It has often been argued that it is essential to exclude patients from clinical trials on the basis of functional characteristics (eg, too infirm to participate, medical complications that could confound interpretation of results, presence of extensive comorbidities, or simply unable to provide informed consent). However, age alone or the presence of concomitant illness does not warrant the exclusion of elderly individuals from clinical trials.We recently evaluated outcomes in 345 RCTs. We found that elderly patients who met the inclusion and exclusion criteria for the trial did not have worse outcomes associated with exposure to experimental treatments. However, generalizibility of our results to other elderly patients with multiple comorbid conditions was limited because of strict inclusion and exclusion criteria built into the trials we evaluated. Florence Keime-Guibert and colleagues recently performed a randomized trial in which they compared supportive care only vs supportive care plus radiotherapy in the treatment of newly diagnosed anaplastic astrocytoma or glioblastoma for "typical" elderly patients with multiple comorbidities. They demonstrated that it is possible to study elderly patients in RCTs and generate needed evidence to inform future practice.
By 2030, the number of persons in the United States over age 65 will have increased twofold and the number of persons over age 85 will be four times what it is today. Because of the relatively high risk of cancer in the elderly, there will be a high prevalence of cases in this population. For physicians interested in practicing geriatric evidence-based medicine, the fact that the bulk of such evidence in oncology is based on trials conducted in young patients must be disheartening.
We need to improve the treatment of the majority of cancer patients at optimal costs. However, optimal cost-effectiveness analysis in geriatric oncology is currently not possible due to the lack of reliable data related to the "effectiveness" part of the equation. One needed economic analysis should focus on assessing the costs of "appropriate" vs "inappropriate" care. This assessment cannot be conducted until we increase the magnitude of reliable medical evidence to inform care in the elderly.
Ambuj Kumar, MD, MPH
Benjamin Djulbegovic, MD, PHD