Older patients are underrepresented in the clinical trials that determine the standards of care for oncological treatment. We conducted a review to identify whether there have been age-restrictive inclusion criteria in clinical trials over the last twenty five years, focusing on patients with metastatic gastroesophageal cancer. | Hennessy et al. BMC Cancer 2022 22 3 https s12885-021-09103-w RESEARCH Open Access Metastatic gastroesophageal cancer in older patients is this patient cohort represented in clinical trials Maeve A. Hennessy1 Munzir Hamid1 Niamh M. Keegan1 Lynda Corrigan1 Caitriona Goggin1 Nay Myo Oo1 Marie Carrigan2 David Mockler3 Anita O Donovan4 and Anne M. Horgan1 Abstract Background Older patients are underrepresented in the clinical trials that determine the standards of care for oncological treatment. We conducted a review to identify whether there have been age-restrictive inclusion criteria in clinical trials over the last twenty five years focusing on patients with metastatic gastroesophageal cancer. Methods A search strategy was developed encompassing Embase PubMed and The Cochrane Library databases. Completed phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesoph- ageal malignancies from 1st January 1995 to 18th November 2020 were identified. These were screened for eligibility using reference management software Covidence Veritas Health Innovation Ltd . Data including age inclusion exclu- sion criteria and median age of participants were recorded. The percentage of patients 65 enrolled was collected where available. The change over time in the proportion of studies using an upper age exclusion was estimated using a linear probability model. Results Three hundred sixty-three phase III studies were identified and screened with 66 trials remaining for final analysis. The majority of trials were Asian 48 n 32 and predominantly evaluated gastric malignancies 86 n 56 . The median age of participants was 62 range 18 94 . Thirty-two percent n 21 of studies specified an upper age limit for inclusion and over half of these were Asian studies. The median age of exclusion was 75 range 65 80 . All studies prior to 2003 used an upper age exclusion n 12 whereas only 9 that started in 2003 or later did 17 . Among .
