The 2013 Institute of Medicine (IOM) report Delivering High Quality Cancer Care: Charting a New Course for a System in Crisis1 identified the dearth of evidence on older adults as a major quality-of-care issue. The U.S. population is aging at a rapid rate, and cancer is a disease that primarily affects older adults. More than 50% of cancer diagnoses and nearly 70% of cancer deaths occur in individuals aged 65 and older.2 The majority of cancer survivors are also in this age range. Recent projections of cancer incidence anticipate a 67% increase in cancer diagnoses in patients aged 65 and older between 2010 and 2030 but only an 11% increase in younger adults.
Despite the strong association between cancer and aging, older adults are routinely underrepresented in cancer clinical research. Multiple studies have found that people aged 65 and older are underrepresented in both cancer registration trials and the National Clinical Trial Network’s trials (formerly the Cooperative Groups), and there has been little improvement over time. Trials focused exclusively on older adults are also rare.
Improving Our Evidence Base
As a result, medical oncologists do not have the information needed to make evidence-based treatment decisions in older adults with cancer. Moreover, there is a projected shortage of health-care providers with geriatric expertise.
The IOM report made two recommendations to improve our evidence base and strengthen the national workforce that cares for older patients with cancer: (1) increase the breadth of collected data by matching the characteristics of the study population to those of patients with the disease (ie, enroll more elderly patients onto clinical trials), and (2) increase the depth of collected data by capturing a more detailed characterization of the study population through evaluation tools, such as a comprehensive geriatric assessment.
It is important to understand, however, that the IOM issues recommendations to address pressing policy issues but does not take steps to implement those recommendations. Thus, in response to the IOM’s report, ASCO formed a working group composed of 11 individuals with expertise in geriatric oncology to review the IOM report and to identify actionable strategies for improving research on older adults with cancer.
After more than a year of deliberations, conference calls, and approval from ASCO’s Cancer Research Committee and Board Executive Committee, the working group published the article Improving the Evidence Base for Treating Older Adults With Cancer: American Society for Clinical Oncology Statement.3 The statement is summarized in this issue of The ASCO Post.
Actionable Strategies
The ASCO Statement makes five overarching recommendations that address key strategies to improve the evidence base for the treatment of older adults with cancer through advocacy, research, and education. Each recommendation includes a list of specific action items. In particular, the recommendations include:
- Increase the U.S. Food and Drug Administration’s (FDA’s) authority to incentivize and require research on older adults with cancer.
- Use clinical trials to improve the evidence base for treating older adults with cancer.
- Leverage the full range of research designs and infrastructure for generating evidence on older adults with cancer.
- Increase clinicians’ recruitment of older adults with cancer to clinical trials.
- Utilize journal policies to improve researchers’ reporting on the age distribution and health-risk profiles of research participants.
The first recommendation entails policy and/or legal changes to the FDA’s authority to require and incentivize clinical trials that include older adults, which can be achieved through the engagement of the multiple stakeholders involved in cancer clinical research. The concept is modeled after the strategy used in pediatrics to increase research on children.
For example, the Best Pharmaceuticals for Children Act provides industry with the financial incentive of an additional 6 months of market exclusivity for studying a product in children. The Pediatric Research Equity Act requires pharmaceutical companies to test their products in children under certain circumstances when submitting new drug applications. These acts have successfully increased pediatric research and, if adapted to geriatrics, would likely produce a similar increase in clinical trials studying older adults. ASCO’s advocacy department is in the process of developing an advocacy strategy for addressing this component of the statement.
Recommendations two, three, and four speak to the need for increased research to guide evidence-based care of older patients. Aging is a heterogeneous process, and many older adults are able and willing to participate in clinical trials. Recent articles in the Journal of Clinical Oncology4,5 provided recommendations on designing clinical trials in older adults with cancer.
A key component of clinical trials in older adults is the inclusion of a geriatric assessment, which provides clinicians with information on the heterogeneity of the aging process beyond chronologic age. Many of the domains of a geriatric assessment, including functional status, comorbidity, and psychosocial status, can be collected through patient-reported questionnaires. Predictive models have been developed that include geriatric assessment items (Cancer Aging Research Group6 and CRASH7 score) to identify a patient’s risk for severe chemotherapy toxicity. Further research is underway to understand how the information garnered from these tools can be utilized to inform clinical decision-making and guide interventions to improve outcomes in older adults receiving chemotherapy.
Recommendation five leverages information collected in ongoing research studies through improved reporting of clinical trials in medical journals on the age distribution and health-risk profiles of research participants and age-related data analyses. Substantial evidence is being collected on older adults that is not reported in a format that has the potential to inform clinical care. Providing more detailed information on the age distribution of trial participants (not just the age ranges of the population), as well as any preplanned or hypothesis-generating outcomes by age, could inform clinicians about important age-related efficacy, safety, and dosing considerations.
Moving Forward
The ASCO statement lays out a blueprint for ensuring that all patients have access to evidence-based care, including the growing older population of patients. Medical oncologists and oncology health-care providers play a key role in developing this much-needed evidence. Together with patient advocates, regulatory bodies, research institutions, and medical journals, we can fill the knowledge gap needed to improve the care of our growing population of older adults with cancer. ■
Disclosure: Ms. Levit reported no potential conflicts of interest. Dr. Hurria has received research funds to City of Hope from Celgene and GlaxoSmithKline and is also a consultant for GTx, Inc., Boehringer Ingelheim Pharmaceuticals, and On Q Health.
References
1. Institute of Medicine: Delivering high-quality cancer care: Charting a new course for a system in crisis, in Levit L, Balogh E, Nass S, et al (eds). Washington, DC, National Academies Press, 2013.
2. National Cancer Institute: SEER Stat Fact Sheets: All cancer sites. Available at http://seer.cancer.gov/statfacts/html/all.html, 2015. Accessed September 22, 2015.
3. Hurria A, Levit LA, Dale W, et al: Improving the evidence base for treating older adults with cancer: American Society of Clinical Oncology statement. J Clin Oncol. July 20, 2015 (early release online).
4. Wildiers H, Mauer M, Pallis A, et al: End points and trial design in geriatric oncology research: A joint European organisation for research and treatment of cancer—Alliance for Clinical Trials in Oncology—International Society of Geriatric Oncology position article. J Clin Oncol 31:3711-3718, 2013.
5. Hurria A, Dale W, Mooney M, et al: Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations. J Clin Oncol 32:2587-2594, 2014.
6. Hurria A, Togawa K, Mohile SG, et al: Predicting chemotherapy toxicity in older adults with cancer: A prospective multicenter study. J Clin Oncol 29:3457-3465, 2011.
7. Extermann M, Boler I, Reich RR, et al: Predicting the risk of chemotherapy toxicity in older patients: The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score. Cancer 118:3377-3386, 2012.
Ms. Levit is Associate Director of Research and Analysis at ASCO, and Dr. Hurria is Director of Cancer and Aging Research Program, City of Hope, Duarte, California.
