Characteristics of elderly-specific oncology trials registered in ClinicalTrials.gov.
Authors: Bian Wu, Yun Yang, Yun Tang, Yongqiang Zheng, Mingxing Xie, Kunyu Yang, Gang Wu
Journal: Journal of Clinical Oncology (2021)

12040 Background: Clinical trials dedicated to the elderly cancer patients are essential to help to define optimal cancer therapy for this rapidly growing population. Our study aimed to analyze the characteristics and the evolution of elderly-specific oncology trials registered in ClinicalTrials.gov. Methods: A dataset of 61120 oncology trials registered in ClinicalTrials.gov between Jan 1th, 2000 and Dec 17th, 2019 was downloaded. Interventional trials were identified and systematically reviewed to validate classification into elderly-specific (at least using a chronological landmark to define the elderly) and age-unspecified trials. Cancer type and other registration information were extracted. Characteristics of elderly-specific trials were compared with characteristics of age-unspecified trials. Chronological shifts in elderly-specific trials between 2000 to 2009, and 2010 to 2019 were analyzed. Results: Of the 49273 trials eligible for analysis, only 791 (1.6%) were elderly-specific. The most frequently used threshold to define the old was 60 years (36%), followed by 70 years (28%) and 65 years (26%). More than half of the elderly-specific trials were phase 2 (56.8%) trials and enrolled 100 or fewer participants (59.4%). Compared with age-unspecified trials, elderly-specific trials were less likely to be funded by industry (28.3% vs 37.1%; p &lt; 0.001), and more likely to be conducted in Europe (42.1% vs 24.5%, p &lt; 0.001). During the two time periods between 2000 to 2009, and 2010 to 2019, the proportion of elderly-specific trials of all the oncology trials remained stable (1.57% vs 1.62%). The proportion of treatment-oriented trials decreased from 91.9% to 71.4% (p &lt; 0.001) while supportive care-oriented trials increased from 1.9% to 13.2% (p &lt; 0.001). Industry-funded elderly-specific trials decreased from 34.0% to 25.6% (p = 0.014). Concerningly, the use of clinically meaningful end points in elderly such as disease-specific survival, patient-reported outcomes (PROs) and functional status as a primary end point were uncommon (0.5%, 8.0%, and 6.9%, respectively). However, the use of PROs as a primary end point tended to increase in the second time period, from 2.4% to 10.5% (p &lt; 0.001). There was no correlation between the number of trials for a given cancer type and relative incidence and mortality. 336/791 (42.5%) of the trials were conducted for patients with blood cancer, although the incidence and mortality of blood cancer were relatively low. The most common solid cancer types were breast cancer (13.9%), lung cancer (10.0%), and colorectal cancer (7.8%). Conclusions: Although the majority of all new cases of cancer occur in the elderly population, elderly-specific trials account for only a minority of all oncology trials. Our study helps us to better understand the current state of elderly-specific trials and provides insights for future development that can improve the care of elder patients with cancer.