医学
内科学
危险系数
临床试验
逻辑回归
比例危险模型
优势比
置信区间
肿瘤科
临床意义
随机对照试验
代理终结点
生存分析
中期分析
终点测定
作者
Carla Casulo,Jesse G. Dixon,Jennifer Le-Rademacher,Eva Hoster,Howard S. Hochster,Wolfgang Hiddemann,Robert Marcus,Eva Kimby,Michael Herold,Catherine Sebban,Emmanuel Gyan,Kenneth A. Foon,Tina Nielsen,Umberto Vitolo,Gilles Salles,Qian Shi,Christopher R. Flowers
出处
期刊:Blood
[American Society of Hematology]
日期:2021-10-06
卷期号:139 (11): 1684-1693
被引量:2
标识
DOI:10.1182/blood.2020010263
摘要
Observational studies and stand-alone trials indicate that patients with follicular lymphoma (FL) who experience disease progression within 24 months of front-line chemoimmunotherapy (POD24), have poor outcomes. We performed a pooled analysis of 13 randomized clinical trials of patients with FL in the pre- and postrituximab eras to identify clinical factors that predict POD24. Logistic regression models evaluated the association between clinical factors and POD24. Cox regression evaluated the association between POD24 as a time-dependent factor and subsequent overall survival (OS). A landmark analysis evaluated the association of POD24 with OS for the subset of patients who were alive at 24 months after trial registration. Patients without progression at 24 months at baseline had favorable performance status (PS), limited-stage (I/II) disease, low-risk FL International Prognostic Index (FLIPI) score, normal baseline hemoglobin, and normal baseline β2 microglobulin (B2M) level. In a multivariable logistic regression model, male sex (odds ratio [OR], 1.30), PS ≥2 (OR, 1.63), B2M (≥3 mg/L; OR, 1.43), and high-risk FLIPI score (3-5; OR, 3.14) were associated with increased risk of progression before 24 months. In the time-dependent Cox model and the 24-month landmark analysis, POD24 was associated with poor subsequent OS (hazard ratio, 4.85 and 3.06, respectively). This is the largest pooled analysis of clinical trials data validating POD24 as a robust indicator of poor FL survival and identified clinical predictors of early death and progression that can aid in building comprehensive prognostic models incorporating clinical and molecular predictors of POD24.
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