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“Geriatricizing” drug development – A Young International Society of Geriatric Oncology letter to the editor

  • Nabiel Mir
    Correspondence
    Corresponding author at: Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, United States of America.
    Affiliations
    Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, United States of America

    Clinical Pharmacology and Pharmacogenomics Training Program, University of Chicago, Chicago, IL, United States of America
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  • Giuseppe Dario Testa
    Affiliations
    Division of Geriatric and Intensive Care Medicine, University of Florence and Azienda Ospedaliero Universitaria Careggi, Florence, Italy
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  • Stuart Lichtman
    Affiliations
    Department of Gynecologic Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America
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Published:October 29, 2022DOI:https://doi.org/10.1016/j.jgo.2022.10.013
      We read Lee and colleagues' systematic review on geriatric assessments (GA) in cancer clinical trials [
      • Lee W.
      • Cheng S.J.
      • Grant S.J.
      • et al.
      Use of geriatric assessment in cancer clinical trials: a systematic review.
      ] with great interest. This study provides a comprehensive review of how the GA has been adopted and adapted for use in existing cancer clinical trials. We wish to discuss gaps and next steps on topics highlighted by Lee et al. using recent solutions proposed during the 2021 National Academies of Sciences, Engineering, and Medicine (NASEM) workshop on improving the evidence base for older adults with cancer which brought together geriatric oncology experts from within and across the clinical research and regulatory strata (see Table 1).
      Table 1NASEM improving the evidence base for treatment decision making for older adults with cancer virtual workshop 2021 adapted recommendations.
      Adapted from: Moderators Summaries of Issues and Solutions. Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: A Virtual Workshop. The National Academies of Sciences, Engineering, and Medicine, 2021.
      • Optimize Eligibility
        • o
          Require implementation of modernized eligibility criteria as standard practice
        • o
          Utilize standardized GA measures to design trials for vulnerable/frail older adults
        • o
          Include geriatric oncology experts on therapeutic development and study design teams
        • o
          Conduct separate, adequately powered studies with eligibility limited to older or frail adults (when possible)
      • Patient Preferences as Endpoints
        • o
          Conduct older adult-specific trials with emphasis on treatment tolerance and geriatric-focused endpoints
        • o
          Develop and validate new endpoints that better define clinical benefit in older or more frail adults
      • Innovate and Leverage Technology
        • o
          Incorporate a standardized set of core GA measures (minimum data set) into all treatment trials enrolling older adults
        • o
          Leverage local trial/practice sites to use web- and app-based tools for symptom assessment
        • o
          Extend geroscience to the nonclinical investigation of anticancer agent efficacy and toxicity
      low asterisk Adapted from: Moderators Summaries of Issues and Solutions. Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: A Virtual Workshop. The National Academies of Sciences, Engineering, and Medicine, 2021.
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