November 06, 2020 By Jennifer
Byrne Source/Disclosures
Cancer is a disease of aging, with those aged 70 years or older
representing 42% of the total cancer population.
However, fewer than 25% of patients in cancer clinical trials registered
with the FDA are in this age group.
“One of the challenges that we have in taking care of older
patients with cancer is that they represent a large number of the patients who
we see, yet very little information about them is included in cancer clinical
trials,” Mina S. Sedrak, MD, MS, deputy director of
the Center for Cancer and Aging at City of Hope who specializes in the care of
older women with breast cancer, said in an interview with Healio. “In the
clinic, when we’re making decisions about treatments — for example, when
deciding whether to give [an older] woman chemotherapy based
on harms and benefits — there is not enough information out there about this
population to guide the decision.”
Given this problem, Sedrak and colleagues at City of Hope
conducted a systematic review of the literature to identify barriers to older
adult participation in cancer clinical trials and interventions designed to
increase their enrollment in these trials.
Sedrak discussed the findings and their implications with
Healio.
Question: What inspired you to embark on
this study?
Answer: Age is a major risk factor for cancer, and the
U.S. population is aging. In 2011, the baby boomer population started to turn
65 years old. From 2010 to 2030, the incidence of cancer is expected to
increase by 67% among people aged older than 65 years. Yet, despite these
demographic changes, few older adults participate in the clinical studies used
to determine standard-of-care guidelines for patients with cancer. Older adults
are left behind when it comes to cancer research. Study after study has shown
this disparity. We wanted to find out why this was the case and what has been
done to make it better.
Q: How did you select the studies you included
in your systematic review?
A: We did a comprehensive search of literature using rigorous
systematic review methods. We worked with a medical science information
specialist to identify the best search strategy. We applied the search strategy
across multiple large scientific search engines and identified over 8,000
unique articles, of which we reviewed the abstracts and titles to determine
those that were relevant to our question. At the end of this process, we
identified 12 studies that asked the question, “Why are older patients underrepresented?”
and one study that examined an intervention to address this problem.
Q: What barriers did you find?
A: We found that the barriers were multifactorial and interrelated,
involving system, clinician, patient and caregiver challenges. For example, studies
were designed in a way that inherently excluded older adults due to stringent
exclusion criteria, which prohibited participation for patients with comorbid
conditions, such as heart disease and diabetes, limited performance status, or
kidney and liver function. We also found that physicians were reluctant to
enroll older adults for clinical trials because they felt these patients were
at more risk for harm or toxicities. They seemed unsure of how to examine the
risk for toxicities among older patients. Patients themselves had some
barriers; there were issues of transportation.
Q: What has been done to address these
barriers?
A: Aside from trials designed specifically for older patients
(which are few in number), we found only one study that examined an
intervention or strategy to specifically address the barriers that hinder older
adult enrollment in cancer research. That was a study done in 2004 in a large
cancer clinical trial cooperative group called the Alliance for Clinical Trials
in Oncology. Physicians at randomly selected sites received an educational
intervention about older adults and the need to include this population in
clinical trials. At the end of the study, 1 and 2 years later, there was no
difference in the number of older adults who participated in the trials across
the sites, regardless of whether the site got the intervention. It was
concluded as a negative study, meaning the physician-targeted educational
intervention did not work.
Q: What can be done to improve this
situation?
A: Multisystem problems need multisystem solutions by
multi-stakeholder partnership. I do not think there is one simple answer to this
problem. We need to work together with policymakers, funders, oncologists,
geriatricians, patient advocates and pharmaceutical companies to restructure
our approach to cancer clinical trials. We need to restructure the system to
make sure older adults have a seat at the table. If the system isn’t thinking
about how it is inherently excluding older adults, that’s not something it is
going to address.
Q: Is this happening now?
A: Yes, multiple organizations are actually working together to
tackle this problem, including the FDA, NIH, American Cancer Society and ASCO.
There is an increase in the number of policy and guideline statements coming
out from these organizations that encourage investigators to ensure that cancer
research is representative of older patients — not just the very few fit,
young, healthy older patients who don’t represent the majority of the patients
we see in the clinic, but also the frail older adults.
Q: Do you think these groups speaking out will
encourage more efforts to include older adults in trials?
A: Awareness is the first step. We’re trying to create discussion
through workshops and conferences. We’re writing policy statements and
guidelines. But now, we need some concrete action. We need to figure out how to
fill the gaps in knowledge of how to care for older adults with cancer. We need
to design trials specifically for them. Maybe the answer isn’t including them
in every trial, because some trials need to be focused on efficacy and need
that stringent criteria because it’s a new therapy. But if we cannot
operationalize their inclusion, how could we develop new strategies to expand
the science needed to provide the highest quality of care for this growing and
vulnerable population? Would we develop specific trials with relevant endpoints
for them, or would we incentivize organizations to answer the questions that
are relevant for older adults? This is what we want to determine.
Q: Do you plan to conduct more studies on
this?
A: Yes. We’re looking at designing trials for older patients with
cancer and determining the prototype for these trials. What does the ideal
study look like? How do we design trials for older patients who are not so fit,
have poor health status and comorbidities? What infrastructures can we use to
design trials for them? Simultaneously, we are working to better understand how
to leverage real-world data to answer these questions. Do we gather data from
medical records or from large registries and tumor databases? Just as we are
focused on precision medicine, we should also be focused on including older
adults so we can understand this population and how they tolerate different
therapies.
This also is relevant when we think about COVID-19. We know that
COVID-19 disproportionately affects older adults and causes more deaths,
hospitalizations and complications in these patients. Yet, we hardly include
older adults in vaccine trials. Who is monitoring that? How are we ensuring
that when the vaccine comes out, older adults can benefit? Not just older
adults, but frail ones — those with obesity, diabetes, bad kidneys. This is the
message.
Our study is focused on patients with cancer, but this is about
systemic ageism. It leads to inequalities and disparities that cause problems
across the spectrum of health care.
For more information:
Mina S. Sedrak, MD, MS, can
be reached at City of Hope, 1500 E. Duarte Road, Duarte, CA 91010; email:
msedrak@coh.org.
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