical quality and regulatory program. Biol Blood Marrow Transpl. 2020;26:1386–93.
Maus MV, Nikiforow S. The why, what, and how of the new FACT standards for immune effector cells. J Immunother Cancer. 2017;5:36.
Myers GD, Verneris MR, Goy A, Maziarz RT. Perspectives on outpatient administration of CAR-T cell therapy in aggressive B-cell lymphoma and acute lymphoblastic leukemia. J Immunother Cancer. 2021;9
Beaupierre A, Kahle N, Lundberg R, Patterson A. Educating multidisciplinary care teams, patients, and caregivers on CAR T-cell therapy. J Adv Pract Oncol. 2019;10:29–40.
Neelapu SS, Tummala S, Kebriaei P, et al. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018;15:47–62.
Perica K, Curran KJ, Brentjens RJ, Giralt SA. Building a CAR garage: preparing for the delivery of commercial CAR T cell products at memorial Sloan Kettering cancer center. Biol Blood Marrow Transpl. 2018;24:1135–41.
Salter AI, Pont MJ, Riddell SR. Chimeric antigen receptor-modified T cells: CD19 and the road beyond. Blood. 2018;131:2621–9.
Shank BR, Do B, Sevin A, Chen SE, Neelapu SS, Horowitz SB. Chimeric antigen receptor T cells in hematologic malignancies. Pharmacotherapy. 2017;37:334–45.
Philip J, Sarkar RS, Pathak A. Adverse events associated with apheresis procedures: incidence and relative frequency. Asian J Transfus Sci. 2013;7:37–41.
Hill JA, Seo SK. How I prevent infections in patients receiving CD19-targeted chimeric antigen receptor T cells for B-cell malignancies. Blood. 2020;136:925–35.
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Lucena, M., Gatwood, K.S., Savani, B.N., Oluwole, O.O. (2022). Roadmap for Starting an Outpatient Cellular Therapy Program. In: Ghobadi, A., DiPersio, J.F. (eds) Gene and Cellular Immunotherapy for Cancer . Cancer Drug Discovery and Development. Humana, Cham. https://doi.org/10.1007/978-3-030-87849-8_18
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DOI: https://doi.org/10.1007/978-3-030-87849-8_18
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