Studies have shown that older adults account for most of the cancer diagnoses and deaths that occur in the United States and make up the majority of cancer survivors. More than 50% of cancers in the U.S. occur in people aged 65 and older, a demographic that is expected to grow exponentially in the coming years. However, the evidence base for treating this patient group is lacking. In addition, few policy initiatives have targeted the lack of evidence on older adults with cancer.
“Older adults are largely underrepresented in clinical trials, and it’s rare when these trials are designed specifically for older adults,” says Arti Hurria, MD. “This patient population tends to have different experiences and outcomes with cancer treatment than younger counterparts. We’re also expecting a doubling of the U.S. population that is 65 and older, and we project a 67% increase in cancer incidence among this age group. These data emphasize the importance of involving older adults in clinical trials so that we can optimize treatment for these patients.”
In response to this issue, the American Society of Clinical Oncology (ASCO) recently released landmark recommendations to improve the evidence base for treating older adults with cancer. The call-to-action statement was developed by ASCO’s Cancer Research Committee and published in the Journal of Clinical Oncology. It made five overarching recommendations to improve the evidence base for treating older adults with cancer (Table).
Improving Trial Designs
The first recommendation from ASCO is to use clinical trials to improve the evidence base for treating older adults. There is growing recognition that eligibility criteria in clinical trials could be relaxed without compromising scientific rigor. Efforts should also be made to gather additional data elements in trials, such as the impact of treatment on function or cognition. The statement notes that government groups should encourage and incentivize more involvement of older adults in trials. “The goal should be to make it possible to enroll more adults who are older into clinical trials, even if they have comorbidities,” says Dr. Hurria.
ASCO also recommends leveraging research designs and infrastructure to improve the evidence base for treating older adults by extended trial designs and adaptive trials. Innovative designs are needed to fill knowledge gaps.
Help Needed From Stakeholders
Another key recommendation, according to Dr. Hurria, is to increase the FDA’s authority to incentivize and require research on older cancer patients. “The FDA has issued guidance that encourages manufacturers to generate evidence on the effectiveness of their products in older adults, but it doesn’t require it,” she says. “Laws are needed to change this so that we can better capture information regarding older patients.”
The ASCO statement also recommends that clinicians aim to increase recruitment of older adults with cancer into clinical trials. One of the biggest predictors of whether patients decide to enroll into a clinical trial is if their clinician has discussed and recommended it. “Educational programs will be necessary to reduce clinicians’ reluctance to enroll older adults into trials,” Dr. Hurria says. Increasing reimbursement for clinicians who enroll patients into clinical trials may also improve recruitment.
The final overarching recommendation made by ASCO is to utilize journal policies to incentivize researchers to consistently report on age distribution and health risk profiles of clinical trial participants. “Researchers collect a substantial amount of data about older adults that are not being analyzed or reported,” says Dr. Hurria. “This represents an easily addressed but often missed opportunity to identify differences in safety, efficacy, and dosing that is associated with age. Using journal policies could improve the reporting of data as it relates to the treatment of older adults.”
The ASCO recommendations detail 16 specific action steps that should be implemented in order to achieve the five overarching themes discussed in the call-to-action statement. These include asking regulatory agencies, research funders, and researchers to carefully consider if there is evidence to support eligibility criteria based on age, performance status, or comorbid conditions. These are three critical reasons that older adults are excluded from clinical trials.
“The ASCO position statement has given clinicians a roadmap to conduct a multipronged approach that will help expand participation of older adults with cancer in clinical trials,” says Dr. Hurria. “While some of these recommendations are achievable in the short term, others will require longer-term commitments and collaboration from multiple stakeholders who are involved in clinical research. Considering how rapidly our population is aging, it’s clear that now is the time to take action to ensure that all patients with cancer—regardless of age—receive high-quality, evidence-based care.”
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 Onc. 2015 Jul 20 [Epub ahead of print]. Available at: http://jco.ascopubs.org/content/early/2015/07/14/JCO.2015.63.0319.full.
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. 2014;32:2587-2594.
Scher KS, Hurria A: Under-representation of older adults in cancer registration trials: Known problem, little progress. J Clin Oncol. 2012;30:2036-2038.