Investigating the disparate enrollment of older adults on phase I clinical trials: Evolving participation patterns of patients 65 years and older w advanced cancer on phase I trials.

Authors

Ishwaria M. Subbiah

Ishwaria Mohan Subbiah

The University of Texas MD Anderson Cancer Center, Houston, TX

Ishwaria Mohan Subbiah , Aman Buzdar , Ecaterina Elena Ileana Dumbrava , Siqing Fu , Filip Janku , Daniel D. Karp , Aung Naing , Shubham Pant , Jordi Rodon , Apostolia Maria Tsimberidou , Timothy A Yap , Vivek Subbiah , Funda Meric-Bernstam , David S. Hong

Organizations

The University of Texas MD Anderson Cancer Center, Houston, TX, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, Department of Investigational Cancer Therapeutics (Phase I Program), The University of Texas MD Anderson Cancer Center, Houston, TX, University of Texas MD Anderson Cancer Center, Houston, TX

Research Funding

No funding received
None

Background: While safety and dose-finding remain the primary objective of Phase 1 trials, the potential for clinical benefit has taken a greater meaning in the last decade with the novel therapies. With data from phase I trials being submitted for regulatory approval, the finer details of these studies are under even more scrutiny: in particular, do the trial participants reflect the general patient population for whom the drug may be indicated? To that end, we investigated age-based enrollment on phase I clinical trials over time. Methods: We queried a prospectively maintained database at a major phase I trials center to identify eligible patients and demographic + clinical variables including phase I trial characteristics, age at date of enrollment into 3 age-based cohorts: AYA ages 15-39y, mid-age 40-64y, older adults aged 65y+. We calculated descriptive statistics, and explored correlations (Pearson/Spearman) and associations (linear regression) between age and independent variables. Results: Over a 3-year period (1/1/17 to 12/31/19), we identified 6267 pts enrolled on 338 phase I trials. Median overall age 58.4y (range 15.5-95.1y). 729 (12%, median age 34.8y) were AYA, 3652 (58%, median age 55.4y) mid-age and 1886 (30%, median 70y) older adults, of whom 870 pts were aged 70-79y and 76 pts aged 80y+ (18 being >85y). There was no association b/w senior participation and year of enrollment (2017 31%, 2018 29%, 2019 30%, b/w age and type of therapy (i.e. targeted vs immunotherapy, etc.) or b/w age and # of drugs given on trial (single agent vs combo) (all p > 0.05). Conclusions: Older adults remain underrepresented on phase I trials esp. when compared to incidence of cancer in that age group (30% enrollment vs 60% incidence), a discordance more staggering in the oldest old pts (85y+; only 18 pts enrolled over 3 yrs when compared to 140,690 pts 85y+ w a new cancer dx in just 2019). Once enrolled, older adults received similar types of phase I therapies with comparable number of drugs as compared to middle age patients, i.e. older adults were just as likely to get immunotherapy or targeted therapy as well mono- vs combo therapy as mid-age pts.

Types of TherapyOlder adult%Midage%
Immunotherapy agent(s)66235%129235%
     Single Agent IO28643%58545%
    Combo IO37657%70755%
Chemotherapy493%792%
    Single Agent4796%7797%
    Combo24%23%
Targeted80142%156643%
    Single Agent63379%126080%
    Combo16821%30620%
Immuno+Targeted25914%46313%
Targeted+Chemo855%1715%
Other (biologics, combo)302%812%

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Symptoms and Survivorship

Track

Symptom Science and Palliative Care

Sub Track

Geriatric Models of Care

Citation

J Clin Oncol 38: 2020 (suppl; abstr 12044)

DOI

10.1200/JCO.2020.38.15_suppl.12044

Abstract #

12044

Poster Bd #

332

Abstract Disclosures

Similar Abstracts