70 Background: With demographic shifts leading to an aging cancer population, the American Society of Clinical Oncology (ASCO) has recommended that journal editors improve the reporting of clinical trial data specific to older adults. This study aimed to assess the current reporting status of clinical trial data regarding older adults with cancer. Methods: This was a review of oncologic therapeutic phase-3 clinical trial data published from 07/01/2016-06/30/2017. Based on a keyword search of EMBASE and PubMed, 929 manuscripts were identified. Removing duplicates (n = 116) and articles that did not meet this study’s cancer inclusion criteria (n = 589), a total of 224 were identified. In the pilot phase there was 85% agreement among the reviewers. Results: Thus far, 197 papers (88%), have been independently reviewed with 118 evaluated by more than one reviewer. Reviewed papers were published in 57 journals including Journal of Clinical Oncology (28, 14.2%), Lancet Oncology (25, 12.7%), and NEJM (20, 10.2%). Much of the literature focused upon the following cancer sites: Breast (33, 16.7%), Lung (27, 13.7%), Colorectal (18, 9.1%), and Prostate (12, 6.1%). 175 articles included inclusion/exclusion criteria, 32 (16.2%) had upper age exclusion criteria. Age was presented in 184 articles and data was stratified by age in 84 (42.6%). Age stratification of effectiveness and toxicity were presented in the results section in 65 (38.2%) and 21 (14.4%). Effectiveness by age was in the discussion section in 37 (18.8%) and toxicity by age in 16 (8.1%). Reviewers could not determine the proportion of study participants who were older adults in 111 articles (56.2%). In the remainder of the articles, the proportion ranged from 0% to 81%, except one in which all participants were older adults. Conclusions: A slim minority of phase-3 oncologic clinical trials included and discussed age-referenced results regarding the effectiveness and toxicity of treatments in older adults. Clinical investigators and journal editors should consider the ASCO recommendation and increase the reporting of oncologic clinical trial data specific to older adults.
Will AstraZeneca be able to provide clinical trial data on its COVID‐19 vaccine efficacy in older adults?
