OHC Cincinnati, Cincinnati, OH, USA.
Bristol Myers Squibb, Lawrenceville, NJ, USA.
Lung Cancer. 2021 Jun;156:41-49. doi: 10.1016/j.lungcan.2021.04.007. Epub 2021 Apr 14.
First-line (1L) immunotherapy (I-O) has improved outcomes in patients with advanced non-small cell lung cancer (NSCLC) in clinical trials and is now routinely used alone or combined with chemotherapy. Although efficacy and safety of I-O therapies have been established in clinical trials, little is known about their performance and long-term efficacy in the real-world setting. We aimed to characterize real-world outcomes for patients with advanced NSCLC treated with 1L I-O therapy in the United States.
Patients aged ≥18 years with confirmed advanced (stage III-IV) NSCLC who received either 1L I-O monotherapy or single-agent I-O combined with chemotherapy on or after January 1, 2016 were identified from the Flatiron Health database. Primary objectives were to examine overall survival (OS) and real-world progression-free survival. Index date was defined as date of 1L treatment initiation; data cut-off date was June 30, 2020.
Among 4271 patients receiving I-O plus chemotherapy, median OS was 10.6 (95 % confidence interval [CI], 9.3-11.8) months in patients with squamous NSCLC (n=814) and 12.0 (95 % CI, 11.3-12.8) months in those with non-squamous disease (n=3457). Regardless of histology, patients with high (≥50 %) tumor programmed death ligand 1 (PD-L1) expression demonstrated longer median OS vs those with low expression. Among 3041 patients receiving I-O monotherapy, median OS was 11.3 (95 % CI, 9.8-12.8) months in patients with squamous NSCLC (n=875) and 14.1 (95 % CI, 12.4-15.8) months in those with non-squamous disease (n=2166). OS benefit appeared to be greatest in the ≥50 % tumor PD-L1 expression group of the non-squamous cohort.
Survival estimates were generally lower than those reported in pivotal clinical trials. These findings indicate that there remains room for improvement of real-world survival outcomes in patients with advanced NSCLC who receive 1L I-O-based regimens and for identification of subgroups of patients not benefitting from treatment with current I-O regimens.
一线（1L）免疫治疗（I-O）在临床试验中改善了晚期非小细胞肺癌（NSCLC）患者的预后，目前单独或联合化疗常规使用。尽管 I-O 治疗的疗效和安全性已在临床试验中得到证实，但对于其在真实环境中的表现和长期疗效知之甚少。我们旨在描述美国接受 1L I-O 治疗的晚期 NSCLC 患者的真实世界结局。
从 Flatiron Health 数据库中确定了 2016 年 1 月 1 日或之后接受 1L I-O 单药治疗或单药 I-O 联合化疗治疗的年龄≥18 岁、经证实的晚期（III-IV 期）NSCLC 患者。主要目的是检查总生存（OS）和真实世界无进展生存。索引日期定义为 1L 治疗开始日期；数据截止日期为 2020 年 6 月 30 日。
在接受 I-O 联合化疗的 4271 例患者中，鳞状 NSCLC 患者（n=814）的中位 OS 为 10.6（95%置信区间[CI]，9.3-11.8）个月，非鳞状疾病患者（n=3457）的中位 OS 为 12.0（95%CI，11.3-12.8）个月。无论组织学类型如何，高（≥50%）肿瘤程序性死亡配体 1（PD-L1）表达的患者中位 OS 均长于低表达患者。在接受 I-O 单药治疗的 3041 例患者中，鳞状 NSCLC 患者（n=875）的中位 OS 为 11.3（95%CI，9.8-12.8）个月，非鳞状疾病患者（n=2166）的中位 OS 为 14.1（95%CI，12.4-15.8）个月。在非鳞状队列的≥50%肿瘤 PD-L1 表达组中，OS 获益似乎最大。
生存估计值通常低于关键临床试验报告的值。这些发现表明，在接受 1L I-O 为基础方案治疗的晚期 NSCLC 患者中，真实世界的生存结局仍有改善的空间，并且需要确定当前 I-O 方案治疗无获益的患者亚组。
