Harpreet Singh

Expanding the Evidence Base in Geriatric Oncology: Action Items From an FDA-ASCO Workshop

As part of the ongoing efforts to address the lack of clinical research on older adults with cancer, the American Society of Clinical Oncology (ASCO) and the US Food and Drug Administration cosponsored a public workshop on geriatric oncology in November 2017. The goals were to review progress, build collaborations across stakeholders, and generate new action items for increasing the evidence base for treating older adults with cancer. It built on previous work of the Institute of Medicine, ASCO, and the U13 Conferences convened by the Cancer and Aging Research Group, the National Cancer Institute, and the National Institute of Aging between 2010 and 2015. The workshop drew a diverse group of presenters, panelists, and attendees, including academic and clinical oncologists, regulators, other government officials, representatives from industry, and patient advocacy groups. Attendees at the workshop were tasked with proposing next steps to address the lack of evidence on treating older adults with cancer. Based on the workshop discussions, four new action items to move the field forward were developed: 1) increase enrollment of older adults in clinical trials, 2) collect more information on older adults enrolled on clinical trials, 3) expand the use of real-world data in research on older adults, and 4) strengthen collaboration between stakeholders to develop advocacy and policy solutions. These action items, alongside the previous ASCO, Institute of Medicine, and U13 recommendations, provide a strategy for improving the evidence base for treating older adults with cancer and ensuring all patients with cancer receive high-quality, evidence-based care.

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.