FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration.

Abstract

10009 Background: Older adults are a growing segment of our oncology population, with an expected increase in cancer incidence of 67% from 2010 to 2030 in people age 65 and older. However, older adults have been proportionally underrepresented in clinical trials. We sought to analyze the age-related enrollment of cancer patients onto trials supporting registration of new drugs or new indications approved by the US Food and Drug Administration from 2005 to 2015. Methods: This study involved retrospective analyses of demographic data of cancer patients enrolled onto trials supporting registration from 2005-2015. The data on 224,766 cancer patients supporting 105 drug applications were analyzed according to age distributions of <65, 65-69, 70-74, 75-79, and ≥80 years. The rates of enrollment were compared with the corresponding rates in the US cancer population. The age distributions of the US cancer population were derived from the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute for the year 2013 based on the 2010 US Census. Conclusions: Older adults were under-represented in the registration trials of new cancer therapies, especially those over age 75. Various strategies may be needed to evaluate cancer therapies for older adults in prospective clinical trials and to improve cancer care in adults over age 75. These include re-evaluating what may be considered restrictive eligibility criteria so as not to exclude older adults. Incorporating elements from geriatric assessment tools may help identify older adults most likely to benefit from treatment. More detailed labeling information that reflects the clinical experience with older adults could be considered. The FDA encourages drug sponsors as well as clinical trial cooperative groups to devise strategies to recruit patients that are reflective of their intended population. [Table: see text]

Inclusion of Older Patients with Cancer in Clinical Trials: The SAGE Prospective Multicenter Cohort Survey

“…We found a difference between over 80s and under 80s. This finding agrees with a recent U.S. Food and Drug Administration analysis of the enrollment of older adults in clinical trials for cancer drug registration . Javid et al did not find any difference in invitation rates between older (over 65) and younger (under 65) patients—in contrast to a case‐control study based on 10 Cancer and Leukemia Group institutions .…”

Patient-reported distress in Hodgkin lymphoma across the survivorship continuum

“…Results of these studies may not represent the current profile of distress in HL, however, as treatment approaches evolved [ 7 – 12 ] and recommendations for managing late effects in HL survivors [ 2 ] emerged during the 15 years since these studies were published. In addition, clinical trial participants differ from patients receiving treatment in a non-experimental setting [ 13 ]. More recent studies estimating the prevalence of distress in hematologic malignancies have not distinguished between leukemias and lymphomas [ 14 ], have not described distress separately in HL and non-Hodgkin lymphoma [ 15 , 16 ] or have evaluated distress in HL patients receiving a bone marrow transplant [ 17 ], which represents a minority of HL cases.…”

Inclusion of older patients with cancer in randomised controlled trials with patient-reported outcomes: a systematic review

“…A recent US Food and Drug Administration analysis of trials supporting registration of new cancer therapies and conducted from 2005 to 2015 found that older people, in particular, those aged >75 years, were under-represented 31. Earlier, Lewis and colleagues5 found that only 32% of phase II and III cancer trials enrolled older patients, despite the fact that 61% of patients with incident cancers were older.…”