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2015 DEPARTMENT OF MEDICINE RESEARCH DAY
Title of Poster: Low Elderly Participation in Non-Small Cell Lung Cancer Clinical Trials
Presenter: Amy Cummings
Division: Department of Medicine
☐Faculty ☐Fellow ☒Resident ☐Post-doc Research Fellow ☐Graduate Student ☐Medical Student ☐Other
Principal Investigator/Mentor: Jonathan Goldman
Co-Investigators: Melody Mendenhall
Thematic Poster Category: Clinical Observations and Clinical Trials
Abstract
Background: Lung cancer, with a median age at diagnosis of 70 years, is the current leading cause
of cancer mortality in the United States1. A lack of elderly enrollment in lung cancer clinical trials,
however, has led to difficulty establishing elderly guidelines for treatment 2,3 and has been highlighted
by the Institute of Medicine (IoM) and the American Society of Clinical Oncologists (ASCO) as a key
area for improvement4,5. While there have been few elderly-specific clinical trials investigating
chemoradiotherapy in lung cancer, there have been no elderly-specific trials investigating targeted
therapy or immunotherapy, and little is known about elderly outcomes with these agents.
Methods: The PubMed database was queried for Medical Subject Headings including NSCLC/therapy
and “Phase I”. Limits were set to clinical trials in English in the past 5 years with human subjects. A
total of 192 studies met these criteria; 37 were excluded for descriptive, retrospective, mislabeled, or
observational methodology. Of the remaining 155 studies, 49 included treatment with targeted
therapy or immunotherapy without protocolized chemoradiotherapy. These articles were assessed
based on age demographics and outcomes. Elderly patients were considered 70 years and above;
extreme elderly 85 years and above.
Results: Approximately two-thirds of the studies meeting inclusion criteria involved advanced
NSCLC; the remaining studies evaluated two or more solid malignancies. Targeted therapy was the
focus of 70% of the studies, 24% involved immunotherapy, 6% involved other agents. Sample size
ranged from 5-495 participants. The mean/median age ranged from 46-69 years. Twelve percent of
studies had a mean/median age of 65-69 years; no studies had a mean/median age of 70 years or
greater (Figure 1). The maximum age of an enrolled participant was 94 years6; Garon 2015 included a
93 year-old7. Ten trials had at least one extreme elderly patient (Figure 2); two of these studies
involved a lead author from UCLA7,8. The five studies that published age-specific outcomes9-13
suggested that targeted therapy and immunotherapy may be well-tolerated and have comparable
outcomes in the elderly, but included only 2-5 elderly patients.
Conclusions: Elderly participation in phase I targeted therapy and immunotherapy NSCLC clinical
trials is unrepresentative. Additional research involving elderly enrollment and outcomes in NSCLC
clinical trials is warranted. These findings support the IoM and ASCO position statements that
increased recruitment of the elderly in clinical trials and publication of elderly-specific outcomes in
lung cancer research is key to improving treatment guidelines in this field. Single center retrospective
and prospective protocols are in development to investigate elderly screening failure rates,
participation, and outcomes in UCLA phase I clinical trials.
Figures & Tables:
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