Barriers to older-adult participation in cancer trials ‘likely exist above the patient’
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Adults aged older than 70 years expressed the same level of interest in participating in cancer clinical trials as younger adults, according to study results in a research letter published in JAMA Network Open.
However, stringent trial criteria leave older adults more often unable to enroll in studies for novel cancer therapies, findings showed.
Background
Most of the data clinicians use to guide cancer treatments are based on studies that exclude or do not include older patients, even though most patients with cancer are older adults, according to Mina S. Sedrak, MD, MS, oncologist and deputy director of clinical trials for the Center for Cancer and Aging at City of Hope.
"The science of cancer care is being advanced by data that misses the largest population of those with cancer,” Sedrak told Healio. “As a result, we are making guesses in the clinic that are not evidence-based, and we lack the ability to make high-quality decisions based on evidence for the largest population of patients with cancer.”
Previous research has examined barriers to older-adult participation in clinical trials, but most have focused on those seeking treatment at large academic medical centers, Sedrak said. His group took advantage of data accumulated by a network of community sites that provided NCI-sponsored trials.
"We thought there was an opportunity to see if there were clinical trial enrollment patterns and barriers among younger and older adults in the community setting,” he noted.
Methodology
Sedrak and colleagues conducted a cross-sectional analysis of community-level participants in NCI-sponsored clinical trials.
The investigators used screening logs obtained between 2016 and 2019 from NCI’s Community Oncology Research Program database. The logs included information on trial characteristics, patient eligibility, whether patients enrolled in a study and reasons for not enrolling.
Researchers divided participants into two cohorts based on age range, with a “younger” group comprising adults aged 50 to 69 years (n = 1,709; mean age, 60 ± 5.7 years; range, 50-69; 80% women) and an “older” group of adults aged 70 years or older (n = 586; mean age, 74.7 ± 4.4 years; range, 70-92; 64% women).
The investigators chose age 70 years as the cutoff for analysis because those aged 70 or older are known to be underrepresented in NCI and FDA clinical trials.
Key findings
Significantly more younger adults were offered clinical trial participation than older adults (74% vs. 26%; P < .001). However, older and younger adults had similar enrollment rates (65% vs. 68%).
Only 18% of younger adults failed to meet trial eligibility criteria compared with 23% of older adults.
The most common reasons for trial ineligibility included having a comorbidity (23% of younger adults vs. 26% of older adults) and failure to meet disease stage criteria (30% vs. 24%).
Both groups reported concern over severity of treatment-related adverse events as the most common reason for eligible patients to decline trial enrolment (22% for younger vs. 21% for older adults). The investigators reported similar lack of desire to participate in clinical research among younger and older adults in the analysis (20% vs. 18%).
"The key message from these results is that when offered [enrollment in] a clinical trial, older adults are as willing to participate as younger patients,” Sedrak told Healio. “The barriers to older patients not participating are not the patients themselves and likely exist above the patient.”
Clinical implications
The study results broaden the availability of what is known about clinical trial participation to include patients treated at community clinics and not just academic centers, according to Li-Wen Huang, MD, assistant professor of medicine, and Sunny Wang, MD, associate professor of medicine, both at University of California, San Francisco.
“Although patient decision-making is often thought to be a primary barrier to clinical trial participation, many obstacles upstream of the patient preclude older [patients with cancer] from participating in trials before they are even offered the choice,” Huang and Wang wrote in an accompanying editorial.
“Given the complexity of the problem, widespread efforts to address obstacles at different levels are needed to ensure that patients enrolled in oncology clinical trials are representative of the patients being treated in community settings,” they added.
To correct this imbalance, Sedrak said systemic changes are needed to alter the way trials are constructed by sponsors, so they incorporate the participation of older patients where possible.
"We must be purposeful about developing trials with older adults in mind that do not prohibit their participation through age restrictions or excessive requirements — such as comorbidities or organ function status — that are inherent to natural aging,” he said.
“Physicians also need to have a better understanding that older adults are interested and willing to participate in clinical trials,” Sedrak added. “Even when physicians are concerned about their older patients participating in a study, there at least needs to be a conversation about having the option.”
References :
- Huang LW, et al. JAMA Netw Open. 2022;doi:10.1001/jamanetworkopen.2022.35718.
- Sedrak MS, et al. JAMA Netw Open. 2022;doi:10.1001/jamanetworkopen.2022.35714.
For more information :
Mina S. Sedrak, MD, MS, can be reached at Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA 91010; email: msedrak@coh.org.
Perspective
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Dale R. Shepard, MD, PhD
There is a need for improvements in how we treat cancer in older adults. This is the population most likely to get many cancers, but those most often not adequately represented in the clinical trials that lead to their treatments. There has been substantial work in geriatric oncology assessment of patients to determine which older patients are most likely to benefit from treatment. Once that decision is made, how should the chemotherapy be dosed? Are there differences in adverse effects?Not surprisingly, understanding treating this population will rely on inclusion of older patients in our clinical trials. This study by Sedrak and colleagues is an important contribution to understanding the barriers to trial participation by older adults. Focusing on patients in the community, where most patients are treated, gives this study relevance. Choosing 70 years of age for their breakpoint is along NCI and FDA guidance and represents a significant number of patients in our clinics. It is notable that younger patients were offered a clinical trial nearly three times more often than older patients, but those meeting trial eligibility were nearly the same (18% vs. 23%). The lack of interest in participating in a trial was equivalent (20% vs. 18%) and older patients were not more concerned about toxicity.
The take away is that, when approached for clinical trials, older patients had the same interest and were as likely to meet eligibility as younger patients. Although the exclusion of older patients is often ascribed to their apprehension or comorbidities, perhaps we need to be more introspective. Maybe an important barrier to enrollment of older patients is us. Older patients will only participate in trials if they are offered. If we are going to optimize the care of these patients, it is incumbent on us to not be the obstacle.
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