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Is it feasible to require enrollment of elderly patients in oncology clinical trials?
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Yes, but more information is needed.
The over-65 segment is the fastest growing segment of the world’s population. More than half of cancer survivors are aged 65 years or older, and this number is projected to rise substantially over the next 25 years.
Despite these trends, the elderly remain underrepresented in clinical trials, with fewer than 4% participating in clinical trials. This ongoing mismatch leads to questions regarding best care practices for elderly patients and how to best manage the expected increase in cost for this care.
There are numerous challenges to including elderly patients in clinical trials. Concerns around elderly patients experiencing higher rates of adverse events have historically led to a reluctance to include them in clinical trials. Data on toxicities in elderly patients is scarce; however, several studies suggest physicians are less likely to discuss clinical trials with patients older than 65 years. Elderly patients may have multiple comorbid conditions that may not meet inclusion/exclusion criteria. In addition, there are ethical concerns regarding adequate informed consent in potentially vulnerable populations. Elderly patients also may experience logistical issues, particularly with transportation and adequate social support systems. Financial barriers exist not only for patients, but also for sponsors. Elderly patients may require more frequent follow-up when initiating therapy, and this will contribute to overall costs. The challenges encountered in treating elderly patients are complex.
To accommodate increased numbers of elderly patients in clinical trials, several interventions have been proposed. Clinical trials should be designed to include elderly patients with endpoints pertinent to the older population. Additionally, late-stage clinical trials should enroll enough patients across age groups to compare outcomes in different groups and identify differences in the incidence of adverse events. Additional study staff may be needed to help work through logistical issues. Physicians may consider consultation with a geriatric oncologist if there are concerns regarding appropriateness for therapy. The potential for increased time and costs should be included in the trial budget.
Patients in a clinical trial must be representative of the target population, so they must include geriatric and younger participants. Studies have demonstrated clinical benefit to elderly patients participating in clinical trials, including phase 1 clinical trials; however, the elderly remain consistently underrepresented. Additionally, the number of elderly patients with cancer is expected to increase dramatically in the next 2 decades, and the predicted cost of cancer treatment is projected to increase by 40% from 2010 to 2020. It is evident we need additional information about the best and most cost-effective way to treat our elderly oncology patients and survivors.
Jennifer Gray, ACNP-BC, MSN, is an acute care nurse practitioner at the Levine Cancer Institute at Carolinas HealthCare System. She can be reached at jennifer.r.gray@carolinashealthcare.org. Disclosure: Gray reports no relevant financial disclosures.
The current research structure makes it very difficult to enroll any patients with comorbidities onto clinical trials.
Our research questions are not necessarily pertinent to patients who have other medical problems. This is true for therapeutic questions and quality-of-life questions.
Unfortunately, because of the way we’ve developed data over time, clinical trials have not given us data on safety and efficacy for standard of care in patients with comorbidities. By default, patients with comorbidities and other medical problems are not included in new clinical trials because even the standard-of-care arm may not be applicable to them.
This also is true for intervention studies. Studies of survivorship, exercise and cancer prevention mechanisms with nutrition, often are designed for younger patients who are able to complete patient-recorded outcomes in one sitting, and who are more engaged in the research process because they have less chronic health conditions that take up their time and resources. Older patients may not be equipped to participate in trials that involve significant travel and burdensome research procedures.
In cooperative groups, the geriatric oncology community has advocated for experts who have outside expertise in comorbidities, multiple chronic conditions and frailties, so that they provide input into the study design, the eligibility criteria and the research procedures. However, there are few people who do this, and their perspective is often lost. The system is geared toward younger, more fit patients, and patients who may be older but do not have comorbidities or poor performance status. We found that when experts sit at the table during trial design, they are able to make simple changes to patient burden issues, eligibility requirements that aren’t routine, the exclusion of patients with clearance issues when treatments are not easily metabolized, overtly excluding patients who have comorbidities without any justification, putting in high age cutoffs and not allowing enrollment of patients over a certain age.
There also are issues of funding. When drugs get on the market, it is up to the pharmaceutical companies to pay for additional clinical trials. There are no overt mandates from the FDA, nor incentives to do so. To try to go back and include patients with other medical problems and learn about what happens with the treatments that are already on the market for this population is almost impossible.
One of the other issues is that research right now is very centered around cancer centers and tertiary care centers in academic medical centers. The population of patients who have the most noncancer issues often are not seen at these medical centers and are not recruited to trials. There is a huge need to be able to recruit in the community.
We are looking at a geriatric assessment model of care in which we’ve enrolled over 600 older patients who have cancer plus frailty, and functional and cognitive impairment comorbidities. These are pragmatic studies and we are learning all about decision-making for treatment, toxicities with certain regimens, and dosing. We’re getting some information, but we need to shift the pragmatic design principles into explanatory studies, so our research allows for patients with comorbidities.
Supriya G. Mohile, MD, MS, is associate professor of medicine at James Wilmot Cancer Center of University of Rochester. She can be reached at supriya_mohile@urmc.rochester.edu. Disclosure: Mohile reports no relevant financial disclosures.