Special Issues and Implications for Older Adults

Geriatric patients with cancer are underrepresented in oncology clinical trials for many reasons—yet this population has a high cancer burden. The resources in this section address this disparity and suggest ways to improve clinical trial design to increase the participation of older adults with cancer and generate more research on their needs and potential therapies.

Cancer and Aging Research Group U13 Consensus Papers

Since 2010, the Cancer and Aging Research Group, the National Cancer Institute (NCI), and the National Institute on Aging (NIA) have come together for several meetings to discuss the current state of research on older adults with cancer. After each conference, the group publishes its findings and recommendations.

• Biological, Clinical, and Psychosocial Correlates at the Interface of Cancer and Aging Research: At the first of the conferences, in 2010, the groups discussed the current state of geriatric oncology research and the ways it can be improved and expanded. They then outlined a plan—published in this Journal of the National Cancer Institute article—to address gaps in research over the next 10 years. The plan’s specific steps include enhancing geriatric and biologic assessments, focusing more research trials on the most vulnerable cohorts of older adults with cancer, and making clinical trial participation more convenient for the geriatric population.
   
• Designing Therapeutic Clinical Trials for Older and Frail Adults with Cancer: U13 Conference Recommendations: The groups met again in 2012 with members from the Alliance for Clinical Trials in Oncology, NIA, and NCI. The goal was to craft recommendations for increasing the participation of older adults with cancer in clinical trials. The group focused on uncovering the knowledge gaps in this area and designing therapeutic clinical trials that are applicable and tailored to older adults with cancer. These recommendations are detailed in this JCO article.
   
• End Points and Trial Design in Geriatric Oncology Research Joint European Organization for Research and Treatment of Cancer--Alliance for Clinical Trials in Oncology--International Society of Geriatric Oncology Position Article: This JCO special article focuses on the importance of end points and trial design in clinical studies of older adults with cancer. Some established and well-used end points and trial designs may not work as well for the geriatric population. Therefore, the three-oncology groups represented in this article recommend other end points. These include disease-specific survival, composite end points, and treatment failure-free survival. The study also discusses changes to trial design that take into account older patients’ increased risk of death and clinical trials’ potential impact on quality of life.
   
• Participation of Patients 65 Years of Age or Older in Cancer Clinical Trials: In this study, published in JCO, Lewis and colleagues evaluated the low participation of older adults in oncology clinical trials. At the time of the study, the geriatric population accounted for only 25% of cancer clinical trial participants, even though more than 60% of new cases of cancer were being diagnosed among older adults. After studying data from almost 60,000 patients, the team recommended improving insurance coverage for older adults and changing trial designs so as not to exclude this population from oncology studies.