Development and testing of a lymphoma clinical trial-specific frailty index: a secondary analysis of the NCIC-CTG LY.12 clinical trial.

IF 2.2 4区 医学 Q3 HEMATOLOGY Leukemia & Lymphoma Pub Date : 2024-07-09 DOI:10.1080/10428194.2024.2370437
Abi Vijenthira, Xinzhi Li, Michael Crump, Annette E Hay, Lois Shepherd, Ralph M Meyer, Marina Djurfeldt, Bingshu E Chen, Anca Prica
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Abstract

The prevalence of frailty in clinical trials of lymphoma is unknown. We conducted a secondary analysis of the phase III LY.12 trial in which patients with relapsed aggressive non-Hodgkin lymphoma were randomized to different salvage regimens before autologous stem cell transplant. The primary objective was to construct a lymphoma clinical trials-specific frailty index (LyFI) using previously described methods. The secondary objective was to describe the association of frailty withover all and event-free survival (OS, EFS). The LyFI was constructed using 619 patients, and11% (N = 70) were classified as frail. Frailty was associated with EFS (HR 1.94, 95%CI 1.53-2.46) and OS (HR 2.01, 95%CI 1.57-2.58) in univariable analysis, but was only significant as a continuous (not binary) variable in multivariable analysis controlling for prognostic score, suggesting limitations of a FI in this trial population. Future work could validate the FI using clinical assessments and/or apply it to an older trial population.

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开发和测试淋巴瘤临床试验专用虚弱指数:对 NCIC-CTG LY.12 临床试验的二次分析。
在淋巴瘤临床试验中,体弱的发生率尚不清楚。我们对III期LY.12试验进行了二次分析,在该试验中,复发的侵袭性非霍奇金淋巴瘤患者在自体干细胞移植前被随机分配到不同的挽救方案中。研究的主要目的是利用之前描述的方法构建淋巴瘤临床试验特异性虚弱指数(LyFI)。次要目标是描述虚弱与总生存期和无事件生存期(OS、EFS)的关系。LyFI 是利用 619 名患者构建的,其中 11% 的患者(N = 70)被归类为体弱者。在单变量分析中,虚弱与EFS(HR 1.94,95%CI 1.53-2.46)和OS(HR 2.01,95%CI 1.57-2.58)相关,但在控制预后评分的多变量分析中,虚弱仅作为连续变量(而非二元变量)具有显著性,这表明虚弱指数在该试验人群中存在局限性。未来的工作可以通过临床评估和/或将其应用于老年试验人群来验证FI。
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来源期刊
Leukemia & Lymphoma
Leukemia & Lymphoma 医学-血液学
CiteScore
4.10
自引率
3.80%
发文量
384
审稿时长
1.8 months
期刊介绍: Leukemia & Lymphoma in its fourth decade continues to provide an international forum for publication of high quality clinical, translational, and basic science research, and original observations relating to all aspects of hematological malignancies. The scope ranges from clinical and clinico-pathological investigations to fundamental research in disease biology, mechanisms of action of novel agents, development of combination chemotherapy, pharmacology and pharmacogenomics as well as ethics and epidemiology. Submissions of unique clinical observations or confirmatory studies are considered and published as Letters to the Editor
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