Association between Prior Malignancy Exclusion Criteria and Age Disparities in Cancer Clinical Trials

Roshal R. Patel, Rose Parisi, Vivek Verma, Ramez Kouzy, Joseph Abi Jaoude, Timothy A. Lin, Clifton David Fuller, Noam A. Vanderwalde, Reshma Jagsi, Benjamin D. Smith, Beverly Ashleigh Guadagnolo, Charles R. Thomas, Ethan B. Ludmir

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Prior malignancy exclusion criteria (PMEC) are often utilized in cancer clinical trials; however, the incidence of PMEC and the association of PMEC with trial participant age disparities remain poorly understood. This study aimed to identify age disparities in oncologic randomized clinical trials as a result of PMEC. Using a comprehensive collection of modern phase III cancer clinical trials obtained via ClinicalTrials.gov, we assessed the incidence and covariates associated with trials excluding patients with prior cancers within 5+ years from registration (PMEC-5). Using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database, we further sought to determine the correlation between PMEC-5 and age disparities. PMEC-5 were used in 41% of all trials, with higher PMEC-5 utilization among industry-supported trials as well as trials evaluating a targeted therapy. Comparing trial patient median ages with population-matched median ages by disease site and time-period, we assessed the association between PMEC-5 and age disparities among trial participants. PMEC-5 were independently associated with heightened age disparities, which further worsened with longer exclusionary timeframes. Together, PMEC likely contribute to age disparities, suggesting that eligibility criteria modernization through narrower PMEC timeframes may work toward reducing such disparities in cancer clinical trial enrollment.

Original languageEnglish (US)
Article number1048
JournalCancers
Volume14
Issue number4
DOIs
StatePublished - Feb 1 2022

Keywords

  • Age disparities
  • Cancer clinical trials
  • Phase III
  • Prior malignancy exclusion criteria

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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