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Cancer & Aging Research Group (CARG)
Lessons Learned from the U13 NIA-NCI
Conference U13 (2012):
Eligibility Criteria and Enrollment
of Older Adults in Cancer
Research
American Geriatrics Society
May 2, 2013
William Dale, MD, PhD
University of Chicago
General Issues of Eligibility
for Cancer Research
Why Eligibility Requirements?
1.
Define the population being studied
2.
Protect patients from risk
3.
Facilitate comparisons across studies
4.
Minimize between-patient variability
5.
Enable drug labeling
Impact of Eligibility Requirements:
The “Goldilocks” Approach

Too broad
1.
2.
3.
4.

Patient safety (potentially) jeopardized
Population too heterogeneous to detect tx effect
Non cancer-related events may limit interpretation
of cancer-related endpoints
Encourages retrospective subset analysis
Too narrow
1.
2.
3.
4.
Barrier to effective accrual
Results not able to be generalized
Patient selection may yield “optimistic” results
Molecularly-defined subsets may have different
natural history from historical controls
Application to Older
Adults
A Recent Example from the
Alliance Coop Group
 Phase
III trial of combined oxaliplatin,
fluorouracil, and leucovorin (FOLFOX4)
with or without cetuximab.
 Suspended
until additional safety
precautions were implemented to address
the increased toxicities seen with older
age.
Need for Recruitment of Oldest-Old
and Frail Adults into Trials

Consideration of trial design to capture data on patients
not eligible for standard clinical trials (e.g. observational
cohort studies)

Alternative dosing strategies

Extra safety precautions for those with comorbidities,
functional losses, cognitive impairment, and frailty.

More consistent and earlier research collaboration
between oncology and geriatrics researchers when
designing trials is essential.

Inclusion of QOL and Functional End-points
Potential Barriers to Enrollment of
Older Patients in Cancer Research
 Patient
Preference
 Physician
 Social
Bias
Support
 Eligibility
Criteria
Patient Attitudes to Trial Enrollment
1.
Patient attitudes have not been shown to lower
trial enrollment.
2.
Do not view age as a reason for not enrolling.
3.
Stated reasons for not participating in trials are
similar between older and younger patients.
4.
The majority of older patients report a positive
attitude toward participation in clinical trials.
5.
75% of patients 70+ years are willing to
participate in clinical trials
Cesari M et al:. J Gerontol A Biol Sci Med Sci 59:242-8, 2004;
Physician Role in Trial Enrollment

Physicians’ recommendations are an important factor in patients’ likelihood
of participation in trials

Physician bias is one the largest barriers to the enrollment of older patients.

Physicians may be wary of randomizing older patients to regimens viewed
as overly toxic, and the laudable goal of avoiding toxicity can interfere with
the recruitment of older patients.

Safety profiles can be complicated by issues of polypharmacy, since older
patients are more likely to have multiple comorbidities for which they take
other medications.

Age- and comorbidity-related changes in pharmacokinetics,
pharmacodynamics, organ function, and drug toxicity add even more
complexity.
Summary
Townsley CA et al, J Clin Oncol 23:3112-24, 2005.
Lessons from Geriatricized
Emergency Departments
The Geriatric ED
Hwang & Morrison. J Am Geriatr Soc 55:1873–1876,2007.
NYT: For the Elderly, Emergency
Rooms of Their Own
Needed Structural Changes
1.
Sufficient time for Geriatric Assessments
2.
Provide geriatrics-specific training to support staff
3.
Exam rooms and equipment that accommodates older
patients for assessments
4.
Resources to facilitate/support caregivers and
transportation
5.
Allow for data collection from remote areas with
technology to facilitate data collection
A Modest Proposal:
It Is Time for Geriatric “Clinical Trial Suite”
SOCARE Clinic:
Oncology-Embedded Geriatrics

Started in 2006
 Collaboration
 Aging Assessment
 Research Hub

Personnel




3 MDs
1 APN
Trainees (Fellows)
Social Work
http://www.uchospitals.edu/specialties/
cancer/geriatric-oncology/
And Special Thanks…