Bringuier Michael, Carton Matthieu, Debieuvre Didier, Pasquier David, Perol Maurice, Filleron Thomas, Léna Herve, Quantin Xavier, Simon Gaëtane, Baldini Capucine
Department of Medical Oncology and Department of Supportive Care, Institut Curie, PSL Research University, Saint-Cloud, France.
Department of Biostatistics, Institut Curie, PSL Research University, Saint-Cloud, France.
J Geriatr Oncol. 2023 Mar;14(2):101423. doi: 10.1016/j.jgo.2022.101423. Epub 2023 Jan 17.
There is a great need for data based on clinical trials for the older population in order to improve treatment. Historically, the inclusion rate of older adults in clinical trials has been low, but the rate specific to lung cancer is unknown, as are the factors associated with enrolment.
We used the national Epidemio-Strategy and Medical Economics Advanced or Metastatic Lung Cancer (AMLC) Data Platform, a multicentre real-life database. Inclusion criteria were patients with advanced or metastatic non-small cell lung cancer (AMNSCLC) aged 70 years or older, with at least one line of systemic treatment from 01 January 2015 to 31 December 2018. The primary objective was to evaluate the proportion of older adults enrolled in clinical trials. Secondary objectives were to identify factors associated with enrolment in clinical trials for older patients and to compare the overall survival of older adults included in trials versus those not included.
There were 3488 patients aged ≥70 years (median age at AMNSCLC 75 years). Among older patients, 234 (6.7%) were enrolled in a clinical trial in the first-line setting. Significant factors associated with enrolment in the multivariable analysis in older patients were: good Eastern Cooperative Oncology Group (ECOG) Performance Status (PS 0) (p < 0.001), de novo versus recurrent presentation at diagnosis (p < 0.001), and non-central nervous system (CNS) metastases versus advanced setting or CNS metastases (p < 0.001). Medical history was associated with fewer inclusions (odds ratio [OR] = 0.74, 95% confidence interval [CI] [0.56; 0.99]). Among older patients, being enrolled in a trial in the first-line setting was not associated with better overall survival (OS) (hazard ratio [HR] = 1.03; 95%CI 0.86-1.22) in the multivariable analysis.
In this large database, few older AMNSCLC patients were enrolled in a trial. Factors associated with enrolment were: good ECOG PS, absence of medical history, de novo AMNSCLC, and presentation with non-CNS metastases.
为了改善治疗效果，非常需要基于老年人群临床试验的数据。从历史上看，老年人在临床试验中的纳入率一直很低，但肺癌的具体纳入率尚不清楚，与入组相关的因素也不明确。
我们使用了国家肿瘤流行病学策略与医学经济学晚期或转移性肺癌（AMLC）数据平台，这是一个多中心真实世界数据库。纳入标准为年龄在70岁及以上的晚期或转移性非小细胞肺癌（AMNSCLC）患者，在2015年1月1日至2018年12月31日期间接受过至少一线全身治疗。主要目的是评估参与临床试验的老年人比例。次要目的是确定老年患者参与临床试验的相关因素，并比较参与试验的老年人与未参与试验的老年人的总生存期。
共有3488例年龄≥70岁的患者（AMNSCLC诊断时的中位年龄为75岁）。在老年患者中，234例（6.7%）在一线治疗时参与了临床试验。老年患者多变量分析中与入组相关的显著因素为：东部肿瘤协作组（ECOG）良好的体能状态（PS 0）（p<0.001）、诊断时初发与复发表现（p<0.001）、非中枢神经系统（CNS）转移与晚期或CNS转移（p<0.001）。病史与较少的入组相关（比值比[OR]=0.74，95%置信区间[CI][0.56；0.99]）。在老年患者中，多变量分析显示一线治疗时参与试验与更好的总生存期（OS）无关（风险比[HR]=1.03；95%CI 0.86 - 1.22）。
在这个大型数据库中，很少有老年AMNSCLC患者参与试验。与入组相关的因素为：良好的ECOG PS、无病史、初发AMNSCLC以及非CNS转移表现。
