IMPORTANCESeminal investigation 2 decades ago alerted the oncology community to age disparities in participation in cooperative group trials; less is known about whether these disparities persist in industry-funded research. OBJECTIVE To characterize the age disparities among trial enrollees on randomized clinical trials (RCTs) of common cancers in clinical oncology and identify factors associated with wider age imbalances. DATA SOURCES Phase 3 clinical oncology RCTs were identified through ClinicalTrials.gov. STUDY SELECTION Multiarm RCTs assessing a therapeutic intervention for patients with breast, prostate, colorectal, or lung cancer (the 4 most common cancer disease sites) were included. DATA EXTRACTION AND SYNTHESIS Trial data were extracted from ClinicalTrials.gov. Trial screening and parameter identification were independently performed by 2 individuals. Data were analyzed in 2018. MAIN OUTCOMES AND MEASURESThe difference in median age (DMA) between the trial participant median age and the population-based disease-site-specific median age was determined for each trial.RESULTS Three hundred two trials met inclusion criteria. The trials collectively enrolled 262 354 participants; 249 trials (82.5%) were industry-funded. For all trials, the trial median age of trial participants was a mean of 6.49 years younger than the population median age (95% CI, −7.17 to −5.81 years; P < .001). Age disparities were heightened among industry-funded trials compared with non-industry-funded trials (mean DMA, −6.84 vs −4.72 years; P = .002). Enrollment criteria restrictions based on performance status or age cutoffs were associated with age disparities; however, industry-funded trials were not more likely to use these enrollment restrictions than non-industry-funded trials. Age disparities were also larger among trials that evaluated a targeted systemic therapy and among lung cancer trials. Linear regression modeling revealed a widening gap between trial and population median ages over time at a rate of −0.19 years annually (95% CI, −0.37 to −0.01 years; P = .04). CONCLUSIONS AND RELEVANCEAge disparities between trial participants and the incident disease population are pervasive across trials and appear to be increasing over time. Industry sponsorship of trials is associated with heightened age imbalances among trial participants. With an increasing role of industry funding among cancer trials, efforts to understand and address age disparities are necessary to ensure generalizability of trial results as well as equity in trial access.

Learning Objectives Compare survival and toxicity outcomes of older patients with head and neck cancer with those of their younger cohorts. Describe the role played by comorbidity, quality of life, and supportive care in the treatment decision and treatment process of older patients with head and neck cancer.

Older adults with squamous cell carcinomas of the head and neck (HNSCC) pose unique treatment and supportive care challenges to oncologists and other cancer care providers. The majority of patients with HNSCC present with locoregionally advanced (LA) disease, for which combined modality treatment integrating chemotherapy and radiation therapy is often necessary to maximize tumor control. However, applying these approaches to an older population with concomitant comorbidities and higher risk for functional impairments remains challenging, and is exacerbated by the paucity of studies involving older adults. The purpose of this paper is to identify knowledge gaps in the evaluation and management of older adults with HNSCC and their caregivers, particularly those undergoing concurrent chemoradiation, through a review of the literature conducted by clinicians, researchers, and patient advocates. The findings highlight the importance of a geriatric assessment and the therapeutic paradigms and challenges relevant to this population. Furthermore, we identify the need for additional research and interventions related to key supportive care issues that arise during and after treatment in older adults with LA-HNSCC. Based on our findings, we prioritized these issues to guide future patient-oriented research endeavors to address these knowledge gaps and thus better serve this growing patient population.

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