Older persons are the fastest-growing segment of the U.S. population and account for the majority of cancer diagnoses and deaths and the majority of cancer survivors. However, since this population is underrepresented in clinical trials, the evidence base for treating older patients is poor. As reported in the Journal of Clinical Oncology by co–first authors Arti ­Hurria, MD, of City of Hope, and Laura A. ­Levit, JD, of ASCO, and their colleagues, ASCO has issued a statement designed to encourage improvement of the evidence base for treating older adults with cancer.¹ The statement includes five basic recommendations and associated action items, as reproduced below.

“Some of the recommendations are achievable in a short timeframe. Others will require longer-term commitments and the collaboration of multiple stakeholders involved in clinical research,” noted the authors. “Given the rapidly aging population, this is a crucial time to act to ensure all patients with cancer receive high-quality, evidence-based care.”

Recommendation 1: Use clinical trials to improve the evidence base for treating older adults with cancer.

Action Items

• Regulatory agencies, funders of cancer clinical research, and researchers should carefully consider whether there is evidence supporting limitations to eligibility criteria based on age, performance status, or comorbid conditions. Researchers should provide a rationale, informed by input from experts in aging and geriatric oncology, when trials include eligibility criteria that are restricted based on these factors.
• The National Cancer Institute (NCI), U.S. Food and Drug Administration (FDA), and other organizations that are developing common sets of data elements for researchers to collect in clinical trials should include measures from the geriatric assessment domains.
• Funders of cancer clinical trials in which tumor specimens are studied should require researchers to report the age distribution of samples studied and whether this is reflective of the age distribution of the population enrolled onto the trial and the population with the disease overall.
• The NCI should collaborate with the National Institute on Aging, National Institutes of Health (NIH), and other funders of cancer clinical research to encourage and incentivize research involving older adults.

Recommendation 2: Leverage research designs and infrastructure to improve the evidence base for treating older adults with cancer.

Action Items

• Researchers and funders of cancer clinical research should use the full range of research designs, including innovative trial designs, to fill knowledge gaps in the treatment of older adults with cancer.
• Funders of comparative-effectiveness research should require researchers evaluating the role of a standard or novel cancer treatment to include a plan to study a population that mirrors the age distribution and health risk profile of patients with the disease.
• Developers of research and clinical databases should ensure that their systems collect geriatric assessment data and have the functionality to support studies designed to improve the evidence base supporting the treatment of older adults with cancer.
• The Centers for Medicare & Medicaid Services (CMS) should use its coverage with evidence development authority to cover the off-label use of marketed drugs in select cancer clinical trials. The CMS should work with the NIH, patients, and researchers to prioritize trials for this additional coverage.

Recommendation 3: Increase the authority of the FDA to incentivize and require research involving older adults with cancer.

Action Items

• Congress should provide the FDA authority to require a drug or biologic marketing application to contain a plan to gather data and develop recommendations on safety, efficacy, and dosing in older adults.
• Congress should grant the FDA authority to create incentives for companies that conduct clinical trials of new cancer treatments in older adults.
• The FDA should include experts in aging and geriatric oncology on its advisory boards to provide advice on the assessment of novel agents and emerging federal policies.

Recommendation 4: Increase clinician recruitment of older adults with cancer to clinical trials.

Action Items

• Professional societies should develop educational materials for clinicians and researchers to encourage recruitment of older adults to clinical trials.
• The American Medical Association should establish new common procedural terminology codes to reimburse clinicians who offer older patients the opportunity to participate in clinical trials, enroll them onto these trials, and conduct management and follow-up of these patients for the additional time and effort involved. These codes should be reimbursed by Medicare, Medicaid, and third-party payers.

Recommendation 5: Use journal policies to incentivize researchers to consistently report the age distribution and health risk profiles of research ­participants.

Action Items

• Authors should be required to submit and report the detailed age distribution (by decade) of the population included in the study, not just the age ranges of population, and data analyses that could potentially yield valuable age-related information, including age-based analyses of response, benefit, and toxicity.
• Geriatric oncology experts should be included in the pool of editorial board members who serve as peer reviewers of manuscripts.
• Peer reviewers should be instructed to consider whether the authors have adequately reported the age distribution of the population included in the study, the generalizability of the results to the population with the disease, and data analyses that could potentially yield valuable age-related information. ■

Disclosure: For full disclosures of the statement authors, visit jco.ascopubs.org.

Reference

1. 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).