Abstract

Low Elderly Participation in Non-Small Cell Lung Cancer Clinical Trials

Amy L Cummings, Melody Mendenhall and Jonathan W Goldman

Background: Lung cancer, with a median age at diagnosis of 70 years, is the current leading cause of cancer mortality in the United States. A lack of elderly enrollment in lung cancer clinical trials, however, has led to difficulty establishing elderly guidelines for treatment and has been highlighted by the Institute of Medicine and the American Society of Clinical Oncology as a key area for improvement. While there have been few elderly-specific clinical trials investigating chemoradiotherapy in lung cancer, there have been no elderly-specific trials investigating targeted therapy or immunotherapy and little is known about elderly outcomes with these agents. Methods: PubMed was queried for phase I clinical trials involving non-small cell lung cancer (NSCLC) in English in the past five years. Of these 192 studies, 49 investigated targeted therapy and/or immunotherapy without protocolized chemoradiotherapy. These articles were reviewed and assessed based on age demographics and outcomes. Results: Twelve percent of studies had a mean/median age of 65-69 years; no studies had a mean/median age of 70 years or greater. Of the seven studies with published information on age distribution, only four had information regarding the percentage of participants 70 years or older, which ranged from 8-33% and was limited by a total sample size of 15-26. The few studies that published information on age-specific outcomes suggested that targeted therapy and immunotherapy in the elderly may be as well tolerated and have similar treatment outcomes, but were limited by the small number of elderly participants in these trials. Conclusion: Additional research involving elderly enrollment and outcomes in NSCLC clinical trials is warranted. Increased recruitment of the elderly in clinical trials and publication of elderly-specific outcomes in lung cancer research is key to improving treatment guidelines in this field.