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.
摘要：
淋巴瘤临床试验中虚弱的患病率尚不清楚。我们对III期LY.12试验进行了二次分析，其中复发性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抢救方案。主要目的是使用先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无事件生存的关联(OS，EFS）。LyFI是由619名患者组成的，11%(N=70)被归类为虚弱。在单变量分析中，虚弱与EFS（HR1.94，95CI1.53-2.46）和OS（HR2.01，95CI1.57-2.58）相关，但在控制预后评分的多变量分析中仅作为连续（非二元）变量有意义，提示该试验人群中FI的局限性。未来的工作可以使用临床评估来验证FI和/或将其应用于年龄较大的试验人群。
