文章：

老年患者一线接受曲贝替定治疗晚期软组织肉瘤的老年综合评估：德国跨学科肉瘤研究组（GISG-13）的E-TRAB研究

Geriatric Assessment of Older Patients Receiving Trabectedin in First-Line Treatment for Advanced Soft Tissue Sarcomas: The E-TRAB Study from The German Interdisciplinary Sarcoma Group (GISG-13)

原文发布日期：28 January 2024

DOI: 10.3390/cancers16030558

类型: Article

开放获取: 是

英文摘要：

E-TRAB was a non-interventional, prospective trial investigating the feasibility and predictive value of geriatric assessments (GA) in older STS patients treated with trabectedin as first-line therapy. Primary endpoints were overall survival (OS), quality of life and individual clinical benefit assessed by the patient-reported outcome measures QLQ-C30 and PRO-CTCAE. Further, several GA tools were applied and correlated with clinical outcomes and treatment-related toxicities. The final analyses included 69 patients from 12 German-speaking sites. The median age of patients was 78 years (range: 55 to 88). Baseline data on PROs and GA identified a diverse population of older patients with respect to their global health status, although a large proportion of them suffered from limitations, required geriatric help and had a high risk of morbidity. The Cancer and Age Research Group (CARG) score classified 38%, 29% and 23% of the patients with low, intermediate and high risks for therapy-related side effects, respectively. Median OS was 11.2 months [95%CI: 5.6; 19.4]. The study confirmed that trabectedin as first-line treatment in older patients with STS has an acceptable and manageable safety profile. Potential prognostic factors for clinical outcome and therapy-related toxicity were identified among the GA tools. Long Timed Up and Go (TUG) showed a significant correlation to OS and early death, whereas a high CARG score (>9) was associated with an increase in unplanned hospitalizations and the incidence of toxicities grade ≥ 3.

摘要翻译： 

E-TRAB是一项非干预性、前瞻性试验，旨在探讨老年评估（GA）在接受曲贝替定一线治疗的老年软组织肉瘤（STS）患者中的可行性和预测价值。主要终点包括总生存期（OS）、生活质量以及通过患者报告结局指标QLQ-C30和PRO-CTCAE评估的个体临床获益。此外，研究应用了多种GA工具，并将其与临床结局和治疗相关毒性进行关联分析。最终分析纳入了来自12个德语区中心的69例患者。患者中位年龄为78岁（范围：55至88岁）。基于患者报告结局和老年评估的基线数据显示，尽管大部分患者存在功能限制、需要老年护理支持且具有较高的发病风险，但老年患者的整体健康状况存在较大差异。癌症与老年研究组（CARG）评分将患者分为低、中、高风险组，分别占38%、29%和23%。中位总生存期为11.2个月[95%CI：5.6；19.4]。研究证实曲贝替定作为老年STS患者的一线治疗具有可接受且可控的安全性特征。在老年评估工具中识别出临床结局和治疗相关毒性的潜在预后因素，其中计时起立行走测试（TUG）时间延长与总生存期缩短及早期死亡显著相关，而高CARG评分（>9分）则与非计划住院率增加及≥3级毒性发生率升高相关。

原文链接：

Geriatric Assessment of Older Patients Receiving Trabectedin in First-Line Treatment for Advanced Soft Tissue Sarcomas: The E-TRAB Study from The German Interdisciplinary Sarcoma Group (GISG-13)