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ASCO issues recommendations for the inclusion of older adults in clinical trials
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ASCO has issued recommendations calling for federal agencies and cancer researchers to include older adults in clinical trials.
Over 60% of cancers diagnosed in the U.S. occur in people aged 65 years or older. However, this population remains underrepresented in clinical trials, therefore leading to a lack of evidence to inform treatment decisions for this population, according to a press release.
“Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,” Julie M. Vose, MD, MBA, FASCO, chief of the division of hematology and oncology in the department of internal medicine at the University of Nebraska Medical Center and president of ASCO, said in the 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 toxicities.”
Julie M. Vose
Two articles — both published in Journal of Clinical Oncology — outlined ASCO’s recommended guidelines for the inclusion of older patients with cancer in clinical trials. One of the papers — by Edward S. Kim, MD, chair of solid tumor oncology and investigational therapeutics at the Levine Cancer Institute in Charlotte, North Carolina, and a HemOnc Today Editorial Board member, and colleagues — described the need to modernize eligibility criteria for molecularly driven trials. In the other paper, Arti Hurria, MD, associate professor of medical oncology and population sciences and director of the Cancer and Aging Research Program at City of Hope, Comprehensive Cancer Center, as well as HemOnc Today’s geriatric oncology section editor, and colleagues sought to outline ways to improve the evidence base for treating older patients with cancer
Edward S. Kim
Hurria and colleagues wrote that overly restrictive clinical trial eligibility criteria often lead to the exclusion of representative populations of older adults.
“There is growing recognition that eligibility criteria in clinical trials could be relaxed without compromising scientific rigor,” Hurria and colleagues wrote. “From 1999 to 2005, the median number of eligibility criteria per trial increased from 31 to 49. In addition, it is estimated that only 20% to 40% of patients treated at cancer centers are eligible to participate in clinical trials, primarily as a result of stringent eligibility criteria.”
Other strong recommendations from Hurria and colleagues included:
- Leveraging research designs and infrastructure to improve the evidence base for treating older adults, including the use of innovative trial designs;
- Increasing the authority of the FDA to incentivize and require research including older adults, including congressional requirements requiring drug or biologic marketing applications to contain a plan to gather data and develop dosing recommendations germane to older adults;
- Increasing clinical recruitment of older adults to clinical trials, including the development and promotion of educational materials for clinicians and researchers to encourage greater recruitment of older adults; and,
- Using journal policies to incentivize researchers to consistently report on the age distribution and health–risk profiles of study participants, including the requirement that authors submit detailed reports on age distribution by decade of the study population and the inclusion of geriatric oncology experts in the pool of editorial board members serving as peer reviewers.
“We need to see clinical trials that mirror the age distribution and health–risk profile of patients with cancer,” Hurria said in a press release. “ASCO has laid out a multi-pronged approach to expand the participation of older adults in clinical trials, ensuring that all patients will receive high-quality, evidence-based cancer care.”
Further, Kim and colleagues highlighted the need for the inclusion of older patients in molecularly driven clinical trials. The article focused on the refinement of eligibility criteria to be more representative of the entire patient population.
Although researchers seek to streamline drug development and approval processes of molecularly targeted agents to hasten drug access, the use of narrow populations in clinical trials may lead to questions about the agents’ generalizability, according to the authors.
“There are many eligibility criteria that are grandfathered into clinical trial protocols, not because they are appropriate for the trial, but because they were carried over from previous protocols written for previous study populations,” Kim and colleagues wrote. “As the pressure of speeding up approval of promising drugs mounts, there may be a tendency to include a greater number of eligibility criteria as smaller numbers of patients are evaluated, efficacy signals are more readily detected, and patient safety is more carefully scrutinized.”
The authors reviewed the eligibility criteria from 26 clinical trials — including phase 1 to phase 3 industry and cooperative group non-molecularly targeted and molecularly targeted trials — before issuing their recommendations.
Recommendations from Kim and colleagues included:
- The development of eligibility criteria focused on the scientific objectives of the study, excluding criteria unrelated to the scientific objectives or key safety considerations;
- That the study patient population be generalizable to the nonstudy but clinically eligible patient population;
- Using the specific toxicity profile of the drug and its mechanism of action to drive the selection of inclusion and especially exclusion criteria; and,
- The regular review of eligibility criteria through the protocol development process and in situations where an active study experiences poor accrual.
“Understanding the risks and benefits of a treatment in the intended patient population is the fundamental goal of clinical trials,” Kim said in a press release. “Enrollment into clinical trials has not been optimal and needs urgent reassessment. The era of molecularly-targeted therapy is an exciting one and requires us to reevaluate how we meet this primary objective in order to expedite approval of promising drugs into the clinic.” – by Cameron Kelsall
Disclosure: Hurria reports research funding from Celgene and GlaxoSmithKline and consultant roles with Boehringer Ingelheim, GTx and Seattle Genetics. Kim reports research funding and honoraria from and consulting roles with Celgene, Eli Lilly and Myriad Genetics. Vose reports no relevant financial disclosures. Please see the full articles for a list of all other authors’ relevant financial disclosures.
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