Geriatric drug trials on solid tumor are scarce worldwide

Huiyao Huang; Dandan Cui; Ye Leng; Kaiting Zhang; Anqi Yu; Yanting Wang; Hanli Wu; Yu Tang; Feng Yu; Ning Li

doi:10.3389/fmed.2023.1063648

Geriatric drug trials on solid tumor are scarce worldwide

Front Med (Lausanne). 2023 Feb 6:10:1063648. doi: 10.3389/fmed.2023.1063648. eCollection 2023.

Authors

Huiyao Huang¹, Dandan Cui², Ye Leng³, Kaiting Zhang⁴, Anqi Yu¹, Yanting Wang⁵, Hanli Wu⁶, Yu Tang¹, Feng Yu³, Ning Li¹

Affiliations

¹ Department of Clinical Trials Center, National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
² Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Hebei Cancer Hospital, Langfang, China.
³ School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu, China.
⁴ Phase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
⁵ Department of Pharmacy National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
⁶ Department of Kidney Internal Medicine, Yidu Central Hospital of Weifang, Weifang, Shandong, China.

Abstract

Background: Conducting geriatric trials is the most feasible way to address the vast underrepresentation of older adults in clinical trials of cancer therapies. This study is a globally comprehensive examination of geriatric trials for solid tumor worldwide over the last decade.

Methods: Up-to-date information on cancer drug trials in older adults aged over 59 years from the beginning of 2012 to the end of 2021 was collected from Trialtrove and Pharmaprojects. The number of identified trials was the dependent variable and corresponding analysis was conducted from the perspective of time trend, status quo and comparisons by region and country, sponsor type and cancer type, study status and phase.

Results: A total of 292 geriatric cancer drug trials were identified, of which 287 were single-region studies, 219 were initiated by academic groups, and 55 (18.8%) were terminated. Decreasing trends in the annual number of all trials (-9.2% per year) and the annual number of trials by academic groups (-9.4%) were observed over time. Of the geriatric trials, 183 were conducted in Asia; this number was significantly higher than that in Europe (74), North America (37), Oceania (4), and South America (1). Similar difference was found in participation rate in trials by academic groups ranging from 71.7% in Asia to 0.5% in South America. Of the trials, 19 and 97 were initiated before drug and indication approval, respectively, and the remaining 176 were initiated after indication approval. Phase II trials accounted for the highest proportion of trials (213, 72.9%), while phase I trials accounted for the lowest proportion (14, 4.8%). Trials by academic groups had a higher termination rate (21.5% vs. 11.0%) and fewer were phase IV trials (8.2% vs. 21.9%). Treatment was explored for 16 different cancers, with lung, colorectal and breast cancers being the most common.

Conclusion: Geriatric trials of solid tumor drugs are scarce and partially prematurely terminated. Moreover, the number of geriatric trials has decreased and differs according to region. Global guidance and regulatory supervision are needed to facilitate the acquisition of adequate evidence on drug risk-benefit profiles in older adults, and thus to achieve high-quality care and safe medication.

Keywords: ageism; clinical trial; elderly patients; neoplasms; temporal trend.

Grants and funding

The analysis and interpretation of the manuscript was supported by National Key Research and Development Program (Integrating China in the International Consortium for Personalized Medicine 2021YFE0192400) and Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (Construction and Application of Clinical Trial and Institution Evaluation System 2021-I2M-1-045).