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. 2022 Sep;13(7):907-913.
doi: 10.1016/j.jgo.2022.04.014. Epub 2022 May 9.

Use of geriatric assessment in cancer clinical trials: A systematic review

Affiliations

Use of geriatric assessment in cancer clinical trials: A systematic review

Woojung Lee et al. J Geriatr Oncol. 2022 Sep.

Abstract

Background: Older adults are underrepresented in cancer clinical trials despite accounting for most of the disease burden. Geriatric assessment (GA) could be used in clinical trials of cancer drugs for older adults to improve the clinical evidence for cancer drug use among older adults.

Objective: To examine patterns of use of GA in cancer clinical trials.

Methods: We undertook a systematic review of the studies reporting use of GA in a clinical trial setting for all cancer types and published between January 2010 and January 2020. Characteristics of GA use were extracted for each study, along with study phase, cancer type, and participant age (PROSPERO: CRD42020170584).

Results: We identified 320 studies and 63 studies met the final inclusion criteria. Among 74 purposes of GA use, the most common was to examine the association between impairments in GA domains and clinical outcomes (28/74, 38%). Among 258 GA domains assessed across 63 studies, physical status (59/258, 23%) and comorbidities (50/258, 19%) were most often evaluated. There was significant heterogeneity in the instruments used to assess physical function (n = 16) and mood disorders (n = 7). Most studies were phase 2 (32/63, 51%).

Conclusions: GA is most often used in clinical trial settings to examine associations between GA-identified deficits and clinical outcomes. Significant heterogeneity exists in the GA instruments used across trials. Comprehensive and consistent incorporation of GA into future cancer clinical trial designs could help collect more older adult-specific clinical information and adjust trial eligibility criteria to increase representation by older adults.

Keywords: Cancer clinical trials; Geriatric assessment; Older adults.

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Conflict of interest statement

Declaration of Competing Interest Woojung Lee, Spencer J. Cheng, Zachary A. Marcum, and Beth Devine have no conflict of interest to declare. Shakira Grant is supported by National Comprehensive Institute Grant No. (5-K12-CA120780-13; PI: William Kim) and National Institute on Aging Grant No, (1 R03 AG074030-01; PI: Shakira Grant).

Figures

Fig. 1.
Fig. 1.
PRISMA flow diagram.
Fig. 2.
Fig. 2.
The frequency of geriatric assessment (GA) domains assessed in cancer clinical trials (n = 285).
Fig. 3.
Fig. 3.
Characteristics of cancer clinical trials that incorporated geriatric assessment (n = 63); Study design and phase (top), cancer type (middle) and median or mean age of study participants (bottom).

Comment in

References

    1. Jansen PA, Brouwers JR. Clinical pharmacology in old persons. Scientifica (Cairo) 2012;2012:723678. 10.6064/2012/723678. - DOI - PMC - PubMed
    1. Koren G, Nordon G, Radinsky K, Shalev V. Clinical pharmacology of old age. Expert Rev Clin Pharmacol 2019. Aug;12(8):749–55. 10.1080/17512433.2019.1632188. - DOI - PubMed
    1. Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. Future of cancer incidence in the United States: burdens upon an aging, changing nation. J Clin Oncol 2009;27(17):2758–65. 10.1200/JCO.2008.20.8983. - DOI - PubMed
    1. Tack L, Lefebvre T, Lycke M, Pottel L, Cool L, Ketelaars L, et al. Underrepresentation of vulnerable older patients with cancer in phase II and III oncology registration trials: a case-control study. J Geriatr Oncol 2020. Mar;11(2): 320–6. 10.1016/j.jgo.2019.09.003. - DOI - PubMed
    1. Sedrak MS, Freedman RA, Cohen HJ, Muss HB, Jatoi A, Klepin HD, et al. Older adult participation in cancer clinical trials: a systematic review of barriers and interventions. CA Cancer J Clin 2021. Jan;71(1):78–92. 10.3322/caac.21638. - DOI - PMC - PubMed

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