VA Boston Healthcare System, Boston, MA.
Massachusetts General Hospital, Boston, MA.
JCO Clin Cancer Inform. 2020 Oct;4:918-928. doi: 10.1200/CCI.20.00084.
Increasingly broad patient groups are being treated with immune checkpoint inhibitors (ICIs) in clinical practice, but few studies have assessed their usage and outcomes in large, comprehensive real-world cohorts. We identified patients who received ICIs in the Veterans Affairs (VA) health care system and described patient characteristics and survival outcomes across multiple indications.
We conducted a retrospective analysis using electronic health record data from VA facilities nationwide. Overall survival (OS) from time of ICI initiation for key indications was estimated by Kaplan-Meier. We also stratified OS by frailty status, as defined by a surrogate index developed in VA data. For select indications, we further compared outcomes to historic and concurrent control patients treated with standard-of-care regimens at the VA.
We identified 11,888 patients who were treated with ICIs and determined the cancer type and indication for which they were treated. The cohort is enriched for patient groups that are under-represented in pivotal clinical trials (PCTs), including older, non-White, and/or higher disease burdened patients. Generally, OS observed in the VA cohort is lower than that reported in PCTs. After stratifying VA patients by frailty status, OS among nonfrail patients is more similar to OS reported in PCTs for some indications. Compared with internal VA control cohorts, patients treated with ICIs generally exhibited longer OS for all indications considered.
This study describes ICI outcomes across multiple tumor types in a real-world population at the VA. For most indications, real-world survival outcomes are observed to be lower than those reported in PCTs, but patients receiving ICIs still achieve longer survival relative to patients receiving standard of care.
在临床实践中,越来越广泛的患者群体正在接受免疫检查点抑制剂(ICI)治疗,但很少有研究在大型综合真实世界队列中评估其使用情况和结果。我们确定了在退伍军人事务部(VA)医疗保健系统中接受 ICI 治疗的患者,并描述了多个适应症的患者特征和生存结果。
我们使用来自全国 VA 设施的电子健康记录数据进行了回顾性分析。通过 Kaplan-Meier 估计关键适应症从 ICI 开始时的总生存(OS)。我们还根据 VA 数据中开发的替代指标,按脆弱状态对 OS 进行分层。对于某些适应症,我们还将 VA 患者的结果与接受 VA 标准护理方案治疗的历史和同期对照患者的结果进行了比较。
我们确定了 11888 名接受 ICI 治疗的患者,并确定了他们接受治疗的癌症类型和适应症。该队列中包含在关键临床试验(PCT)中代表性不足的患者群体,包括年龄较大、非白人、以及/或疾病负担较重的患者。一般来说,VA 队列中的 OS 观察值低于 PCT 报告的值。根据脆弱状态对 VA 患者进行分层后,某些适应症中非脆弱患者的 OS 与 PCT 报告的 OS 更为相似。与内部 VA 对照队列相比,接受 ICI 治疗的患者在所有考虑的适应症中通常表现出更长的 OS。
本研究描述了 VA 真实世界人群中多种肿瘤类型的 ICI 结果。对于大多数适应症,观察到真实世界的生存结果低于 PCT 报告的值,但接受 ICI 治疗的患者的生存时间仍然比接受标准护理的患者长。