Sanofi, Inc., 450 Water Street, Cambridge, MA, 02142, USA.
James Comprehensive Cancer Center, The Ohio State University, 460 West 10th Avenue, Columbus, OH, 43210, USA.
BMC Cancer. 2024 Apr 6;24(1):424. doi: 10.1186/s12885-024-12126-8.
Patients from non-small cell lung cancer (NSCLC) controlled clinical trials do not always reflect real-world heterogeneous patient populations. We designed a study to describe the real-world patient characteristics and treatment patterns of first-line treatment in patients in the US with NSCLC.
This was an observational, retrospective cohort study based on electronic medical records of US adults with locally advanced or metastatic disease in the ConcertAI Patient360 NSCLC database who initiated first-line treatment with anti-programmed cell death protein 1/programmed cell death ligand 1 (PD-1/PD-L1) therapy between July 2016 and December 2020. The analysis used patient attributes, clinical characteristics, and treatments from each patient's medical records.
A total of 2175 patients were eligible for analysis. The median age was 68 years, and 26.2% of the patients were ≥75 years old. At treatment initiation, 96.4% and 3.6% of the patients had Stage 4 and Stage 3 (B or C) NSCLC, respectively. The most common histology type was nonsquamous adenocarcinoma (66.4%), and 19.8% had Eastern Cooperative Oncology Group performance status ≥2. Immunosuppressive medications were being used by 17.7% of patients, and 11.0% were immunocompromised. Almost all patients had metastases: 64.6% had 1, 23.2% had 2, and 8.0% had ≥3 metastatic sites. Brain metastases were present in 22.9% of patients. Treatment evolution was observed with first-line standard of care shifting from single-agent immunotherapy in 2016 (90.2%) to combination immunotherapy and chemotherapy in 2020 (60.2%).
Between 2016 and 2020, the first-line treatment paradigm for advanced NSCLC in the US shifted from anti-PD-1/PD-L1 monotherapy to combination chemoimmunotherapy, with increasing biomarker testing. Further research in heterogeneous patient populations to characterize treatment strategies is warranted.
非小细胞肺癌（NSCLC）临床试验中的患者并不总是反映真实世界中异质的患者人群。我们设计了一项研究，以描述美国 NSCLC 患者的真实世界患者特征和一线治疗模式。
这是一项基于 ConcertAI Patient360 NSCLC 数据库中电子病历的观察性、回顾性队列研究，该数据库纳入了 2016 年 7 月至 2020 年 12 月期间接受一线抗程序性细胞死亡蛋白 1/程序性细胞死亡配体 1（PD-1/PD-L1）治疗的局部晚期或转移性疾病的美国成年患者。分析使用了每位患者病历中的患者属性、临床特征和治疗方法。
共有 2175 名患者符合分析条件。中位年龄为 68 岁，26.2%的患者年龄≥75 岁。在开始治疗时，分别有 96.4%和 3.6%的患者为Ⅳ期和Ⅲ期（B 或 C 期）NSCLC。最常见的组织学类型是非鳞状腺癌（66.4%），19.8%的患者的东部肿瘤协作组体能状态≥2 分。17.7%的患者正在使用免疫抑制药物，11.0%的患者免疫功能低下。几乎所有患者都有转移灶：64.6%的患者有 1 个转移灶，23.2%的患者有 2 个转移灶，8.0%的患者有≥3 个转移灶。22.9%的患者有脑转移。观察到一线标准治疗的演变，2016 年一线治疗从单药免疫治疗（90.2%）转变为 2020 年的联合免疫治疗和化疗（60.2%）。
2016 年至 2020 年间，美国晚期 NSCLC 的一线治疗模式从抗 PD-1/PD-L1 单药治疗转变为联合化疗和免疫治疗，生物标志物检测的应用也有所增加。需要在异质患者人群中进一步研究治疗策略。
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