Clinical trials need older adults, ASCO says. City of Hope’s Arti Hurria explains
July 29, 2015 | by Tami Dennis
Few clinical cancer trials include older adults – and yet, more than 60 percent of cancer cases in the United States occur in people age 65 and older. The result is a dearth of knowledge on how to treat the very population most likely to be diagnosed with cancer.
Now, the American Society of Clinical Oncology (ASCO) has issued landmark recommendations directed at ending this inequity. The organization is urging federal agencies and the cancer research community to include more older adults in clinical trials. The call to action was published July 20 in the Journal of Clinical Oncology.
City of Hope’s Arti Hurria, M.D., director of the Cancer and Aging Research Program at City of Hope, was a co-author of the ASCO position statement, “Improving the Evidence Base for Treating Older Adults with Cancer.”
“We need to see clinical trials enroll a patient population that mirrors the age distribution and health risk profile of patients with cancer,” Hurria said. “ASCO has laid out a multipronged approach to expand the participation of older adults in clinical trials, ensuring that we will develop the evidence base so that patients across all ages can receive high-quality, evidence-based cancer care.”
The statement highlights these core recommendations:
• Use clinical trials to improve the evidence base for treating older adults. • Leverage research designs and infrastructure to improve the evidence base for treating older adults. • Increase Food and Drug Administration authority to incentivize and require research on older adults with cancer. • Increase clinicians’ recruitment of older adults with cancer into clinical trials. • Utilize journal policies to incentivize researchers to consistently report on the age distribution and health risk profiles of research participants.“Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,” said ASCO President Julie M. Vose, M.D., M.B.A., in the press release. “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.”
Here, Hurria explains the need for more research on older adults – and what the impact would be.
Why are the recommendations coming now?
"The issue now is that the population is aging. The first of the baby boomers turned age 65 in 2011, meaning that the number of adults 65 and older will double by 2030. Because cancer is a disease associated with aging, we expect a 67 percent increase in cancer diagnoses from 2010 to 2030 in people 65 and older.
"Our key point is that older adults have been underrepresented in cancer clinical trials – and there’s been essentially no change in the representation of older adults in NCI clinical trials over the past decade – so measures need to be taken to improve the enrollment of these older adults.
"Because of the impending population change, this is a critical time in which to address the needs of the growing number of older adults who will be affected by cancer."
Are older adults’ treatment needs really so different from younger adults’ needs? Why do they need specific attention?
"We know there are changes in physiology as we age, with declines in each organ system, which can impact how an individual tolerates therapy. These changes begin on average at age 30, but the change happens at a very unique pace – so much so that age no longer becomes a great marker of who will tolerate cancer therapy. Appropriate treatment really requires a much more thorough assessment of the older adult so we can understand their functional age rather than their chronological age.
"If we have more studies that focus on older adults, we can better understand how to personalize therapy for these individuals."
What are the next steps?
"What needs to happen is a change in policy. The 2013 Institute of Medicine Report “Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis” [on which Hurria was an author] was in large part driven by the needs of the aging population. But the IOM establishes recommendations – it doesn’t take the next step of implementing them.
"In writing the ASCO recommendations, we asked: 'What can we really do?' The hope now is to start to approach this from an advocacy standpoint, because some of the actions are going to require a change in the law.
"One very discreet example of the need for advocacy is shown in drug package inserts. Each insert has something called a geriatric usage section. Unfortunately, these often include limited information in how to dose the drug in older adults. What we want is for this type of guidance and information to be a part of the Food and Administration approval process, and that means we need to understand the drug’s impact on older adults.
"Today, clinical trials always have to address the planned enrollment of women and minorities but that wasn’t always the case. Therefore, we need a law that says clinical trials must also develop a plan to enroll individuals with the age distribution of the disease.
"In the end, it’s going to take advocacy."
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