FROM JOURNAL OF CLINICAL ONCOLOGY

Cancer research must include more older adult participants because the evidence base for treating this patient population is too sparse, according to an American Society of Clinical Oncology position statement published online July 20 in Journal of Clinical Oncology.

Key evidence is lacking because older adults are usually excluded from clinical trials, even though most cancer patients are aged 65 and older. Both patients and their clinicians are forced to base treatment plans on data from younger, healthier patients, from studies that often don’t even consider endpoints that matter most to them: not just survival rates but quality of life measures and rates of functional independence.

Moreover, older adults respond differently than younger adults to cancer treatments, because of age-associated physiologic changes, a higher incidence of comorbidities, and greater use of medications that may interact with cancer therapies. “We need to see clinical trials that mirror the age distribution and health risk profile of patients with cancer,” said Dr. Arti Hurria, coauthor of the statement and director of the cancer and aging research program at City of Hope, Duarte, Calif., and his associates.

The position statement includes five recommendations and 16 specific action items to achieve this goal.

First, the cancer research community – regulatory agencies, study funders, and researchers – must expand eligibility criteria so more older adults can participate in studies. A rationale must be provided for all restrictions based on age, performance status, or comorbidities. And funders such as the National Cancer Institute and the National Institute on Aging should incentivize research that includes older adults.

Second, research design and infrastructure must be used to incentivize the inclusion of older adults. For example, Medicare could cover the off-label use of cancer therapies in older patients in selected trials, and research databases could be encouraged to collect information pertaining to older patients.

Third, the Food and Drug Administration should be given authority to both incentivize and require studies to include older adults. For example, the agency could reward drug manufacturers for including older patients in trials of new cancer therapies by granting them 6-month patent extensions, or it could encourage the development of new agents by expediting their review. Alternatively, the FDA could limit the compensation available to manufacturers that don’t include older study subjects. And the FDA should include geriatrics experts on its advisory boards, such as the Oncology Drug Advisory Committee.

Fourth, clinicians should increase the recruitment of their older patients into clinical trials. The single most important predictor of whether or not a cancer patient enrolls in a study is that his or her clinician has recommended it. And one way to increase such recommendations is to increase reimbursement for the time and effort it takes clinicians to find and explain relevant studies to patients.

Finally, professional journals should incentivize researchers to report on the substantial data they already collect about older study subjects but do not analyze or report on. And professional journals should include geriatric oncology experts on their editorial boards and as peer reviewers, to ensure that cancer research results are applicable to the majority of people who have cancer, according to the position statement (J. Clin. Oncol. 2015 July 20 [ doi:10.1200/JCO.2015.63.0319 ]).

In a separate report, ASCO also called for the cancer research community to redefine eligibility criteria specifically for studies of molecular medicine. The Cancer Research Committee developed a list of questions to be used to streamline such criteria. Streamlining, in turn, is expected to enhance enrollment in studies of targeted biologics, expedite their development and approval, and better inform clinicians about their use in real-world patients, said Dr. Edward S. Kim,, immediate past chair of the committee and chair of solid tumor oncology and investigational therapeutics, Levine Cancer Institute, Charlotte, N.C., and his associates.

ASCO plans to organize a public workshop “with input from regulatory bodies and key stakeholders, with a goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols,” he said (J. Clin. Oncol. 2015 July 20 [ doi:10.1200/JCO.2015.62.1854 ]).

This position statement was supported by a subcommittee of the American Society of Clinical Oncology’s cancer research committee. Dr. Hurria reported serving as a consultant or advisor for and receiving research funding from GTx, Seattle Genetics, Boehringer Ingelheim, GlaxoSmithKline, and Celgene; his associates reported ties to numerous industry sources. Dr. Kim reported ties to Celgene, Eli Lilly, and Myriad Genetics, and his associates reported ties to numerous industry sources.

tor@frontlinemedcom.com

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