ASCO Statement on Increasing the Number of Older Patients in Clinical Trials
While most cancer drugs are prescribed to older adults, they are underrepresented in clinical trials.
The American Society of Clinical Oncology (ASCO) issued groundbreaking recommendations to improve the evidence base for treating older adults with cancer and modernize eligibility criteria for clinical trials.
The recommendations, published online ahead of print in the Journal of Clinical Oncology, are based on critical needs identified by the Institute of Medicine (IOM).1
More than half of new cancer cases and nearly 70% of cancer-related deaths occur in people 65 or older.2 This is the fastest-growing population in the United States and it is projected to double by 2050.3
Yet older adults are underrepresented in clinical trials, and few trials are designed that specifically target them. The evidence base for treating older adults is lacking as a result.
Arti Hurria, MD, Director of City of Hope's Cancer and Aging Research Program and co-author of the ASCO position statement said in an interview with Cancer Therapy Advisor, “It should no longer be acceptable that a drug is tested in primarily younger patients and delivered to primarily older patients.”
Examples as to why older adults respond differently to cancer treatments than younger patients include age-related physiological changes, high incidence of comorbidities, and potential drug interactions.
“Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,” ASCO President Julie M. Vose, MD, MBA, FASCO, said in a press release.4
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“As we age, for example, the risk of adverse reactions from treatment significantly increases. Older adults must be involved in clinical trials so we can learn the best way to treat older cancer patients resulting in improved outcomes and manageable toxicity.”
In the statement, “Improving the Evidence Base for Treating Older Adults with Cancer,” ASCO makes five key recommendations:1
To improve the conduct of research:
- Use clinical trials to improve the evidence base for treating older adults with cancer
- Leverage research designs and infrastructure for generating evidence on older adults with cancer
To improve the research environment:
- Increase the U.S. Food and Drug Administration's authority to incentivize and require research involving older adults with cancer
- Increase clinicians' recruitment of older adults with cancer to clinical trials
- Use journal policies to improve researchers' reporting on the age distribution and health-risk profiles of research participants