A recent call to action from ASCO (American Society of Clinical Oncology) published in the Journal of Clinical Oncology recommends expanding clinical trials to include more older adults.
Given that greater than 60% of cancers in the United States occur in adults 65 and older, evidence-based data is scarce, since this population is under-represented in clinical trials.
The article quotes ASCO president Julie M. Vose, MD, MBA, FASCO: “Older people living with cancer have different experiences and outcomes in their treatment than younger cancer patients. 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.”
The position statement, “Improving the Evidence Base for Treating Older Adults with Cancer,” crafted by ASCO’s Cancer Research Committee, makes five recommendations:
1. Use clinical trials to improve the evidence base for treating older adults
2. Leverage research designs and infrastructure to improve the evidence base for treating older adults.
3. Increase Food and Drug Administration (FDA) authority to incentivize and require research on older adults with cancer.
4. Increase clinicians’ recruitment of older adults with cancer into clinical trials.
5. Utilize journal policies to incentivize researchers to consistently report on the age distribution and health risk profiles of research participants.
ASCO has detailed action steps to implement their recommendations, which includes asking researchers, research funders and regulatory agencies to “carefully consider whether evidence exists to support eligibility criteria based on age, performance status or comorbid conditions, the three primary reasons older adults are excluded from clinical trials.” (ASCO.org)
Next steps include ASCO’s organizing a public meeting which will include feedback from key stakeholders with the goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols. The meeting will be in the fall of 2016.
To read both statements:
Improving the Evidence Base for Treating Older Adults with Cancer: ASCO Statement
Modernizing Eligibility Criteria for Molecularly Driven Trials