Multiple myeloma (MM) is an incurable blood cancer that primarily affects older adults. Several frailty tools have been developed to address the heterogeneity of aging in this population. Uptake of these measures has been variable, leading to a gap in knowledge regarding the proportion of enrolled trial participants considered frail and uncertainty in the treatment-related effects and outcomes among this high-risk population. We performed a systematic review of therapeutic interventional MM clinical trials reporting on frailty. We included 43 clinical trials (24 randomized controlled trials and 19 non-randomized trials) which met eligibility criteria. Frailty was increasingly incorporated in studies in more recent years with 41.9% of included studies being reported in the last two years. Commonly used frailty tools included the International Myeloma Working Group (IMWG) frailty index (41.8%), and the simplified frailty score (39.5%). Frailty status was categorized with 3 levels as (frail, intermediate fit, or fit) in 51.2% of the studies and dichotomized (frail, non-frail) in 18.6% of studies. Frailty prevalence greatly varied across trials ranging from 17.2% to 73.6% of the cohort. Of the included studies, 72.0% conducted subgroup analysis (planned or post-hoc) based on frailty status. Most studies demonstrated a consistent benefit of MM interventions among the frail and non-frail populations, however in general, frail patients had worse outcomes compared to the fit. Although frailty is increasingly being incorporated in MM clinical trials, due to the variation in both the definition and categorization of frailty, there remains heterogeneity in the prevalence of frailty and its potential associated impact on outcomes.
多发性骨髓瘤（MM）是一种无法治愈的血液系统恶性肿瘤，主要影响老年人。目前已开发多种衰弱评估工具以应对该患者群体衰老的异质性。这些工具的应用情况不一，导致对临床试验入组者中衰弱患者比例的认识存在空白，且对该高危人群治疗相关效果和结局的判断仍不确定。我们对报告衰弱指标的多发性骨髓瘤治疗性干预临床试验进行了系统综述。共纳入符合标准的43项临床试验（24项随机对照试验和19项非随机试验）。近年来衰弱评估在研究中应用日益增多，其中41.9%的纳入研究发表于最近两年。常用的衰弱评估工具包括国际骨髓瘤工作组衰弱指数（41.8%）和简化衰弱评分（39.5%）。51.2%的研究将衰弱状态分为三级（衰弱、中等体能、体能良好），18.6%的研究采用二分法（衰弱与非衰弱）。各试验中衰弱患病率差异显著，波动于17.2%至73.6%之间。72.0%的纳入研究基于衰弱状态进行了亚组分析（预先设计或事后分析）。大多数研究显示MM干预措施在衰弱与非衰弱人群中均具有一致的获益，但总体而言衰弱患者结局较差。尽管衰弱评估在多发性骨髓瘤临床试验中的应用日益广泛，但由于衰弱定义和分类方法的差异，衰弱患病率及其对结局的潜在影响仍存在异质性。
肿瘤(癌症)患者之家