Abstract
Objectives: Operationalizing workflows to manage cytokine release syndrome (CRS) in community practices presents challenges for multidisciplinary teams. Real-world experience was gathered from OneOncology community health-care professionals to establish best-practice workflows for CRS management. Methods: Qualitative data were gathered via focus groups from hematology-oncology MDs, PharmDs, and nurse providers (N = 13) with experience treating patients with bispecific T-cell–engaging antibodies (BsAbs). Theme matrix techniques facilitated analysis. Results: Three themes were identified: (1) creating a coordinated workflow plan, (2) building network partnerships, and (3) understanding patient support. Workflow decisions were driven by community practices managing patients treated with BsAbs or partnering with sites for initial dosing and maintenance. Catalysts for developing CRS workflows included: FDA approval of BsAbs; BsAbs clinical trial experience; BsAbs on formulary; having patients receiving BsAbs; and practice champion(s) for protocol development. Key steps included defining communication during and after practice hours, designating training leads, and creating practice-specific plans for interdisciplinary team coordination. Inpatient admission processes developed with hospital staff and hospital staff training were fundamental for successful patient management. Communication processes among practice, pharmacy, and hospital staff throughout BsAbs treatment were established, along with methods to ensure the availability of CRS treatment if needed. Continuous patient/caregiver education on BsAbs treatment, monitoring for adverse events (particularly CRS), and how/when to access care were described. Conclusions: BsAb use in community settings requires multidisciplinary coordination between practices and hospitals. Actions included identifying practice champions, establishing clear workflows for transitioning patients between inpatient and outpatient settings, and ensuring continuous training of staff, patients, and caregivers.
References
Adkins, S. (2019). CAR T-cell therapy: Adverse events and management. Journal of the Advanced Practitioner in Oncology, 10(Suppl 3), 21–28. https://doi.org/10.6004/jadpro.2019.10.4.11
Adu, Y., Das, S., Ailawadhi, D., Fernandez, A., Parrondo, R., Roy, V., Sher, T., O’Connell, S., Rasheed, A., Chanan-Khan, A. A., & Ailawadhi, S. (2023). Patient awareness of CAR-T and bispecific antibody treatments for multiple myeloma: Real-world learnings and disparities. Blood, 142(Suppl 1), 2418. https://doi.org/10.1182/blood-2023-189642
Ahn, M. J., Cho, B. C., Felip, E., Korantzis, I., Ohashi, K., Majem, M., Juan-Vidal, O., Handzhiev, S., Izumi, H., Lee, J. S., Dziadziuszko, R., Wolf, J., Blackhall, F., Reck, M., Bustamante Alvarez, J., Hummel, H. D., Dingemans, A. C., Sands, J., Akamatsu, H., Owonikoko, T. K.,…DeLLphi-301 Investigators (2023). Tarlatamab for patients with previously treated small-cell lung cancer. The New England Journal of Medicine, 389(22), 2063–2075. https://doi.org/10.1056/NEJMoa2307980
Association of Community Cancer Centers & Society for Immunotherapy of Cancer. (2023). Expanding access to cellular and bispecific therapies: Considerations and recommendations. https://higherlogicdownload.s3.amazonaws.com/SITCANCER/2c19e5a6-3adb-4d01-b46c-c01e11745b3a/UploadedImages/Policy/SITC_ACCC_Expanding_Access_Workshop_Report.pdf
Baeuerle, P. A., & Wesche, H. (2022). T-cell-engaging antibodies for the treatment of solid tumors: Challenges and opportunities. Current Opinion in Oncology, 34(5), 552–558. https://doi.org/10.1097/CCO.0000000000000869
Braun, A., Gouni, S., Pulles, A., Strati, P., Minnema, M. C., & Budde, L. E. (2024). Bispecific antibody use in patients with lymphoma and multiple myeloma. American Society of Clinical Oncology Educational Book, 44(3), e433516. https://doi.org/10.1200/EDBK_433516
Crombie, J. L., Graff, T., Falchi, L., Karimi, Y. H., Bannerji, R., Nastoupil, L., Thieblemont, C., Ursu, R., Bartlett, N., Nachar, V., Weiss, J., Osterson, J., Patel, K., Brody, J., Abramson, J. S., Lunning, M., Shah, N. N., Ayed, A., Kamdar, M.,…Dickinson, M. (2024). Consensus recommendations on the management of toxicity associated with CD3×CD20 bispecific antibody therapy. Blood, 143(16), 1565–1575. https://doi.org/10.1182/blood.2023022432
Feldman, T., Farber, C. M., Choi, K., Faria, C., Goy, A., Connors, J., Paramanathan, D., Kaur, S., Schultz, E., McGuire, M., & Goldberg, S. L. (2017). Treatment of peripheral T-cell lymphoma in community settings. Clinical Lymphoma, Myeloma and Leukemia, 17(6), 354–361. https://doi.org/10.1016/j.clml.2017.05.001
Kotch, C., Barrett, D., & Teachey, D. T. (2019). Tocilizumab for the treatment of chimeric antigen receptor T cell-induced cytokine release syndrome. Expert Review of Clinical Immunology, 15(8), 813–822. https://doi.org/10.1080/1744666X.2019.1629904
Lee, D. W., Santomasso, B. D., Locke, F. L., Ghobadi, A., Turtle, C. J., Brudno, J. N., Maus, M. V., Park, J. H., Mead, E., Pavletic, S., Go, W. Y., Eldjerou, L., Gardner, R. A., Frey, N., Curran, K. J., Peggs, K., Pasquini, M., DiPersio, J. F., van den Brink, M. R. M., Komanduri, K. V.,…Neelapu, S. S. (2019). ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biology of Blood and Marrow Transplantation, 25(4), 625–638. https://doi.org/10.1016/j.bbmt.2018.12.758
Noori, M., Yazdanpanah, N., & Rezaei, N. (2023). Safety and efficacy of T-cell-redirecting bispecific antibodies for patients with multiple myeloma: A systematic review and meta-analysis. Cancer Cell International, 23(1), 193. https://doi.org/10.1186/s12935-023-03045-y
Salvaris, R., Ong, J., & Gregory, G. P. (2021). Bispecific antibodies: A review of development, clinical efficacy and toxicity in B-cell lymphomas. Bispecific antibodies: An area of research and clinical applications, 11(5), 355. https://doi.org/10.3390/jpm11050355
Shimabukuro-Vornhagen, A., Gödel, P., Subklewe, M., Stemmler, H. J., Schlößer, H. A., Schlaak, M., Kochanek, M., Böll, B., von Bergwelt-Baildon, M. S. (2018). Cytokine release syndrome. Journal for ImmunoTherapy of Cancer, 6(1), 56. https://doi.org/10.1186/s40425-018-0343-9
U. S. Food and Drug Administration. (2024). Bispecific antibodies: An area of research and clinical applications. https://www.fda.gov/drugs/spotlight-cder-science/bispecific-antibodies-area-research-and-clinical-applications
van de Donk, N. W. C. J., & Zweegman, S. (2023). T-cell-engaging bispecific antibodies in cancer. The Lancet, 402(10396), 142–158. https://doi.org/10.1016/S0140-6736(23)00521-4