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阿那莫林对癌症恶病质患者的治疗效果与格拉斯哥预后评分之间的关联研究:一项竞争风险分析。

Investigation of the association between therapeutic effectiveness of anamorelin and Glasgow prognostic score in patients with cancer cachexia: a competing risk analysis.

作者信息

Shimomura Kazuhiro, Ogata Takatsugu, Maeda Akimitsu, Narita Yukiya, Taniguchi Hiroya, Murotani Kenta, Fujiwara Yutaka, Tajika Masahiro, Hara Kazuo, Muro Kei, Uchida Kosaku

机构信息

Department of Pharmacy, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-Ku, Nagoya, Aichi, 464-8681, Japan.

Biostatistics Center, Kurume University, Kurume, Japan.

出版信息

Invest New Drugs. 2025 Feb;43(1):118-125. doi: 10.1007/s10637-024-01503-6. Epub 2025 Jan 9.

DOI:10.1007/s10637-024-01503-6
PMID:39789368
Abstract

Anamorelin, a highly selective ghrelin receptor agonist, enhances appetite and increases lean body mass in patients with cancer cachexia. However, the predictors of its therapeutic effectiveness are uncertain. This study aimed to investigate the association between the Glasgow prognostic score (GPS), used for classifying the severity of cancer cachexia, the therapeutic effectiveness of anamorelin, and the feasibility of early treatment based on cancer types. A retrospective analysis included patients with gastric, pancreatic, colorectal, and non-small-cell lung cancer treated with anamorelin between May 2021 and July 2022. The endpoints were the response rate for increased appetite within 3 weeks of treatment initiation and the time to treatment failure (TTF) due to therapeutic failure of anamorelin. Multivariate logistic regression model and Fine and Gray's model were used for analysis. Of the 137 patients in this analysis, 51% of patients had a GPS of 0 or 1, and 49% of those had a GPS of 2. Patients with a GPS of 2 showed a lower response for increased appetite than those with a GPS of 0 or 1 (adjusted odds ratio 0.29 [95% CI 0.12-0.72], P = 0.007). Additionally, TTF was shorter in patients with a GPS of 2 with a GPS of 0 or 1 (adjusted subdistribution hazard ratio 2.22 [95% CI 1.22-4.03], P = 0.009). Anamorelin could be more effective in improving appetite and prolonging the duration of treatment effect in patients with a GPS of 0 or 1 than those with a GPS of 2.

摘要

阿那莫林是一种高选择性的胃饥饿素受体激动剂,可增强癌症恶病质患者的食欲并增加瘦体重。然而,其治疗效果的预测因素尚不确定。本研究旨在探讨用于分类癌症恶病质严重程度的格拉斯哥预后评分(GPS)、阿那莫林的治疗效果以及基于癌症类型的早期治疗可行性之间的关联。一项回顾性分析纳入了2021年5月至2022年7月期间接受阿那莫林治疗的胃癌、胰腺癌、结直肠癌和非小细胞肺癌患者。终点指标为开始治疗后3周内食欲增加的缓解率以及因阿那莫林治疗失败导致的治疗失败时间(TTF)。采用多因素逻辑回归模型和Fine and Gray模型进行分析。在本分析的137例患者中,51%的患者GPS评分为0或1,49%的患者GPS评分为2。GPS评分为2的患者食欲增加的反应低于GPS评分为0或1的患者(调整优势比0.29 [95%CI 0.12 - 0.72],P = 0.007)。此外,GPS评分为2的患者TTF短于GPS评分为0或1的患者(调整后亚分布风险比2.22 [95%CI 1.22 - 4.03],P = 0.009)。与GPS评分为2的患者相比,阿那莫林在改善GPS评分为0或1的患者食欲和延长治疗效果持续时间方面可能更有效。

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本文引用的文献

1
Diagnosis and outcomes of cachexia in Asia: Working Consensus Report from the Asian Working Group for Cachexia.亚洲恶病质的诊断与转归:亚洲恶病质工作组共识报告
J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):1949-1958. doi: 10.1002/jcsm.13323. Epub 2023 Sep 5.
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A systematic review examining the relationship between cytokines and cachexia in incurable cancer.系统评价探讨不可治愈癌症中细胞因子与恶病质的关系。
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Cancer cachexia in adult patients: ESMO Clinical Practice Guidelines.
在现实世界中,阿那莫林对患有全身性炎症的晚期癌症患者是否有有益作用?
Invest New Drugs. 2025 Apr;43(2):433-434. doi: 10.1007/s10637-025-01537-4. Epub 2025 Apr 28.
成人癌症恶病质:ESMO 临床实践指南。
ESMO Open. 2021 Jun;6(3):100092. doi: 10.1016/j.esmoop.2021.100092.
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Framework for the treatment and reporting of missing data in observational studies: The Treatment And Reporting of Missing data in Observational Studies framework.观察性研究中缺失数据的处理和报告框架:观察性研究中缺失数据的处理和报告框架。
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6
A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia.一项关于 anamorelin(ONO-7643)治疗晚期胃肠癌合并癌性恶液质患者的多中心、开放标签、单臂研究。
Cancer. 2019 Dec 1;125(23):4294-4302. doi: 10.1002/cncr.32406. Epub 2019 Aug 15.
7
Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04).阿那莫林(ONO-7643)治疗非小细胞肺癌合并恶液质患者的疗效:来自一项日本患者的随机、双盲、安慰剂对照、多中心研究的结果(ONO-7643-04)。
Cancer. 2018 Feb 1;124(3):606-616. doi: 10.1002/cncr.31128. Epub 2017 Dec 4.
8
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Understanding tumor anabolism and patient catabolism in cancer-associated cachexia.了解癌症恶病质中的肿瘤合成代谢和患者分解代谢。
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ESPEN guidelines on nutrition in cancer patients.ESPEN 肿瘤患者营养指南。
Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.