Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium.

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  • Additional Information
    • Affiliation:
      The University of Texas MD Anderson Cancer Center, Houston, TX
      Moffitt Cancer Center, Tampa, FL
      Stanford University Medical Center, Stanford, CA
      Washington University School of Medicine and Siteman Cancer Center, St Louis, MO
      Mayo Clinic, Rochester, MN
      University of Maryland School of Medicine and Greenebaum Comprehensive Cancer Center, Baltimore, MD
      University of Nebraska Medical Center, Omaha, NE
      University of Miami Miller School of Medicine, Miami, FL
      University of Rochester Medical Center, Rochester, NY
      Vanderbilt-Ingram Cancer Center, Nashville, TN
      University of Kansas Medical Center, Kansas City, KS
      Karmanos Cancer Institute, Wayne State University, Detroit, MI
      UPMC Hillman Cancer Center, Pittsburgh, PA
      John Theurer Cancer Center, Hackensack Meridian Health, Hackensack, NJ
      Cleveland Clinic, Cleveland, OH
      University of California, San Francisco, San Francisco, CA
      Banner MD Anderson Cancer Center, Gilbert, AZ
    • Abstract:
      Purpose: Axicabtagene ciloleucel (axi-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory large B-cell lymphoma (LBCL) on the basis of the single-arm phase II ZUMA-1 trial, which showed best overall and complete response rates in infused patients of 83% and 58%, respectively. We report clinical outcomes with axi-cel in the standard-of-care (SOC) setting for the approved indication.Patients and Methods: Data were collected retrospectively from all patients with relapsed/refractory LBCL who underwent leukapheresis as of September 30, 2018, at 17 US institutions with the intent to receive SOC axi-cel. Toxicities were graded and managed according to each institution's guidelines. Responses were assessed as per Lugano 2014 classification.Results: Of 298 patients who underwent leukapheresis, 275 (92%) received axi-cel therapy. Compared with the registrational ZUMA-1 trial, 129 patients (43%) in this SOC study would not have met ZUMA-1 eligibility criteria because of comorbidities at the time of leukapheresis. Among the axi-cel-treated patients, grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 7% and 31%, respectively. Nonrelapse mortality was 4.4%. Best overall and complete response rates in infused patients were 82% (95% CI, 77% to 86%) and 64% (95% CI, 58% to 69%), respectively. At a median follow-up of 12.9 months from the time of CAR T-cell infusion, median progression-free survival was 8.3 months (95% CI, 6.0 to15.1 months), and median overall survival was not reached. Patients with poor Eastern Cooperative Oncology Group performance status of 2-4 and elevated lactate dehydrogenase had shorter progression-free and overall survival on univariable and multivariable analysis.Conclusion: The safety and efficacy of axi-cel in the SOC setting in patients with relapsed/refractory LBCL was comparable to the registrational ZUMA-1 trial.
    • Journal Subset:
      Biomedical; Editorial Board Reviewed; Expert Peer Reviewed; Peer Reviewed; USA
    • ISSN:
      0732-183X
    • MEDLINE Info:
      PMID: NLM32401634 NLM UID: 8309333
    • Grant Information:
      P30 CA076292/CA/NCI NIH HHS/United States; K23 CA201594/CA/NCI NIH HHS/United States; P30 CA016672/CA/NCI NIH HHS/United States
    • Publication Date:
      In Process
    • Publication Date:
      20201030
    • DOI:
      10.1200/JCO.19.02104
    • Accession Number:
      145886943
  • Citations
    • ABNT:
      NASTOUPIL, L. J. et al. Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium. Journal of Clinical Oncology, [s. l.], v. 38, n. 27, p. 3119–3128, 2020. DOI 10.1200/JCO.19.02104. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=145886943. Acesso em: 26 nov. 2020.
    • AMA:
      Nastoupil LJ, Jain MD, Feng L, et al. Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium. Journal of Clinical Oncology. 2020;38(27):3119-3128. doi:10.1200/JCO.19.02104
    • APA:
      Nastoupil, L. J., Jain, M. D., Feng, L., Spiegel, J. Y., Ghobadi, A., Lin, Y., Dahiya, S., Lunning, M., Lekakis, L., Reagan, P., Oluwole, O., McGuirk, J., Deol, A., Sehgal, A. R., Goy, A., Hill, B. T., Vu, K., Andreadis, C., Munoz, J., & Westin, J. (2020). Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium. Journal of Clinical Oncology, 38(27), 3119–3128. https://doi.org/10.1200/JCO.19.02104
    • Chicago/Turabian: Author-Date:
      Nastoupil, Loretta J., Michael D. Jain, Lei Feng, Jay Y. Spiegel, Armin Ghobadi, Yi Lin, Saurabh Dahiya, et al. 2020. “Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium.” Journal of Clinical Oncology 38 (27): 3119–28. doi:10.1200/JCO.19.02104.
    • Harvard:
      Nastoupil, L. J. et al. (2020) ‘Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium’, Journal of Clinical Oncology, 38(27), pp. 3119–3128. doi: 10.1200/JCO.19.02104.
    • Harvard: Australian:
      Nastoupil, LJ, Jain, MD, Feng, L, Spiegel, JY, Ghobadi, A, Lin, Y, Dahiya, S, Lunning, M, Lekakis, L, Reagan, P, Oluwole, O, McGuirk, J, Deol, A, Sehgal, AR, Goy, A, Hill, BT, Vu, K, Andreadis, C, Munoz, J & Westin, J 2020, ‘Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium’, Journal of Clinical Oncology, vol. 38, no. 27, pp. 3119–3128, viewed 26 November 2020, .
    • MLA:
      Nastoupil, Loretta J., et al. “Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium.” Journal of Clinical Oncology, vol. 38, no. 27, Sept. 2020, pp. 3119–3128. EBSCOhost, doi:10.1200/JCO.19.02104.
    • Chicago/Turabian: Humanities:
      Nastoupil, Loretta J., Michael D. Jain, Lei Feng, Jay Y. Spiegel, Armin Ghobadi, Yi Lin, Saurabh Dahiya, et al. “Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium.” Journal of Clinical Oncology 38, no. 27 (September 20, 2020): 3119–28. doi:10.1200/JCO.19.02104.
    • Vancouver/ICMJE:
      Nastoupil LJ, Jain MD, Feng L, Spiegel JY, Ghobadi A, Lin Y, et al. Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium. Journal of Clinical Oncology [Internet]. 2020 Sep 20 [cited 2020 Nov 26];38(27):3119–28. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=145886943