Progress Through Collaboration: An ASCO and U.S. Food and Drug Administration Workshop to Improve the Evidence Base for Treating Older Adults With Cancer.

Older adults represent the majority of patients diagnosed with cancer, yet the evidence base used to guide therapy for this growing segment of the population is limited compared with data available for younger adults. Information is particularly limited for adults commonly seen in practice, including those over age 75 and those with comorbidity or frailty. Efforts have been underway to raise awareness of this substantial gap in evidence and identify strategies to build an evidence base for older adults. Recently, the ASCO and the U.S. Food and Drug Administration convened a public workshop to address this issue. There is a need for innovative trial design to test the efficacy and tolerability of therapies among generalizable older adult populations. Incorporation of endpoints such as functional independence and quality of life as well as investigation of geriatric assessment-based treatment allocation strategies will be needed to individualize care planning. Strategies to increase trial enrollment need to be emphasized, including modernizing eligibility criteria, addressing patient and provider barriers to clinical trial enrollment, and consideration of incentives for patients, providers, and sponsors. Finally, investigation of real-world data and incorporation of patient-reported outcomes into the drug-development process may provide opportunities to build evidence related to treatment benefit and tolerance with an emphasis on the patient experience among older adults in diverse treatment settings.