Significant variation exists in the outcomes used in cancer cachexia trials, including measures of body composition, which are often selected as primary or secondary endpoints. To date, there has been no review of the most commonly selected measures or their potential sensitivity to detect changes resulting from the interventions being examined. The aim of this systematic review is to assess the frequency and diversity of body composition measures that have been used in cancer cachexia trials. MEDLINE, Embase and Cochrane Library databases were systematically searched between January 1990 and June 2021. Eligible trials examined adults (≥18 years) who had received an intervention aiming to treat or attenuate the effects of cancer cachexia for >14 days. Trials were also of a prospective controlled design and included body weight or at least one anthropometric, bioelectrical or radiological endpoint pertaining to body composition, irrespective of the modality of intervention (e.g., pharmacological, nutritional, physical exercise and behavioural) or comparator. Trials with a sample size of <40 patients were excluded. Data extraction used Covidence software, and reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. This review was prospectively registered (PROSPERO: CRD42022276710). A total of 84 clinical trials, comprising 13 016 patients, were eligible for inclusion. Non-small-cell lung cancer and pancreatic cancer were studied most frequently. The majority of trial interventions were pharmacological (52%) or nutritional (34%) in nature. The most frequently reported endpoints were assessments of body weight (68 trials, n = 11 561) followed by bioimpedance analysis (BIA)-based estimates (23 trials, n = 3140). Sixteen trials (n = 3052) included dual-energy X-ray absorptiometry (DEXA)-based endpoints, and computed tomography (CT) body composition was included in eight trials (n = 841). Discrepancies were evident when comparing the efficacy of interventions using BIA-based estimates of lean tissue mass against radiological assessment modalities. Body weight, BIA and DEXA-based endpoints have been most frequently used in cancer cachexia trials. Although the optimal endpoints cannot be determined from this review, body weight, alongside measurements from radiological body composition analysis, would seem appropriate. The choice of radiological modality is likely to be dependent on the trial setting, population and intervention in question. CT and magnetic resonance imaging, which have the ability to accurately discriminate tissue types, are likely to be more sensitive and provide greater detail. Endpoints are of particular importance when aligned with the intervention's mechanism of action and/or intended patient benefit.

中文翻译：

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癌症恶病质临床试验中的体重和成分终点：恶病质终点系列的系统回顾 4

癌症恶病质试验中使用的结果存在显着差异，包括身体成分的测量，通常被选为主要或次要终点。迄今为止，尚未对最常用的措施或其潜在的敏感性进行审查，以检测正在检查的干预措施引起的变化。本系统评价的目的是评估癌症恶病质试验中使用的身体成分测量的频率和多样性。 1990 年 1 月至 2021 年 6 月期间对 MEDLINE、Embase 和 Cochrane 图书馆数据库进行了系统检索。符合条件的试验研究了接受旨在治疗或减轻癌症恶病质影响超过 14 天的干预措施的成年人（≥18 岁）。试验也是前瞻性对照设计，包括体重或至少一个与身体成分有关的人体测量、生物电或放射学终点，无论干预方式（例如药理学、营养、体育锻炼和行为）或比较器如何。样本量<40 名患者的试验被排除在外。数据提取使用 Covidence 软件，报告遵循系统评价和荟萃分析的首选报告项目指南。该综述是前瞻性注册的（PROSPERO：CRD42022276710）。共有 84 项临床试验符合纳入条件，涉及 13 016 名患者。非小细胞肺癌和胰腺癌的研究最为频繁。大多数试验干预措施本质上是药物干预（52%）或营养干预（34%）。最常报告的终点是体重评估（68 项试验，n  = 11 561），其次是基于生物阻抗分析 (BIA) 的估计（23 项试验，n  = 3140）。 16 项试验 ( n = 3052) 包括基于双能 X 射线吸收测定 (DEXA) 的终点，8 项试验 ( n  = 841) 包括计算机断层扫描 (CT) 身体成分。当使用基于 BIA 的瘦组织质量估计值与放射学评估方式进行干预的效果进行比较时，差异很明显。基于体重、BIA 和 DEXA 的终点最常用于癌症恶病质试验。尽管本次审查无法确定最佳终点，但体重以及放射学身体成分分析的测量结果似乎是合适的。放射学方式的选择可能取决于试验环境、人群和相关干预措施。 CT 和磁共振成像能够准确区分组织类型，可能更加灵敏并提供更多细节。当与干预措施的作用机制和/或预期的患者利益相一致时，终点尤为重要。