关键词: Cancer Clinical study Clinical trial Frailty Geriatric assessment Geriatric evaluation Geriatric screening Oncology

Mesh : Humans Geriatric Assessment / methods Aged Neoplasms / drug therapy therapy Medical Oncology / methods Frailty / diagnosis Aged, 80 and over Clinical Trials as Topic

来  源:   DOI:10.1016/j.jgo.2023.101684

Abstract:
Therapeutic options in oncology keep on expanding. Nonetheless, older adults are underrepresented in clinical trials and those enrolled often have a better health status than their average peers, resulting in a lack of representative evidence for this heterogenous population. The inclusion of older patients and a uniform categorization of \"frailty\" is becoming increasingly urgent. Standardized tools could contribute to the quality and comparability of clinical trials and facilitate clinical decisions. The aim of this literature review was to elaborate an overview of the use of geriatric evaluation (GE) methods in clinical cancer research.
We performed a literature review of the PubMed database. Clinical pharmacotherapy studies that applied or evaluated a clearly defined system for the GE of oncological patients were included. Data retrieved encompassed the applied GE method(s), cancer type(s), and pharmacotherapy investigated, the number of included patients, study type, year of publication, as well as the primary purpose of the GE. The GEs used most frequently were depicted in more depth.
In this literature review, 103 publications were selected for inclusion. The biggest proportion of studies (36%, n = 34) used clearly defined, but not previously validated, GE methods (study-specific GE). Standardized GE methods encountered in at least five publications were the G8 screening test (applied in 18% of included studies, n = 17), the Balducci score (7%, n = 7), and a geriatric assessment based on Hurria (5%, n = 5). The primary purpose of GE was predominantly an appraisal of its potential role in pharmacotherapy optimization. The GE also served as baseline and outcome measure, inclusion/exclusion criterion, factor for stratified randomization, and to determine treatment allocation.
The wide range of GE methods used across studies make direct comparisons difficult, and many methods are poorly characterized and/or not previously validated. The further inclusion of representative older patients in clinical trials combined with the use of a standardized GE could help clinicians in the decision-making process.
摘要:
背景:肿瘤学的治疗选择不断扩大。尽管如此,老年人在临床试验中的代表性不足,参加临床试验的人往往比一般同龄人有更好的健康状况,导致缺乏这种异质人群的代表性证据。纳入老年患者和“虚弱”的统一分类变得越来越紧迫。标准化工具可以提高临床试验的质量和可比性,并促进临床决策。这篇文献综述的目的是阐述在临床癌症研究中使用老年评估(GE)方法的概述。
方法:我们对PubMed数据库进行了文献综述。包括应用或评估肿瘤患者GE明确定义的系统的临床药物治疗研究。检索到的数据包含应用的GE方法,癌症类型,和药物治疗研究,纳入患者的数量,研究类型,出版年份,以及GE的主要目的。使用最频繁的GE被更深入地描述。
结果:在这篇文献综述中,选择了103种出版物。最大比例的研究(36%,n=34)使用明确定义,但之前没有验证,GE方法(研究特定的GE)。在至少五个出版物中遇到的标准化GE方法是G8筛选测试(在18%的纳入研究中应用,n=17),Balducci得分(7%,n=7),和基于Hurria的老年评估(5%,n=5)。GE的主要目的主要是评估其在药物治疗优化中的潜在作用。GE还作为基线和结果衡量标准,纳入/排除标准,分层随机化的因素,并确定治疗分配。
结论:研究中广泛使用的GE方法使直接比较变得困难,和许多方法是不充分的表征和/或以前没有验证。在临床试验中进一步纳入具有代表性的老年患者,结合使用标准化的GE可以帮助临床医生进行决策。
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