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Differences in lymphoma patients between chimeric antigen receptor T-cell therapy trials and the general population

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Abstract

Chimeric antigen receptor (CAR)-T cell therapies appear to be promising treatments for non-Hodgkin’s and B-cell lymphoma. However, several CAR-T therapies approved by the US Food and Drug Administration have only been tested for efficacy in relatively few single-arm clinical trials with small sample sizes. We sought to examine the differences between patients in these trials and the general population of patients with non-Hodgkin’s and B-cell lymphoma. Five hundred and twenty-two patients from 15 CAR-T trials found in a systematic review and 417,492 patients from the Surveillance, Epidemiology, and End Results (SEER) Program database were compared. CAR-T study participants appeared to be younger (46.7% under 70 years old vs. 42.2%), more male (68.0% vs. 55.7%), and followed for a shorter period of time compared to patients in the SEER population (mean [M] 45.6 months, 95% confidence interval [CI] 17.7 to 63.3 months follow-up vs. M 57.1 months, 95% CI 57.0 to 57.3 months survival). CAR-T study participants may differ significantly from the general population of patients with non-Hodgkin’s and B-cell lymphoma. Effectiveness of CAR-T therapies in the general population of lymphoma patients may differ from effectiveness demonstrated in trials. Newly created CAR-T patient registries are essential to establishing population-level effectiveness of the therapies.

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Availability of data and material

Included studies are listed in Supplementary Material. SEER data is available at https://seer.cancer.gov/data/.

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Acknowledgements

We thank Thomas Concannon, Paul Koegel, William Lawrence, Gowri Raman, Jennifer Reck, and Jeanne Ringel for helpful comments. We also thank Jennifer Gildner for assistance with data retrieval and analysis, and Sydne Newberry for editorial assistance.

Funding

Research reported in this manuscript was funded through a contract with the Patient-Centered Outcomes Research Institute (PCORI; TORFP # PCO-Genetic Therapy-Task Order # 8). Dr. Apaydin was funded by an Advanced Fellowship in Health Services Research & Development awarded by the Office of Academic Affiliations in the Veterans Health Administration in the United States Department of Veterans Affairs.

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Authors and Affiliations

  1. Southern California Evidence-Based Practice Center, RAND Corporation, 1776 Main St, Santa Monica, CA, 90401-3208, USA

    Eric A. Apaydin, Sangita Baxi, Olamigoke Akinniranye, Jody Larkin, Aneesa Motala & Susanne Hempel

  2. Center for the Study of Healthcare Innovation, Implementation and Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA

    Eric A. Apaydin

  3. Southern California Evidence-Based Practice Center, RAND Corporation, Pittsburgh, PA, USA

    Andrea S. Richardson

  4. Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA

    Jerry Vockley

  5. Southern California Evidence Review Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

    Aneesa Motala & Susanne Hempel

Authors
  1. Eric A. Apaydin
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  2. Andrea S. Richardson
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  3. Sangita Baxi
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  4. Jerry Vockley
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  5. Olamigoke Akinniranye
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  6. Jody Larkin
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  7. Aneesa Motala
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  8. Susanne Hempel
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Correspondence to Eric A. Apaydin.

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The contents of this work are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee, or the United States Department of Veterans Affairs.

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Apaydin, E.A., Richardson, A.S., Baxi, S. et al. Differences in lymphoma patients between chimeric antigen receptor T-cell therapy trials and the general population. Clin Exp Med 22, 151–155 (2022). https://doi.org/10.1007/s10238-021-00724-w

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  • DOI: https://doi.org/10.1007/s10238-021-00724-w

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