Changes in the Use of Comprehensive Geriatric Assessment in Clinical Trials for Older Patients with Cancer over Time

The oncologist

article

Olivia Le Saux¹  Claire Falandry³  Hui K. Gan⁵  Benoit You¹  Gilles Freyer¹  Julien Péron¹ 

[1] Medical Oncology Department;Lyon 1 University;Geriatric Unit, Centre Hospitalier Lyon Sud;CarMen biomedical research laboratory (Cardiovascular diseases, Université de Lyon;Olivia Newton-John Cancer Research Institute;School of Cancer Medicine, La Trobe University;Department of Medicine, Melbourne University;Statistics unit, Hospices Civils de Lyon (IC-HCL);UMR 5558 Biometry and Evolutionary Biology laboratory Université Lyon 1

关键词: Comprehensive geriatric assessment;    Older patients;    Clinical trials;   

DOI  :  10.1634/theoncologist.2018-0493

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

Background The objective of this study was to describe the implementation of comprehensive geriatric assessment (CGA) in clinical trials dedicated to older patients before and after the creation of the International Society of Geriatric Oncology in the early 2000s. Subjects, Materials, and Methods All phase I, II, and III trials dedicated to the treatment of cancer among older patients published between 2001 and 2004 and between 2011 and 2014 were reviewed. We considered that a CGA was performed when the authors indicated an intention to do so in the Methods section of the article. We collected each geriatric domain assessed using a validated tool even in the absence of a clear CGA, including nutritional, functional, cognitive, and psychological status, comorbidity, comedication, overmedication, social status and support, and geriatric syndromes. Results A total of 260 clinical trials dedicated to older patients were identified over the two time periods: 27 phase I, 193 phase II, and 40 phase III trials. CGA was used in 9% and 8% of phase II and III trials, respectively; it was never used in phase I trials. Performance status was reported in 67%, 79%, and 75% of phase I, II, and III trials, respectively. Functional assessment was reported in 4%, 11%, and 13% of phase I, II, and III trials, respectively. Between the two time periods, use of CGA increased from 1% to 11% ( p  = .0051) and assessment of functional status increased from 3% to 14% ( p  = .0094). Conclusion The use of CGA in trials dedicated to older patients increased significantly but remained insufficient. Implications for Practice This article identifies the areas in which research efforts should be focused in order to offer physicians well-addressed clinical trials with results that can be extrapolated to daily practice.

【 授权许可】

CC BY|CC BY-NC