癌症恶病质临床试验中的物理功能终点:恶病质终点系列的系统评价1。

IF 8.9 1区 医学 Journal of Cachexia, Sarcopenia and Muscle Pub Date : 2023-09-06 DOI:10.1002/jcsm.13321
James McDonald, Judith Sayers, Stefan D. Anker, Jann Arends, Trude Rakel Balstad, Vickie Baracos, Leo Brown, Asta Bye, Olav Dajani, Ross Dolan, Marie T. Fallon, Eilidh Fraser, Christine Griel, Aleksandra Grzyb, Marianne Hjermstad, Mariam Jamal-Hanjani, Gunnhild Jakobsen, Stein Kaasa, Donald McMillan, Matthew Maddocks, Iain Philips, Inger O. Ottestad, Kieran F. Reid, Mariana S. Sousa, Melanie R. Simpson, Ola Magne Vagnildhaug, Richard J. E. Skipworth, Tora S. Solheim, Barry J. A. Laird, the Cancer Cachexia Endpoints Working Group
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引用次数: 0

摘要

在癌症恶病质试验中,通常使用身体功能测量作为终点。为了获得监管部门的批准,药物试验可能需要在物理功能终点方面的疗效以及其他措施。然而,尚不清楚应使用哪些物理功能端点。本系统综述的目的是评估癌症恶病质试验中物理功能终点的频率和多样性。在对MEDLINE、Embase和Cochrane(1990-2021)进行全面的电子文献检索后,检索到了记录。符合条件的试验符合以下标准:成人(≥18岁)、对照设计、40名以上参与者、恶病质干预使用超过14天以及使用身体功能终点。身体功能测量被归类为客观测量(握力[HGS]、爬楼梯功率[SCP]、定时出发[TUG]测试、6分钟步行测试[6MWT]和短身体性能电池[SPP]),临床医生对功能的评估(Karnofsky Performance Status[KPS]或Eastern Cooperative Oncology Group-Performance Status[ECOG-PS])或患者报告的结果(欧洲癌症研究和治疗组织的身体功能分量表[EORTC QLQ-C30或C15])。使用Covidence进行数据提取,并遵循PRISMA指南(PROSPERO注册号:CRD42022276710)。共检查了5975项潜在研究,其中71项符合条件。对38项试验(54%)进行了药理学干预评估。其中11例(29%,n=1184)检查了甲地孕酮,5例(13%,n=1928)检查了阿那莫林;在21项试验中评估了营养干预措施(30%);在6项试验中评估了基于运动的干预措施(8%)。其余六项试验(8%)评估了多模式干预措施。在身体功能的客观测量(评估为主要或次要终点)中,HGS最常被检查(33项试验,n=5081),并在12项(36%)试验(n=2091)中显示出具有统计学意义的发现。6MWT在12项试验中进行了评估(n=1074),在4项试验中(33%)具有统计学意义(n=403),而SCP、TUG和SPPB分别在3项试验中评估。KPS比新的ECOG-PS更常见(16项试验对9项试验),25项试验报告了患者报告的EORTC QLQ-C30身体功能。HGS是癌症恶病质临床试验中最常用的物理功能终点。然而,研究设计、人群、干预和终点选择的异质性使得很难对最佳终点以及如何衡量这一点发表评论。我们提供了一些建议/考虑因素,以改进癌症恶病质未来临床试验的设计。
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Physical function endpoints in cancer cachexia clinical trials: Systematic Review 1 of the cachexia endpoints series

In cancer cachexia trials, measures of physical function are commonly used as endpoints. For drug trials to obtain regulatory approval, efficacy in physical function endpoints may be needed alongside other measures. However, it is not clear which physical function endpoints should be used. The aim of this systematic review was to assess the frequency and diversity of physical function endpoints in cancer cachexia trials. Following a comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990–2021), records were retrieved. Eligible trials met the following criteria: adults (≥18 years), controlled design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a physical function endpoint. Physical function measures were classified as an objective measure (hand grip strength [HGS], stair climb power [SCP], timed up and go [TUG] test, 6-min walking test [6MWT] and short physical performance battery [SPPB]), clinician assessment of function (Karnofsky Performance Status [KPS] or Eastern Cooperative Oncology Group-Performance Status [ECOG-PS]) or patient-reported outcomes (physical function subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ-C30 or C15]). Data extraction was performed using Covidence and followed PRISMA guidance (PROSPERO registration: CRD42022276710). A total of 5975 potential studies were examined and 71 were eligible. Pharmacological interventions were assessed in 38 trials (54%). Of these, 11 (29%, n = 1184) examined megestrol and 5 (13%, n = 1928) examined anamorelin; nutritional interventions were assessed in 21 trials (30%); and exercise-based interventions were assessed in 6 trials (8%). The remaining six trials (8%) assessed multimodal interventions. Among the objective measures of physical function (assessed as primary or secondary endpoints), HGS was most commonly examined (33 trials, n = 5081) and demonstrated a statistically significant finding in 12 (36%) trials (n = 2091). The 6MWT was assessed in 12 trials (n = 1074) and was statistically significant in 4 (33%) trials (n = 403), whereas SCP, TUG and SPPB were each assessed in 3 trials. KPS was more commonly assessed than the newer ECOG-PS (16 vs. 9 trials), and patient-reported EORTC QLQ-C30 physical function was reported in 25 trials. HGS is the most commonly used physical function endpoint in cancer cachexia clinical trials. However, heterogeneity in study design, populations, intervention and endpoint selection make it difficult to comment on the optimal endpoint and how to measure this. We offer several recommendations/considerations to improve the design of future clinical trials in cancer cachexia.

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来源期刊
Journal of Cachexia, Sarcopenia and Muscle
Journal of Cachexia, Sarcopenia and Muscle Medicine-Orthopedics and Sports Medicine
自引率
12.40%
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0
期刊介绍: The Journal of Cachexia, Sarcopenia, and Muscle is a prestigious, peer-reviewed international publication committed to disseminating research and clinical insights pertaining to cachexia, sarcopenia, body composition, and the physiological and pathophysiological alterations occurring throughout the lifespan and in various illnesses across the spectrum of life sciences. This journal serves as a valuable resource for physicians, biochemists, biologists, dieticians, pharmacologists, and students alike.
期刊最新文献
Comment on 'Diagnosis of Sarcopenia by Evaluating Skeletal Muscle Mass by Adjusted Bioimpedance Analysis Validated With Dual-Energy X-Ray Absorptiometry' by Cheng et al. Comment on 'Association Between Dynapenic Obesity and Risk of Cardiovascular Disease: The Hisayama Study' by Setoyama et al. Comment on 'Detection of Cancer-Associated Cachexia in Lung Cancer Patients Using Whole-Body [18F]FDG-PET/CT Imaging: A Multicentre Study' by Ferrara et al. Comment on 'Factors Associated With Skeletal Muscle Mass in Middle-Aged Men Living With HIV' by Xu et al. Comment on 'Impact of Cachexia and First-Line Systemic Therapy for Previously Untreated Advanced Non-Small Cell Lung Cancer: NEJ050A' by Miura et al.
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