Department of Oncology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Academy of Geriatric Cancer Research (AgeCare), Odense University Hospital, Odense, Denmark; Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark.
J Geriatr Oncol. 2021 Nov;12(8):1270-1276. doi: 10.1016/j.jgo.2021.06.004. Epub 2021 Jun 25.
Older patients with cancer constitute a heterogeneous group with varying degrees of frailty; therefore, geriatric assessment with initial geriatric oncology screening is recommended. The Geriatric 8 (G8) and the modified Geriatric 8 (mG8) are promising screening tools with high accuracy and an association with survival. However, evidence is sparse regarding patient-centered outcomes. This protocol describes a study, which aims to address the predictive and prognostic value of the G8 and mG8, with quality of life (QoL) as the primary outcome.
In this single-center prospective cohort study, patients, age ≥70 years with solid malignancies, will be screened with the G8 and mG8 prior to receiving 1st line antineoplastic treatment. Patients will contribute medical record data including; cancer type, Charlson comorbidity index score, performance status, and treatment intent, type, and dosage, at baseline. Patients will complete QoL questionnaires (EORTC QLQ-C30 and ELD-14) at baseline, 3, 6, 9, and 12-months follow-up. Two functional measurements (the 30-s chair stand test and the handgrip strength test) will be conducted at baseline to assess the added predictive and prognostic value. At 12 months follow-up, initially administered treatment and treatment adherence will be recorded and assessed with generalized linear models, while overall survival and cancer-specific survival will be assessed using survival analysis models with time-varying covariates. The relationship between frailty (G8 ≤ 14, mG8 ≥ 6) and QoL within 12 months will be examined using mixed regression models.
Geriatric oncology screening may identify a subgroup of older patients with frailty, at risk of experiencing diminishing QoL and poor treatment adherence. With the proposed screening program, patients who require treatment modification and additional support to maintain their QoL may be identified. It is our hope, that these insights may facilitate the formation of national guidelines for the treatment of older patients with cancer. Registration:NCT04644874.
老年癌症患者构成一个异质性群体,其虚弱程度不同;因此,建议进行老年评估并进行初始老年肿瘤学筛查。老年 8 项(G8)和改良老年 8 项(mG8)是两种很有前途的筛查工具,具有较高的准确性和与生存率的相关性。然而,关于以患者为中心的结果的证据还很缺乏。本研究旨在探讨 G8 和 mG8 的预测和预后价值,以生活质量(QoL)为主要结局。
在这项单中心前瞻性队列研究中,年龄≥70 岁的实体恶性肿瘤患者将在接受一线抗肿瘤治疗前接受 G8 和 mG8 筛查。患者将在基线时提供病历数据,包括癌症类型、Charlson 合并症指数评分、体能状态以及治疗意图、类型和剂量。患者将在基线、3、6、9 和 12 个月随访时完成 EORTC QLQ-C30 和 ELD-14 生活质量问卷。在基线时将进行两项功能测量(30 秒椅立测试和握力测试),以评估其附加的预测和预后价值。在 12 个月随访时,将记录并使用广义线性模型评估初始治疗和治疗依从性,而使用具有时变协变量的生存分析模型评估总生存和癌症特异性生存。使用混合回归模型探讨 12 个月内虚弱(G8≤14,mG8≥6)与 QoL 之间的关系。
老年肿瘤学筛查可以识别出一组患有虚弱症的老年患者亚群,这些患者有生活质量下降和治疗依从性差的风险。通过拟议的筛查计划,可以识别出需要调整治疗和额外支持以维持生活质量的患者。我们希望这些见解能够促进制定针对老年癌症患者的国家治疗指南。
NCT04644874。